CHEMICAL SAFETY REPORT - ECHA - European Union

CHEMICAL SAFETY REPORT

Substance Name: C. I. Pigment Yellow 34

EC Number: 215-693-7

CAS Number: 1344-37-2

Registrant's Identity: DCC Maastricht B. V. OR

C.I. Pigment Yellow 34

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Table of Contents

Part A ...................................................................................................................................................................... 1 1. SUMMARY OF RISK MANAGEMENT MEASURES ................................................................................ 1 2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED ............................ 1 3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED ........................ 1

Part B ...................................................................................................................................................................... 1 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES ......................... 1

1.1. Name and other identifiers of the substance ............................................................................................ 1 1.2. Composition of the substance .................................................................................................................. 1 1.3. Physicochemical properties ..................................................................................................................... 2 1.4. Category document .................................................................................................................................. 7

2. MANUFACTURE AND USES .................................................................................................................... 16 2.1. Manufacture ........................................................................................................................................... 16 2.2. Identified uses ........................................................................................................................................ 17 2.3. Uses advised against .............................................................................................................................. 26

3. CLASSIFICATION AND LABELLING ..................................................................................................... 30 3.1. Classification and labelling according to CLP / GHS ............................................................................ 30 3.2. Classification and labelling according to DSD / DPD ........................................................................... 33

3.2.1. Classification and labelling in Annex I of Directive 67/548/EEC .................................................. 33 3.2.2. Self classification(s) ........................................................................................................................ 35 3.2.3. Other classification(s) ..................................................................................................................... 35

4. ENVIRONMENTAL FATE PROPERTIES ................................................................................................ 36 4.1. Degradation ........................................................................................................................................... 36

4.1.1. Abiotic degradation ........................................................................................................................ 36 4.1.1.1. Hydrolysis ................................................................................................................................ 36 4.1.1.2. Phototransformation/photolysis ............................................................................................... 36

4.1.1.2.1. Phototransformation in air ................................................................................................ 36 4.1.1.2.2. Phototransformation in water ............................................................................................ 36 4.1.1.2.3. Phototransformation in soil ............................................................................................... 36

4.1.2. Biodegradation ................................................................................................................................ 36 4.1.2.1. Biodegradation in water ........................................................................................................... 36

4.1.2.1.1. Screening tests .................................................................................................................. 37 4.1.2.1.2. Simulation tests (water and sediments) ............................................................................. 37 4.1.2.1.3. Summary and discussion of biodegradation in water and sediment .................................. 37

4.1.2.2. Biodegradation in soil .............................................................................................................. 37 4.1.3. Summary and discussion of degradation ........................................................................................ 37

4.2. Environmental distribution .................................................................................................................... 38 4.2.1. Adsorption/desorption .................................................................................................................... 38 4.2.2. Volatilisation................................................................................................................................... 40 4.2.3. Distribution modelling .................................................................................................................... 40 4.2.4. Summary and discussion of environmental distribution ................................................................. 40

4.3. Bioaccumulation .................................................................................................................................... 41 4.3.1. Aquatic bioaccumulation ................................................................................................................ 41 4.3.2. Terrestrial bioaccumulation ............................................................................................................ 43 4.3.3. Summary and discussion of bioaccumulation ................................................................................. 43

4.4. Secondary poisoning .............................................................................................................................. 45 5. HUMAN HEALTH HAZARD ASSESSMENT .......................................................................................... 46

5.1. Toxicokinetics (absorption, metabolism, distribution and elimination) ................................................ 46 5.1.1. Non-human information ................................................................................................................. 46 5.1.2. Human information ......................................................................................................................... 48 5.1.3. Summary and discussion of toxicokinetics ..................................................................................... 48

5.2. Acute toxicity ........................................................................................................................................ 49 5.2.1. Non-human information ................................................................................................................. 49

5.2.1.1. Acute toxicity: oral .................................................................................................................. 49 5.2.1.2. Acute toxicity: inhalation ......................................................................................................... 50 5.2.1.3. Acute toxicity: dermal ............................................................................................................. 50 5.2.1.4. Acute toxicity: other routes ...................................................................................................... 50


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5.2.2. Human information ......................................................................................................................... 50 5.2.3. Summary and discussion of acute toxicity ...................................................................................... 50

5.3. Irritation ................................................................................................................................................. 51 5.3.1. Skin ................................................................................................................................................. 51

5.3.1.1. Non-human information........................................................................................................... 51 5.3.1.2. Human information .................................................................................................................. 51

5.3.2. Eye .................................................................................................................................................. 51 5.3.2.1. Non-human information........................................................................................................... 51 5.3.2.2. Human information .................................................................................................................. 52

5.3.3. Respiratory tract .............................................................................................................................. 52 5.3.3.1. Non-human information........................................................................................................... 52 5.3.3.2. Human information .................................................................................................................. 52

5.3.4. Summary and discussion of irritation ............................................................................................. 52 5.4. Corrosivity ............................................................................................................................................. 53

5.4.1. Non-human information ................................................................................................................. 53 5.4.2. Human information ......................................................................................................................... 53 5.4.3. Summary and discussion of corrosion ............................................................................................ 53

5.5. Sensitisation ........................................................................................................................................... 53 5.5.1. Skin ................................................................................................................................................. 53

5.5.1.1. Non-human information........................................................................................................... 53 5.5.1.2. Human information .................................................................................................................. 54

5.5.2. Respiratory system .......................................................................................................................... 54 5.5.2.1. Non-human information........................................................................................................... 54 5.5.2.2. Human information .................................................................................................................. 54

5.5.3. Summary and discussion of sensitisation........................................................................................ 54 5.6. Repeated dose toxicity ........................................................................................................................... 55

5.6.1. Non-human information ................................................................................................................. 55 5.6.1.1. Repeated dose toxicity: oral ..................................................................................................... 55 5.6.1.2. Repeated dose toxicity: inhalation ........................................................................................... 56 5.6.1.3. Repeated dose toxicity: dermal ................................................................................................ 56 5.6.1.4. Repeated dose toxicity: other routes ........................................................................................ 56

5.6.2. Human information ......................................................................................................................... 56 5.6.3. Summary and discussion of repeated dose toxicity ........................................................................ 56

5.7. Mutagenicity .......................................................................................................................................... 58 5.7.1. Non-human information ................................................................................................................. 58

5.7.1.1. In vitro data .............................................................................................................................. 58 5.7.1.2. In vivo data .............................................................................................................................. 59

5.7.2. Human information ......................................................................................................................... 60 5.7.3. Summary and discussion of mutagenicity ...................................................................................... 60

5.8. Carcinogenicity ...................................................................................................................................... 61 5.8.1. Non-human information ................................................................................................................. 61

5.8.1.1. Carcinogenicity: oral ................................................................................................................ 61 5.8.1.2. Carcinogenicity: inhalation ...................................................................................................... 61 5.8.1.3. Carcinogenicity: dermal ........................................................................................................... 61 5.8.1.4. Carcinogenicity: other routes ................................................................................................... 61

5.8.2. Human information ......................................................................................................................... 63 5.9. Toxicity for reproduction ....................................................................................................................... 66

5.9.1. Effects on fertility ........................................................................................................................... 66 5.9.1.1. Non-human information........................................................................................................... 66 5.9.1.2. Human information .................................................................................................................. 67

5.9.2. Developmental toxicity ................................................................................................................... 67 5.9.2.1. Non-human information........................................................................................................... 67 5.9.2.2. Human information .................................................................................................................. 68

5.9.3. Summary and discussion of reproductive toxicity .......................................................................... 68 5.10. Other effects ........................................................................................................................................ 69

5.10.1. Non-human information ............................................................................................................... 69 5.10.1.1. Neurotoxicity ......................................................................................................................... 69 5.10.1.2. Immunotoxicity ...................................................................................................................... 69 5.10.1.3. Specific investigations: other studies ..................................................................................... 69

5.10.2. Human information ....................................................................................................................... 69


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5.10.3. Summary and discussion of other effects ..................................................................................... 69 5.11. Derivation of DNEL(s) and other hazard conclusions ......................................................................... 69

5.11.1. Overview of typical dose descriptors for all endpoints ................................................................. 69 5.11.2. Selection of the DNEL(s) or other hazard conclusion for critical health effects .......................... 70

6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES ..................... 76 6.1. Explosivity ............................................................................................................................................. 76 6.2. Flammability .......................................................................................................................................... 76 6.3. Oxidising potential ................................................................................................................................ 76

7. ENVIRONMENTAL HAZARD ASSESSMENT ........................................................................................ 79 7.1. Aquatic compartment (including sediment) ........................................................................................... 79

7.1.1. Fish ................................................................................................................................................. 80 7.1.1.1. Short-term toxicity to fish ........................................................................................................ 80 7.1.1.2. Long-term toxicity to fish ........................................................................................................ 81

7.1.2. Aquatic invertebrates ...................................................................................................................... 82 7.1.2.1. Short-term toxicity to aquatic invertebrates ............................................................................. 82 7.1.2.2. Long-term toxicity to aquatic invertebrates ............................................................................. 83

7.1.3. Algae and aquatic plants ................................................................................................................. 84 7.1.4. Sediment organisms ........................................................................................................................ 85 7.1.5. Other aquatic organisms ................................................................................................................. 86

7.2. Terrestrial compartment ......................................................................................................................... 87 7.2.1. Toxicity to soil macro-organisms ................................................................................................... 87 7.2.2. Toxicity to terrestrial plants ............................................................................................................ 88 7.2.3. Toxicity to soil micro-organisms .................................................................................................... 90 7.2.4. Toxicity to other terrestrial organisms ............................................................................................ 90

7.3. Atmospheric compartment ..................................................................................................................... 91 7.4. Microbiological activity in sewage treatment systems .......................................................................... 91 7.5. Non compartment specific effects relevant for the food chain (secondary poisoning) .......................... 92

7.5.1. Toxicity to birds .............................................................................................................................. 92 7.5.2. Toxicity to mammals ...................................................................................................................... 92

7.6. PNEC derivation and other hazard conclusions ..................................................................................... 92 8. PBT AND vPvB ASSESSMENT ................................................................................................................. 99

8.1.1. PBT/vPvB criteria and justification ................................................................................................ 99 8.1.2. Summary and overall conclusions on PBT or vPvB properties ...................................................... 99

9. EXPOSURE ASSESSMENT (and related risk characterisation) ............................................................... 100 9.0. Introduction ......................................................................................................................................... 100

9.0.1. Overview of uses and Exposure Scenarios ................................................................................... 100 9.0.2. Introduction to the assessment ...................................................................................................... 107

9.0.2.1. Environment .......................................................................................................................... 107 9.0.2.2. Man via environment ............................................................................................................. 109 9.0.2.3. Workers.................................................................................................................................. 110 9.0.2.4. Consumers ............................................................................................................................. 115 9.0.2.5. Waste management ................................................................................................................ 115

9.1. Exposure scenario 1: Formulation - Distribution and mixing pigment powder in an industrial

environment into solvent-based paints for non-consumer use. Pigment choice depends on product

specifications on visibility, shade and colour, durability, other requirements and Regulations ................. 118 9.1.1. Environmental contributing scenario 1: Distribution and mixing pigment powder in an industrial

environment into solvent-based paints for non-consumer use ................................................................ 119 9.1.1.1. Conditions of use ................................................................................................................... 119 9.1.1.2. Releases ................................................................................................................................. 120 9.1.1.3. Exposure and risks for the environment and man via the environment ................................. 121

9.1.2. Worker contributing scenario 1: Delivery, storage and handling of closed bags with pigment

powder (PROC 3) ................................................................................................................................... 121 9.1.2.1. Conditions of use ................................................................................................................... 122 9.1.2.2. Exposure and risks for workers .............................................................................................. 122

9.1.3. Worker contributing scenario 2: Pigment powder quality control / lab work (PROC 15) ............ 123 9.1.3.1. Conditions of use ................................................................................................................... 123 9.1.3.2. Exposure and risks for workers .............................................................................................. 125

9.1.4. Worker contributing scenario 3: Manual dosing of pigment powder (PROC 8a) ......................... 126 9.1.4.1. Conditions of use ................................................................................................................... 126 9.1.4.2. Exposure and risks for workers .............................................................................................. 127


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9.1.5. Worker contributing scenario 4: Automated dosing of pigment powder (PROC 8b) ................... 128 9.1.5.1. Conditions of use ................................................................................................................... 128 9.1.5.2. Exposure and risks for workers .............................................................................................. 130

9.1.6. Worker contributing scenario 5: Re-packaging of pigment powder (PROC 9) ............................ 131 9.1.6.1. Conditions of use ................................................................................................................... 131 9.1.6.2. Exposure and risks for workers .............................................................................................. 132

9.1.7. Worker contributing scenario 6: Mixing of pigment paste (PROC 5) .......................................... 133 9.1.7.1. Conditions of use ................................................................................................................... 133 9.1.7.2. Exposure and risks for workers .............................................................................................. 134

9.1.8. Worker contributing scenario 7: Storage of pigment paste / Transfer of pigment paste through

closed piping (PROC 2) .......................................................................................................................... 135 9.1.8.1. Conditions of use ................................................................................................................... 136 9.1.8.2. Exposure and risks for workers .............................................................................................. 136

9.1.9. Worker contributing scenario 8: Manual cleaning / scraping of mixing vessels, equipment and lids

(PROC 21) .............................................................................................................................................. 137 9.1.9.1. Conditions of use ................................................................................................................... 138 9.1.9.2. Exposure and risks for workers .............................................................................................. 138

9.1.10. Worker contributing scenario 9: Cleaning of vessel with solvent (PROC 10) ............................ 140 9.1.10.1. Conditions of use ................................................................................................................. 140 9.1.10.2. Exposure and risks for workers ............................................................................................ 141

9.1.11. Worker contributing scenario 10: Pigment paste testing by smearing (PROC 10) ..................... 142 9.1.11.1. Conditions of use ................................................................................................................. 142 9.1.11.2. Exposure and risks for workers ............................................................................................ 143

9.1.12. Worker contributing scenario 11: Pigment paste charging/discharging by gravity or manual

handling (PROC 8a) ............................................................................................................................... 144 9.1.12.1. Conditions of use ................................................................................................................. 144 9.1.12.2. Exposure and risks for workers ............................................................................................ 145

9.1.13. Worker contributing scenario 12: Pigment paste charging/discharging using a dedicated

installation (PROC 8b) ........................................................................................................................... 146 9.1.13.1. Conditions of use ................................................................................................................. 146 9.1.13.2. Exposure and risks for workers ............................................................................................ 147

9.1.14. Worker contributing scenario 13: Pigment paste filling into drums/cans at a filling line (PROC 9)

................................................................................................................................................................ 148 9.1.14.1. Conditions of use ................................................................................................................. 148 9.1.14.2. Exposure and risks for workers ............................................................................................ 149

9.1.15. Worker contributing scenario 14: Mixing colour paste in closed drum mixing machine with

automated dosing of paste (PROC 2)...................................................................................................... 150 9.1.15.1. Conditions of use ................................................................................................................. 150 9.1.15.2. Exposure and risks for workers ............................................................................................ 151

9.1.16. Worker contributing scenario 15: Mixing colour paste into paint in closed mixing vessel (PROC

3) ............................................................................................................................................................. 152 9.1.16.1. Conditions of use ................................................................................................................. 152 9.1.16.2. Exposure and risks for workers ............................................................................................ 153

9.1.17. Worker contributing scenario 16: Pigment paint filling into drums/cans at a filling line (PROC 9)


9.1.18. Worker contributing scenario 17: Pigment paint charging/discharging using a dedicated

installation (PROC 8b) ........................................................................................................................... 157 9.1.18.1. Conditions of use ................................................................................................................. 157 9.1.18.2. Exposure and risks for workers ............................................................................................ 158

9.1.19. Worker contributing scenario 18: Equipment cleaning: scraping and brushing (PROC 10) ...... 159 9.1.19.1. Conditions of use ................................................................................................................. 159 9.1.19.2. Exposure and risks for workers ............................................................................................ 161

9.1.20. Worker contributing scenario 19: Dried pigment paint cleaning (PROC 21) ............................. 162 9.1.20.1. Conditions of use ................................................................................................................. 162 9.1.20.2. Exposure and risks for workers ............................................................................................ 163

9.1.21. Worker contributing scenario 20: Spray testing of pigment paint in industrial booth (PROC 7) 164 9.1.21.1. Conditions of use ................................................................................................................. 164 9.1.21.2. Exposure and risks for workers ............................................................................................ 165


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9.1.22. Worker contributing scenario 21: Pigment paint testing by brushing/rolling (PROC 10) .......... 167 9.1.22.1. Conditions of use ................................................................................................................. 167 9.1.22.2. Exposure and risks for workers ............................................................................................ 168

9.1.23. Worker contributing scenario 22: Pigment paste or paint laboratory operations (PROC 15) ..... 169 9.1.23.1. Conditions of use ................................................................................................................. 169 9.1.23.2. Exposure and risks for workers ............................................................................................ 170

9.2. Exposure scenario 2: Use at industrial site - Industrial application of paints on metal surfaces

(machines, vehicles, structures, signs, road furniture, coil coating). Pigment choice is governed by end

product specifications on visibility, colour, durability, other technical requirements and Regulations ...... 172 9.2.1. Environmental contributing scenario 1: Industrial application of paints on metal surfaces

(machines, vehicles, structures, signs, road furniture, coil coating) ....................................................... 173 9.2.1.1. Conditions of use ................................................................................................................... 173 9.2.1.2. Releases ................................................................................................................................. 174 9.2.1.3. Exposure and risks for the environment and man via the environment ................................. 174

9.2.2. Worker contributing scenario 1: Laboratory handling of pigment paste and/or paints (PROC 15)

................................................................................................................................................................ 175 9.2.2.1. Conditions of use ................................................................................................................... 175 9.2.2.2. Exposure and risks for workers .............................................................................................. 176

9.2.3. Worker contributing scenario 2: Handling of packaged colour paste and/or paint, including

distribution (PROC 2) ............................................................................................................................. 177 9.2.3.1. Conditions of use ................................................................................................................... 177 9.2.3.2. Exposure and risks for workers .............................................................................................. 179

9.2.4. Worker contributing scenario 3: Mixing colour paste with paint in closed mixing machine with

automated dosing of paste (PROC 3)...................................................................................................... 180 9.2.4.1. Conditions of use ................................................................................................................... 180 9.2.4.2. Exposure and risks for workers .............................................................................................. 181

9.2.5. Worker contributing scenario 4: Equipment cleaning: scraping, brushing and wiping (PROC 10)


9.2.6. Worker contributing scenario 5: Dried pigment paste and/or paint cleaning (PROC 21) ............. 184 9.2.6.1. Conditions of use ................................................................................................................... 185 9.2.6.2. Exposure and risks for workers .............................................................................................. 186

9.2.7. Worker contributing scenario 6: Mixing of paste and/or coating with extra solvents or additives

before use (PROC 5) ............................................................................................................................... 187 9.2.7.1. Conditions of use ................................................................................................................... 187 9.2.7.2. Exposure and risks for workers .............................................................................................. 188

9.2.8. Worker contributing scenario 7: Filling of equipment with pigment paint (PROC 8a) ................ 189 9.2.8.1. Conditions of use ................................................................................................................... 190 9.2.8.2. Exposure and risks for workers .............................................................................................. 191

9.2.9. Worker contributing scenario 8: Filling of spray equipment with pigment paints in dedicated

settings (PROC 8b) ................................................................................................................................. 192 9.2.9.1. Conditions of use ................................................................................................................... 192 9.2.9.2. Exposure and risks for workers .............................................................................................. 193

9.2.10. Worker contributing scenario 9: Transfer of pigment paint to/from drums/cans e.g. at a filling

line before application (PROC 9) ........................................................................................................... 194 9.2.10.1. Conditions of use ................................................................................................................. 194 9.2.10.2. Exposure and risks for workers ............................................................................................ 195

9.2.11. Worker contributing scenario 10: Automated pigment paint spray application in an industrial

booth (PROC 7) ...................................................................................................................................... 196 9.2.11.1. Conditions of use ................................................................................................................. 196 9.2.11.2. Exposure and risks for workers ............................................................................................ 198

9.2.12. Worker contributing scenario 11: Manual pigment paint spray application in an industrial booth

(PROC 7) ................................................................................................................................................ 199 9.2.12.1. Conditions of use ................................................................................................................. 199 9.2.12.2. Exposure and risks for workers ............................................................................................ 200

9.2.13. Worker contributing scenario 12: Handling and manipulation of dried painted articles (PROC 21)



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9.2.14. Worker contributing scenario 13: Pigment paint testing by brushing/rolling (PROC 10) .......... 204 9.2.14.1. Conditions of use ................................................................................................................. 204 9.2.14.2. Exposure and risks for workers ............................................................................................ 205

9.2.15. Worker contributing scenario 14: Pigment paint application and heat curing (PROC 6) ........... 206 9.2.15.1. Conditions of use ................................................................................................................. 206 9.2.15.2. Exposure and risks for workers ............................................................................................ 207

9.3. Exposure scenario 3: Use by professional worker - Professional, non-consumer application of paints on

metal surfaces (machines, vehicles, structures, signs, road furniture) or as road marking. Pigment choice is

governed by requirements on visibility, colour, durability, technical performance and Regulations ......... 209 9.3.1. Environmental contributing scenario 1: Professional, non-consumer application of paints on metal

surfaces (machines, vehicles, structures, signs, road furniture) or as road marking ............................... 210 9.3.1.1. Conditions of use ................................................................................................................... 210 9.3.1.2. Releases ................................................................................................................................. 210 9.3.1.3. Exposure and risks for the environment and man via the environment ................................. 211

9.3.2. Worker contributing scenario 1: Handling of packaged colour paste and/or paint, including

distribution (PROC 2) ............................................................................................................................. 212 9.3.2.1. Conditions of use ................................................................................................................... 212 9.3.2.2. Exposure and risks for workers .............................................................................................. 213

9.3.3. Worker contributing scenario 2: Dosing of colour paste into paint premix (PROC 9) ................. 214 9.3.3.1. Conditions of use ................................................................................................................... 214 9.3.3.2. Exposure and risks for workers .............................................................................................. 215

9.3.4. Worker contributing scenario 3: Mixing colour paste with paint in closed mixing machine with

automated dosing of paste (PROC 3)...................................................................................................... 216 9.3.4.1. Conditions of use ................................................................................................................... 216 9.3.4.2. Exposure and risks for workers .............................................................................................. 217

9.3.5. Worker contributing scenario 4: Filling of spray equipment with colour paints (PROC 9) ......... 218 9.3.5.1. Conditions of use ................................................................................................................... 219 9.3.5.2. Exposure and risks for workers .............................................................................................. 220

9.3.6. Worker contributing scenario 5: Pigment paint spray application in a make-shift booth on location


9.3.7. Worker contributing scenario 6: Pigment paint spray application in a professional spray booth


9.3.8. Worker contributing scenario 7: Mixing of pigment paint in an open vessel (PROC 5) .............. 226 9.3.8.1. Conditions of use ................................................................................................................... 226 9.3.8.2. Exposure and risks for workers .............................................................................................. 227

9.3.9. Worker contributing scenario 8: Pigment paint application by rolling/brushing (PROC 10) ....... 228 9.3.9.1. Conditions of use ................................................................................................................... 228 9.3.9.2. Exposure and risks for workers .............................................................................................. 229

9.3.10. Worker contributing scenario 9: Cleaning of wet pigment paint on equipment by wiping and

brushing (PROC 10) ............................................................................................................................... 230 9.3.10.1. Conditions of use ................................................................................................................. 231 9.3.10.2. Exposure and risks for workers ............................................................................................ 232

9.3.11. Worker contributing scenario 10: Cleaning of dried pigment paint on equipment by wiping,

brushing, scraping etc. (PROC 21) ......................................................................................................... 233 9.3.11.1. Conditions of use ................................................................................................................. 233 9.3.11.2. Exposure and risks for workers ............................................................................................ 234

9.3.12. Worker contributing scenario 11: Manipulation of pigment painted articles (dry) (PROC 21) .. 235 9.3.12.1. Conditions of use ................................................................................................................. 235 9.3.12.2. Exposure and risks for workers ............................................................................................ 236

9.4. Exposure scenario 4: Service life (worker at industrial site) - Service life of coated articles.

Performance and longevity depend on the pigment quality for bright lasting colours improving visibility

and safety, light and weather fastness (durability), chemical fastness, impact resistance and heat stability

.................................................................................................................................................................... 238 9.4.1. Environmental contributing scenario 1: Sanding of painted/coated articles ................................. 239

9.4.1.1. Conditions of use ................................................................................................................... 239 9.4.1.2. Releases ................................................................................................................................. 239


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9.4.1.3. Exposure and risks for the environment and man via the environment ................................. 240 9.4.2. Worker contributing scenario 1: Cutting painted metal sheet (dry) (PROC 21) ........................... 240

9.4.2.1. Conditions of use ................................................................................................................... 240 9.4.2.2. Exposure and risks for workers .............................................................................................. 241

9.4.3. Worker contributing scenario 2: Sanding of dried paint on machines, vehicles, other metal articles

etc. (PROC 24) ....................................................................................................................................... 242 9.4.3.1. Conditions of use ................................................................................................................... 242 9.4.3.2. Exposure and risks for workers .............................................................................................. 243

9.4.4. Worker contributing scenario 3: Welding, torchcutting of painted metal (dry) (PROC 25) ......... 244 9.4.4.1. Conditions of use ................................................................................................................... 244 9.4.4.2. Exposure and risks for workers .............................................................................................. 245

9.5. Exposure scenario 5: Service life (professional worker) - Service life of coated articles. Performance

and longevity depend on the pigment quality for bright lasting colours improving visibility and safety, light

and weather fastness (durability), chemical fastness, impact resistance and heat stability ......................... 247 9.5.1. Environmental contributing scenario 1: Leaching from painted metal surfaces (machines, vehicles,

structures, signs, road furniture, coil coating) during service life ........................................................... 248 9.5.1.1. Conditions of use ................................................................................................................... 248 9.5.1.2. Releases ................................................................................................................................. 248 9.5.1.3. Exposure and risks for the environment and man via the environment ................................. 249

9.5.2. Environmental contributing scenario 2: Sanding of painted/coated articles ................................. 249 9.5.2.1. Conditions of use ................................................................................................................... 249 9.5.2.2. Releases ................................................................................................................................. 250 9.5.2.3. Exposure and risks for the environment and man via the environment ................................. 250

9.5.3. Environmental contributing scenario 3: Leaching from painted road marking during service life

................................................................................................................................................................ 251 9.5.3.1. Conditions of use ................................................................................................................... 251 9.5.3.2. Releases ................................................................................................................................. 251 9.5.3.3. Exposure and risks for the environment and man via the environment ................................. 251

9.5.4. Worker contributing scenario 1: Cutting painted metal sheet (dry) (PROC 21) ........................... 252 9.5.4.1. Conditions of use ................................................................................................................... 252 9.5.4.2. Exposure and risks for workers .............................................................................................. 253

9.5.5. Worker contributing scenario 2: Sanding of dried paint on machines, vehicles, other articles etc.


9.5.6. Worker contributing scenario 3: Welding, torchcutting of painted metal (dry) (PROC 25) ......... 256 9.5.6.1. Conditions of use ................................................................................................................... 256 9.5.6.2. Exposure and risks for workers .............................................................................................. 257

9.6. Exposure scenario 6: Formulation - Distribution and mixing pigment powder in an industrial

environment into liquid or solid premix to colour plastic/plasticised articles. Pigment choice depends on

product specifications on visibility, colour, heat stability, durability and Regulations .............................. 259 9.6.1. Environmental contributing scenario 1: Distribution and mixing pigment powder in an industrial

environment into a premix or pre-compound to add colour to plastic or plasticised articles.................. 261 9.6.1.1. Conditions of use ................................................................................................................... 261 9.6.1.2. Releases ................................................................................................................................. 261 9.6.1.3. Exposure and risks for the environment and man via the environment ................................. 262

9.6.2. Worker contributing scenario 1: Delivery, storage and handling of closed paper bags with pigment

powder (PROC 3) ................................................................................................................................... 263 9.6.2.1. Conditions of use ................................................................................................................... 263 9.6.2.2. Exposure and risks for workers .............................................................................................. 264

9.6.3. Worker contributing scenario 2: Pigment powder quality control / lab work (PROC 15) ............ 265 9.6.3.1. Conditions of use ................................................................................................................... 265 9.6.3.2. Exposure and risks for workers .............................................................................................. 266

9.6.4. Worker contributing scenario 3: Manual dosing of pigment powder (PROC 8a) ......................... 267 9.6.4.1. Conditions of use ................................................................................................................... 267 9.6.4.2. Exposure and risks for workers .............................................................................................. 269

9.6.5. Worker contributing scenario 4: Automated dosing of pigment powder (PROC 8b) ................... 270 9.6.5.1. Conditions of use ................................................................................................................... 270 9.6.5.2. Exposure and risks for workers .............................................................................................. 271

9.6.6. Worker contributing scenario 5: Mixing of pigment with resins and additives to form a liquid pre-


2013-07-15 CSR-PI-5.4.1 CHEMICAL SAFETY REPORT ix

mix/pre-compound (PROC 5) ................................................................................................................. 272 9.6.6.1. Conditions of use ................................................................................................................... 272 9.6.6.2. Exposure and risks for workers .............................................................................................. 274

9.6.7. Worker contributing scenario 6: Storage of premix/pre-compound / Transfer of pre-mix/pre-

compound through closed piping (PROC 2) ........................................................................................... 275 9.6.7.1. Conditions of use ................................................................................................................... 275 9.6.7.2. Exposure and risks for workers .............................................................................................. 276

9.6.8. Worker contributing scenario 7: Premix/pre-compound charging/discharging by gravity or manual

handling (PROC 8a) ............................................................................................................................... 277 9.6.8.1. Conditions of use ................................................................................................................... 277 9.6.8.2. Exposure and risks for workers .............................................................................................. 278

9.6.9. Worker contributing scenario 8: Premix/pre-compound charging/discharging using a dedicated

installation (PROC 8b) ........................................................................................................................... 279 9.6.9.1. Conditions of use ................................................................................................................... 279 9.6.9.2. Exposure and risks for workers .............................................................................................. 281

9.6.10. Worker contributing scenario 9: Premix/pre-compound filling into drums/cans at a filling line


9.6.11. Worker contributing scenario 10: Manual cleaning / scraping of mixing vessels, equipment and

lids (PROC 21) ....................................................................................................................................... 284 9.6.11.1. Conditions of use ................................................................................................................. 284 9.6.11.2. Exposure and risks for workers ............................................................................................ 286

9.6.12. Worker contributing scenario 11: Cleaning of vessel with resin (PROC 10) ............................. 287 9.6.12.1. Conditions of use ................................................................................................................. 287 9.6.12.2. Exposure and risks for workers ............................................................................................ 288

9.6.13. Worker contributing scenario 12: Premix/pre-compound quality control / lab work (PROC 15)


9.6.14. Worker contributing scenario 13: Production of coloured plastic granules or masterbatch by

extrusion, compression and/or pelletisation (PROC 14) ......................................................................... 292 9.6.14.1. Conditions of use ................................................................................................................. 292 9.6.14.2. Exposure and risks for workers ............................................................................................ 293

9.6.15. Worker contributing scenario 14: Mixing pigment powder or premix/pre-compound into matrix

in closed mixing vessel (PROC 3) .......................................................................................................... 294 9.6.15.1. Conditions of use ................................................................................................................. 295 9.6.15.2. Exposure and risks for workers ............................................................................................ 296

9.6.16. Worker contributing scenario 15: Production of plastic articles by extrusion, injection moulding

and other processes (PROC 14) .............................................................................................................. 297 9.6.16.1. Conditions of use ................................................................................................................. 297 9.6.16.2. Exposure and risks for workers ............................................................................................ 298

9.6.17. Worker contributing scenario 16: Quality control / lab work with coloured plastics (PROC 15)


9.6.18. Worker contributing scenario 17: Handling of articles and single coloured granules (PROC 21)


9.6.19. Worker contributing scenario 18: Handling of mixed coloured granules and articles (PROC 21)


9.6.20. Worker contributing scenario 19: Transfer of articles and single coloured granules (PROC 8a)307 9.6.20.1. Conditions of use ................................................................................................................. 307 9.6.20.2. Exposure and risks for workers ............................................................................................ 309

9.6.21. Worker contributing scenario 20: Transfer of articles and single coloured granules (PROC 8b)

................................................................................................................................................................ 310 9.6.21.1. Conditions of use ................................................................................................................. 310


2013-07-15 CSR-PI-5.4.1 CHEMICAL SAFETY REPORT x

9.6.21.2. Exposure and risks for workers ............................................................................................ 311 9.6.22. Worker contributing scenario 21: Transfer of mixed coloured granules and articles (PROC 8a)


9.6.23. Worker contributing scenario 22: Transfer of mixed coloured granules and articles (PROC 8b)


9.6.24. Worker contributing scenario 23: Pigment powder dosing before mixing (PROC 8b) .............. 317 9.6.24.1. Conditions of use ................................................................................................................. 318 9.6.24.2. Exposure and risks for workers ............................................................................................ 319

9.6.25. Worker contributing scenario 24: Mixing of pigment powder with other solid additives (PROC 3)


9.6.26. Worker contributing scenario 25: Filling of small packages with pigment powder (PROC 9) .. 322 9.6.26.1. Conditions of use ................................................................................................................. 322

9.6.27. Worker contributing scenario 26: Manual handling of pigment contained in small sealed plastic

bags (<1 kg) (PROC 1) ........................................................................................................................... 325 9.6.27.1. Conditions of use ................................................................................................................. 325 9.6.27.2. Exposure and risks for workers ............................................................................................ 325

9.6.28. Worker contributing scenario 27: Pigment powder manual cleaning, wiping, scraping etc. (PROC

19) ........................................................................................................................................................... 326 9.6.28.1. Conditions of use ................................................................................................................. 327 9.6.28.2. Exposure and risks for workers ............................................................................................ 328

9.7. Exposure scenario 7: Use at industrial site - Use of colour premixes and pre-compounds to colour

plastic or plasticised articles for non-consumer use. Pigment choice depends on product specifications on

visibility, colour, heat stability, chemical fastness, durability and Regulations ......................................... 330 9.7.1. Environmental contributing scenario 1: Use of colour premixes and pre-compounds to colour

plastic or plasticized articles for non-consumer use ............................................................................... 331 9.7.1.1. Conditions of use ................................................................................................................... 331 9.7.1.2. Releases ................................................................................................................................. 332 9.7.1.3. Exposure and risks for the environment and man via the environment ................................. 333

9.7.2. Worker contributing scenario 1: Delivery, storage and handling of coloured plastic granules

(PROC 3) ................................................................................................................................................ 333 9.7.2.1. Conditions of use ................................................................................................................... 333 9.7.2.2. Exposure and risks for workers .............................................................................................. 334

9.7.3. Worker contributing scenario 2: Delivery, storage and handling of packed plastic premix or pre-

compound (PROC 3) .............................................................................................................................. 335 9.7.3.1. Conditions of use ................................................................................................................... 335 9.7.3.2. Exposure and risks for workers .............................................................................................. 337

9.7.4. Worker contributing scenario 3: Transfer of articles and single coloured granules (PROC 8a) ... 338 9.7.4.1. Conditions of use ................................................................................................................... 338 9.7.4.2. Exposure and risks for workers .............................................................................................. 339

9.7.5. Worker contributing scenario 4: Transfer of articles and single coloured granules (PROC 8b) ... 340 9.7.5.1. Conditions of use ................................................................................................................... 340 9.7.5.2. Exposure and risks for workers .............................................................................................. 342

9.7.6. Worker contributing scenario 5: Transfer of mixed coloured granules and articles (PROC 8a) .. 343 9.7.6.1. Conditions of use ................................................................................................................... 343 9.7.6.2. Exposure and risks for workers .............................................................................................. 345

9.7.7. Worker contributing scenario 6: Transfer of mixed coloured granules and articles (PROC 8b) .. 346 9.7.7.1. Conditions of use ................................................................................................................... 346 9.7.7.2. Exposure and risks for workers .............................................................................................. 347

9.7.8. Worker contributing scenario 7: Charging/discharging of coloured plastic granules (PROC 9) .. 348 9.7.8.1. Conditions of use ................................................................................................................... 348 9.7.8.2. Exposure and risks for workers .............................................................................................. 350

9.7.9. Worker contributing scenario 8: Mixing coloured plastic granules in closed mixing vessel (PROC

3) ............................................................................................................................................................. 351 9.7.9.1. Conditions of use ................................................................................................................... 351


2013-07-15 CSR-PI-5.4.1 CHEMICAL SAFETY REPORT xi

9.7.9.2. Exposure and risks for workers .............................................................................................. 352 9.7.10. Worker contributing scenario 9: Production of plastic articles by extrusion and injection

moulding or other processes (PROC 14) ................................................................................................ 353 9.7.10.1. Conditions of use ................................................................................................................. 353 9.7.10.2. Exposure and risks for workers ............................................................................................ 355

9.7.11. Worker contributing scenario 10: Charging/discharging of coloured plastic premix or pre-

compound (PROC 8a) ............................................................................................................................. 356 9.7.11.1. Conditions of use ................................................................................................................. 356 9.7.11.2. Exposure and risks for workers ............................................................................................ 357

9.7.12. Worker contributing scenario 11: Charging/discharging of coloured plastic premix or pre-

compound (PROC 9) .............................................................................................................................. 358 9.7.12.1. Conditions of use ................................................................................................................. 358 9.7.12.2. Exposure and risks for workers ............................................................................................ 360

9.7.13. Worker contributing scenario 12: Roll application and heat curing of coloured plastic paste


9.7.14. Worker contributing scenario 13: Handling and manipulation of pigment plastic articles and

plastic coated textiles (PROC 21) ........................................................................................................... 363 9.7.14.1. Conditions of use ................................................................................................................. 363 9.7.14.2. Exposure and risks for workers ............................................................................................ 364

9.8. Exposure scenario 8: Use by professional worker - Use of colour premixes and pre-compounds in the

application of hotmelt road marking. Pigment choice depends on end product specifications on visibility &

night time reflectivity, colour, heat stability, durability, chemical fastness and Regulations ..................... 366 9.8.1. Environmental contributing scenario 1: Use of colour premixes and pre-compounds in the

application of hotmelt road marking ....................................................................................................... 367 9.8.1.1. Conditions of use ................................................................................................................... 367 9.8.1.2. Releases ................................................................................................................................. 367 9.8.1.3. Exposure and risks for the environment and man via the environment ................................. 368

9.8.2. Worker contributing scenario 1: Charging/discharging premix or pre-compound (PROC 8a)..... 368 9.8.2.1. Conditions of use ................................................................................................................... 368 9.8.2.2. Exposure and risks for workers .............................................................................................. 369

9.8.3. Worker contributing scenario 2: Storage and mixing of plastic compounds in an open vessel before

application (PROC 5) ............................................................................................................................. 370 9.8.3.1. Conditions of use ................................................................................................................... 371 9.8.3.2. Exposure and risks for workers .............................................................................................. 371

9.8.4. Worker contributing scenario 3: Application of hotmelt road marking (plastic compound) to road

pavement (PROC 10) .............................................................................................................................. 372 9.8.4.1. Conditions of use ................................................................................................................... 373 9.8.4.2. Exposure and risks for workers .............................................................................................. 373

9.8.5. Worker contributing scenario 4: Handling and manipulation of coloured road marking (PROC 21)


9.8.6. Worker contributing scenario 5: High energy manipulation/removal of coloured road marking

using abrasive techniques like grinding, drilling or sanding (PROC 24) ................................................ 376 9.8.6.1. Conditions of use ................................................................................................................... 376 9.8.6.2. Exposure and risks for workers .............................................................................................. 377

9.9. Exposure scenario 9: Service life (worker at industrial site) - Service life of coloured plastic or

plasticised articles. Performance and longevity depend on pigment quality, for bright lasting colours

improving visibility and safety, heat stability, durability, other technical specifications and Regulations 379 9.9.1. Environmental contributing scenario 1: Industrial service life of coloured plastic or plasticised

articles, including hotmelt road marking ................................................................................................ 380 9.9.1.1. Conditions of use ................................................................................................................... 380 9.9.1.2. Releases ................................................................................................................................. 380 9.9.1.3. Exposure and risks for the environment and man via the environment ................................. 381

9.9.2. Worker contributing scenario 1: Handling and manipulation of pigment plastic articles, plastic

coated textiles and coloured road marking (PROC 21) .......................................................................... 381 9.9.2.1. Conditions of use ................................................................................................................... 381 9.9.2.2. Exposure and risks for workers .............................................................................................. 382


2013-07-15 CSR-PI-5.4.1 CHEMICAL SAFETY REPORT xii

9.9.3. Worker contributing scenario 2: High energy manipulation of pigment plastic articles, plastic

coated textiles and coloured road marking using abrasive techniques like mechanical cutting, grinding,

drilling or sanding (PROC 24) ................................................................................................................ 383 9.9.3.1. Conditions of use ................................................................................................................... 383 9.9.3.2. Exposure and risks for workers .............................................................................................. 384

9.10. Exposure scenario 10: Service life (professional worker) - Service life of coloured plastic or

plasticised articles. Performance and longevity depend on pigment quality, for bright lasting colours

improving visibility and safety, heat stability, durability, other technical specifications and Regulations 386 9.10.1. Environmental contributing scenario 1: Service life of coloured plastic and plasticised articles,

including hotmelt road marking (leaching) ............................................................................................. 387 9.10.1.1. Conditions of use ................................................................................................................. 387 9.10.1.2. Releases ............................................................................................................................... 387 9.10.1.3. Exposure and risks for the environment and man via the environment ............................... 388

9.10.2. Environmental contributing scenario 2: Removal of hotmelt road marking ............................... 388 9.10.2.1. Conditions of use ................................................................................................................. 388 9.10.2.2. Releases ............................................................................................................................... 389 9.10.2.3. Exposure and risks for the environment and man via the environment ............................... 389

9.10.3. Worker contributing scenario 1: Handling and manipulation of pigment plastic articles, plastic

coated textiles and coloured road marking (PROC 21) .......................................................................... 390 9.10.3.1. Conditions of use ................................................................................................................. 390 9.10.3.2. Exposure and risks for workers ............................................................................................ 390

9.10.4. Worker contributing scenario 2: High energy manipulation of pigment plastic articles, plastic

coated textiles and coloured road marking using abrasive techniques like mechanical cutting, grinding,

drilling or sanding (PROC 24) ................................................................................................................ 391 9.10.4.1. Conditions of use ................................................................................................................. 392 9.10.4.2. Exposure and risks for workers ............................................................................................ 392

10. RISK CHARACTERISATION RELATED TO COMBINED EXPOSURE ........................................... 394 10.1. Human health ..................................................................................................................................... 394

10.1.1. Workers ...................................................................................................................................... 394 10.1.2. Consumer .................................................................................................................................... 394

10.2. Environment (combined for all emission sources) ............................................................................ 394 10.2.1. All uses (regional scale) .............................................................................................................. 394

10.2.1.1. Total releases ....................................................................................................................... 394 10.2.1.2. Regional exposure ................................................................................................................ 395

10.2.2. Local exposure due to all wide dispersive uses .......................................................................... 395 10.2.3. Local exposure due to combined uses at a site ........................................................................... 397


2013-07-15 CSR-PI-5.4.1 CHEMICAL SAFETY REPORT 1

Part A

1. SUMMARY OF RISK MANAGEMENT MEASURES

The operational conditions and risk management measures required for safe use are listed in Chapter 9 of this

Chemical Safety Report.

2. DECLARATION THAT RISK MANAGEMENT

MEASURES ARE IMPLEMENTED

As the substance is only imported into the EU, the registrant has no own uses within the EU. The uses of the

manufacturer are outside the jurisdiction of the REACH regulation.

3. DECLARATION THAT RISK MANAGEMENT

MEASURES ARE COMMUNICATED

The operational conditions and risk management measures will be communicated by means of the extended

safety data sheet to the downstream users without undue delay after registration.



Part B

1. IDENTITY OF THE SUBSTANCE AND PHYSICAL

AND CHEMICAL PROPERTIES

1.1. Name and other identifiers of the substance

The substance C. I. Pigment Yellow 34 is a mono constituent substance (origin: inorganic) having the

following characteristics and physical–chemical properties (see the IUCLID dataset for further details).

The following public name is used: lead sulfochromate yellow.

Table 1. Substance identity

EC number: 215-693-7

EC name: Lead sulfochromate yellow

CAS number (EC inventory): 1344-37-2

CAS name: C.I. Pigment Yellow 34

IUPAC name: lead sulfochromate yellow

Annex I index number: 082-010-00-5

Molecular formula: Pb (Cr,S) O4

Molecular weight range: 355.25

Colour Index description Lead sulphochromate (PbCrSO4) with oxides of Lanthanides, Al, Ce, Sb, Si,

Sn, Ti, Zn, Zr and Fluorine salts

Structural formula:

1.2. Composition of the substance

Name: lead sulfochromate yellow

Description: This substance is identified in the Colour Index by Colour Index Constitution Number, C. I. 77603.

Degree of purity: >= 80.0 — <= 100.0 % (w/w)

Table 2. Constituents

Constituent Typical concentration Concentration range Remarks

C.I. Pigment Yellow 34 >= 80.0 — <= 100.0 %



Constituent Typical concentration Concentration range Remarks

EC no.: 215-693-7 (w/w)

Table 3. Impurities

Impurity Typical concentration Concentration range Remarks

Unknown substance >= 0.0 — <= 1.0 % (w/w)

Table 4. Additives

Additive Function Typical

concentration

Concentration

range

Remarks

Diantimony trioxide

EC no.: 215-175-0

stabiliser >= 1.0 — <= 3.5 %

(w/w)

silicon dioxide

EC no.: 231-545-4

stabiliser >= 1.5 — <= 20.0 %

(w/w)

aluminium oxide

(oxo(oxoalumanyloxy)alu

mane)

EC no.: 215-691-6

stabiliser >= 0.0 — <= 3.0 %

(w/w)

Lead(II) fluoride

EC no.: 231-998-8

stabiliser >= 0.0 — <= 1.7 %

(w/w)

1.3. Physicochemical properties

Table 5. Physicochemical properties

Property Description of key

information

Value used for CSA / Discussion

Physical state The substance is a solid,

described as a yellow

odourless powder.

Value used for CSA: solid at 20°C and 101.3 kPa

Melting / freezing

point

The melting point is derived

by read across from

supporting substances (lead

chromate, lead sulfate) on

which the solid solution is

based, which have melting

points above 800 °C.

Value used for CSA: 800 °C at 101.3 kPa

Boiling point In accordance with column 2

of REACH Annex VII, the

boiling point does not need

to be performed as the

substance is a solid with the

melting point above 300°C.

Relative density The density information

ranges from 5.6 to 6 g/cm3 at

20 °C. Thus ca 6 g/cm3 is

used.

Value used for CSA: 6 at 20°C

Granulometry Mean Particle Size Particle size distribution:




information


C.I. Pigment Yellow 34:

17.3-24.6 µm

C.I. Pigment Red 104: 16.1-

22.3 µm

Dustiness:

For C.I. Pigment Yellow 34,

the respirable fraction of the

inhalable dustiness mass

fraction is 0.9%

The particle size distribution of C.I. Pigment Yellow 34

and C.I. Pigment Red 104 was measured using a Coulter®

LS Particle Size Analyser. Four different samples from

each pigment were measured. The mean particle size

ranged from 17.3-24.6 µm for C.I. Pigment Yellow 34

and from 16.1-22.3 µm for C.I. Pigment Red 104, under

the conditions of this test.

Particle size distribution:

Pigme

nt

sample

Mean particle size in μm

%<D10 %<D50 %<D90 Mean (100%)

C.I.

PY.34

1.7 17.5 44.1 20.2

C.I.

PR.104

1.8 12.7 43.1 18.2

Dustiness testing:

The dustiness of DCC Yellow 1007 (Regular Pigment

Yellow 34) was investigated according to EN 15051 using

the rotating drum method. The dustiness results of sample

DCC Yellow 1007 (Regular Pigment Yellow 34) are as

follows (at 21ºC and RH of 44 +/-3%):

The average inhalable dustiness mass fraction is 780 mg

kg-1 and is classified as low.

The average thoracic dustiness mass fraction is 118 mg

kg-1 and is classified as low.

The average respirable dustiness mass fraction is 7 mg kg-

1 and is classified as very low.

For C.I. Pigment Yellow 34, the respirable fraction of the

inhalable dustiness mass fraction is 7/780 *100% = 0.9%

Vapour pressure In accordance with column 2


vapour pressure study does

not need to be performed as

the melting point is above

300°C.

Partition coefficient

n-octanol/water (log

value)

In accordance with column 2


partition coefficient does not

need to be performed as the

substance is inorganic.

Water solubility The dissolved concentration

of lead in a 1 mg/l mixture of

Value used for CSA: 36.8 µg/L at 20 °C

The transformation/dissolution of chromium and lead




information


C.I. Pigment Yellow 34 after

28 days at pH 6 according to

OECD test guideline 29

(Transformation/dissolution

protocol) was 36.8 ug lead/l.

After 28 days a plateau was

reached.

from representative samples of C.I. Pigment Yellow 34

and C.I.Pigment Red 104 and from C.I. Pigment Yellow

34 used in paint and plastic matrix) was determined

according to OECD guideline 29 under GLP using ICP-

MS. The tests were performed at pH 6 and 8 in a

screening test (24h) at 100 mg test item per liter and both

Chromium and Lead were analysed.

Chromium dissolution was higher at pH 8 and lead

dissolution was higher at pH 6. Overall the dissolution of

lead was considerably higher than that of chromium. As

the toxicity of lead also seems to be higher than that of

chromium, it was decided that the full test should be

carried out with lead at pH 6.

The full test was performed with the pigments (1, 10 and

100 mg/l) and the paint and plastic matrix (100 mg/l).

The dissolution of samples at 10 and 100 mg/l were

followed for 1 week. For the pigment sample of 1 mg/l

and the paint and plastic matrix the duration was 28 days.

The curve of the dissolution over time shows that a

plateau level was reached after 28 days. For C.I. Pigment

Yellow 34 and C.I. Pigment Red 104 dissolved lead

concentrations were found to be 36.8 and 69.3 ug/L after

28 days at a loading rate of 1 mg/L respectively. For the

paint and plastic matrices, this was 28.9 and 1.1 ug/L.

This represents circa 0.2% of the lead contents in all

cases. When related to the surface area of the pigments,

the dissolution was 5.1 and 7.2 mg lead/m2 after 28 days.

Surface tension In line with column 2 of

REACH Annex VII, the

surface activity does not

need to be conducted as the

water solubility is below 1

mg/L at 20°C. Based on the

chemical structure, no

surface activity is expected.

Flash point In accordance with section 1

of REACH Annex XI, the

flash point does not need to

be tested as the substance is

a solid (scientifically

unjustified) and in

accordance with column 2 of

REACH Annex VII, the

flash point does not need to

be performed as the

substance is inorganic (other

justification).

Autoflammability /

self-ignition

temperature



auto flammability does not

need to be conducted as the

substance is a solid and self-

heating of the substance up




information


to 400° C is excluded.

Flammability In accordance with section 1


flammability does not need

to be performed as the

substance is a non

combustible solid, non

flammable upon ignition.

The substance has no

pyrophoric properties and

does not yield flammable

gases on contact with water.

Value used for CSA:

non flammable

Explosive properties In accordance with column 2


explosiveness of the

substance does not need to

be tested, because there are

no chemical groups

associated with explosive

properties in the molecule

Value used for CSA: non explosive

Oxidising properties EC Physico/Chemical Test

A17, Oxidizing Properties

(Solid) Test: not oxidising

(read across to C.I. Pigment

Red 104)

Value used for CSA: Oxidising: no

The oxidising properties of read across substance C.I.

Pigment Red 104 were determined in accordance with the

EC Physico/Chemical Test A17, Oxidizing Properties

(Solid) Test. In the preliminary test, the burning time of

C.I. Pigment Red 104 was determined to be more than the

reference sample in the preliminary screening test.

Therefore the full train test was conducted.

In the full train test, the highest burning rate recorded

from the six samples of C.I. Pigment Red 104 in cellulose

was 0.36 mm/s, which was the sample with 80% of the

test substance. This value should be compared to the

highest burning rate of the reference substance Barium

Nitrate, which was 0.85mm/s. It can be concluded that the

sample of C.I. Pigment Red 104 should not be classed as

an oxidizing substance since in any percentage of C.I.

Pigment Red 104/Cellulose, it has a burning rate of less

than that of Barium Nitrate/Cellulose per EC

Physico/Chemical Test A17, Oxidizing Properties (Solid)

Test.

Stability in organic

solvents and identity

of relevant

degradation products


of REACH Annex IX, the

stability in organic solvents

does not need to be

performed as the substance is

inorganic.

Dissociation constant In accordance with section 1


dissociation constant study

does not need to be


not soluble in water and does

not contain any ionic

structure.




information


Viscosity In accordance with section 2


viscosity does not need to be


a solid.

Data waiving

Information requirement: Boiling point

Reason: other justification

Justification: In accordance with column 2 of REACH Annex VII, the boiling point does not need to be

performed for a solid which melts above 300°C.

Information requirement: Vapour pressure


Justification: In accordance with column 2 of REACH Annex VII, the vapour pressure study does not need

to be performed as the melting point is above 300°C.

Information requirement: Partition coefficient n-octanol/water (log value)


Justification: In accordance with column 2 of REACH Annex VII, the partition coefficient does not need to

be performed as the substance is inorganic.

Information requirement: Surface tension


Justification: In line with column 2 of REACH Annex VII, the surface tension of the substance does not

need to be tested because due to its chemical structure, no surface activity is predicted; in addition, the study

does not need to be conducted as the water solubility is below 1mg/L at 20°C.

Information requirement: Flash point

Reason: study scientifically unjustified

Justification: In accordance with section 1 of REACH Annex XI, the flash point does not need to be tested

as the substance is a solid (scientifically unjustified) and

in accordance with column 2 of REACH Annex VII, the flash point does not need to be performed as the

substance is inorganic (other justification).

Information requirement: Self-ignition temperature


Justification: In accordance with column 2 of REACH Annex VII, the auto flammability does not need to

be conducted as the substance is a solid and self-heating of the substance up to 400° C is excluded.

Information requirement: Flammability


Justification: In accordance with section 1 of REACH Annex XI, the flammability does not need to be

performed as the substance is non combustible.

Information requirement: Explosive properties


Justification: In accordance with column 2 of REACH Annex VII, the explosiveness of the substance does



not need to be tested, because there are no chemical groups associated with explosive properties in the

molecule

Information requirement: Stability in organic solvents and identity of relevant degradation products


Justification: In accordance with column 2 of REACH Annex IX, the stability in organic solvents does not

need to be performed as the substance is inorganic.

Information requirement: Dissociation constant


Justification: In accordance with section 1 of REACH Annex XI, the dissociation constant study does not

need to be performed as the substance is not soluble in water and tthe substance does not contain any ionic

structure

Information requirement: Viscosity

Reason: study technically not feasible

Justification: In accordance with section 2 of REACH Annex XI, the viscosity does not need to be

performed as the substance is a solid.

Information requirement: Viscosity


Justification: In accordance with section 2 of REACH Annex XI, the viscosity study does not need to be

conducted as the substance is a solid.

1.4. Category document

Category document for C.I. Pigment Yellow 34 and C.I.

Pigment Red 104

1. Category definition and its members

1.1. Category definition

1.1.a Category hypothesis

In the SVHC support documents for both C.I. Pigment Yellow 34 (Lead sulfochromate) and C.I.

Pigment Red 104 (Lead moly sulfochromate), grouping of the lead sulfochromate based

pigments family is proposed. C.I. Pigment Yellow 34 is a mixed phase crystal that contains lead

sulphochromate with oxides of lanthanides, Al, Ce, Sb, Si, Sn, Ti, Zn, Zr and fluorine salts. C.I.

Pigment Red 104 is a mixed phase crystal that contains lead molybdosulphochromate with

oxides of lanthanides, Al, Ce, Sb, Si, Sn, Ti, Zn, Zr and fluorine salts.

Both C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are inorganic substances that are used to

add colour to paints and plastic and other matrices. The mentioned pigments can be considered as

a group because of the similarity of the structures. For both pigments a small proportion of the

substances may dissolve and release transformation products chromate (VI) and lead ions.

Extensive information concerning the (eco)toxicity of these transformation products is available

and should be taken into account when assessing the hazardous properties of the pigment

substances.

No hazards linked to the physico-chemical properties have been established for the pigments.



Based on the fact that the pigments chemically belong to the same family and share chemical

similarities, similar technical performances and similar uses, it is expected that they will have a

similar hazard profile and classification and labelling. As (eco)toxicity will mainly depend on the

toxicity of the transformation products, the extensive information available for these

transformation products will be taken into account to define the hazard profiles of the pigments.

1.1.b Applicability domain of the category

The category applies to pigment substances containing lead sulfochromate.

1.1.c List of endpoint covered

The category approach was applied for the following endpoints:

- Eye irritation (Annex VII/VIII)

- Skin irritation (Annex VII/VIII)

- Skin sensitization (Annex VII)

- Acute toxicity oral route (Annex VII)

- Repeated dose toxicity (oral/dermal/inhalation) (Annex VIII)

- Carcinogenicity (Annex X)

- Toxicity to reproduction/developmental toxicity (Annex VIII)

- Long-term toxicity testing on invertebrates (Annex IX)

- Long-term toxicity testing on fish (Annex IX)

- Adsorption/desorption screening (Annex VIII)

- Bioaccumulation (Annex IX)

- Effects on terrestrial organisms (Annex IX/X)

- Long-term toxicity to sediment organisms (Annex X)

1.2. Category members

For the purpose of REACH registration this category consists of pigment substances containing

lead sulfochromate. The identification of each member is presented in the table below.

Substances of the Group Pigments containing lead sulfochromate for data evaluation and

REACH registration

EINECS # CAS # EINECS NAME Name in this document

215-693-7 1344-37-2 lead sulfochromate yellow C.I. Pigment Yellow 34

235-759-9 12656-85-8

lead chromate molybdate

sulfate red C.I. Pigment Red 104

The group of pigment substances containing lead sulfochromate may be more extensive than the

ones listed in the table. However, the pigments listed in this paragraph 1.2 are subject to REACH

registration and authorisation and therefore constitute for that purpose this Category.

1.3. Purity / impurities

Both C.I. Pigment Yellow 34 and C.I. Pigment Red 104 have 1% unknown impurities, which are

considered not relevant for classification and labelling. Purity is 90% for C.I. Pigment Yellow

34, and 91% for C.I. Pigment Red 104. The remaining 9% and 8% for PY.34 and PR.104,

respectively, consist of additives that are used as stabilisers. The additives are not considered

relevant for the classification and labelling of the pigments.

2. Category justification

Both C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are mixed phase crystals containing lead

chromate and lead sulphate. In addition, C.I. Pigment Red 104 also contains lead molybdate.

Although the substances classify as insoluble in water, a small proportion of the substances will

dissociate into transformation products chromate (VI) and lead ions, which are the substances

that will mostly contribute to (eco)toxicity. The inorganic substances show similar

physical/chemical properties based on these transformation products. The presence of lead



molybdate in C.I. Pigment Red 104 does not have an influence on physical/chemical parameters

but should be taken into account with regards to (eco)toxicity.

The test results of the Transformation/Dissolution (IUCLID 4.8) and Bioelution (IUCLID 7.1.1)

tests are crucial in the risk assessments. These tests quantify the dissolution of chromium and

lead ions from C.I. Pigment Yellow 34 and C.I. Pigment Red 104 into an aqueous medium and

simulated body fluids. Next to a risk assessment for the two pigments, the exposure of man and

the environment to chromium and lead ions is used in the human and environmental risk

assessment.

The results of the screening tests for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 showed

that concentrations of lead and chromium ions detected in the medium compared very well

between the two pigments. Therefore, the full tests were carried out only with C.I. Pigment

Yellow 34 and the results were read across to C.I. Pigment Red 104.

3. Data matrix

Physico-chemical and (eco)toxicological data are presented in the data matrix.

4. Conclusion per endpoint for C&L and PBT

Physical/chemical properties

Read across between the pigments in this category and their transformation products is

considered justified because the pigments chemically belong to the same family and share

chemical similarities, similar technical performances and similar uses. No hazards linked to the

physico-chemical properties have been established for the pigments.

Oxidizing properties

Rationale & Experimental data

The oxidising properties of C.I. Pigment Red 104 were determined in accordance with the EC

Physico/Chemical Test A17, Oxidizing Properties (Solid) Test. In the preliminary test, the

burning time of C.I. Pigment Red 104 was determined to be more than the reference sample in

the preliminary screening test. Therefore the full train test was conducted. In the full train test,

the highest burning rate recorded from the six samples of C.I. Pigment Red 104 in cellulose was

0.36 mm/s, which was the sample with 80% of the test substance. This value should be compared

to the highest burning rate of the reference substance Barium Nitrate, which was 0.85mm/s. It

can be concluded that the sample of C.I. Pigment Red 104 should be classed not an oxidizing

substance since in any percentage of C.I. Pigment Red 104/Cellulose, it has a burning rate of less

than that of Barium Nitrate/Cellulose per EC Physico/Chemical Test A17, Oxidizing Properties

(Solid) Test.

The results of the study with C.I. Pigment Red 104 can be read across to C.I. Pigment Yellow 34

as it can be assumed that the absence of lead molybdate in this pigment will not lead to

differences in oxidising properties.

Conclusion

Based on read across to the results of the study on oxidising properties with C.I. Pigment Red

104, C.I. Pigment Yellow 34 can be considered not oxidising.

Classification & Labelling

C.I. Pigment Yellow 34 does not have to be classified for oxidising properties.

Human toxicity

Read across between the pigments in this category and their transformation products is

considered justified because the pigments chemically belong to the same family and share

chemical similarities, similar technical performances and similar uses. Extensive reviews that

have been published for transformation products chromate (VI) and lead were used to provide

data on some critical endpoints such as skin sensitisation, carcinogenicity and toxicity to

reproduction and developmental toxicity.

With regard to chromate, publications and reviews are (amongst others) available in an EU Risk



Assessment Report (RAR) from 2005, from the Scientific Committee on Occupational Exposure

Limits (SCOEL;2004), Seidler et al. (2012) and NTP, 2008. The Seidler el al. (2012) study, in

which a health-based Risk Assessment for Hexavalent Chromium was presented, was used as a

basis for the derivation of the DMEL for inhalation exposure. Several health effects are

associated with occupational exposure to hexavalent chromium compounds, with carcinogenicity

(specifically lung cancer) being the most serious. Therefore, lung cancer is taken as the critical

effect upon which the occupational exposure limit was based. In addition, the excess lifetime

intestinal cancer risk for workers after oral exposure to hexavalent chromium was calculated,

based on the observation of excess risk after oral exposure in a well conducted NTP

carcinogenicity study in mice.

For lead, the voluntary Risk Assessment Report (vRAR) from 2008 was taken into account, as

well as the SCHER opinion on the vRAR, which was published in 2009. The main effect that

was taken into account for the pigments was the effect on reproduction and possible

developmental neurotoxicological effects. Furthermore, the Panel on Contaminants in the Food

Chain (CONTAM) of the European Food Safety Authority published a scientific opinion on lead

in food, in which a Benchmark Dose Level (BMDL) was determined for the effects of lead on

neurobehavioral development.

Eye irritation (Annex VII/VIII)


An in vivo eye irritation study in accordance with OECD 405 and under GLP-conditions was

performed with C.I. Pigment Red 104 in rabbits. Slight effects on cornea and conjunctivae were

observed, however, they were all reversible within 14 days, and scores did not trigger

classification. Therefore, C.I. Pigment Red 104 is not considered to be irritating to the eyes.

The results of the study with C.I. Pigment Red 104 can be read across to C.I. Pigment Yellow 34

as it can be assumed that the absence of lead molybdate in this pigment will not lead to different

eye irritation potential.

Conclusion

Based on read across to the results of the eye irritation study with C.I. Pigment Red 104, C.I.

Pigment Yellow 34 can be considered not irritating to the eye.


C.I. Pigment Yellow 34 does not have to be classified for eye irritation.

Skin irritation (Annex VII/VIII)


An in vivo skin irritation study in accordance with OECD 404 and under GLP-conditions was

performed with C.I. Pigment Yellow 34. Very slight erythema was observed in two animals

which was reversible within 72 hours, and scores did not trigger classification. Therefore, C.I.

Pigment Yellow 34 is not considered to be irritating to the skin.

The results of the study with C.I. Pigment Yellow 34 can be read across to C.I. Pigment Red 104.

It can be assumed that the presence of lead molybdate in this pigment will not lead to different

skin irritation potential, based on the absence of skin irritating properties reported in the

disseminated REACH-dossiers of calcium molybdate and disodium molybdate.

Conclusion

Based on read across to the results of the skin irritation study with C.I. Pigment Yellow 34, C.I.

Pigment Red 104 can be considered not irritating to the skin.


C.I. Pigment Red 104 does not have to be classified for skin irritation.

Skin sensitization(Annex VII)

Rationale & experimental data

No information is available for the pigments C.I. Pigment Yellow 34 and C.I. Pigment Red 104.

However, one of the transformation products of both pigments, i.e. chromium (Cr (VI)) is a



known sensitiser, as is demonstrated in the RAR. In the RAR it is stated that skin sensitisation

resulting from contact with Cr (VI) is relatively common in humans working with the

compounds. Several investigations including patch testing of contact dermatitis patients and

investigations of various occupational groups confirm this. In addition, standard and modified

guinea pig maximisation tests and the mouse ear swelling test clearly demonstrate skin

sensitisation potential.

The available information for Cr (VI) can be read across to address the skin sensitising potential

of both pigments, as it can be assumed that the skin sensitising properties of this transformation

product will be responsible for the skin sensitising potential of the pigments.

Conclusion

Based on read across to transformation product Cr (VI), C.I. Pigment Yellow 34 and C.I.

Pigment Red 104 can be considered to be sensitising to the skin.


C.I. Pigment Yellow 34 and C.I. Pigment Red 104 have to be classified as sensitising to the skin.

Acute toxicity oral route (Annex VII)

Rationale & experimental data

Two acute toxicity studies with C.I. Pigment Yellow 34 are available, both performed according

to a method similar to OECD 401 and pre-GLP. Both studies were performed as a limit test with

a concentration of 10,000 mg/kg bw. No mortality was observed at this dose level. Therefore,

C.I. Pigment Yellow 34 is not considered to be acutely toxic via the oral route.

The results of the study with C.I. Pigment Yellow 34 can be read across to C.I. Pigment Red 104

as it can be assumed that the absence of lead molybdate in this pigment will not lead to an

increase of acute toxicity.

Conclusion

Based on read across to the results of the acute toxicity studies with C.I. Pigment Yellow 34, C.I.

Pigment Red 104 can be considered not to be acute toxic via the oral route.


C.I. Pigment Red 104 does not have to be classified for acute toxicity via the oral route.

Repeated dose toxicity (Annex VIII)


Two sub-chronic repeated dose toxicity studies are available with C.I. Pigment Yellow 34, one in

rats and one in beagle dogs. Rats and dogs were dosed at 2000, 5000 and 20,000 ppm in the feed

in 90 day studies that are similar to OECD guideline 408 and 409, respectively, although

ophthalmological examinations were not performed. Lead carbonate was given to the dogs as a

positive control substance in concentrations of 100, 300 or 1000 ppm in the diet. In rats,

mortality was not significantly elevated and effects involved mainly increased relative weight of

the kidneys, although without histopathological changes. In dogs, all but one of the high dose

animals died. Treatment-related changes involved mainly the kidney and the liver.

Hematological changes were also observed in a dose-dependent manner. In both rats and dogs,

blood lead concentrations were elevated in a dose-related manner. The mid dose was determined

as the NOAEL in the rat study (5000 ppm), whereas in the dog study, no NOAEL could be

determined. The LOAEL in this study was determined to be 2000 ppm.

The results of the study with C.I. Pigment Yellow 34 can be read across to C.I. Pigment Red 104

as it can be assumed that the absence of lead molybdate in this pigment will not lead to a higher

repeated dose toxicity.

Conclusion

Based on read across to the results of the sub-chronic repeated dose toxicity studies with C.I.

Pigment Yellow 34, a NOAEL of 271.4 mg/kg bw/day (5000 ppm) in rats and a LOAEL of 80.4

mg/kg bw/d (2000 ppm) in dogs can be expected for C.I. Pigment Red 104.




Based on the accumulation of lead ions in different tissues in a time and dose-dependent manner

in the study with C.I. Pigment Yellow 34, C.I. Pigment Red 104 needs to be classified as R33 or

STOT repeated exposure Cat. 2, in accordance with the criteria outlined in Annex VI of

67/548/EEC and Annex I of 1272/2008/EC, respectively. Further classification is not warranted

because of the R45 / Carc. Cat. 1B categorization (see carcinogenicity).

Carcinogenicity (Annex X)


For both C.I. Pigment Yellow 34 and C.I. Pigment Red 104 studies have been included in the

dossier. Both substances have been classified by the EU as carcinogenic (R45/Carc Cat 1B) in

accordance with lead chromate (CAS 7758-97-6), based on the presence of chromate (VI) in

these substances. For Chromate (VI) compounds, Seidler et al. (2012) systematically reviewed

the scientific literature and quantified the respiratory cancer risk for occupational exposure to

hexavalent chromium. Seidler et al. (2012) included 5 studies in their paper, each providing more

than one level of occupational Cr (VI) exposure, considering the confounder smoking and using

adequate methodology. Linear regressions models were used to calculate relative risks and to

estimate excess absolute risks. The absolute excess lung cancer risk was found to be 4 excess

lung cancer cases per 100,000 workers for life time exposure to hexavalent chromium at a Cr(VI)

concentration of 0.01 ug/m3.

The Scientific Committee on Occupational Exposure Limits published a recommendation in

2004 (SCOEL/SUM/86). In this document a large number of epidemiological studies and other

Risk Assessments of occupational exposure to Hexavalent Chromium were reviewed. Based on

this information, the SCOEL calculated that the numbers of excess lung cancers per 1000 male

workers exposed for a working lifetime to 50 µg/m3 of hexavalent chromium and followed to

age 85 years are predicted to be in the range of 5-28. Estimated ranges of excess lung cancers for

exposure levels of 25, 10, 5 and 1 µg/m3 have been estimated at 2-14, 1-6, 0.5-3 and 0.1-0.6,

respectively.

In addition, SCOEL prepared a recommendation with regard to the occupational exposure limits

for Lead Chromates (SCOEL/SUM/117, 2004). In this document reference is made to the

SCOEL recommendation for Chromate (VI) compounds. The very low solubility of Lead

Chromate (0.06 g/L), is mentioned as explanation for the apparently low carcinogenic potential

compared to other hexavalent Chromium compounds. However, as mutagenicity and

clastogenicity were observed after solubilisation of Lead Chromates, carcinogenicity potential

cannot be excluded.

With respect to the excess lifetime intestinal cancer risk for workers after oral exposure to

hexavalent chromium, a review on the carcinogenicity dose-response analysis of Cr(VI)- and As-

containing substances from ECHA (ECHA project SR11) was used for read across. The data was

deduced from a well conducted NTP carcinogenicity study in mice.

The reviews by Seidler et al. (2012), SCOEL for hexavalent Chromium compounds and Lead

Chromate are read across to C.I. Pigment Yellow 34 and C.I. Pigment Red 104 as the reviews are

crucial for the hazard assessment and derivation of the DMEL for inhalation.

The review by ECHA and NTP carcinogenicity study for hexavalent Chromium compounds are

read across to C.I. Pigment Yellow 34 and C.I. Pigment Red 104 as the reviews are crucial for

the hazard assessment and derivation of the DNEL via oral exposure.

Conclusion

In accordance with the current EU classification for C.I. Pigment Yellow 34 and C.I. Pigment

Red 104, which was based on read across from other more soluble hexavalent chromium

compounds, C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are classified for carcinogenicity,

although the likelihood of carcinogenicity risk is considered very low due to very poor

bioavailability of these two substances. Three epidemiological studies in lead chromate pigment

manufacturing plants "did not produce evidence supporting any association between lead

chromate [pigments] and lung cancer". However limitations in cohort size, due to the limited

number of workers in this industry, limits the use of such studies. Nonetheless as the worst case,



the carcinogenicity risk of these two pigments will be assessed in this application for

authorization, using the carcinogenic properties of hexavalent chromium compounds as

described by Seidler et al. (2012) for Cr(VI) compounds. However, the very poor solubility and

bioavailability of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 should be taken into account

when deriving the DMEL.

With respect to the excess lifetime intestinal cancer risk for workers after oral exposure to

hexavalent chromium, the review by ECHA and NTP carcinogenicity study for hexavalent

Chromium compounds are taken into account.


C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are included in Annex VI of the CLP-

regulation and should be classified as Carcinogenic, Category 1B.

Toxicity to reproduction/developmental toxicity (Annex VIII)


No reliable studies with regard to toxicity to reproduction/developmental toxicity are available

for C.I. Pigment Yellow 34 and C.I. Pigment Red 104. However, both substances are included in

Annex VI of the CLP-regulation and should be classified as Repr. 1A (H360Df), based on the

developmental effects observed for transformation product lead.

In the voluntary Risk Assessment Report for lead and inorganic lead compounds, lead

compounds were found to have effects on male fertility, female reproductive parameters, and on

neurobehavioral development, which was the most critical effect. Effects on neurobehavioral

performance after pre-natal and post-natal exposure have been reported in several animal studies.

However, the available data are inadequate to establish dose-effect relationships. The vRAR

suggest a blood lead level above 10 µg/dL (in females) to take into account for the risk

assessment with regard to developmental effects. In the opinion of the Scientific Committee on

Health and Environmental Risks (SCHER) on the voluntary Risk Assessment Report (vRAR), it

is concluded that the health part of the vRAR is of good quality, comprehensive, and that the

exposure and effects assessment follow the Technical Guidance Document.

In the risk assessment on lead from food which was performed by the European Food Safety

Authority (EFSA, 2010), the Bench Mark Dose approach (BMD) is used to estimate the

BMDL01, which is the blood-lead concentration corresponding to the 1 -percentile of the

Confidence Interval of the chosen Bench Mark Response of an IQ deficit of 1 IQ point. The

BMR is chosen and set at 1 IQ point by the CONTAM panel of EFSA. Using this approach, the

BMDL01 for lead was estimated to be 1.2μg/dL (mentioned as 12μg/L by EFSA).

The reviews on available information in the vRAR, SCHER-opinion, and EFSA-opinion are read

across to C.I. Pigment Yellow 34 and C.I. Pigment Red 104 as the reviews are crucial for the

hazard assessment and derivation of the DMEL.

Conclusion

Based on read across to the vRAR, SCHER-opinion, and EFSA-opinion with respect to the toxic

properties of lead compounds with respect to development and reproduction, C.I. Pigment

Yellow 34 and C.I. Pigment Red 104 are considered to have effects on neurobehavioral

development.


C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are included in Annex VI of the CLP-

regulation and should be classified as Repr. 1A (H360Df).

Environmental fate and ecotoxicological endpoints

In the environment C.I. Pigment Yellow 34 and C.I. Pigment Red 104 may release small

amounts of Pb2+

and CrO42-

under certain conditions. Therefore, the toxicity of these two

transformation products will serve as the basis for the environmental risk assessment. The results

of the 28day Transformation/Dissolution test with 1 mg of C.I. Pigment Yellow 34 (pH 6)

showed that a plateau level was reached after 28 days. This is considered as a 'worst case' of the



amount of lead ions that will dissolve in time in the environment. The estimated concentrations

in the receiving environmental compartments are converted to proportional concentrations of

lead and chromium ions that will then distribute further into the environment.

It turned out that the dissolution of chromium was higher with pH 8, whereas the dissolution of

lead was higher at pH 6. Since the PNECs for lead were generally lower than for chromium, lead

was finally taken as the lead compound for the risk characterisation.

For lead, information from the Voluntary RAR (vRAR) of lead and lead compounds (2008) was

used to determine toxicity to the environment. The lead vRAR was produced by industry on the

basis of the principles applied in the Existing Substances Regulation and has been reviewed by

the Technical Committee on New and Existing substances (TC NES) in 2008.

For the ecotoxicological properties of chromium, information from the EU Risk Assessment

Report (RAR) on chromium trioxide, sodium chromate, sodium dichromate, ammonium

dichromate and potassium dichromate (2005) was used, which was produced in the context of

EU Existing Substances Regulation EEC no 793/93 by the UK Rapporteur, agreed by the

Technical Committee on New and Existing substances and published by the European

Communities in 2005.

Next to lead and chromium, C.I. Pigment Red 104 also contains 1 to 3% of Molybdenium. The

PNECs of molybdenium are compared to those for lead and chromium, as far as these are based

on experimental data, see table below. The toxicity of molybdenium is far less than that of lead

and chromium. Only the toxicity for soil organisms is somewhat lower for molybdenium than for

lead (a factor of 4). In view of the very low concentration and the lower toxicity, molybdenium

has not been considered for the risk assessment.

Summary of PNEC’s for molybdate, lead, and chromium

Molybdate

(disseminated PNECs,

ECHA site)

Lead Chromium

PNECaqua (freshwater) 12.7 mg/l 2.7 µg/l 3.4 µg/l

PNECaqua (marine) 1.91 mg/l 0.27 µg/l 3.4 µg/l

PNECaqua

(intermittent)

- 2.7 µg/l 3.4 µg/l

PNEC STP 21.7 mg/l 0.1 mg/l 0.21 mg/l

PNEC sediment

(freshwater)

174 mg/kg

sediment dw

PNEC sediment

(marine water)

17.4 mg/kg

sediment dw

PNEC soil 39 mg/kg soil dw 166 mg/kg soil dw

Based on the information above, PNECs were extracted for both lead and chromium.

Long-term toxicity testing on invertebrates (Annex IX)

For both lead and chromium, available information in the vRAR of lead and lead compounds and

in the RAR of hexavalent chromium compounds was read across to determine the potential long-

term toxicity to invertebrates of C.I. Pigment Yellow 34 and C.I. Pigment Red 104.

Long-term toxicity testing on fish (Annex IX)



term toxicity to fish of C.I. Pigment Yellow 34 and C.I. Pigment Red 104.

Adsorption/desorption screening (Annex VIII)

Due to the poor solubility of C.I. Pigment Yellow 34 and C.I. Pigment Red 104, their

adsorption/desorption cannot be determined. Yet a small fraction will transform into chromium

and lead ions. For both lead and chromium, available information in the vRAR of lead and lead

compounds and the RAR of hexavalent chromium compounds was used instead to determine the

adsorption/desorption potential of the transformation products released from C.I. Pigment

Yellow 34 and C.I. Pigment Red 104.



Bioaccumulation (Annex IX)


in the RAR of hexavalent chromium compounds was used instead to determine the

bioaccumulation potential of the transformation products released from C.I. Pigment Yellow 34

and C.I. Pigment Red 104.

Effects on terrestrial organisms (Annex IX/X)


in the RAR of hexavalent chromium compounds was read across to determine the potential

toxicity to terrestrial organisms of C.I. Pigment Yellow 34 and C.I. Pigment Red 104.

Long-term toxicity to sediment organisms (Annex X)



term toxicity to sediment organisms of C.I. Pigment Yellow 34 and C.I. Pigment Red 104.

Classification & Labelling for the environment

Based on the ecotoxicological profile of lead and chromate, C.I. Pigment Yellow 34 and C.I.

Pigment Red 104 have been officially classified by the EU as Aquatic Acute 1 (H400) and

Aquatic Chronic 1 (H410).

PBT

A PBT assessment is not relevant, since the substances are inorganic.



2. MANUFACTURE AND USES

Table 6. Quantities (in tonnes/year)

Year Total tonnage Uses exempted from CSR Used for article

2008 Manufactured:

Imported:

Directly exported:

Uses as intermediate under strictly

controlled conditions (on-site):

Used as intermediate under strictly

controlled conditions (transported):

Used for research purposes:

Imported in articles:

Tonnage in produced articles:

2009 Manufactured:

Imported:

Directly exported:








2010 Manufactured:

Imported:

Directly exported:








2011 Manufactured:

Imported:

Directly exported:








2012 Manufactured:

Imported:

Directly exported:








2013 Manufactured:

Imported:

Directly exported:








2.1. Manufacture



No information available on manufacture

No information available on manufacturing process related to the specified manufacture(s)

No information available on production of articles covered by the specified use(s)

2.2. Identified uses

Table 7. Formulation

Identifiers Use descriptors Other information

F-1: Distribution and

mixing pigment

powder in an

industrial

environment into

solvent-based paints

for non-consumer

use. Pigment choice

depends on product

specifications on

visibility, shade and

colour, durability,

other requirements

and Regulations.

Environmental release category (ERC):

ERC 2: Formulation of preparations

Process category (PROC):

PROC 2: Use in closed, continuous process with

occasional controlled exposure

PROC 3: Use in closed batch process (synthesis or

formulation)

PROC 5: Mixing or blending in batch processes for

formulation of preparations and articles (multistage

and/or significant contact)

PROC 7: Industrial spraying

PROC 8a: Transfer of substance or preparation

(charging/discharging) from/to vessels/large

containers at non-dedicated facilities

PROC 8b: Transfer of substance or preparation


containers at dedicated facilities

PROC 9: Transfer of substance or preparation into

small containers (dedicated filling line, including

weighing)

PROC 10: Roller application or brushing

PROC 15: Use as laboratory reagent

PROC 21: Low energy manipulation of substances

bound in materials and/or articles

Product Category formulated:

PC 9a: Coatings and paints, thinners, paint removes

Technical function of the substance during

formulation:

Colouring agents, pigments

Tonnage of substance: 1200.0

Number of sites: 10-100

Substance supplied to that use:

As such

In a mixture

Remarks:

C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are unique in their value in use

proposition. They combine superb colouristic properties such as a wide range of

clean, vivid shades for visibility, colour stability, excellent coverage or hiding power

with technical performance requirements such as low rheology, light and weather

fastness (durability), chemical fastness, non-bleeding/migration, impact resistance and

heat stability. This combination cannot be guaranteed through the use of other

pigments or combination of pigments. Their superior performance coupled with price

position, make alternatives less favourable.

Colour shade spectrum: C.I. Pigment Yellow 34 and C.I. Pigment Red 104 have a

wide shade spectrum covering shades from green shade yellow up to blue shade red.

No other pigment chemistry, other than cadmium-based products, have such a broad

colour shade spectrum. As such, it is often not possible to match certain shades

without the use of C.I. Pigment Yellow 34 and C.I. Pigment Red 104. The colour




palette of end users will be limited without these pigments.

Opacity/hiding power: one of the main functions of a paint or coating is to colour/hide

the substrate it is covering. The more opaque a paint or coating is, the less number of

coatings are required to hide the substrate. The more coatings that are required results

in a higher environmental impact as more solvents, resins, additives and energy will

be used. When taking into account the target colour shade that is required, alternatives

to C.I. Pigment Yellow 34 and C.I. Pigment Red 104 often require more coating

applications to achieve the same level of hiding. As such, alternatives often have an

indirect environmental impact through the need to apply more coatings leading to the

use of more energy, solvents and resins.

Durability: durability or weather fastness is a critical technical requirement for many

coatings applications. If the colour of a paint changes by fading or darkening it can

lead to the need for repainting or disposal of the painted article. This can lead to

environmental issues through the use of more paint (and thus more energy, solvents

and resins) or through waste disposal at landfill.

F-2: Distribution and

mixing pigment

powder in an

industrial

environment into

liquid or solid

premix to colour

plastic/plasticised

articles. Pigment

choice depends on

product

specifications on

visibility, colour,

heat stability,

durability and

Regulations.


ERC 3: Formulation in materials


PROC 1: Use in closed process, no likelihood of

exposure




formulation)












weighing)


PROC 14: Production of preparations or articles by

tabletting, compression, extrusion, pelletisation


PROC 19: Hand-mixing with intimate contact and

only PPE available.




PC 32: Polymer preparations and compounds

PC 34: Textile dyes, finishing and impregnating

products; including bleaches and other processing

aids


formulation:





As such

In a mixture

Remarks:







with technical performance requirements such as light and weather fastness

(durability), chemical fastness, non-migration, impact resistance and heat stability.

This combination cannot be guaranteed through the use of other pigments or

combination of pigments. Their superior performance coupled with price position,

make alternatives less favourable.



No other pigment chemistry, other than cadmium-based products, has such a broad



palette of end users will be limited without these pigments


applications. If the colour of a matrix changes by fading or darkening it can lead to

endangering the public and industrial safety and to the increased need for repair or

disposal of the article. This will subsequently lead to environmental issues through the

use of more additives, plasticisers and resins, through the use of more energy or

through waste disposal at landfill or incineration.

Table 8. Uses at industrial sites


IW-1: Industrial

application of paints

on metal surfaces

(machines

vehicles,structures,si

gns,road

furniture,coil

coating).Pigment

choice is governed

by end product

specifications on

visibility,colour,dura

bility,other technical

requirements and

Regulations.


ERC 5: Industrial use resulting in inclusion into or

onto a matrix





formulation)




PROC 6: Calendering operations

PROC 7: Industrial spraying









weighing)





Product Category used:


Sector of end use:




In a mixture

Subsequent service life relevant

for that use: yes

Link to the subsequent service

life:

A-1: Service life of coated

articles. Performance and

longevity depend on the

pigment quality for bright

lasting colours improving

visibility and safety, light and

weather fastness (durability),

chemical fastness, impact

resistance and heat stability.




SU 15: Manufacture of fabricated metal products,

except machinery and equipment

SU 17: General manufacturing, e.g. machinery,

equipment, vehicles, other transport equipment

SU 19: Building and construction work


formulation:


Remarks:

Paints and coatings containing C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are

applied in particular to equipment or substrates to ensure a long life-time of the

paint/coating for optimal protection, visibility and safety, and to maintain the

replacement value of the end product. Other motivation to use this type of

paint/coating is the extreme durability and quality of the paint/coating which reduces

the need to repair or repaint on places that are difficult to reach, in dangerous

situations, or where idle time of equipment would incur high costs. The desired

combination of colouristic properties (such as a wide range of clean, vivid shades for

visibility, colour stability, excellent coverage or hiding power) together with technical

performance characteristics (such as rheology, light and weather fastness (durability),

chemical fastness, non-bleeding/migration, impact resistance) cannot be guaranteed

through other pigments or combination of pigments. Their superior performance

coupled with price position, make alternatives less favourable.








the substrate it is covering. With a more opaque paint or coating, a lower number of

coating layers is required to hide the substrate. When more coating layers are

required, more solvents, resins, additives and energy will be used resulting in a higher

environmental impact. When taking into account the target colour shade that is

required, alternatives to C.I. Pigment Yellow 34 and C.I. Pigment Red 104 often

require more coating applications to achieve the same level of hiding. As such,

alternatives often have an indirect environmental impact through the need to apply

more coatings leading to the use of more energy, solvents and resins.


coatings applications. If the colour of a paint/coating changes by fading or darkening

it can lead to the need for repainting or disposal of the painted/coated article. This can

lead to environmental issues through the use of more paint/coating (and thus more

energy, solvents and resins) or through waste disposal at landfill.

IW-2: Use of colour

premixes and pre-

compounds to colour

plastic or plasticised

articles for non-

consumer use.

Pigment choice

depends on product

specifications on

visibility, colour,

heat stability,

chemical fastness,

durability and


ERC 5: Industrial use resulting in inclusion into or

onto a matrix



formulation)

PROC 6: Calendering operations








In a mixture


for that use: yes


life:

A-2: Service life of coloured




Regulations. (charging/discharging) from/to vessels/large




weighing)

PROC 14: Production of preparations or articles by

tabletting, compression, extrusion, pelletisation







aids

Sector of end use:

SU 12: Manufacture of plastics products, including

compounding and conversion



formulation:


plastic or plasticised articles.

Performance and longevity

depend on pigment quality

for bright lasting colours

improving visibility and

safety, heat

stability,durability, chemical

fastness, tenchical

requirements and Regulations

Remarks:




with technical performance requirements such as light and weather fastness

(durability), chemical fastness, non-migration, impact resistance, heat stability and

night time reflectivity. This combination cannot be guaranteed through the use of

other pigments or combination of pigments. Their superior performance coupled with

price position, makes alternatives less favourable.

Colouring with C.I. Pigment Yellow 34 and C.I. Pigment Red 104 is applied to ensure

optimal visibility, for safety reasons, as well as long-term protection of the article

against degradation.



No other pigment chemistry, other than cadmium-based products, have such a broad





applications. If the colour of a matrix changes by fading or darkening it can lead to

endangering the public and industrial safety and to the increased need for repair or

disposal of the article. This will subsequently lead to environmental issues through the

use of more additives, plasticisers, and resins, through the use of more energy or

through waste disposal at landfill or incineration.

Table 9. Uses by professional workers


PW-1:

Professional,non-

consumer application

of paints on metal


ERC 8c: Wide dispersive indoor use resulting in

inclusion into or onto a matrix






surfaces

(machines,vehicles,st

ructures,signs,road

furniture) or as road

marking. Pigment

choice is governed

by requirements on

visibility,colour,dura

bility,technical

performance and

Regulations.

ERC 8f: Wide dispersive outdoor use resulting in






formulation)






weighing)


PROC 11: Non industrial spraying





Sector of end use:

SU 12: Manufacture of plastics products, including

compounding and conversion



formulation:


In a mixture


for that use: yes


life:

A-1: Service life of coated

articles. Performance and

longevity depend on the

pigment quality for bright

lasting colours improving

visibility and safety, light and

weather fastness (durability),

chemical fastness, impact

resistance and heat stability.

Remarks:



paint/coating for optimal protection, visibility and safety, and to maintain the

replacement value of the end product. Other motivation to use this type of

paint/coating is the extreme durability and quality of the paint/coating which reduces

the need to repair or repaint on places that are difficult to reach, in dangerous

situations, or where idle time of equipment would incur high costs. The desired

combination of colouristic properties (such as a wide range of clean, vivid shades for

visibility, colour stability, excellent coverage or hiding power) together with technical

performance characteristics (such as rheology, light and weather fastness (durability),

chemical fastness, non-bleeding/migration, impact resistance) cannot be guaranteed

through other pigments or combination of pigments. Their superior performance

coupled with price position, make alternatives less favourable.

Especially for road markings in the airport area but also on public roads, time plays an

important and critical role. The applied paint or coating needs to perform in one

application and needs to dry as quickly as possible, as work is done whilst

operational. Paints and coatings based on other pigments do not meet these critical

requirements.











the substrate it is covering. With a more opaque paint or coating, a lower number of

coating layers is required to hide the substrate. When more coating layers are

required, more solvents, resins, additives and energy will be used resulting in a higher

environmental impact. When taking into account the target colour shade that is








lead to environmental issues through the use of more paint (and thus more energy,

solvents and resins) or through waste disposal at landfill.

PW-2: Use of colour

premixes and pre-

compounds in the

application of

hotmelt road

marking. Pigment

choice depends on

end product

specifications on

visibility & night

time reflectivity,

colour, heat stability,

durability, chemical

fastness and

Regulations.


ERC 8c: Wide dispersive indoor use resulting in


ERC 8f: Wide dispersive outdoor use resulting in












PROC 24: High (mechanical) energy work-up of

substances bound in materials and/or articles





aids

Sector of end use:



formulation:




In a mixture


for that use: yes


life:

A-2: Service life of coloured

plastic or plasticised articles.

Performance and longevity

depend on pigment quality

for bright lasting colours

improving visibility and

safety, heat

stability,durability, chemical

fastness, tenchical


Remarks:



clean, vivid shades for visibility, night time reflectivity, colour stability, excellent

coverage or hiding power with technical performance requirements such as heat

stability, light and weather fastness (durability), chemical fastness, non-migration and

impact resistance. This combination cannot be guaranteed through the use of other

pigments or combination of pigments. Their superior performance coupled with price

position, make alternatives less favourable.

Colouring with C.I. Pigment Yellow 34 and C.I. Pigment Red 104 is applied to ensure

optimal visibility, for safety reasons, as well as long-term protection of the plastic




road marks against degradation.








applications. If the colour of the matrix changes by fading or darkening it can lead to

endangering the public and industrial safety and to the increased need for repair. This

will subsequently lead to environmental issues through the use of more additives,

plasticisers and resins, through the use of more energy or through waste disposal at

landfill or incineration.

Table 10. Article service life


SL-1: Service life of

coated articles.

Performance and

longevity depend on

the pigment quality

for bright lasting

colours improving

visibility and safety,

light and weather

fastness (durability),

chemical fastness,

impact resistance and

heat stability.

Article category related to subsequent service life

(AC):

AC 1: Vehicles

AC 2: Machinery, mechanical appliances,

electrical/electronic articles

AC 4: Stone, plaster, cement, glass and ceramic

articles

AC 7: Metal articles

Exposure related description of article:

Articles with foreseeable exposure to dust and

fumes during maintenance and recycling processes,

e.g. abrasive surface cleaning, dismantling and

milling

Articles with particular waste collection and

treatment schemes, e.g. electronic equipment


ERC 10a: Wide dispersive outdoor use of long-life

articles and materials with low release

ERC 10b: Wide dispersive outdoor use of long-life

articles and materials with high or intended release

(including abrasive processing)

ERC 11a: Wide dispersive indoor use of long-life


ERC 11b: Wide dispersive indoor use of long-life



ERC 12a: Industrial processing of articles with

abrasive techniques (low release)

ERC 12b: Industrial processing of articles with

abrasive techniques (high release)






PROC 25: Other hot work operations with metals

Article used by:

workers


Typical concentration of the

substance in article: 0.3





formulation:


Remarks:



coating and the coated object for optimal protection, visibility and safety, and to

maintain the replacement value of the object. Other motivation to use this type of

paint/coating on objects is the extreme durability and quality of the paint/coating

which reduces the need to repair or repaint on places that are difficult to reach, in

dangerous situations, or where idle time of equipment would incur high costs. The

desired combination of colouristic properties (such as a wide range of clean, vivid

shades for visibility, colour stability, excellent coverage or hiding power) together

with technical performance characteristics (such as rheology, light and weather

fastness (durability), chemical fastness, non-bleeding/migration, impact resistance)

cannot be guaranteed through other pigments or combination of pigments. Their

superior performance coupled with price position, make alternatives less favourable








the substrate it is covering. The more opaque a paint or coating is, the less number of

coating layers are required to hide the substrate. The more coating layers that are

required results in a higher environmental impact as more solvents, resins, additives

and energy will be used. When taking into account the target colour shade that is








lead to environmental issues through the use of more paint (and thus more energy,

solvents and resins) or through waste disposal at landfill.

SL-2: Service life of

coloured plastic or

plasticised articles.

Performance and

longevity depend on

pigment quality for

bright lasting colours

improving visibility

and safety, heat

stability,durability,

chemical fastness,

tenchical

requirements and

Regulations

Article category related to subsequent service life

(AC):

AC 13: Plastic articles

Exposure related description of article:

Articles with particular waste collection and

treatment schemes, e.g. electronic equipment

Articles with foreseeable exposure to dust and

fumes during maintenance and recycling processes,

e.g. abrasive surface cleaning, dismantling and

milling


ERC 10a: Wide dispersive outdoor use of long-life


ERC 10b: Wide dispersive outdoor use of long-life


Article used by:

workers


Typical concentration of the

substance in article: 3.0





ERC 11a: Wide dispersive indoor use of long-life


ERC 11b: Wide dispersive indoor use of long-life



ERC 12a: Industrial processing of articles with

abrasive techniques (low release)







formulation:


Remarks:



clean, vivid shades for visibility, night time reflectivity, colour stability, excellent

opacity or hiding power with technical performance requirements such as light and

weather fastness (durability), chemical fastness, non-migration, impact resistance and

heat stability. This combination cannot be guaranteed through the use of other

pigments or combination of pigments. Indeed most alternatives fail in one or more of

the above technical characteristics. The superior performance of C.I. Pigment Yellow

34 and C.I. Pigment Red 104 coupled with price position, make alternatives less

favourable.

These pigments are used in plastic objects to ensure a long-lasting high quality colour

and protection or to ensure high visibility related to occupational or public safety.

Alternative and less effective pigments often lead to the use of more UV-stabilisers

and plasticisers due to inadequate weather fastness or higher oil adsorption. In

addition, due to their lower opacity (more transparency), the alternative pigments will

demonstrate lower night time reflectivity causing potential safety issues in road

marking matrices.

2.3. Uses advised against

Table 11. Formulation

Identifiers Use descriptors

F-5: Formulation of

pigment in paints,

plastics and

plasticised articles

for consumer use


ERC 2: Formulation of preparations

ERC 3: Formulation in materials



PC 9c: Finger paints


PC 34: Textile dyes, finishing and impregnating products; including bleaches and

other processing aids

Technical function of the substance during formulation:





Other information Remarks:

Use is restricted in Annex XVII of REACH, as C.I. Pigment Yellow 34 and C.I.

Pigment Red 104 fall into the criteria of entries 28 and 30 of this Annex.

Column 1 Designation of the substance, of the group of substances or of the mixture

28. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008

classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2

(Table 3.2) and listed as follows:

- Carcinogen category 1A (Table 3.1)/ carcinogen category 1 (Table 3.2) listed in

Appendix 1

- Carcinogen category 1B (Table 3.1)/ carcinogen category 2 (Table 3.2) listed in

Appendix 2


classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to

reproduction category 1 or 2 (Table 3.2) and listed as follows:

- Reproductive toxicant category 1A adverse effects on sexual function and fertility or

on development (Table 3.1) or reproductive toxicant category 1 with R60 (May impair

fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 5

- Reproductive toxicant category 1B adverse effects on sexual function and fertility or



Column 2 Conditions of restriction

Without prejudice to the other parts of this Annex the following shall apply to entries

28 to 30:

1. Shall not be placed on the market, or used,

- as substances,

- as constituents of other substances, or,

- in mixtures,

for supply to the general public when the individual concentration in the substance or

mixture is equal to or greater than:

- either the relevant specific concentration limit specified in Part 3 of Annex VI to

Regulation (EC) No 1272/2008, or,

- the relevant concentration specified in Directive 1999/45/EC.

Without prejudice to the implementation of other Community provisions relating to

the classification, packaging and labelling of substances and mixtures, suppliers shall

ensure before the placing on the market that the packaging of such substances and

mixtures is marked visibly, legibly and indelibly as follows:

‘Restricted to professional users’.

2. By way of derogation, paragraph 1 shall not apply to:

(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive

2001/83/ EC;

(b) cosmetic products as defined by Directive 76/768/EEC;

(c) the following fuels and oil products:

- motor fuels which are covered by Directive 98/70/EC,

- mineral oil products intended for use as fuel in mobile or fixed combustion plants,

- fuels sold in closed systems (e.g. liquid gas bottles);

(d) artists’ paints covered by Directive 1999/45/ EC;

(e) the substances listed in Appendix 11, column 1, for the applications or uses listed

in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the

derogation shall apply until the said date.

Table 12. Consumer uses




C-5: Consumer use

of paints, plastics

and plasticised

articles containing

the pigment


ERC 8c: Wide dispersive indoor use resulting in inclusion into or onto a matrix

ERC 8f: Wide dispersive outdoor use resulting in inclusion into or onto a matrix



PC 9c: Finger paints

PC 34: Textile dyes, finishing and impregnating products; including bleaches and

other processing aids

Technical function of the substance during formulation:


Other information Remarks:

Use is restricted in Annex XVII of REACH, as C.I. Pigment Yellow 34 and C.I.

Pigment Red 104 fall into the criteria of entries 28 and 30 of this Annex.

Column 1 Designation of the substance, of the group of substances or of the mixture


classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2

(Table 3.2) and listed as follows:

- Carcinogen category 1A (Table 3.1)/ carcinogen category 1 (Table 3.2) listed in

Appendix 1

- Carcinogen category 1B (Table 3.1)/ carcinogen category 2 (Table 3.2) listed in

Appendix 2


classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to

reproduction category 1 or 2 (Table 3.2) and listed as follows:

- Reproductive toxicant category 1A adverse effects on sexual function and fertility or



- Reproductive toxicant category 1B adverse effects on sexual function and fertility or



Column 2 Conditions of restriction

Without prejudice to the other parts of this Annex the following shall apply to entries

28 to 30:

1. Shall not be placed on the market, or used,

- as substances,

- as constituents of other substances, or,

- in mixtures,

for supply to the general public when the individual concentration in the substance or

mixture is equal to or greater than:

- either the relevant specific concentration limit specified in Part 3 of Annex VI to

Regulation (EC) No 1272/2008, or,

- the relevant concentration specified in Directive 1999/45/EC.

Without prejudice to the implementation of other Community provisions relating to

the classification, packaging and labelling of substances and mixtures, suppliers shall

ensure before the placing on the market that the packaging of such substances and

mixtures is marked visibly, legibly and indelibly as follows:

‘Restricted to professional users’.

2. By way of derogation, paragraph 1 shall not apply to:

(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive




2001/83/ EC;

(b) cosmetic products as defined by Directive 76/768/EEC;

(c) the following fuels and oil products:

- motor fuels which are covered by Directive 98/70/EC,

- mineral oil products intended for use as fuel in mobile or fixed combustion plants,

- fuels sold in closed systems (e.g. liquid gas bottles);

(d) artists’ paints covered by Directive 1999/45/ EC;

(e) the substances listed in Appendix 11, column 1, for the applications or uses listed

in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the

derogation shall apply until the said date.



3. CLASSIFICATION AND LABELLING

3.1. Classification and labelling according to CLP / GHS

Name: lead sulfochromate yellow

Implementation: EU

State/form of the substance: powder

Related composition: lead sulfochromate yellow

Classification

The substance is classified as follows:

Table 13. Classification and labelling according to CLP / GHS for physicochemical properties

Endpoint Hazard category Hazard statement Reason for no

classification

CSR

section*)

Explosives: conclusive but

not sufficient for

classification

6.1

Flammable

gases:

conclusive but

not sufficient for

classification

6.2

Flammable

aerosols:

conclusive but

not sufficient for

classification

6.2

Oxidising gases: conclusive but

not sufficient for

classification

6.3

Gases under

pressure:

conclusive but

not sufficient for

classification

Flammable

liquids:

conclusive but

not sufficient for

classification

6.2

Flammable

solids:

conclusive but

not sufficient for

classification

6.2

Self-reactive

substances and

mixtures:

conclusive but

not sufficient for

classification

Pyrophoric

liquids:

conclusive but

not sufficient for

classification

6.2

Pyrophoric

solids:

conclusive but

not sufficient for

classification

6.2

Self-heating

substances and

mixtures:

conclusive but

not sufficient for

classification



Substances and

mixtures which

in contact with

water emit

flammable

gases:

conclusive but

not sufficient for

classification

6.2

Oxidising

liquids:

conclusive but

not sufficient for

classification

6.3

Oxidising solids: conclusive but

not sufficient for

classification

6.3

Organic

peroxides:

conclusive but

not sufficient for

classification

Corrosive to

metals:

conclusive but

not sufficient for

classification

*) Justification for (non) classification can be found in the CSR section indicated

Table 14. Classification and labelling according to CLP / GHS for health hazards


classification

CSR

section*)

Acute toxicity -

oral:

conclusive but

not sufficient for

classification

5.2.3

Acute toxicity -

dermal:

data lacking 5.2.3

Acute toxicity -

inhalation:

data lacking 5.2.3

Skin corrosion /

irritation:

conclusive but

not sufficient for

classification

5.3.4 and

5.4.3

Serious damage

/ eye irritation:

conclusive but

not sufficient for

classification

5.3.4

Respiration

sensitization:

Resp. Sens. 1 H334: May cause allergy or

asthma symptoms or breathing

difficulties if inhaled.

5.5.3

Skin sensitation: Skin Sens. 1 H317: May cause an allergic

skin reaction.

5.5.3

Aspiration

hazard:

conclusive but

not sufficient for

classification

5.2.3

Reproductive

Toxicity:

Repr. 1A H360: May damage fertility or

the unborn child <state specific

effect if known > <state route

of exposure if it is conclusively

proven that no other routes of

exposure cause the hazard>.

5.9.3

Reproductive

Toxicity: Effects

on or via

data lacking 5.9.3



lactation:

Germ cell

mutagenicity:

data lacking 5.7.3

Carcinogenicity: Carc. 1B H350: May cause cancer <state

route of exposure if it is

conclusively proven that no

other routes of exposure cause

the hazard>.

5.8.3

Specific target

organ toxicity -

single:

conclusive but

not sufficient for

classification

5.2.3 and

5.3.4

Specific target

organ toxicity -

repeated:

STOT Rep. Exp. 2

Affected organs:

Cardiovascular system, liver,

kidney

H373: May cause damage to

organs <or state all organs

affected, if known> through

prolonged or repeated exposure

<state route of exposure if it is

conclusively proven that no

other routes of exposure cause

the hazard>.

5.6.3


Table 15. Classification and labelling according to CLP / GHS for environmental hazards


classification

CSR

section*)

Hazards to the

aquatic

environment

(acute/short-

term):

Aquatic Acute 1 H400: Very toxic to aquatic

life.

7.6

Hazards to the

aquatic

environment

(long-term):

Aquatic Chronic 1 H410: Very toxic to aquatic

life with long lasting effects.

7.6

M-Factor acute: 1

M-Factor chronic: 1

Hazardous to the

ozone layer:

data lacking 7.6


Labelling

Signal word: Danger

Hazard pictogram:

GHS08: health hazard

GHS09: environment



Hazard statements:

H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure

cause the hazard>.

H360: May damage fertility or the unborn child <state specific effect if known > <state route of exposure if it is

conclusively proven that no other routes of exposure cause the hazard>.

H317: May cause an allergic skin reaction.

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.

H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated

exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

H410: Very toxic to aquatic life with long lasting effects.

Notes:

Note 1

3.2. Classification and labelling according to DSD / DPD

3.2.1. Classification and labelling in Annex I of Directive 67/548/EEC

Chemical name: lead sulfochromate yellow

Remarks: Official CLP Annex VI classification - please note that the substance is also considered to be a skin

and respiratory sensitiser but this is not included below as it is not part of the official classification. Therefore

the reason for no classification for this endpoint is set to 'data lacking'.

Classification

The substance is classified as follows:

Table 16. Classification and labelling in Annex I of Directive 67/548/EEC for physicochemical properties

Endpoint Classification Reason for no

classification

CSR

section*)

Explosiveness: conclusive but not

sufficient for

classification

6.1

Oxidising properties: conclusive but not

sufficient for

classification

6.2

Flammability: conclusive but not

sufficient for

classification

6.3

Thermal stability: conclusive but not

sufficient for

classification


Table 17. Classification and labelling in Annex I of Directive 67/548/EEC for health hazards




classification

CSR

section*)

Acute toxicity: conclusive but not

sufficient for

classification

5.2.3

Acute toxicity -

irreversible damage

after single exposure:

conclusive but not

sufficient for

classification

5.2.3

Repeated dose

toxicity:

R33 Danger of cumulative effects. 5.6.3

Irritation / Corrosion: conclusive but not

sufficient for

classification

5.3.4 and

5.4.3

Sensitisation: data lacking 5.5.3

Carcinogenicity: Carc. Cat. 2; R45 May cause cancer. 5.8.3

Mutagenicity -

Genetic Toxicity:

data lacking 5.7.3

Toxicity to

reproduction -

fertility:

Repr. Cat. 3; R62 Possible risk of impaired fertility 5.9.3

Toxicity to

reproduction -

development:

Repr. Cat. 1; R61 May cause harm to the unborn

child.

5.9.3

Toxicity to

reproduction -

breastfed babies:

data lacking 5.9.3


Table 18. Classification and labelling in Annex I of Directive 67/548/EEC for the environment


classification

CSR

section*)

Environment: N; R50/53 Dangerous for the environment; Very

toxic to aquatic organisms, may cause long-term

adverse effects in the aquatic environment.

7.6


Labelling

Indication of danger:

T - toxic

N - dangerous for the environment

R-phrases:

R45 - May cause cancer

R61 - May cause harm to the unborn child

R62 - Possible risk of impaired fertility

R33 - Danger of cumulative effects

R50/53 - Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

Notes:

Note 1



3.2.2. Self classification(s)

No relevant information available

3.2.3. Other classification(s)




4. ENVIRONMENTAL FATE PROPERTIES

General discussion of environmental fate and pathways:

After release of C. I. Pigment Yellow 34 and/or C. I. Pigment Red 104 into the environment, a small fraction

consisting of chromate ions (CrO42-

) and lead ions (Pb2+

) will dissociate from the solids and partition in the

environmental compartments.

Both lead and chromium will bioaccumulate in fish and other aquatic organisms. The (median) BCF fish for

lead was 23 L/kg whereas the 50th percentile for a mixed diet was 1553 L/kg. Chromium (VI) appears to be

reduced to chromium (III) once it has been taken up in the organisms. Therefore a BCF of 100 was estimated

from the total chromium concentration in biota / chromium (VI) concentration in water. Mean BAFs for

earthworm were 0.11 and 0.10 kg/kg ww for chromium and lead, respectively.

The relatively high Kd-values for lead and chromium indicate that both moieties may adsorb to suspended

particles and soil. The partitioning of lead and chromium depends on pH, Fe-oxide, mineral particles and DOC-

contents of water and soil. At neutral pH lead mostly forms carbon-lead complexes, whereas at low pH lead

exists predominantly in the more mobile ionic form. Soil pH has a comparable effect on chromium; with

increasing pH the adsorption of chromium increases. Furthermore, at neutral pH CrO42-

ions are expected to be

reduced to the less mobile chromium III in the environment. The mobility of both ions decreases with increasing

proportion of organic matter in soils.

4.1. Degradation

4.1.1. Abiotic degradation

4.1.1.1. Hydrolysis

Data waiving

Information requirement: Hydrolysis


Justification: The substance is inorganic and possesses no hydrolizable groups. Furthermore the water

solubility is very low (waiving according to Column 2 in Annex VIII, 9.2.2.1).

Discussion

The following information is taken into account for any hazard / risk / persistency assessment:

According to structural properties, hydrolysis is not expected or probable

4.1.1.2. Phototransformation/photolysis

4.1.1.2.1. Phototransformation in air


4.1.1.2.2. Phototransformation in water


4.1.1.2.3. Phototransformation in soil


4.1.2. Biodegradation

4.1.2.1. Biodegradation in water



4.1.2.1.1. Screening tests

Data waiving

Information requirement: Biodegradation in water: screening test


Justification: Not applicable; C. I. Pigment Yellow 34 is an inorganic substance (waiving according to

Column 2 in Annex VII, 9.2.1.1)

4.1.2.1.2. Simulation tests (water and sediments)

Data waiving

Information requirement: Simulation testing for biodegradation in water and sediment



Annex VII, 9.2.1.1)

4.1.2.1.3. Summary and discussion of biodegradation in water and sediment

Discussion (screening testing)


The substance is inorganic and therefore a study on the biodegradation is not required (Column 2 in Annex VII,

9.2.1.1).

Discussion (simulation testing)



9.2.1.1).

4.1.2.2. Biodegradation in soil

Data waiving

Information requirement: Soil simulation testing



Annex VII, 9.2.1.1)

Discussion



9.2.1.1).

4.1.3. Summary and discussion of degradation Abiotic degradation

C. I. Pigment Yellow 34 is an inorganic substance. Due to the lack of hydrolysable groups hydrolysation is not

expected to occur.

Biotic degradation

C. I. Pigment Yellow 34 is an inorganic substance. Therefore biodegradation is not expected and biodegradation

rates cannot be calculated.



4.2. Environmental distribution

4.2.1. Adsorption/desorption

The studies on adsorption/desorption are summarised in the following table:

Table 19. Studies on adsorption/desorption

Method Results Remarks Reference

Study type: adsorption (sediment)

calculated

The partitioning of trace metals

in rivers were investigated. The

coefficients were modelled using

a combination of WHAM and

SCAMP models (Tipping 1994,

Lofts and Tipping 1998).

Observed and predicted log Kd

were compared.

Adsorption coefficient:

log Kd: 5.41 — 5.71 (first

value: observed; second value:

predicted)

Kd: 512861 (recalculated from

predicted log Kd (as cited in

publication))

2 (reliable with

restrictions)

key study

read-across from

supporting substance

(structural analogue

or surrogate)

Test substance: Lead

Lofts S, Tipping E.

(2000)

Study type: adsorption (soil)

calculation

Soil-liquid partitioning

coefficients were compiled from

studies. Multiple linear

regressions were perfomed with

the data in order to pedict Kd

values.

Partitioning coefficients (Kd in L

/kg):

Chromium Kd: 14920, log10 Kd

4.17

Lead Kd: 171214, log10 Kd 5.23

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Chromium and lead

Sauvé S,

Hendershot W,

Allen HE (2000)

Discussion

Data on adsorption of C. I. Pigment Yellow 34 and C. I. Pigment Red 104 are not available. However, chromate

ions (CrO42-


) may dissociate from the substance and adsorb to suspended particles and soil.

Experimental and calculated log Kd-values for lead and chromium indicate that both moieties may adsorb to

suspended particles and soil. However, the partitioning of lead and chromium depends on pH, Fe-oxide, mineral

particles and DOC-contents of water and soil. At neutral pH lead mostly forms carbon-lead complexes, whereas

at low pH lead exists predominantly in the more mobile ionic form. Soil pH has a comparable effect on

chromium; with increasing pH the adsorption of chromium increases. Furthermore, at neutral pH CrO42-

ions are

expected to be reduced to the less mobile chromium III in the environment. The mobility of both ions decreases

with increasing proportion of organic matter in soils.

The following log Kd values for lead (resulting from investigations for rivers (Lofts and Tipping, 2000)) were

reported: 5.41 (observed) - 5.71 (predicted). For chromium the mean of calculated log Kd values for pH ranging

from 2 -10 (from Sauve et al, 2000) was 4.17.

For the risk assessment, use is made of the extensive work carried out for the risk evaluations of chromium and

lead at the EU level.

The Kd values used for PEC and PNEC calculations for chromium (EU RAR) and lead (vRAR) are presented in

the Table. When available, also Kd values given in the ECHA Guidance Appendix R.7.13 -2 Metals are

included.

Substance Type Kd (L/kg) remarks




Chromium (VI)

Kd (suspended matter –

water)

2000 Acid conditions

200 Neutral-alkaline conditions

Kd (sediment – water)



Kd (soil – water)

50 Acid conditions


Chromium (III)


water)



Kd (sediment matter –

water)



Kd (soil – water)

800 Acid conditions


Lead


water)

295121 L/kg Freshwater data

50th percentile n= 12, from

vRAR

(same value reported in

REACH guidance Appendix

R.7.13-2 Metals)

954993 L/kg Estuarine data


vRAR

1698244 L/kg Marine data


vRAR

Kd (sediment – water)

154882 L/kg 50th percentile n= 5 (REACH

guidance Appendix R.7.13-2

Metals)

153848 L/kg Average of two median Kd

values derived from datasets

with many measured




background and ambient

concentrations (vRAR)

Kd (soil – water)

6400 L/kg 50th percentile n= 60

(REACH guidance Appendix

R.7.13-2 Metals)

6400 L/kg Average of two median

measured Kd, n= 60 from

vRAR

Chromium

The Kd for chromium (VI) and chromium (III) are based on the available measured data. Kd could not be

derived from a statistical distribution due to the lack of sufficient data. Instead the Rapporteur of the EU RAR

selected the values by inspection of the available data set to reflect the available information under acid (pH < 5)

and neutral-alkaline (pH > 6) conditions.

Lead

A large number of measured sorption data is available for lead. 10th, 50th and 90th percentile Kd have been

derived from the fitted distributions in the vRAR. Median Kd have been used for the derivation of PEC and

PNEC. This is in agreement with the REACH guidance in Appendix R.7.13-2: Environmental risk assessment

for metals and metal compounds.

Kd suspended matter – water was determined seperately for freshwater, estuarine and marine data for lead. The

10th, 50th, and 90th percentiles of the fitted distributions were reported in the vRAR lead. In line with REACH

guidance the median values should be used for PEC and PNEC derivation. The 10th and 90th percentiles could

be used for an uncertainty analysis.

Kd sediment is derived from the REACH Guidance document Appendix R.7.13 Metals, Table 7.13.2. A similar

value was proposed for Kd sediment in the vRAR based on the average of two median Kd derived from

respectively environmental concentration distributions for background or ambient lead concentrations in surface

water and sediment (Kd sediment).

Similarly Kd soil was determined as the average of two medians derived from two data sets where Kd was based

on measured concentrations of lead in pore water and Kd was normalised to a typical soil with pH 6.5, 2%

organic matter content and 27.4 mgPb/kg soil.

The following information is taken into account for any environmental exposure assessment:

For the risk assessment of the pigments, the Kd values for lead are used to estimate partitioning to suspended

matter, sediment and soil.

4.2.2. Volatilisation


4.2.3. Distribution modelling


4.2.4. Summary and discussion of environmental distribution

C. I. Pigment Yellow 34 is a solid, inorganic substance and will therefore not evaporate into the atmosphere.

The solubility of the substance is very low and thus the substance will not dissolve in water. Furthermore the

undissolved substance is not expected to adsorb to sediment and soil.

Chromate ions (CrO42-

) and lead ions (Pb²+) may dissociate from the substance. Lead and chromium may adsorb



to suspended particles, sediment and soil. Thus, when released to the environment moieties dissolving from the

parent substance will probably mainly be found in sediment and soil. A minor part of the dissolved metal ions

may be found in water.

4.3. Bioaccumulation

C. I. Pigment Yellow 34 is poorly soluble in water and therefore the potential for bioaccumulation is expected to

be low.

4.3.1. Aquatic bioaccumulation

The studies on aquatic bioaccumulation are summarised in the following table:

Table 20. Studies on aquatic bioaccumulation


Selenastrum capricornutum,

Daphnia magna, Poecilia

reticulata

aqueous (freshwater)

flow-through

Total uptake duration: 4 wk

A tri-trophic food chain including

algae, Daphnia and fish was

established. The three species

were exposed to a solution of

leadnitrate in four separate but

connected compartments of the

test apparatus. In the first

compartment algae were bread.

Via a discharge test solution and

algae were flowing into a second

tank where Daphnia were bred.

Via a discharge a third tank

where fish were kept received

test solution and Daphnia. A

fourth tank with fish received

only test solution via an

overflow. The fish in the fourth

tank were fed with untreated

Daphnia.

concentration factor in fish fed

with contaminated Daphnia: 1900

(14 days of exposure)





with uncontaminated Daphnia:

700 (14 days of exposure)
















2 (reliable with

restrictions)

key study

read-across from



or surrogate)


nitrate

Vighi M. (1981)

Salmo gairdneri (new name:

Oncorhynchus mykiss)

aqueous (freshwater)

static

Total uptake duration: 15 — 30 d

Two tests were performed. In a

first test fish were exposed to

several concentrations of

chromium for 15, 24 days and 30

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Chromium

Fromm PO and

Stokes RM (1962)




respecitvely. Chromium contents

in fish were determined. In order

to investigate the uptake route

and mode of action of chromium

the oxygen consumption of

pyloric caeca, liver and kidney

tissues were determined.

Furthermore blood lactic acid and

glucose and muscle glycogen

were determined.

Gillichthys mirabilis

aqueous (saltwater)

semi-static

Total uptake duration: 120 d

Tissues of lead-exposed fish in

seawater were analysed for

accumulation and decay of lead.

Tests were performed in natural

or lead-dosed sea water. Tests

were performed at different lead

levels, temperature and salinity.

2 (reliable with

restrictions)

supporting study

read-across from



or surrogate)


acetate

Somero GN, Chow

TJ, Snyder Y,

Snyder CB (1977)

Mytilus edulis

sediment (saltwater)

static

Type of sediment: natural

sediment

Total uptake duration: 7 d

Total depuration duration: 21 d

The bioaccumulation of Cr (III)

and Cr(VI) in phytoplankton was

investigated by exposing

phytoplanton species to different

concentrations of crhomium. Cell

growth and accumulated Cr was

measured periodically.

2 (reliable with

restrictions)

supporting study

read-across from



or surrogate)

Test substance: Cr

(III), Cr (VI)

Wang W_X,

Griscom SB,

Fisher NS (1997)

Potamonautes perlatus

(freshwater)

field study

Type of sediment: natural

sediment

The lead contamination of Eerste

River in South Africa and the

accumulation of Pb in

Potamonautes perlatus was

determined.

BSAF: 3.4 — 3.6 (whole body

w.w.) (steady state)

BCF: ca. 500 L/kg (whole body

w.w.) (steady state)

2 (reliable with

restrictions)

supporting study

read-across from



or surrogate)


Reinecke AJ,

SNyman RG, Nel

JAJ (2003)



4.3.2. Terrestrial bioaccumulation


4.3.3. Summary and discussion of bioaccumulation

Aquatic bioaccumulation

Due to the very low solubility of C. I. Pigment Yellow 34 in water the bioavailability of the substance is

expected to be low. Therefore, the bioaccumulation potential of the substance is expected to be low.

However, a small proportion of the parent substance may dissolve and release chromate ions (CrO42-

) and lead

ions (Pb²+). The Transformation/Dissolution study showed that at pH 6 less than 1% of the lead actually

dissolved and less than 0.1% of lead dissolved at pH 8 and less than 0.1% of chromium dissolved at both pHs.

The following information is taken into account for any hazard / risk / bioaccumulation assessment:

Significant accumulation of C. I. Pigment Yellow 34 in organisms is not expected.

A small proportion of the parent substance C. I. Pigment Red 104 or C. I. Pigment Yellow 34 may dissolve and

release chromate ions (CrO42-


).

The IUCLID data set includes results from a literature search on the bioaccumulation of both chromium and

lead. Both moieties of the pigments may accumulate in organisms (Tulasi et al. 1992, Avenant-Oldewage and

Marx 2000). For lead a concentration factor of 360 was detected in Poecilia reticulata after 28 days of exposure

to 50 µg lead/l (Vighi, 1981). Generally biomagnification of lead is not exptected. Similary the BCF in the crab

Potamonautes perlatus was circa 500 L/kg after exposure to 30-40 µg lead/l. The bioconcentration factor for the

sediment was 3.5 (dimensionless, Reinecke et al., 2003).

For chromium (VI) a BCF of 1 l/kg was determined (Fromm and Stokes 1962). However, CrO42-

ions will be

reduced to less reactive chromium (III) ions under most environmental conditions. Chromium (III) is less

bioavailable and therefore chromium (III) is expected to be less bioaccumulative. In general the

bioaccumulation of both metal ions increases with rising temperature, alkalinity and lower water salinity.

Both lead and chromium have been discussed extensively under the EU-Existing Chemicals Regulation and the

results were reported in a Risk Assessment Report (RAR 2005) for Chromium and the voluntary RAR for Lead

(2008).

The bioconcentration factor for lead from the vRAR (2008) and the bioconcentration factors for chromium (VI)

and chromium (III) proposed in the EU RAR (2005) are presented in the table:

Substance Species Remarks

Chromium (VI)

Fish 1 L/kg Used to estimate

concentration of

chromium (VI) in fish

based food chain

Mussels 1820 L/kg Based on measured values

in marine species

Chromium (III)

Fish 100 L/kg Used to estimate

concentration of

chromium (III) in fish

resulting from uptake and

subsequent reduction in

biota of chromium (VI)

Mussels 560 L/kg Based on measured values



Substance Species Remarks

in marine species

Lead

Fish 23 L/kg 50th percentile of range in

BCFfish

Mollusc diet 675 L/kg 50th percentile of range in

BCFmolluscs

Mixed diet 1553 L/kg 50th percentile of range in

BCFmixed food diet

Chromium:

The BCF values for chromium VI and III were derived from values measured in a variety of systems. The

available data indicated that the BCF for chromium (VI) in fish was low (around 1 L/kg). However, it was

noticed that chromium (VI) appears to be reduced to chromium (III) once it has been taken up in the organisms.

Therefore a BCF of 100 was estimated from the total chromium concentration in biota / chromium (VI)

concentration in water. Direct uptake of chromium (III) from the water phase was not assumed because of the

low water solubility and strong sorption of chromium (III) to sediment under most environmental conditions.

It should be noted however that secondary poisoning for chromium (III) is not assessed in the risk

characterisation (and hence the BCF for chromium (III) has not been used).

The uptake of chromium by aquatic species may be pH dependent, but it was concluded in the EU RAR that

there was not sufficient information available to take this into account for the BCF.

Lead:

The BCF values for lead were derived from field studies taking into account all exposure routes as this was

considered to be more environmentally realistic. BCF of lead in fish and invertebrates were dependent on the

exposure concentration in water because of the active regulation of internal Pb body concentrations in the

organisms. Therefore only BCF of studies with realistic dissolved Pb concentrations (between 0.18 and 15 µg/L)

were selected for the BCF evaluation.

The median BCF fish of the resulting database was 23 L/kg whereas the median BCF mussel of the remaining

studies was 675 L/kg.

The 50th percentile for a mixed diet was calculated as 1553 L/kg. This value was used for the calculation of

PECoral in the mussel-based food chain in the vRAR as it was considered to be more environmentally realistic.

It should be noted that the risk characterisation for secondary poisoning of lead was not included in the vRAR

because there was no agreement on the PNECoral to be used.


The median BCF fish for LEAD in the database of the vRAR was 23 L/kg whereas the median BCF mussel of

the remaining studies was 675 L/kg.

The 50th percentile for a mixed diet was calculated as 1553 L/kg. The latter value was considered more

environmentally realistic.

Value used for CSA: BCF: 1553 L/kg ww

Terrestrial bioaccumulation

Chromium

A range of values for uptake of chromium (VI) in earthworms is presented in the EU RAR and the mean of the

middle of various ranges reported in literature was used to estimate the concentrations in worms. This mean



BCF worm for chromium was calculated as 0.11 kg/kg ww.

Lead

A large amount of bioaccumulation data for terrestrial organisms is available as well for lead. The mean BCF

earthworm derived from a reliable dataset of 101 BAF values was reported as 0.10 kg dw/kg ww.

However, it should be noted that the earthworm food chain was not addressed, neither in the EU RAR for

chromium and nor in the vRAR for lead.


The mean BCF earthworm derived from a reliable dataset of 101 BAF valuesfor lead was 0.10 kg dw/kg ww.

(dimension NOT Liter/kg ww)

Value used for CSA: Terrestrial BCF: 0.1

4.4. Secondary poisoning

Due to the fact that the substance is not bioaccumulative, it is unlikely that a secondary poisoning risk will occur

by this substance. Therefore and for reasons of animal welfare, the assessment of secondary poisoning of this

substance will be based on mammalian data.

For the transformation products Chromium (VI) and Lead, the following PNECoral were derived:

Chromium (VI): PNEC oral 17 mg/kg food

Lead: PNEC oral 0.5 mg/kg food

Interpretation of the available data with regard to the potential to bio-accumulate in the food chain:

Chromium(VI): The very low bioconcentration factors for fish (BCF usually around 1 L/kg) do not trigger the

evaluation of secondary poisoning. However since chromium (VI) uptake from water, sediment and soil has

been reported for a wide range of organisms, the PNECoral derived in the EU RAR has been used here as well.

The PNEC is based on the lowest available chronic NOAEL (20 mg Cr VI/kg body weight/ day for effects on

the testes in mice by exposure via oral gavage) and the lowest available chronic LOAEL (20 mg Cr VI/kg body

weight/ day for developmental effects in mice via the drinking water route). Converting this value of 20 mg/kg

with conversion factor 8.3 gives a NOECfood of 166 mg/kg. Application of an AF of 10 results in the PNECoral

of 16.6 mg chromium VI / kg food.

Chromium(III): PNEC oral was not derived in EU RAR (2005) because of the absence of a review of

mammalian data for chromium (III). In the toxicity studies used for the PNECoral for chromium (VI),

organisms were exposed through gavage or drinking water. Therefore little conversion of chromium (VI) to

chromium (III) was expected (according to the EU RAR).

Lead: Application of AF of 300 to the lowest NOEC for mammals (150 mg/kg food, Rattus sp., ref Kao &

Forbes, 1973)) resulted in PNECoral of 0.5 mg/kg for mammals. It should be noted that the latter value is in the

range of natural background concentrations. The SCHER also discusses the use of lead concentrations in blood

and an SSD approach but concludes that more work is required before a proper assessment of the risk of

secondary poisoning could be conducted.



5. HUMAN HEALTH HAZARD ASSESSMENT

5.1. Toxicokinetics (absorption, metabolism, distribution and

elimination)

5.1.1. Non-human information

The results of studies on absorption, metabolism, distribution and elimination are summarised in the following

table:

Table 21. Studies on absorption, metabolism, distribution and elimination


in vitro study

not applicable, in vitro

studies

Not applicable

Exposure regime:

Gastric fluid: 2 hours

Interstitial, intercellular

and perspiration fluid:

24h and 168h (7 days)

Doses/conc.: Loading

rate:

Gastric fluid: 0.2 g/L

Interstitial, intracellular

and perspiration fluid:

2 g/L

Standard Operating

Procedure (SOP) for

the Bio-accessibility

Testing Programme of

Eurometaux

(November 10, 2010),

based on ASTM

D5517-07: standard

test method for

determining the

extractability of metals

from art materials -

ASTM, 2007

The bio-elution potential of C.I. Pigment

Yellow 34 and C.I. Pigment Red 104 was

determined in four kinds of simulated body

fluids (gastric, interstitial, intracellular and

perspiration fluid), to determine

bioavailability of chrome and lead for

absorption. Results show highest bio-

elution in gastric fluid, in which 22-24% of

chromium and 23-26% of lead dissolved.

For chromium, the percentages dissolved

were 8.34 and 1.33% in interstitial, 3.44

and 3.77% intracellular and 0.07 and 0.08%

in perspiration fluid, for C.I. Pigment

Yellow 34 and C.I. Pigment Red 104

respectively. For lead, the percentages

dissolved were 0 and 0.02% in interstitial,

4.17 and 9.37% in intracellular and 1.64

and 1.8% in perspiration fluid, for C.I.

Pigment Yellow 34 and C.I. Pigment Red

104 respectively.

1 (reliable without

restriction)

key study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

Form: powder

Brouwers, T.

(2013a)

Brouwers, T.

(2013b)

Brouwers, T.

(2013c)

Brouwers, T.

(2013d)

Brouwers, T.

(2013e)

Brouwers, T.

(2013f)

Brouwers, T.

(2013g)

Brouwers, T.

(2013h)

rat (Sprague-Dawley)

male/female

oral: gavage

Exposure regime: once

Doses/conc.: 10000

mg/kg bw

determination tissue

After single oral administration, no

additional lead is resorbed from the

pigment than the part that would have been

soluble in 0.25 M HCl, although in the case

of Chromgelb pigments, a higher amount

had to be administered compared to lead

acetate. This could be a consequence of a

shorter retention period and subsequent

cracking of the pigments in the gastro-

intestinal tract, compared to lead(II)acetate.

2 (reliable with

restrictions)

key study

experimental result

Test material

(internal name):

Chromgelb 62 F

BASF AG (1974a)




distribution of lead

after acute oral

treatment of test rats

with test substance

rat (Sprague-Dawley)

male/female

oral: feed

Doses/conc.: 0, 2000,

5000 and 20000 ppm in

diet (corresponding to

appr. 152.9, 287.5 and

1602.1 mg/kg bw per

day considering mean

daily food consumption

of 76.5.2, 77.5 and

80.1 g/kg and mean

body weight of 274.3,

280.3 and 281.7 g)

OECD Guideline 408

(Repeated Dose 90-

Day Oral Toxicity in

Rodents) protocol

including

determination of blood

lead level and tissue


Noticeable increases were observed in the

blood lead concentrations of all test animals

after 30, 60, and 84 days of testing. The

increases in blood lead concentrations were

dose-related.

The lead content of the bone and kidney

samples was markedly increased among

animals fed 2000 ppm or more test

substance. The brain lead content (males

only) and liver lead content (males and

females) were slightly increased when

compared with control values.

Increases in chromium content were noted

in the kidney and liver tissues among most

test animals. The brain chromium content

was slightly increased among a few females

fed 2000 ppm or more and among the

males fed 20000 ppm. Brain chromium

content among male test animals fed 2000

or 5000 ppm was either less than or

comparable to that of the controls.

Increases in chromium content in bone

samples from animals fed either 5000 or

20000 ppm were due to detectable amounts

in 1 of 5 males fed 5000 ppm and in 1 of 5

females fed 20000 ppm. No detectable

amount of chromium was found in the bone

samples from any of the 2000 ppm animals

2 (reliable with

restrictions)

key study

experimental result

Test material (CI

name): CI Pigment

Yellow 34

BASF Farben &

Fasern AG

(1976a)

dog (Beagle)

male/female

oral: feed

Doses/conc.: 0, 2000,

5000 and 20000 ppm in

diet (corresponding to

appr. 75.4, 179.6 and

287.1 mg/kg bw per

day considering mean

weekly food

consumption of 264,

251.5 and 100.5 g/kg)

OECD Guideline 409

(Repeated Dose 90-

Day Oral Toxicity in

Non-Rodents) protocol

including

determination of blood

lead level and tissue


Blood lead concentrations at all three levels

of either lead carbonate or test substance

were elevated in a dose-correlated manner.

The lead content of liver, kidney, bone and

brain tissues was elevated at all levels of

either compound. Increases were directly

proportional to length of time on test and/or

dietary concentration. In dogs fed the 3

levels of lead carbonate, chromium content

in all 4 tissues was comparable to that seen

in untreated controls, either below

detectable limits or found in trace amounts

only.

2 (reliable with

restrictions)

key study

experimental result

Test material (CI

name): CI Pigment

Yellow 34

BASF Farben &

Fasern AG

(1976b)



5.1.2. Human information


5.1.3. Summary and discussion of toxicokinetics

No toxicokinetics study is available for C. I. Pigment Yellow 34, but information on distribution is available

from repeated dose toxicity studies. Furthermore, bioelution studies with C. I. Pigment Yellow 34 were

performed in simulated gastric, interstitial, intracellular and perspiration fluid to determine bioavailability for

absorption via the oral, inhalation and dermal route.

Information from repeated dose toxicity studies

In the first rat study the animals received one treatment (10000 mg/kg bw; Chromgelb 62 F, Chromgelb 72 GS

and the equivalent amount of lead in the form of lead(II) acetate as positive control) test substance by gavage

(BASF AG, 1974). In the remaining studies the animals received 0, 2000, 5000 and 20000 ppm test substance

(CI Pigment Yellow 34) in diet (corresponding to appr. 0, 152.9, 287.5 and 1602.1 mg/kg bw per day in rats and

to appr. 0, 75.4, 179.6 and 287.1 mg/kg bw per day in dogs). In the first study, lead content levels were

determined (atomic absorption spectroscopy; detection limit 1 µg) in kidneys and bone (femur) 14 days after

treatment. In the second and third studies, tissues and body fluids sampled - blood (lead); liver, kidney, brain,

and bone (lead and chromium) – were analyzed using atomic absorption spectrophotometry (limits of detection

and quantification: Pb 0.001 µg/g; Cr 0.010 µg/g in brain tissue; Cr 0.050 µg/g in bone, liver, and kidney).

Additional groups fed lead carbonate as positive control were also evaluated.

Blood Lead determination:

In both oral subchronic studies, noticeable and dose-related increases were observed in the blood lead

concentrations of all test animals after 30, 60, and 84 days of testing with test and positive control substances.

Tissue distribution:

1) Lead:

14 days after single oral administration of the test substance and the equivalent amount of lead in the form of

lead(II) acetate, the metal was detectable in kidneys and femurs of exposed animals.

The lead content of the bone and kidney samples was markedly increased at all levels in the subchronic studies.

The brain lead content (males only) and liver lead content (males and females) were slightly increased when

compared with control values in the rat subchronic study and in all sexes in the dog subchronic study. Increases

were generally directly proportional to length of time on test and/or dietary concentration.

2) Chromium:

2) Increases in chromium content were noted in the kidney and liver tissues among most test animals.

In the rat subchronic study, the brain chromium content was slightly increased among a few females fed 2000

ppm or more and among the males fed 20000 ppm. Brain chromium content among male test animals fed 2000

or 5000 ppm was either less than or comparable to that of the controls. Increases in chromium content in bone

samples from animals fed either 5000 or 20000 ppm were due to detectable amounts in 1 of 5 males fed 5000

ppm and in 1 of 5 females fed 20000 ppm. No detectable amount of chromium was found in the bone samples

from any of the 2000 ppm animals.

Following observations were made in the dog subchronic study:

- At 2000 ppm test substance, chromium content was elevated in all 4 tissues examined, the liver showing the

highest concentration, kidneys the next highest, then bone; brain tissue showed the lowest concentration.

- At 5000 ppm, a similar pattern of elevations was seen, with the concentrations in kidney, bone and brain

tissues essentially comparable to those found in 2000 ppm animals. However, in liver tissue, the chromium

content in 2000 ppm animals was considerably higher than that found in 5000 ppm animals, though both levels

were tested for 90 days.



- At 20000 ppm, chromium content of liver and kidney tissues was much lower than that found in either 2000 or

5000 ppm dogs and in bone, chromium was below detectable limits. These findings correlate with the short time

(3 weeks) the animals were on test. In brain tissue, however, chromium content was comparable to

concentrations found at the 2 lower levels.

Bio-elution studies

The bio-elution potential of C. I. Pigment Yellow 34 and C. I. Pigment 104 was determined in four kinds of

simulated body fluids: gastric, interstitial, intracellular and perspiration fluid, to determine bioavailability of

chrome and lead for absorption. Incubation times were 2h for gastric fluid, and 24h and 7 days for interstitial,

intracellular and perspiration fluid. Chrome and lead concentrations were measured by ICP-MS analysis.

Results show highest bio-elution in gastric fluid, in which 22-24% of chromium and 23-26% of lead dissolved.

For chromium, the percentages dissolved were 8.34 and 1.33% in interstitial, 3.44 and 3.77% in intracellular and

0.07 and 0.08% in perspiration fluid, for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 respectively. For

lead, the percentages dissolved were 0 and 0.02% in interstitial, 4.17 and 9.37% in intracellular and 1.64 and

1.8% in perspiration fluid, for C.I. Pigment Yellow 34 and C.I. Pigment Red 104 respectively.

The values may be used to determine bioavailability of lead and chrome for absorption via the different

exposure routes. The relatively high percentage of dissolved chrome and lead in simulated gastric fluid indicates

that the highest bioavailability will result from oral exposure. Interstitial fluid may be a measure for dissolution

in lung fluid and bioavailability after inhalation. The low dissolution of lead in this fluid indicates that lead will

not be very bioavailable via this route, whereas for chromium bioavailability is relevant via inhalation.

Bioavailability via dermal absorption may be indicated by dissolution in perspiration fluid. This is very low for

chromium (<0.1%) and therefore dermal absorption will not be relevant for chromium. Lead dissolution from C.

I. Pigment Yellow 34 and C. I. Pigment Red 104 in perspiration fluid is less than 1.8%. Therefore,

bioavailability of lead for dermal absorption will also be very low.

The following information is taken into account for any hazard / risk assessment:

BIOAVAILABILITY FOR ABSORPTION

Bioelution test with simulated gastric, interstitial, intracellular and perspiration fluid show highest

bioavailability of both lead and chromium for oral absorption. The low dissolution of lead in interstitial fluid

indicates that lead will not be very bioavailable via this route, whereas for chromium bioavailability is relevant

via inhalation. Bioavailability via dermal absorption may be indicated by dissolution in perspiration fluid. This

is very low for chromium and therefore dermal absorption will not be relevant for chromium. Lead

concentrations in perspiration fluid are <2%, therefore bioavailability for dermal absorption will also be very

low.

DISTRIBUTION OF TEST SUBSTANCE METABOLITES

Blood lead, chromium and/or molybdenum blood absorption and tissue distribution were observed in oral

subchronic toxicity studies in rat (BASF AG, 1974; Report No: XXIV/61, BASF Farben & Fasern AG, 1976;

Report No: 622-06329) and in dogs (BASF Farben & Fasern AG, 1976; Report No: 611-06328).

5.2. Acute toxicity


5.2.1.1. Acute toxicity: oral

The results of studies on acute toxicity after oral administration are summarised in the following table:

Table 22. Studies on acute toxicity after oral administration


rat (Sprague-Dawley) male/female

oral: gavage

equivalent or similar to OECD

LD50: > 10000 mg/kg bw

(male/female) (no mortality at

this unique dose level)

2 (reliable with

restrictions)

key study

BASF AG (1974b)




Guideline 401 (Acute Oral Toxicity)

(test substance evaluated at unique

10000 mg/kg dose level)

experimental result

Test material

(internal name):

Chromgelb 62 F


oral: gavage


Guideline 401 (Acute Oral Toxicity)

(test substance evaluated at unique

10000 mg/kg dose level)

LD50: > 10000 mg/kg bw

(male/female) (no mortality at

this unique dose level)

2 (reliable with

restrictions)

key study

experimental result

Test material

(internal name):

Chromgelb 72 GS

BASF AG (1974c)

5.2.1.2. Acute toxicity: inhalation

Data waiving

Information requirement: Acute toxicity after inhalation exposure


Justification: The substance is a genotoxic carcinogen and exposure is minimized. Further acute toxicity

testing is therefore not warranted.

5.2.1.3. Acute toxicity: dermal

Data waiving

Information requirement: Acute toxicity after dermal administration


Justification: The substance is a genotoxic carcinogen and exposure is minimized. Further acute toxicity

testing is therefore not warranted.

5.2.1.4. Acute toxicity: other routes




5.2.3. Summary and discussion of acute toxicity

In the 2 available studies, rat (Sprague-Dawley; 5 animals per sex) were treated (gavage) with test substance

suspended in 0.5% aqueous CMC (concentration of test substance in vehicle: 35%). Daily check for mortality

and clinical signs were performed up to 14 days after treatment, as well as pathological analysis of death and

survivors animals at necropsy.

No mortality, clinical signs or abnormalities were observed at dose levels up to 10000 mg/kg bw with rats. The

urine and feces were discolored during the first days post substance application. The LD50 was determined to be

in excess of 10000 mg/kg bw in rats.

The acute dermal and inhalation toxicity was not tested.




Two acute oral studies are available (BASF AG, Report No XXIV/62, 08 Oct 1974; BASF AG, Report No

XXIV/61, 08 Oct 1974) all comparable to OECD guideline 401 but were conducted prior to the existence of

guidelines. The LD50 was determined in the 2 studies to be higher than 10000 mg/kg bw.

Justification for classification or non classification

Because the LD50 exceeds the classification limit of 5,000 mg/kg bw (GHS) and 2,000 mg/kg bw

(67/548/EEC), a classification is not warranted.

5.3. Irritation

5.3.1. Skin

5.3.1.1. Non-human information

The results of studies on skin irritation are summarised in the following table:

Table 23. Studies on skin irritation


rabbit (New Zealand

White)

Coverage: semiocclusive

(shaved)

Vehicle: water

OECD Guideline 404

(Acute Dermal Irritation /

Corrosion)

not irritating

Erythema score:

0.3 of max. 4 (animal #1) (Time point:

24-72 h) (fully reversible within: 72 h)

0 of max. 4 (animal #2) (Time point:

24-72 h) (fully reversible within: 72 h)

0.66 of max. 4 (animal #3) (Time

point: 24-72 h) (fully reversible

within: 72 h)

Edema score:

0 of max. 4 (mean) (Time point: 24-72

h) (no effects)

2 (reliable with

restrictions)

key study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

Ciba-Geigy LTD

(1983)

5.3.1.2. Human information


5.3.2. Eye


The results of studies on eye irritation are summarised in the following table:

Table 24. Studies on eye irritation


rabbit (Vienna White)

Vehicle: unchanged (no

vehicle)

BASF test

not irritating

Cornea score:

0 of max. 4 (mean) (Time point: 24-

48-72 hour) (not applicable)

Iris score:


2 (reliable with

restrictions)

key study

experimental result

Test material

(Common name):

BASF AG (1967)




48-72-hour) (not applicable)

Conjunctivae score:



Chemosis score:



Molybdate red

rabbit (New Zealand

White)

Vehicle: unchanged (no

vehicle)

OECD Guideline 405

(Acute Eye Irritation /

Corrosion)

not irritating

Cornea score:

0.44 of max. 4 (mean) (Time point:

24-48-72 hour) (fully reversible

within: 72 hours)

Iris score:



Conjunctivae score:



within: 72 hours, 7 days and 14 days,

respectively in the 3 tested animals)

Chemosis score:



within: 72 hours and 7 days,

respectively in the 2 tested animals

with positive responses)

1 (reliable without

restriction)

key study

experimental result

Test material

(Common name):

Molybdate Orange

Ciba-Geigy

Limited (1986)



5.3.3. Respiratory tract




5.3.4. Summary and discussion of irritation

Skin irritation:

One study with conducted according to the OECD guideline 404 (Acute Dermal Irritation/Corrosion; Ciba-

Geigy LTD, 1983 is available, where the test substance is reported to be not irritating to the rabbit skin.

Eye irritation:

The eye irritation capacity of the test substance can be evaluated based on structure analogy to CI Pigment Red

104 (CAS No: 12656-85 -8) which was shown in at least two studies (one according to the OECD Guideline

405: Acute Eye Irritation / Corrosion) to be not irritating to the rabbit eye.



Respiratory irritation: No data available


One unpublished skin irritation study performed according to the OECD gruideline 404 (Ciba-Geigy LTD,

1983) is available. No conclusive eye irritation study is available, the eye irritation capacity can however be

evaluated based on the structure analogy to CAS No: 12656-85-8. The substance is neither irritating to the eye

nor to the skin

Value used for CSA:

Skin irritation / corrosion: No adverse effect observed (not irritating)

Eye irritation / corrosion: No adverse effect observed (not irritating)


Based on the available information on skin/eye irritation, a classification of the test substance is not warranted

based on EU- and GHS criteria.

5.4. Corrosivity


Please refer to Chapter 5.3



5.4.3. Summary and discussion of corrosion


5.5. Sensitisation

5.5.1. Skin


The results of studies on skin sensitisation are summarised in the following table:

Table 25. Studies on skin sensitisation


review of available information

Review based on different types

of study

Induction: review of available

information

Challenge: review of available

information

Vehicle: not applicable

Information from European

sensitising 2 (reliable with

restrictions)

key study

read-across

based on

grouping of

substances

(category

approach)

Test material:

Chromium

European Union

(2005)




Risk Assessment Report in

which available information on

skin sensitising properties of

hexavalent chromium

compounds was reviewed.

compounds

Form: not

applicable



5.5.2. Respiratory system





5.5.3. Summary and discussion of sensitisation

Skin sensitisation

In the European Union Risk Assessment Report (RAR) on Chromium trioxide, Sodium chromate, Sodium

dichromate, Ammonium dichromate, and Potassium dichromate, the skin sensitizing potential of these

Chromium compounds was reviewed. Skin sensitization has been demonstrated in workers who were exposed to

hexavalent Chromium compounds. Patch testing of contact dermatitis patients and other investigations of

different occupational groups confirm skin sensitizing potential. Furthermore, available animal studies,

including standard and modified guinea pig maximization tests and a mouse ear swelling test, confirm the skin

sensitizing potential of hexavalent Chromium compounds.


Review hexavalent Chromium compounds: skin sensitiser

Value used for CSA: Adverse effect observed (sensitising)

Respiratory sensitisation

In the European Union Risk Assessment Report (RAR) on Chromium trioxide, Sodium chromate, Sodium

dichromate, Ammonium dichromate, and Potassium dichromate, the respiratory sensitizing potential of these

Chromium compounds was reviewed.

Based on the available case reports and evidence from well-conducted bronchial challenge tests, it is concluded

that hexavalent Chromium compounds can cause occupational asthma and should therefore be classified as

respiratory sensitiser.


Review hexavalent Chromium compounds: respiratory sensitising

Value used for CSA: Adverse effect observed (sensitising)


Based on the skin and respiratory sensitising properties of hexavalent Chromium compounds, C. I. Pigment

Yellow 34 should be classified as skin and respiratory sensitiser in accordance with the criteria outlined in

Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.



5.6. Repeated dose toxicity


5.6.1.1. Repeated dose toxicity: oral

The results of studies on repeated dose toxicity after oral administration are summarised in the following table:

Table 26. Studies on repeated dose toxicity after oral administration



subchronic (oral: feed)

0, 2000, 5000 and 20000 ppm in diet

(corresponding to appr. 153, 288 and

1600 mg/kg bw per day considering

mean daily food consumption of

76.5.2, 77.5 and 80.1 g/kg and mean

body weight of 274.3, 280.3 and

281.7 g) (nominal in diet)

Vehicle: unchanged (no vehicle)

Exposure: 90 days (daily)


Guideline 408 (Repeated Dose 90-

Day Oral Toxicity in Rodents)

(blood lead level and tissue

distribution of lead were also

evaluated)

NOEL: 288 mg/kg bw/day

(actual dose received in diet)

(male/female)

LOAEL: ca. 1600 mg/kg

bw/day (actual dose received

in diet) (male/female) (overall

effects

organ weights, solely based

on the impaired kidney and

liver weight)

2 (reliable with

restrictions)

key study

experimental result

Test material (CI

name): CI Pigment

Yellow 34

BASF Farben &

Fasern AG

(1976c)

TSCATS (1992)

dog (Beagle) male/female


0, 2000, 5000 and 20000 ppm in diet

(corresponding to appr. 75.4, 179.6

and 287.1 mg/kg bw per day

considering mean weekly food

consumption of 264, 251.5 and

100.5 g/kg) (nominal in diet)





Day Oral Toxicity in Non-Rodents)



evaluated)

LOAEL: ca. 75.4 mg/kg

bw/day (actual dose received

in diet) (male/female)

(hematological changes;

lesions involving the kidney,

bone marrow, intestines and

liver)

2 (reliable with

restrictions)

key study

experimental result

Test material

(Common name):

CI Pigment Yellow

34

BASF Farben &

Fasern AG

(1976d)

Christofano GE,

Kennedy GL,

Gordon JrDE,

Keplinger ML and

Calandra JC

(1976)

rat (albino rats) male/female


0, 2000, 5000 and 20000 ppm in diet


Increased kidney weight and

kidney to body weight ratios

were observed at all levels

with white lead, at the mid-

and high-dose with molybdate

orange and light chrome

2 (reliable with

restrictions)

supporting study

experimental result

Kennedy JL,

Konoshita DrFS,

Keplinger YL and

Calandra JC

(1975a)





daily food consumption of 22.1 g per

animal and mean body weight of

278.9 g) (nominal in diet)








evaluated)

yellow, and at the high dose

with medium chrome yellow

and primrose chrome yellow.

Histopathological effects were

also observed in kidneys.

Test material

(Common name):

Molybdate Orange



0, 2000, 5000 and 20000 ppm in diet



daily food consumption of 246 g per

animal and mean body weight of 6.9

kg) (nominal in diet)


Exposure: 90 days (diets were

offered ad libitum during a 5 hour

period on each of 90 consecutive

days)






evaluated)

All of the pigments

investigated exerted effects

which were qualitatively

analogous to those seen with

white lead. The effects

observed were those to be

expected from excessive

exposure to lead and were less

severe or slower to appear

with the test pigments than

with equal doses of white

lead. This also was to be

expected in view of the lower

lead content of the test

pigments and the lower

solubility of this lead in dilute

acid. It is apparent, however,

that the lead as it exists in the

test pigments is available for

absorption to some extent.

2 (reliable with

restrictions)

supporting study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

Kennedy JL,

Konoshita DrFS,

Keplinger YL and

Calandra JC

(1975b)

5.6.1.2. Repeated dose toxicity: inhalation


5.6.1.3. Repeated dose toxicity: dermal


5.6.1.4. Repeated dose toxicity: other routes




5.6.3. Summary and discussion of repeated dose toxicity

In a 90 study, rats (20/sex/dose) were fed dietary concentrations of 2,000, 5,000 or 20,000 ppm of the test

substance, which corresponds to approximately 160, 400 and 1600 mg test substance/kg bw, respectively.



Treatment related mortality did not occur and food consumption as well as body weights were comparable to

control animals. Hematology, clinical blood chemistry and gross pathological findings did not differ

significantly between the dose group and control group animals. Aminolevulinic acid was slightly elevated

among males fed 2,000 ppm at examination days 30 and 60 only. Blood lead concentrations were elevated in a

dose-related manner. The lead content of the bone and kidney samples was markedly increased among the test

animals. The brain lead content (males only) and liver lead content (males and females) were only slightly

increased when compared with those of the controls. The chromium content was increased in the kidney and

liver tissues among most test animals. Brain chromium content was slightly elevated among a few females fed

2,000 ppm or more and among the males fed 20,000 ppm. Brain chromium content among males fed 2,000 or

5,000 ppm was either less than, or comparable to, that of the controls. Increases in chromium content in bone

samples from animals fed either 5,000 or 20,000 ppm were due to detectable amounts in the bone samples from

1 animal from each of these levels. No detectable amount of chromium was found in the bone samples from any

of the animals fed 2,000 ppm. The absolute liver and relative kidney and liver weights were significantly

elevated in males fed 20,000 ppm, however, treatment-related histopathological changes were not noted upon

microscopic examination.

In a further 90 day study, beagle dogs (4/sex/dose) were fed dietary concentrations of either 2,000, 5,000 or

20,000 ppm (ca. 70, 180 and 700 mg/kg bw, respectively) of the test material (groups T-I, T-II and T-III,) or

100, 300 or 1,000 ppm of lead carbonate (groups PC-I, PC-II and PC-III). All but one of the T-III animals were

sacrificed in extremis which precluded a meaningful examination of these animals. Body weight development

was not affected in animals fed 2,000 ppm of the test material or 100 ppm of lead carbonate. Animals of the

other T- or PC-groups showed a dose-related increase in body weight suppression, severely so in T-III animals.

Abnormal behavioral reactions were not observed in any of the T-group or PC-group animals. The lead content

of liver, kidney, bone and brain tissues was elevated at all levels of either compound. Increases were directly

proportional to the length of time on test and/or dietary concentration. In dogs fed the 3 levels of lead carbonate,

chromium content in all 4 tissues was comparable to that seen in untreated controls, either below detectable

limits or found in trace amounts only. At 2,000 ppm test material, chromium content was elevated in all 4

tissues examined, the liver showing the highest concentration, kidneys the next highest, then bone; brain tissue

showed the lowest concentration. At 5,000 ppm, a similar pattern of elevations was seen, with the

concentrations in kidney, bone and brain tissues essentially comparable to those found in 2,000 ppm animals.

However, in liver tissue, the chromium content in 2,000 ppm animals was considerably higher than that found in

5,000 ppm animals, though both levels were tested for 90 days. At 20,000 ppm, chromium content of liver and

kidney tissues was much lower than that found in either 2,000 or 5,000 ppm dogs and in bone, chromium was

below detectable limits. These findings correlate with the short time (3 weeks) the animals were on test. In brain

tissue, however, chromium content was comparable to concentrations found at the 2 lower levels.

Hematological studies revealed treatment related effects in parameters related to hematopoiesis (hemoglobin,

hematocrit: decrease) and additionally, a decrease in the mean corpuscular volume, segmented neturophils,

banded neutrophils and changes in the erythrocyte morphology (nucleation, size alteration, color alteration)

were observed. Blood chemistry revealed no relevant changes related to the treatment with either lead carbonate

or the test substance.

Organ weights were unaffected by the treatment with the test substance. Treatment-related lesions observed by

light microscopy occurred in dogs fed either lead carbonate or the test substance. The nature and severity of the

lesions varied, but, in most instances, these lesions were related to either the compound fed, dose level, or length

of exposure. Renal and bone marrow lesions occurred among dogs fed 1,000 ppm of lead carbonate (PC-III

group). The kidney lesions consisted of focal degenerative tubular changes which affected all dogs in this group.

Dose-related lesions involving either the kidney, bone marrow, and/or liver were present among dogs in all

groups fed the test material. There were focal degenerative lesions present involving kidney tubules which

affected a few T-I and most T-II and T-III dogs. Hypocellularity of the sternal bone marrow occurred in 2 of the

T-III animals. The liver lesion, present in 6 of the 8 T-III animals, was characterized by degeneration and

necrosis of hepatocytes located predominantly in the centrilobular region of the liver lobules.

Testicular lesions consisting of either hypospermatogenesis, focal testicular degeneration, or both, occurred

among most of the males of all 3 dose groups of dogs fed lead carbonate. No adverse effects were noted in the

ovaries and uterus of females after they were fed lead carbonate for 90 days. The exact cause for the gonadal

lesions among males fed lead carbonate was not determined. These lesions probably resulted from impairment

in their nutritional status with delayed development of puberty. These lesions were regarded as an indirect effect

rather than a direct effect of lead carbonate on the testes. Males of all 3 test groups had focal testicular

degeneration which was most severe among the T-III group. The gonadal lesions present among animals fed the

test substance appeared to be primarily related to the age of animal at time of sacrifice and only indirectly



related to ingestion of the test material. In the gastrointestinal tract of some of the positive control and test

animals, there was increased mitotic activity of the mucosal epithelial cells located in the glandular crypts. This

finding was regarded as a regenerative change indicative of an increased rate of proliferation of mucosal cells. It

was noted throughout the gastrointestinal tract, but was most pronounced in the distal portion (ileum) of the

small intestine.

In conclusion, the test substance's bioavailability was conclusively shown by findings of lead and chromate ions

in several tissues, independent of the species tested. Also, although the dog seems to be the more sensitive

species, the target organs (liver and kidney) seem to be identical. Hematopoiesis was affected in the dog and

early signs (increase in) was also seen in the rat. Although neurotoxicity was not specifically assessed, abnormal

behavior was not noted in either the rat or the dog.


Two subchronic studies are used for endpoint assessment, one in rats (BASF Farben & Fasern AG, 1976; Report

No 622-06329) and one in beagle dogs (BASF Farben & Fasern AG, 1976; Report No 611-06328). Rats and

dogs were dosed at 2000, 5000 and 20,000 ppm in the feed in 90 day studies that are similar to OECD guideline

408 and 409, respectively, although ophthalmological examinations were not performed. Lead carbonate was

given to the dogs as a positive control substance in concentrations of 100, 300 or 1000 ppm in the diet. In rats,

mortality was not significantly elevated and lesions involved mainly relative weight fo the kidneys, however

without histopathological changes. In dogs, all but one of the high dose animals died. Leasions involved mainly

the kidney and the liver. Hematological changes were also observed in a dose-dependent manner. The mid dose

was determined as the NOAEL in the rat study, however, in the dog study, no NOAEL could not be determined.

Two additional subchonic studies are also available (Kennedy et al., 1975), also conducted in rats and in Beagle

dogs, where lead and lead containing pigments were evaluated. Although the exerted effects were qualitatively

similar, they were in general more severe or earlier in appearance with white lead than with the pigments of

lower lead content. Medium Chrome Yellow, which was the lowest content of acid soluble lead, was clearly less

effective than White Lead or the other pigments of similar lead content but for the group of pigments, the effects

could not be quantitatively related to lead or chromium content or to acid soluble lead.

Value used for CSA (via oral route - systemic effects):

(LOAEL: 70 mg/kg bw/day) (subchronic; dog)

Target organs: cardiovascular / hematological: hematopoiesis; digestive: liver; urogenital: kidneys


The accumulation of lead ions in different tissues in a time and dose-dependent manner justifies a classification

with R33 according to EU-criteria and STOT repeated exposure Cat. 2. A further classification is not warranted

because of the R45 / Carc. Cat. 1B categorization (see carcinogenicity).

5.7. Mutagenicity


5.7.1.1. In vitro data

The results of in vitro genotoxicity studies are summarised in the following table:

Table 27. In vitro genotoxicity studies


bacterial reverse mutation assay

(e.g. Ames test) (gene mutation)

S. typhimurium TA 100 (met.

act.: with and without)

Test concentrations: 0.2, 0.4, 0.8

or 1.6 µg/plate (as (Cr(VI)

determined by atomic absorption

Test results:

positive (only in the presence

of NaOH (with and without

metabolic activation) or of

NTA and without metabolic

activation) for S. typhimurium

TA 100(all strains/cell types

tested (Salmonella

2 (reliable with

restrictions)

key study

experimental result

Test material

(Common name):

Venier P, Montaldi

A, Gava C,

Zentilin L,

Tecchio G,

Bianchi V,

Psglialunga (1985)




spectrophotometry

Positive control substance(s):

Aminofluorene (Fluka, Buchs,

Switzerland) and methyl

methanesulphonate (Merck,

Darmstadt, West Germany)

Ames test

typhimurium TA100)) ; met.

act.: with and without ;

cytotoxicity: yes (in the

presence of NaOH or 100

mg/ml NTA at test substance

concentration levels of 0.8 or

1.6 µg/plate in the absence of

metabolic activation) ; vehicle

controls valid: yes; positive

controls valid: yes

Chromates

sister chromatid exchange assay

in mammalian cells (DNA

damage and/or repair)

pseudodiploid CHO Kt Chinese

hamster fibroblast line (kindly

supplied by Dr. Nuzzo F, Inst of

Biochemical and Evolutionary

Genetics, CNR,Pavia, Italy) (met.

act.: with and without)

Test concentrations: 0.1µg/ml


Additional test compunds showed

positive results


Guideline 479 (Genetic

Toxicology: In Vitro Sister

Chromatid Exchange Assay in

Mammalian Cells)

Test results:

positive (the frequency of SCE

was directly increased (Table

1), due to the relatively long

exposure times (30 h) and the

ability of mammalian cells to

take up insoluble Cr particles

by endocytosis. NTA increases

the ability of all the Cr(VI)

compounds to induce SC) for

Chinese hamster Ovary

(CHO)(all strains/cell types

tested) ; met. act.: with and

without ; cytotoxicity: not

determined ; vehicle controls

valid: yes; negative controls

valid: yes; positive controls

valid: not applicable

2 (reliable with

restrictions)

key study

experimental result

Test material

(Common name):

Chromates

Venier P, Montaldi

A, Gava C,

Zentilin L,

Tecchio G,

Bianchi V,

Psglialunga (1985)

in vitro mammalian chromosome

aberration test and sister

chromatid exchange assay in

mammalian cells (DNA damage

and/or repair)

CHO-Zellen (met. act.: without)

Test concentrations: 0, 5, 25, 150

µg/mL

Positive control substance(s): see

above

Method: Levis AG et al. (1979),

Br J Cancer 40: 523

Test results:

positive(all strains/cell types

tested) ; met. act.: without ;

cytotoxicity: cell growth was

48% of control at

concentration level of 150

µg/ml ; vehicle controls valid:

yes; negative controls valid:

yes; positive controls valid:

additional compounds were

also tested showing positive

results (Table 1)

2 (reliable with

restrictions)

key study

experimental result

Test material

(Common name):

chromium yellow

Levis AG and

Majone F (1981)

IARC Monographs

(1990)

5.7.1.2. In vivo data

The results of in vivo genotoxicity studies are summarised in the following table:

Table 28. In vivo genotoxicity studies


micronucleus assay (chromosome

aberration)

Test results:

Genotoxicity: negative (No

2 (reliable with

restrictions)

Odagiri Y et al.

(1989)




mouse (ICL-ICR) female

intraperitoneal

25, 50, 100 and 2x 100 mg/kg bw

(actual injected (ip))


mitomycin C

- Route of administration: ip

- Doses / concentrations: 2.5

mg/kg bw

Mouse bone marrow

micronucleus test

significant induction of

micronuclei was observed in

bone marrow erythrocytes of

mice treated with any of the

pigments (Table 1). In

contrast, the animals treated

with sodium dichromate

showed a significantly

increased number MNPCEs)

(female); toxicity: no effects

(the compounds, ZPC (zinc

potassium chromate) and ZTO

(zinc tetroxychromate), also

examined in the study showed

cytotoxicity at the highest dose

levels as evidenced by the

significant reduction in PCEs

frequency.) ; vehicle controls

valid: yes; negative controls

valid: some of the chemicals

tested also shwon negative

results; positive controls valid:

yes

key study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow



5.7.3. Summary and discussion of mutagenicity

Two Ames mutagenicity tests in S. typhimurium TA100 are available that were done with and without S9

metabolic activation at concentrations of 0.2 -1.6 and 10 -500 µg/plate, respectively. Neither test followed a

specific guideline. The former test proofed positive even at these very low concentrations of 0.2 -1.6 µg/plate,

the latter was negative on account of a coating that reduced the availability of the toxicophore chromium(VI).

Two sister chromatide exchange assays, one conducted similar to the OECD guideline 479 protocol, were

positive in chinese hamster ovary cells at concentrations of 0.1 or 5 -150 µg/mL. Exposure of the same cell line

in chromosomal aberration tests (one similar to the OECD guideline 479 protocol) did not lead to an increase in

chromosomal aberrations at concentrations of 5 µg/L -5 mg/L. An in vivo mincronucleus test that was

conducted at concentrations of 15, 50 and 2x 100 mg/kg bw with intraperitoneal administration of chrome

yellow in comparison with soluble chromates was negative. The soluble compounds (zinc potassium chromate,

zinc tetroxy chromate and sodium dichromate) were all tested positive at concentrations up to 50 mg/kg bw.


Several in vitro studies addressing Ames-mutagenicity, sister chromatid exchange and chromosomal aberration

are available. Most of them do not follow a guideline but all give a positive result if there were done with

uncoated material in the presence of a metabolizing system. Additionally, an in vivo micronucleus test is

available with intraperitoneal adminstration of 25, 50 and 100 mg/kg bw of the test material that proofed

negative.


Although most in vitro genotoxicty tests were positive, a genotoxic potential could not be verified in vivo.

Therefore, a classification is not warranted.

However, the negative results in the micronucleus test of the test substance, which presented a very low water

solubility (1%; as opposed to 6-8% for zinc potassium chromate or to 2380 g/l for sodium dichromate), are

likely not reliable, because the treatment the chemical did not show evidence for absorption and transport to the

bone marrow, as evidenced by a lack of reduction in PCEs frequency. Thus, although the in vivo genetic toxicity



test gave negative, chromium and its compounds, particularly chromium(VI), may cause chromosomal effects,

indicating carcinogenic potential because interactions with DNA have been linked with the mechanism of

carcinogenicity.

5.8. Carcinogenicity


5.8.1.1. Carcinogenicity: oral

The results of studies on carcinogenicity after oral administration are summarised in the following table:

Table 29. Studies on carcinogenicity after oral administration


mouse (B6C3F1) male/female

oral: drinking water

Group 1 (nominal in water (14.3

mg/L (males and females)))


mg/L (males); 57.3 mg/L (females)))


mg/L (males); 172 mg/L (females)))


mg/L (males); 516 mg/L (females)))

Exposure: 2 years (daily, through

drinking water)

Occupational Exposure Limit

(carcinogenicity): ca. 0.00022

mg/kg bw/day (male/female)

based on: test mat. (An oral

"reference value" of 0.22 µg

Cr(VI)/kg body weight/day

was derived)

Neoplastic effects: yes (See

details on results)

2 (reliable with

restrictions)

key study

read-across based on

grouping of

substances (category

approach)

Test material

(other): Hexavalent

chromium

I. Dewhurst (2013)

Author unknown

(2008)

5.8.1.2. Carcinogenicity: inhalation


5.8.1.3. Carcinogenicity: dermal


5.8.1.4. Carcinogenicity: other routes


The results of studies on carcinogenicity (other routes) are summarised in the following table:

Table 30. Studies on carcinogenicity (other routes)


rat (Wistar) male/female

(intra-bronchially)

Vehicle: test substance was

suspended in cholesterol acting as an

inert carrier material

Exposure: The stainless-steel wire-

mesh pellets were designed to

It is felt that the present study

more accurately represents the

potential of lead chromate-

containing materials as

possible lung carcinogens,

and that lead chromate is non-

carcinogenic or has an

extremely low carcinogenic

potential under the conditions

2 (reliable with

restrictions)

key study

experimental result

Test material

(Common name):

lead chromate

Levy LS, Martin

PA, and Bidstrup

PL (1985)




progressively released the test

substance (once)

A stainless-steel wire-mesh pellet

with anchoring hooks is loaded with

of test substance was surgically

implanted (intra-bronchially) into the

lower left bronchus of rat. This

enables a selected zone of bronchial

epithelium to be exposed for a

continuing period. The rat was then

allowed to live for two years at

which time the study is terminated

and the lung and any abnormal tissue

examined.

of this bioassay system.

However, given the rarity of

squamous bronchial

carcinoma in control rats, it is

important to consider the

relevance of this carcinogenic

potential.

Review on studies from public

literature reporting on occupational

Cr(VI) exposure and cancers of the

respiratory tract

(review of inhalation exposure)

Exposure: Not applicable


(OEL) (carcinogenicity): ca.

0.01 µg/m3 (male/female)

based on: test mat.

(Occupational Exposure Level

(OEL) associated with 4

excess lung cancer case per

100,000 workers for life time

exposure to hexavalent

chromium of 0.01 µg/m3)

2 (reliable with

restrictions)

key study


grouping of


approach)

Test material

(other): Hexavalent

chromium

compounds

Seidler et al.

(2012)

review of all available information

on animal and human data

(review of all available routes of

exposure)

Exposure: Not applicable


(OEL) (carcinogenicity): ca.

0.0167 ug/m3 (male/female)

based on: test mat.

(Occupational Exposure Level

(OEL) associated with 1

excess lung cancer case per

100,000 workers for life time

exposure to hexavalent

chromium of 1/(100*0.6) =

0.0167 µg/m3)

2 (reliable with

restrictions)

supporting study


grouping of


approach)

Test material:

Hexavalent

Chromium

compounds

Scientific

Committee on

Occupational

Exposure Limits

(2004a)


(subcutaneous)

30 mg/animal (corresponding to 120

mg/kg bw assuming a mean body

weight of 250 g for adult animals)

(actual injected)

Vehicle: water

Exposure: only one treatment (single

application)

evaluation of carcinogenicity of test

substance in rats after subcutaneous

the only dose evaluated was

carcinogenic

(carcinogenicity): 30

mg/animal (male/female)

(Rhabdomyosarcomas and

fibrosarcomas were observed

in 26/40 animals)

2 (reliable with

restrictions)

supporting study

experimental result

Test material

(Common name):

lead chromate

Maltoni C et al

(1999)

Maltoni C (1976a)

Maltoni C (1976b)

TSCATS (1983a)




injection

rat (Wistar) male/female

(intratracheal implantation)

see below (ca 250 mg/animal

(corresponding to ca 1000 mg/kg bw

assuming mean body weight of 250

g for adult rats; see below))

Vehicle: cholesterol (50:50

suspension with test substance, 10 g

each)

Exposure: 2 years (continuous (the

pellet implantation enables a selected

zone of bronchial epithelium to be

exposed to a putative carcinogen for

a continuing period.The pellet

implantation enables a selected zone

of bronchial epithelium to be

exposed to a putative carcinogen for

a continuing period))

conducted in accordance with the

guidelines published by the Food

and Drug Administration (FDA) in a

document entitled "Nonclinical

laboratory studies-proposed

regulations for good laboratory

practice" (1976).

the only dose evaluated

indicated possible

carcinogenicity

(carcinogenicity): ca. 1000

mg/kg bw (contained in the

implanted pellet)

(male/female) (1 bronchial

carcinoma observed in one

male, and the incidence of

lung squamous metaplasia

was higher compared to

controls (2x))

2 (reliable with

restrictions)

supporting study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

Levy LS, Martin

PA and Bidstrup

PL (1986)

TSCATS (1983b)

review of all available information

on animal and human data

(review of all available routes of

exposure)


(OEL) (toxicity): ca. 100

ug/m3 (male/female) based

on: test mat. (Occupational

Exposure Level (OEL) based

on neurobehavioural adverse

effects in workers exposed to

lead, equivalent to a

concentration of 25 μg Cr/m3.

The carcinogenic potential is

expected to be low, based on

the low solubility of lead

chromate.)

2 (reliable with

restrictions)

supporting study


grouping of


approach)

Test material: Lead

Chromate

Scientific

Committee on

Occupational

Exposure Limits

(2004b)


The exposure-related observations in humans are summarised in the following table:

Table 31. Exposure-related observations on carcinogenicity in humans


Study type: cohort study (prospective)

Type of population: occupational

Details on study design: HYPOTHESIS

TESTED (if cohort or case control

EXPOSURE

- Average concentrations: could

not be determined due to the

changes (ameliorations)

occurring progressively in the

2 (reliable with

restrictions)

key study

Test material

Haguenoer JM,

Dubois G,

Frimat P,

Cantineau A,

Lefrancois H

and Furon D




study): respiratory tract tumor deaths

induced by the test material

METHOD OF DATA COLLECTION

- Type: recensement

STUDY PERIOD: Jan 1, 1958 -

December 31 1977

STUDY POPULATION

- Total population (total no. of persons in

cohort from which the subjects were

drawn): 251 active workers during the

study period (working in the factory at

least for 6 months, starting before 1978

and still alive in 1958).

- Selection criteria: workers in the factory

at least for 6 months, still alive in 1958

and having start the work in the plant

before 1978.

- Sex/age/race: man

- Total number of subjects at end of

study: 201

COMPARISON POPULATION

- Type: population of the department of

North, France

- Details: statistics of the reference

population were available (from 1958 to

1977), with the numbers of respiratory

tract (non secondary tracheal, bronchial

and pulmonar) tumor related, as well as

total deaths, each 10 years.

HEALTH EFFECTS STUDIED

- Disease(s): respiratory tract tumor

- Diagnostic procedure: cytology and

histology (Biopsy).

Endpoint addressed: carcinogenicity

production.

INCIDENCE / CASES

- Incidence/ Number of cases for

each disease / parameter under

consideration: 30 (from a total

of 50) deaths were attributable

to pulmonary tumor (11), infarct

(3), vasculocerabral accident

(2), cerebral tumor (2), suicide

(2), pulmonary acute edema (1),

acute respiratory insufficiency

(1), pancreatite (1), arterite (1),

accident (1), intoxication (1),

renal insufficiency (1), liver

tumor (1), gastrointestinal tumor

(2). The reason for the

remaining deaths could not be

determined.

(Common

name): lead

chromate

(1981)

5.8.3. Summary and discussion of carcinogenicity

Several review reports or articles are available with respect to the carcinogenicity of hexavalent chromium

compounds. In the key study, Seidler et al. (2012) systematically reviewed the scientific literature and quantified

the respiratory cancer risk for occupational exposure to hexavalent chromium. Seidler et al. (2012) included 5

studies in their paper, each providing more than one level of occupational Cr (VI) exposure, considering the

confounder smoking and using adequate methods. Linear regressions models were used to calculate relative

risks and to estimate excess absolute risks. The absolute excess lung cancer risk was found to be 4 excess lung

cancer cases per 100,000 workers for life time exposure to hexavalent chromium at a Cr(VI) concentration of

0.01 ug/m3.

The OEL derived by Seidler et al (2012) for hexavalent chromium compounds will be used as the starting point

for the derivation of the DMEL. The OEL for hexavalant chromium of 0.01 µg/m3 corresponds to a

concentration of 0.0667 µg/m3 for both C. I. Pigment Yellow 34 and C. I. Pigment Red 104, taking into account

a maximum hexavalent chromium content of 15% in both pigments.

It should be noted that data for poorly soluble hexavalent chromium compounds indicate that these compounds

have lower carcinogenic potency than soluble compounds, which may be explained by the relative low



bioavailability.

The review by the Scientific Committee on Occupational Exposure Limits (SCOEL, 2004), which is included as

a supporting study, defined highly soluble compounds such as sodium and potassium chromates and dichromate

(water solubility >100 g/L), sparingly soluble compounds such as strontium, calcium and zinc chromate (water

solubility 1-100 g/L), and poorly soluble compounds such as lead and barium chromate (<1 g/L).

From the bio-elution studies, summarized in the toxicokinetics section (7.7.1), the biosolubility of C. I. Pigment

Yellow 34 and C. I. Pigment Red 104 could be deduced. At a loading of 2 g/L and after 6 days of incubation in

simulated interstitial lung fluid, the chromium concentrations from C. I. Pigment Red 104 and C. I. Pigment

Yellow 34 were 0.0035 g/L and 0.0225 g/L, respectively. This concentration is at least 44.4 times lower than the

limit of 1 g/L for poorly soluble compounds as defined by SCOEL.

The excess lung cancer risk can only be attributed to the respirable fraction of the hexavalent chromium

compound. The non-respirable fraction will be cleared from the respiratory tract and swallowed in the

gastrointestinal tract. From the particle size distribution and dustiness tests for C. I. Pigment Yellow 34 and C. I.

pigment Red 104 (see section 4.5) it can be estimated that the respirable fraction is < 2% for both pigments. This

implies that the inhalable, non-respirable fraction must be evaluated for excess cancer risk by the oral route of

exposure. In the report on the carcinogenicity dose-response analysis of Cr(VI) - and As-containing substances

(ECHA project SR11), it was concluded that for exposures above 0.22 µg Cr(VI) / kg body weight/day an

excess lifetime intestinal cancer risk = 8 x 10^-4 per µg Cr(VI) / kg body weight/day applies. For oral exposures

below 0.22 µg Cr(VI) / kg body weight/day it is considered that physiological processes will be able to reduce

Cr(VI) to Cr(III), that a threshold for intestinal carcinogenicity exists and that the risks of carcinogenicity are

negligible. The assessment is based on linear extrapolation from intestinal tumour data in mice. The estimate

applies to both occupational and general public exposures and is based on a 70 year exposure scenario (every

day) and a 70 year life expectancy.

SCOEL (2004) also reviewed the available information on the possible health effects of Lead Chromate. In

addition to the information on Lead Chromate, SCOEL Summary Documents on both Lead and Lead

Compounds (SCOEL/SUM 83) and hexavalent Chromium compounds (SCOEL/SUM 86) were taken into

account. Compared to other chromates, Lead Chromate has low carcinogenic potential, based on its poor

solubility, although mutagenicity and clastogenicity have been reported after solubilisation. However, SCOEL

concludes that the risk for lung tumours induced by Lead Chromate must be distinctly lower than the risk

calculated for hexavalent Chromium compounds in general. Therefore, SCOEL based the OEL for Lead

Chromate on the information available for Lead and Lead compounds, resulting in an OEL of 100μg Pb/m3

(ambient air) and BLV of 30μg Pb/dl blood. The OEL of 100μg Pb/m3 would be equivalent to a concentration

of 25μg Cr/m3.

Supporting studies available for C. I. Pigment Yellow 34 are summarized below.

In a study by Maltoni (1976; only one dose group, only one treatment), the test substance was injected in

subcutaneous tissue of the middle right flank (30 mg test substance in 1 ml water, (corresponding to appr. 120

mg/kg bw assuming a mean body weight of 250 g for adult animals). All the animals were kept under

observation until spontaneous death. The spontaneous incidence of subcutaneous sarcomas and of the different

sarcoma histotypes, in the historical controls of the authors' breed of Sprague-Dawley rat were used as a

comparison. Gross pathology was made at spontaneous death and all macroscopic lesions observed at the

control were recorded. A complete autopsy was made on each animal and all major organs examined

histopathologically. 26/40 rats developed sarcoma (rhabdomyosarcoma and fibrosarcoma) at the site of

injection.

Local carcinogenicity effects were also observed when a group of Cr6+-containing substances where intra-

tracheally administered to (a metal wire pellet containing the test material is surgically implanted into the left

bronchus of an anaesthetised rat; Levy et al., 1986). Of the 20 test materials, three groups gave statistically

significant numbers of bronchial carcinomas. Two of these were groups receiving different samples of strontium

chromate which gave 43/99 and 62/99 tumours. The third group, zinc chromate (low solubility), gave 5/100

bronchial carcinomas. A further zinc chromate group (Norge composition) produced 3/100 bronchial

carcinomas which was not statistically significant. TSS 711 Calcium chromate (used as Positive control)

particularly induced 25% bronchial carcinoma in all animals tested with 181000 ppm of Cr6+ content and can

be considered as T25 of local tumor formation.




Review hexavalent Chromium compounds: carcinogen (lung tumours)

Value used for CSA (route: oral):

No adverse effect observed

Value used for CSA (route: dermal):

No adverse effect observed

Value used for CSA (route: inhalation):

Adverse effect observed

Target organs: respiratory: lung


In accordance with the current EU classification for C. I. Pigment Yellow 34 and C. I. Pigment Red 104, which

was based on read across from other more soluble hexavalent chromium compounds, C. I. Pigment Yellow 34

and C. I. Pigment Red 104 are classified for carcinogenicity (R45 or CLP Cat 1B), although the likelihood of

carcinogenicity risk is considered very low due to very poor bioavailability of these two substances. Three

epidemiological studies in lead chromate pigment manufacturing plants "did not produce evidence supporting

any association between lead chromate [pigments] and lung cancer". However limitations in cohort size, due to

the limited number of workers in this industry, limits the use of such studies. Nonetheless as the worst case, the

carcinogenicity risk of these two pigments will be assessed in this application for authorization, using the

carcinogenic properties of hexavalent chromium compounds as described by Seidler et al. (2012) for Cr(VI)

compounds. However, the very poor solubility and bioavailability of C.I. Pigment Yellow 34 and C.I. Pigment

Red 104 should be taken into account when deriving the DMEL.

5.9. Toxicity for reproduction

5.9.1. Effects on fertility


The results of studies on fertility are summarised in the following table:

Table 32. Studies on fertility


Not applicable, review of all

available data

Review of all available data

Not applicable, review of all

available data

Exposure: Not applicable, review of

all available data (Not applicable,

review of all available data)

Information from the voluntary Risk

Assessment Report: a review of all

available information on

developmental toxicity and toxicity

to reproduction of lead and lead

compounds.

NOAEL (P): 45 ug/dL blood

(male) based on: test mat.

(Impact on semen quality

(based on concentration of

lead in blood))

NOAEL (P): 30 ug/dL blood

(female) based on: test mat.

(Pregnancy outcome

(increased spontaneous

abortions) (based on

concentration of lead in

blood))

2 (reliable with

restrictions)

key study


grouping of


approach)

Test material: Lead

and some inorganic

Lead compounds

Form: not applicable

Boreiko, C.,

Battersby, R.

(2008)

not applicable (not applicable),

Review of available data by

European Food Safety Authority

(EFSA)

BMDL01 (F1): 0.5 µg/kg

bw/d (male/female) based on:

test mat. (Neurobehavioural

development (loss of 1 IQ-

2 (reliable with

restrictions)

key study

European Food

Safety Authority

(EFSA) (2010)




not applicable

not applicable (not applicable)

Vehicle: not applicable

Exposure: Not applicable (Not

applicable)

Not applicable

point))

BMDL01 (F1): 1.2 ug/dL

blood (male/female) based on:

test mat. (Neurobehavioural

development (loss of 1 IQ-

point))


grouping of


approach)

Test material: Lead


subchronic

oral: feed

0, 2000, 5000 and 20000 ppm in diet

(corresponding to appr. 75.4, 179.6

and 287.1 mg/kg bw per day

considering mean weekly food

consumption of 264, 251.5 and

100.5 g/kg) (nominal in diet)





Day Oral Toxicity in Non-Rodents)

with evaluation of sexual organs

sexual maturity (subchronic

study): (male) (Males of all 3

test groups had focal testicular

degeneration which was most

severe among the T-III group)

2 (reliable with

restrictions)

supporting study

experimental result

Test material (CI

name): CI Pigment

Yellow 34

BASF Farben &

Fasern AG

(1976a)

Not applicable, Opinion of the

Scientific Committee on Health and

Environmental Risks (SCHER)

In the opinion of the

Scientific Committee on

Health and Environmental

Risks (SCHER) on the

voluntary Risk Assessment

Report (vRAR), it is

concluded that the health part

of the vRAR is of good

quality, comprehensive, and

that the exposure and effects

assessment follow the

Technical Guidance

Document.

2 (reliable with

restrictions)

supporting study


grouping of


approach)

Test material: Lead

and Lead

compounds

Scientific

Committee on

Health and

Environmental

Risks (SCHER)

(2009)

Toxicity to reproduction: other studies




5.9.2. Developmental toxicity


Data waiving



Information requirement: Developmental toxicity / teratogenicity


Justification: Summaries of the results of the voluntary Risk Assessment Report for lead and inorganic lead

compounds, the SCHER opinion on the vRAR, and the EFSA opinion on lead in food are provided in the

toxicity to reproduction section. In these reports, all available studies in humans and experimental animals

have been evaluated for the observed effect of lead upon sexual maturation and semen quality, pregnancy

outcome, and neurobehavioural effects of prenatal and postnatal lead exposure. Effects on development have

been included in the summaries provided in the toxicity to reproduction section.



5.9.3. Summary and discussion of reproductive toxicity

Effects on fertility

In the voluntary Risk Assessment Report for lead and inorganic lead compounds, all available studies in humans

and experimental animals have been evaluated for the observed effect of lead upon sexual maturation and semen

quality, pregnancy outcome, and neurobehavioural effects of prenatal and postnatal lead exposure. Lead


neurobehavioural development, which was the most critical effect.

Developmental toxicity

In the voluntary Risk Assessment Report for lead and inorganic lead compounds, all available studies in humans

and experimental animals have been evaluated for the observed effect of lead upon sexual maturation and semen

quality, pregnancy outcome, and neurobehavioural effects of prenatal and postnatal lead exposure. Lead


neurobehavioural development, which was the most critical effect.

Effects on neurobehavioural performance after pre-natal and post-natal have been reported in several animal

studies. However, the available data are inadequate to establish dose-effect relationships. Observed effects are

upon early measures of mental and physical development, but could not be associated with impacts upon

measures such as IQ. Furthermore, effects of prenatal lead exposure can be difficult to dissociate from those of

postnatal exposure. Effects of pre-natal lead exposure are secondary in magnitude to those produced by

exposures after birth. The vRAR suggest a blood lead level above 10 µg/dL (in females) to take into account for

the risk assessment with regard to developmental effects.

In the opinion of the Scientific Committee on Health and Environmental Risks (SCHER) on the voluntary Risk

Assessment Report (vRAR), it is concluded that the health part of the vRAR is of good quality, comprehensive,

and that the exposure and effects assessment follow the Technical Guidance Document.

In the risk assessment on lead from food which was performed by the European Food Safety Authority (EFSA,

2010), the Bench Mark Dose approach (BMD) is used to estimate the BMDL01, which is the blood-lead

concentration corresponding to the 1 -percentile of the Confidence Interval of the chosen Bench Mark Response

of an IQ deficit of 1 IQ point. The BMR is chosen and set at 1 IQ point by the CONTAM panel of EFSA. Using

this approach, the BMDL01 for lead was estimated to be 1.2μg/dL (mentioned as 12μg/L by EFSA).

A supporting study is included in the dossier in which adverse changes were observed when female Swiss albino

mice were treated with potassium dichromate at 0, 53.2, 101.1, and 152.4 mg of eq. chromium(VI) /kg/day in

drinking at days 6–14 of gestation (Junaid et al., 1996).

The number of dead fetuses (higher in the high-dose group), fetal weight (lower in both intermediate- and high-

dose groups; high dose = 1.06 g, intermediate dose = 1.14 g) were changed as compared to the control value of

1.3 g. A dose-response relationship was also observed in the number of resorption sites (0.31 for controls, 1.00

for the low dose, 1.70 for the intermediate dose, and 2.30 for the high dose), as well as a significantly greater

incidence of post-implantation loss (in the two highest-dose groups of 21 and 34.60% as compared to control

value of 4.32%).



The gross structural abnormalities observed were drooping of the wrist (carpal flexure) and subdermal

hemorrhagic patches on the thoracic and abdominal regions (in 16% in the offspring of the high-dose group).

Significant reduced ossification in nasal frontal, parietal, interparietal, caudal, and tarsal bones were observed

only in the 152.4 mg chromium(VI) /kg/day-treated animals


Developmental toxicity of lead and lead compounds: 1.2 ug/dL blood lead level, or 0.5 ug/kg bw/day

Value used for CSA (route: oral)

Adverse effect observed


Based on the available information and in accordance with the EU-classification, C. I. Pigment Yellow 34

should be considered as toxic to reproduction and the development, in accordance with the criteria outlined in

Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (DSD: Repr. Cat. 1; R61 and Repr. Cat. 3; R62, CLP:

Repr. 1A; H360Df).

5.10. Other effects


5.10.1.1. Neurotoxicity


5.10.1.2. Immunotoxicity


5.10.1.3. Specific investigations: other studies




5.10.3. Summary and discussion of other effects

5.11. Derivation of DNEL(s) and other hazard conclusions

5.11.1. Overview of typical dose descriptors for all endpoints

Table 33. Available dose-descriptor(s) per endpoint as a result of its hazard assessment

Endpoint Route Dose descriptor or qualitative effect

characterisation; test type

Reference to selected study

(see footnotes for justification)

Acute toxicity oral No adverse effect observed

Acute toxicity dermal No adverse effect observed

Irritation /

Corrosivity

skin No adverse effect observed (not irritating)

Irritation /

Corrosivity

eye No adverse effect observed (not irritating)

Sensitisation skin Adverse effect observed (sensitising)

Sensitisation respiratory

tract

Adverse effect observed (sensitising)



Endpoint Route Dose descriptor or qualitative effect

characterisation; test type

Reference to selected study

(see footnotes for justification)

Repeated dose

toxicity

oral LOAEL: 70 mg/kg bw/day (subchronic; dog)

Target organs: cardiovascular /

hematological: hematopoiesis; digestive:

liver; urogenital: kidneys

Carcinogenicity oral Adverse effect observed

The OEL for Chromium VI was set at 0.22 µg

Cr(VI)/ kg body weight/day by ECHA

Carcinogenicity dermal No adverse effect observed

Carcinogenicity inhalation Adverse effect observed

The OEL for Chromium VI was set at 0.01

µg/m3 by Seidler et al. (2012)

Reproductive

toxicity:

developmental

toxicity

oral Adverse effect observed

The BMDL01 for lead was estimated to be

1.2μg/dL (mentioned as 12μg/L) by EFSA

Justification for endpoint selection:

- Sensitisation (skin): Conclusion on skin sensitisation was based on the skin sensitising properties of

hexavalent Chromium compounds.

- Sensitisation (skin): Conclusion on skin sensitisation was based on the respiratory sensitising properties of


- Carcinogenicity (inhalation): Conclusion on carcinogenicity was based on the carcinogenic properties of


- Carcinogenicity (oral): Conclusion on carcinogenicity was based on the carcinogenic properties of


- Reproductive toxicity: developmental toxicity (oral): Based on the review of available information by the

European Food Safety Authority.

5.11.2. Selection of the DNEL(s) or other hazard conclusion for critical health effects

Table 34. Hazard conclusions for workers

Route Type of effect Hazard conclusion Most sensitive endpoint

Inhalation Systemic

effects - Long-

term

DMEL (Derived Minimum Effect Level): 2.96

µg/m³

carcinogenicity (By inhalation)

Inhalation Systemic

effects - Long-

term

DMEL (Derived Minimum Effect Level): 5.8

µg/m³

developmental toxicity /

teratogenicity (By inhalation)

Inhalation Systemic

effects - Acute

No hazard identified

Inhalation Local effects -

Long-term

High hazard (no threshold derived)

Inhalation Local effects - No hazard identified




Acute

Dermal Systemic

effects - Long-

term

DMEL (Derived Minimum Effect Level): 5

mg/kg bw/day

developmental toxicity /

teratogenicity (Oral)

Dermal Systemic

effects - Acute


Dermal Local effects -

Long-term

Medium hazard (no threshold derived)


Acute


Oral Systemic

effects - Long-

term

DNEL (Derived No Effect Level): 1.47 µg/kg

bw/day

carcinogenicity (Oral)

Eyes Local effects No hazard identified

Further explanation on hazard conclusions:

- Inhalation Systemic effects - Long-term: The DMELsystemic, long-term, inhalation is based on the most

critical effect: carcinogenicity caused by hexavalent chromium compounds. However, the DMEL for effects

on neurobehavioural development caused by lead compounds should also be taken into account when

assessing the risks, although this DMEL is higher: 5.8 µg/m3. For justification and comments, reference is

made to the discussion section.

- Inhalation Local effects - Long-term: Chromium compounds are classified for respiratory sensitisation.

- Dermal Systemic effects - Long-term: The DMELsystemic, long-term, dermal is based on the most critical

effect: effects on neurobehavioural development caused by lead compounds.

- Dermal Local effects - Long-term: Chromium compounds are classified for skin sensitisation.

- Oral Systemic effects - Long-term: Reference is made to the discussion section.

Table 35. Further explanation on DNEL derivation for workers

Route / Type of

effect

DNEL derivation Assessment factors (AF) for DNEL

derivation

Inhalation

Systemic effects -

Long-term

DNEL derivation method: DMEL was

derived based on the OEL for hexavalent

Chromium compounds as proposed by

Seidler et al. (2012) corrected for the

chromium amount in the pigment (15%)

Dose descriptor starting point: OEL

0.0667 µg/m³

Dermal

Systemic effects -

Long-term

DNEL derivation method: DMEL was

derived based on the BMDL01 as presented

in the Scientific Opinion on lead in food by

the European Food Safety Authority

(EFSA, 2010)

Dose descriptor starting point: BMDL01

0.5 µg/kg bw/day



Justification for route-to-route extrapolation:

- Inhalation Systemic effects - Long-term: A correction factor of 44.4 was applied based on the very poor

solubility of C. I. Pigment Yellow 34 in simulated interstitial lung fluid, as bioelution tests indicate that the

pigment is at least 44.4 times less soluble than poorly soluble hexavalent chromium compounds in general

(as mentioned in the SCOEL report; 2004).

- Dermal Systemic effects - Long-term: The BMDL01 of 0.5 µg/kg bw/day was corrected for the poor

dermal absorption of pigments (0.01%), arriving at a DMEL long-term systemic dermal of 5000 µg/kg

bw/day or 5 mg/kg bw/day.

Discussion

Carcinogenicity

In accordance with the current EU classification for C. I. Pigment Yellow 34 and C. I. Pigment Red 104, which

was based on read across from other more soluble and more respirable hexavalent chromium compounds, C. I.

Pigment Yellow 34 and C. I. Pigment Red 104 are classified for carcinogenicity, although the likelihood of

carcinogenicity risk is considered very low due to very poor bioavailability of these two substances. Three

epidemiological studies in lead chromate pigment manufacturing plants "did not produce evidence supporting

any association between lead chromate [pigments] and lung cancer". However limitations in cohort size, due to

the limited number of workers in this industry, limits the use of such studies. Nonetheless as the worst case, the

carcinogenicity risk of these two pigments will be assessed, using the carcinogenic properties of hexavalent

chromium compounds as described by Seidler et al. (2012) and in the SCOEL (2004) documents for Cr(VI)

compounds. The very poor solubility and bioavailability of these two lead sulfochromate pigments should be

taken into account when deriving the DMEL.

Several health effects are associated with occupational exposure to hexavalent chromium compounds, with

carcinogenicity (specifically lung cancer) being the most serious. Therefore, lung cancer is the critical effect

upon which to base an occupational exposure limit. In 2012, Seidler et al. published a review and quantification

of respiratory cancer risk for occupational exposure to Hexavalent Chromium.

Seidler et al. reviewed a large number of epidemiological studies and selected 5 studies from 2 cohorts for their

Risk Assessment, based on the presence of multiple exposure levels, consideration of smoking as confounder

and overall adequate methodogy used. They calculated that the numbers of excess lung cancers per 1000 male

workers exposed for a working lifetime to 1 µg/m3 of hexavalent chromium and followed to age 74 - 89 years

are predicted to be in the range of 3.4 - 4.1.

This means that Seidler et al. (2012) derive an Occupational Exposure Level (OEL) associated with 4 excess

lung cancer cases per 100,000 workers for life time exposure to hexavalent chromium of 0.01 µg/m3.

Based on a maximum chromium level of 15% in C. I. Pigment Yellow 34 and C. I. Pigment Red 104, this value

corresponds to a Cr (VI) exposure for both pigments of 0.0667 µg/m3.

Unfortunately, the available epidemiological data do not allow for a reliable ranking of the carcinogenic potency

of the various hexavalent chromium compounds encountered in industry. The data indicate, however, that

poorly soluble hexavalent chromium compounds have a lower carcinogenic potency than soluble compounds.

The relatively lower bioavailability of chromium ions to the intracellular target in the respiratory epithelium

might explain this effect. The Scientific Committee on Occuptional Exposure Levels (SCOEL/SUM/086, 2004)

distinguishes three classes of hexavalent chromium compounds based on water solubility and defines them as:

poorly soluble (<1g/L), sparingly soluble (1-10g/L); highly soluble (>100g/L) compounds.

In addition, SCOEL published a health-based Risk Assessment for lead chromate (SCOEL/SUM/117, 2004). In

this document it is concluded that, based on the specific data available for lead chromate, the OEL could be

based on the information on inorganic lead compounds in general, as, based on the low solubility (a value of

0.06 g/L is mentioned), the likelihood of risk of genotoxicity and carcinogenicity is considered low. SCOEL

recommends an OEL of 100μg Pb/m3 ambient air (corresponding to a Blood Lead Value (BLV) of 30μg Pb/dl

blood. This value would be equivalent to a concentration of 25μg Cr/m3.

Despite the SCOEL recommendations for lead chromate and hexavalent chromium, it is decided to use the



hexavalent chromium OEL from Seidler et al. (2012) as a basis for the DMEL for C. I. Pigment Yellow 34 and

C. I. Pigment Red 104, taking into account the differences in solubility. The solubility of Cr(VI) derived from C.

I. Pigment Yellow 34 and C. I. Pigment Red 104 in aqueous media ranges from 3*10^-6 to 2,3*10^-2 g/L,

depending on the Transformation/Dissolution or bio-elution protocol in aqueous solvents (ECTX studies X02d-

022 and X02d-023). These solubility values are about 40 – 30,000 times lower than the limit for poorly soluble

of 1 g/L in the SCOEL report. The most relevant aqueous medium (simulated interstitial lung fluid) showed

Cr(VI) solubilities from C. I. Pigment Red 104 and C. I. Pigment Yellow 34 of 0.0035 g/L and 0.0225 g/L,

respectively. This is at least 44.4. times less soluble than the level for low solubility given in the SCOEL report.

For this reason, it is considered justified to correct the OEL by a factor of 44.4 to arrive at a DMEL long-term

systemic inhalation of 2.96 µg/m3 for both C. I. Pigment Yellow 34 and C. I. Pigment Red 104.

The excess lung cancer risk from Cr(VI) exposure can only be attributed to the respirable fraction of the

hexavalent chromium compound. The non-respirable fraction will be cleared from the respiratory tract and

swallowed in the gastrointestinal tract. From the particle size distribution and dustiness tests for C. I. Pigment

Yellow 34 and C. I. Pigment Red 104 (see section 4.5) it can be estimated that the respirable fraction is < 2% for

both pigments. This implies that the inhalable, non-respirable fraction must be evaluated for excess cancer risk

from exposure by the oral route. It should be noted that the distribution of respirable and non-respirable

fractions may vary among different uses, based on the formulation of the pigments. This will be taken into

account in the risk assessment.

In the report on the carcinogenicity dose-response analysis of Cr(VI) - and As-containing substances (ECHA

project SR11), it was concluded that for oral exposures above 0.22 µg Cr(VI) / kg body weight/day an excess

lifetime intestinal cancer risk of 8 x 10^-4 per µg Cr(VI) / kg body weight/day applies. For oral exposures below

0.22 µg Cr(VI) / kg body weight/day it is considered that physiological processes will be able to reduce Cr(VI)

to Cr(III), that a threshold for intestinal carcinogenicity exists and that the risks of carcinogenicity are

negligible. The assessment is based on linear extrapolation from intestinal tumour data in mice. The estimate

applies to both occupational and general public exposures and is based on a 70 year exposure scenario (every

day) and a 70 year life expectancy.

Based on a maximum chromium level of 15% in C. I. Pigment Yellow 34 and C. I. Pigment Red 104, this oral

Cr(VI) value corresponds to a Cr (VI) exposure for both pigments of 0.22/0.15 = 1.47 µg/kg body weight/day.

This value will be used as an oral DNEL in the risk assessment to determine the risk due to swallowed non-

respirable dust.

Toxicity to reproduction/developmental toxicity

From the available data it is evident that the carcinogenicity risk will occur via the inhalation route only.

However, effects of the inorganic lead in C. I. Pigment Yellow.34 and C. I. Pigment Red.104 should also be

assessed to exclude all possible effects. Therefore, the available information with regard to effects on

development and reproduction of inorganic lead compounds were assessed. In the voluntary Risk Assessment

Report for lead and inorganic lead compounds, all available studies in humans and experimental animals have

been evaluated for the observed effect of lead upon sexual maturation and semen quality, pregnancy outcome,

and neurobehavioural effects of prenatal and postnatal lead exposure.

Based on the available data it is concluded that effects on neurobehavioural performance after pre-natal and

post-natal exposure to inorganic lead, are the most critical effects, although a dose-effect relationship was not

observed. This conclusion was based on a meta-analysis of several cohort studies correlating blood-lead

concentrations to IQ deficits (Lanphear et al. 2005 and other studies). The result showed that IQ points were lost

at blood-lead concentrations of < 10μg/dL and < 7.5μg/dL and that there was no indication of a threshold below

these levels. In the risk assessment on lead from food which was performed by the European Food Safety

Authority (EFSA, 2010), the Bench Mark Dose approach (BMD) is used to estimate the BMDL01, which is the

blood-lead concentration corresponding to the 1-percentile of the Confidence Interval of the chosen Bench Mark

Response of an IQ deficit of 1 IQ point. The BMR is chosen and set at 1 IQ point by the CONTAM panel of

EFSA.

Using this approach, the BMDL01 for lead was estimated to be 1.2μg/dL (mentioned as 12μg/L by EFSA) and

must be regarded as a DMEL for “minimal” IQ loss due to neurodevelopmental toxicity. This DMEL can be

converted from 1.2μg/dL to 0.5μg/kg body weight/day, which corresponds to 35μg/day for a 70 kg person. Oral

35μg/day corresponds to 3.5μg/m3 (inhalation worker is 10 m3 per workday). This value can be compared to

the DMEL for carcinogenic effects, corrected for the percentage of lead (maximally 60%) in both pigments. The

maximum lead exposure for workers exposed to the DMEL of 4.4μg/m3 (total pigment) is 2.64μg/m3, which is



lower than the BMDL01 of 3.5 µg/m3. Therefore it can be concluded that the DMEL for carcinogenicity will be

valid for neurodevelopmental effects as well (decrease in IQ of less than 0.75 IQ point). In order to perform a

combined risk assessment for the effects on neurobehavioural development, a DMEL of 5.8 µg/m3 can be taken

into account, based on maximally 60% lead in pigment.

With regard to dermal exposure, the VRAR mentions that lead uptake rates via the dermal route are <0.01%,

both for adults and for children. This is supported by an in vitro skin absorption study (HERAG Fact Sheet 01,

Occupational dermal exposure and dermal absorption, 2007; Toner and Roper, 2006) and bio-elution studies

showing <2% solubility of C. I. Pigment Yellow.34 and C. I. Pigment Red.104 in artificial sweat. Therefore it

can be assumed that dermal exposure will not contribute to higher blood lead levels to a large extent. However,

to exclude possible effects from dermal exposure, a DMEL was derived based on the BMDL01 for oral

exposure as presented in the EFSA report. This value of 0.5 µg/kg bw/day should be corrected for dermal

absorption, arriving at a DMEL long-term systemic dermal of 5000 µg/kg bw/day or 5 mg/kg bw/day.

Table 36. Hazard conclusions for the general population


Inhalation Systemic

effects - Long-

term

Not relevant

Inhalation Systemic

effects - Acute

Not relevant


Long-term

Not relevant


Acute

Not relevant

Dermal Systemic

effects - Long-

term

Not relevant

Dermal Systemic

effects - Acute

Not relevant


Long-term

Not relevant


Acute

Not relevant

Oral Systemic

effects - Long-

term

Not relevant

Oral Systemic

effects - Acute

Not relevant

Eyes Local effects Not relevant

Further explanation on hazard conclusions:

- Inhalation Systemic effects - Long-term: Not relevant as no consumer uses are anticipated and no

consumer exposure is expected

- Inhalation Systemic effects - Acute: Not relevant as no consumer uses are anticipated and no consumer

exposure is expected

- Inhalation Local effects - Long-term: Not relevant as no consumer uses are anticipated and no consumer


- Inhalation Local effects - Acute: Not relevant as no consumer uses are anticipated and no consumer




- Dermal Systemic effects - Long-term: Not relevant as no consumer uses are anticipated and no consumer


- Dermal Systemic effects - Acute: Not relevant as no consumer uses are anticipated and no consumer


- Dermal Local effects - Long-term: Not relevant as no consumer uses are anticipated and no consumer


- Dermal Local effects - Acute: Not relevant as no consumer uses are anticipated and no consumer exposure

is expected

- Oral Systemic effects - Long-term: Not relevant as no consumer uses are anticipated and no consumer


- Oral Systemic effects - Acute: Not relevant as no consumer uses are anticipated and no consumer exposure

is expected

- Eyes Local effects: Not relevant as no consumer uses are anticipated and no consumer exposure is expected

Discussion

Not relevant as no consumer uses are anticipated and no consumer exposure is expected



6. HUMAN HEALTH HAZARD ASSESSMENT OF

PHYSICOCHEMICAL PROPERTIES

6.1. Explosivity

Data waiving: see CSR section 1.3 Physicochemical properties.

Discussion


In accordance with column 2 of REACH Annex VII, the explosiveness of the substance does not need to be

tested, because there are no chemical groups associated with explosive properties in the molecule

6.2. Flammability

Flammability

The available information on flammability is summarised in the following table:

Table 37. Information on flammability


other: measured Evaluation of results:

non flammable

Study results:

Ignition on contact with air: no

Remarks:

non combustible solid

2 (reliable with

restrictions)

supporting study

Test material

(IUPAC name):

lead sulfochromate

yellow

GESTIS -

Substance

database of

'Berufsgenossensc

haftlichen Instituts


Discussion


In accordance with section 1 of REACH Annex XI, the flammability does not need to be performed as the

substance is a non combustible solid, non flammable upon ignition.

The substance has no pyrophoric properties and does not yield flammable gases on contact with water.

Flash point


Discussion


In accordance with section 1 of REACH Annex XI, the flash point does not need to be tested as the substance is

a solid (scientifically unjustified) and in accordance with column 2 of REACH Annex VII, the flash point does

not need to be performed as the substance is inorganic (other justification).

6.3. Oxidising potential

The available information on the oxidising potential is summarised in the following table:



Table 38. Information on oxidising potential


Contact with:

powdered cellulose (>

45 — <= 600 s)

EU Method A.17

(Oxidising Properties

(Solids))

Evaluation of results: no oxidising

properties

maximum burning rate of reference

mixture: ca. 0.85 mm/s (60% reference

mixture/cellulose)

maximum burning rate of test mixture: ca.

0.36 mm/s (All mixtures of C.I. Pigment

Red 104 and Cellulose indicated soldering

when burned. The three concentrations with

the highest burning rates are 60%, 70% and

80%, 80% having the highest burning rate.)

Remarks:

Preliminary test

The burning time of C.I. Pigment Red 104

was determined to be more than the

reference sample in the preliminary

screening test. Therefore the full train test

was conducted.

Full train test

The highest burning rate recorded from the

six samples of C.I. Pigment Red 104 in

cellulose was 0.36 mm/s, which was the

sample with 80% of the test substance. This

value should be compared to the highest

burning rate of the reference substance

Barium Nitrate, which was 0.85mm/s. It

can be concluded that the sample of C.I.

Pigment Red 104 should be classed not an

oxidizing substance since in any percentage

of C.I. Pigment Red 104/Cellulose, it has a

burning rate of less than that of Barium

Nitrate/Cellulose per EC Physico/Chemical

Test A17, Oxidizing Properties (Solid)

Test.

2 (reliable with

restrictions)

key study


grouping of


approach)

Test material

(Common name):

C.I. Pigment Red

104

Form: powder

Umbrajkar, S.M.

(2013)

Discussion

The oxidising properties of read across substance C. I. Pigment Red 104 were determined in accordance with the

EC Physico/Chemical Test A17, Oxidizing Properties (Solid) Test. In the preliminary test, the burning time of

C. I. Pigment Red 104 was determined to be more than the reference sample in the preliminary screening test.

Therefore the full train test was conducted.

In the full train test, the highest burning rate recorded from the six samples of C. I. Pigment Red 104 in cellulose

was 0.36 mm/s, which was the sample with 80% of the test substance. This value should be compared to the

highest burning rate of the reference substance Barium Nitrate, which was 0.85mm/s. It can be concluded that

the sample of C. I. Pigment Red 104 should be classed not an oxidizing substance since in any percentage of C.

I. Pigment Red 104/Cellulose, it has a burning rate of less than that of Barium Nitrate/Cellulose per EC

Physico/Chemical Test A17, Oxidizing Properties (Solid) Test.




EC Physico/Chemical Test A17, Oxidizing Properties (Solid) Test: not oxidising (read across to C. I. Pigment

Red 104)

Justification for classification or non-classification:

Based on the available information with read across substance C. I. Pigment Red 104, C. I. Pigment Yellow 34

does not have to be classified as oxidising, in accordance with the criteria outlined in Annex VI of 67/548/EEC

and Annex I of 1272/2008/EC.



7. ENVIRONMENTAL HAZARD ASSESSMENT

7.1. Aquatic compartment (including sediment)

Due to the very low solubility of C. I. Pigment Yellow 34 in water the bioavailability of the substance is

expected to be low. However, a small proportion of the parent substance may dissolve and release chromate ions

(CrO42-

) and lead ions (Pb²+

). For the ecotoxicological tests, a saturated solution of 100 or 125 mg C. I. Pigment

Yellow 34 per liter was stirred and filtered (0.2 or 0.45 micrometer). The concentrations of chromium, lead and

barium in the eluate were determined, see table below. For comparison, the table also presents the results for the

same tests with the similar substance C. I. Pigment Red 104. No effects were observed in any of the tests on

both pigments.

C. I. Pigment Yellow 34

Test with eluate Eluate of Cr (mg/l) Pb (mg/l) Ba (mg/l) Reference

96h-LC50

Leuciscus idus

10 g/l n. d. n. d. n. d. BASF AG 1988

48h-EC50

Daphnia magna

100 mg/l 0.10 0.36 0.25 BASF AG 2000

72h-

EC50/NOEC

Desmodesmus

subspicatus

125 mg/l 0.008 (1) 0.011

(2)

0.005 (1) 0.005

(2)

2.0 (1) 1.7 (2) BASF AG 2000

30 min-EC50

Pseudomonas

putida

non filtered

=<10 g/l

n. d. n. d. n. d. BASF AG 1988

C. I. Pigment Red 104

96h-LC50

Leuciscus idus

10 g/l n. d. n. d. n. d. BASF AG 1988

48h-EC50

Daphnia magna

100 mg/l 0.056 0.5 n. d. BASF AG 2000

72h-

EC50/NOEC

Desmodesmus

subspicatus

125 mg/l <0.005 (1)

<0.005 (2)

0.13 (1) 0.016

(2)

n. d. BASF AG 2000

30 min-EC50

Pseudomonas

putida

non filtered

=<10 g/l

n. d. n. d. n. d. BASF AG 1988



No chronic data are available for C. I. Pigment Yellow 34. No long term toxicity studies are available with the

pigments. Instead, reference is made to the long/term aquatic toxicity of lead and chromium.

The water solubility of the pigment in water is very low and no acute toxicity was observed. No chronic data are

available for C. I. Pigment Yellow 34 or C. I. Pigment Red 104. As shown in the Transformation/Dissolution

study, a small proportion of the parent substance may dissolve and release chromate ions (CrO42 -

, determined as

Cr ions) and lead ions (Pb2 +

).

Data on lead and chromium are summarised below for aquatic invertebrates and fish.

Chromium Endpoint Comments

Fish

Pimephales promelas

412d-NOECmort 1 mg/l

(most sensitive endpoint)

60d-NOECmort/growth rate 1 mg/l

412 days first generation + 60 days

second generation

Pickering 1980

Daphnia magna 3wk-EC16 repro 330 µg/l Biesinger & Christensen 1972

21d-NOEC repro 0.7 mg/l Kuhn et al. 1989

Lead Endpoint Comments

Fish

Onchorhynchus mykiss

3 wk-LOEC 13 µg/l Hematological effects

Hodson & Blunt 1978

Daphnia magna 3wk-EC16 repro 30 µg/l Biesinger & Christensen 1972

7.1.1. Fish

7.1.1.1. Short-term toxicity to fish

The results are summarised in the following table:

Table 39. Short-term effects on fish


Leuciscus idus

freshwater

static

DIN 38 412 L15, 1982. German

standard test guideline, comparable to

OECD 203.

LC50 (96 h): > 10000 mg/L

test mat. (nominal) based

on: mortality

(concentrations above water

solubility. Tested as

dilutions of a filtered

leachate)

2 (reliable with

restrictions)

key study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

BASF AG (1988a)

Oncorhynchus mykiss

freshwater

static

OECD Guideline 203 (Fish, Acute

Toxicity Test)

LC50 (96 h): > 100 mg/L


on: mortality (no significant

mortality or other effects

observed. Concentrations

above water solubility.

Tested as dilutions of a

filtered leachate)

1 (reliable without

restriction)

key study

experimental result

Test material

Stantec Consulting

Ltd (2006)




(IUPAC name):

lead sulfochromate

yellow

Form: powder

Discussion

Two studies are available for the toxicity of Pigment Yellow 34 on fish.

1. In a study according to German standard DIN 38412 Leuciscus idus was exposed to C. I. Pigment Yellow 34

for 96 hours. The test solutions contained undissolved test material and was cloudy and coloured. No mortality

or abnormalities were observed. Complete observation of symptoms was difficult due to the cloudiness of the

solution. The LC50 was > 10000 mg/l (BASF AG, 1988, reliability 2).

2. In a study according to OECD TG 203 Pigment Yellow 34 was tested on Onchorhynchus mykiss (rainbow

trout), under GLP. The test was carried out as a limit test. A suspension of 100 mg per liter was filtered (0.45

micrometer) to remove particles. There was no significant mortality, abnormal appearance or behaviour of

rainbow trout exposed t the filterable portion of the nominal solution of 100 mg/L. Thus the 96h-LC50 of

Pigment Yellow 34 is > 100 mg/l.

Measured concentrations of lead and chromium were 0.19 - 0.26 mg Pb/L and 0.20 - 0.16 mg Cr/L (0 - 96 h,

respectively) (Stantec Ltd 2006, reliability 1).

The following information is taken into account for acute fish toxicity for the derivation of PNEC:

In two short-term toxicity tests on fish, no effects were observed in test concentrations up to 10000 mg/l. The

96h-LC50 is above 10 g/liter (nominal)

Value used for CSA:

LC50 for freshwater fish: 10 g/L

7.1.1.2. Long-term toxicity to fish


Table 40. Long-term effects on fish


Oncorhynchus mykiss (reported as

Salmo gairdneri)

freshwater

adult fish: (sub)lethal effects

flow-through

Acute lethal and chronic sublethal

toxicity was tested in continous-flow

bioassays. (Method according to

Sprague J. B. (1969) Measurement of

pollutant toxicity to fish. I. Bioassay

methods for acute toxicity. Water Res.

3, 793-821.)

Three different experiments were

conducted

2 (reliable with

restrictions)

key study

read-across from



or surrogate)


nitrate

Hodson PV, Blunt

BR, Spry DJ

(1978)

Pimephales promelas NOEC (412 d): 1 mg/L test 2 (reliable with Pickering QH




freshwater

early-life stage: reproduction,

(sub)lethal effects

flow-through

The effect of chromium on hatching,

growth and survival was tested.

mat. (meas. (not specified))

based on: mortality

NOEC (412 d): 3.95 mg/L

test mat. (meas. (not

specified)) based on:

growth rate

NOEC (412 d): > 3.95

mg/L test mat. (meas. (not

specified)) based on:

reproduction

NOEC (60 d): 1 mg/L test


based on: mortality (second

generation)

NOEC (60 d): 1 mg/L test


based on: growth rate

(second generation)

restrictions)

key study

read-across from



or surrogate)

Test substance:

Potassium

dichromate

(1980)

7.1.2. Aquatic invertebrates

7.1.2.1. Short-term toxicity to aquatic invertebrates


Table 41. Short-term effects on aquatic invertebrates


Daphnia magna

freshwater

static

OECD Guideline 202 (Daphnia sp.

Acute Immobilisation Test)

EC50 (48 h): > 100 mg/L

loading of the test material

(nominal) based on:

mobility (Concetrations

above water solubility.

Tested as dilutions of a

filtered leachate)

2 (reliable with

restrictions)

key study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

BASF AG (2000a)

Discussion

The acute toxicity of C. I. Pigment Yellow 34 to Daphnia magna was tested in a guideline study following

OECD 202 (Reliability 2, acceptable restrictions). The test substance was not prepared according to the OECD

29 dissolution protocol (07/2001). An eluate was prepared by stirring 100 mg C. I. pigment Yellow 34 per liter

for 24 hours and filtration over 0.2 micrometer. The concentrations of dissolved metals in the eluate were

determined. The eluate contents for dissolved chromium, lead and barium were 0.10 mg chromium/l, 0.36 mg

lead/l and 0.25 mg barium/l. The 48h-EC50 for daphnia was above the loading rate of 100 mg C. I. Pigment

Yellow 34 per liter (BASF AG, 2000).

The following information is taken into account for short-term toxicity to aquatic invertebrates for the derivation

of PNEC:

In a short-term toxicity test with Daphnia magna, no effects were observed in test concentrations up to 100 mg/l.

Therefore the LC50 is above the loading rate of 100 mg test substance/liter.



Value used for CSA:

EC50/LC50 for freshwater invertebrates: 100 mg/L

7.1.2.2. Long-term toxicity to aquatic invertebrates


Table 42. Long-term effects on aquatic invertebrates


Daphnia magna

freshwater

static

Toxicity of several metals was tested.

Acute and chronic studies were

performed. Daphnids were exposed for

3 weeks, survival, reproduction and

fitness were analysed.

16 % reproduction

impairment (3 wk): 30 µg/L

test mat. (lead) (nominal)

based on: reproduction

LC50 (3 wk): 300 µg/L test

mat. (lead) (nominal) based

on: mortality

50 % reproductive

impairment (3 wk): 100

µg/L test mat. (lead)

(nominal) based on:

reproduction

LC50 (3 wk): 2000 µg/L

test mat. (chromium)

(nominal) based on:

mortality

16 % reproduction


µg/L test mat. (chromium)

(nominal) based on:

reproduction

50 % reproduction



(nominal) based on:

reproduction

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Lead, Chromium

Biesinger KE and

Christensen GM

(1972)

Daphnia magna

freshwater

static

Toxicity of several metals was tested.

Acute and chronic studies were

performed. Daphnids were exposed for

3 weeks, survival, reproduction and

fitness were analysed.

16 % reproduction

impairment (3 wk): 30 µg/L

test mat. (lead) (nominal)

based on: reproduction

LC50 (3 wk): 300 µg/L test

mat. (lead) (nominal) based

on: mortality

50 % reproductive


µg/L test mat. (lead)

(nominal) based on:

reproduction

LC50 (3 wk): 2000 µg/L

test mat. (chromium)

(nominal) based on:

mortality

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Lead, Chromium

Biesinger KE and

Christensen GM

(1972)




16 % reproduction



(nominal) based on:

reproduction

50 % reproduction



(nominal) based on:

reproduction

Daphnia magna

freshwater

semi-static

21 day reproduction test

NOEC (21 d): 0.7 mg/L test

mat. (nominal) based on:

reproduction

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance

Chromium chloride

Kuehn R, Pattard

M, Pernak K-D,

Winter A (1989)

Discussion

Due to the low water solubility of C. I. Pigment Yellow 34 adverse chronic effects of the substance to aquatic

organisms are not expected. However, a minor part of the substance may dissolve and chromate (CrO42-

) and

lead ions (Pb²+) may dissociate from the parent substance. Both substances may have chronic effects on aquatic

invertebrates.

7.1.3. Algae and aquatic plants


Table 43. Effects on algae and aquatic plants


Desmodesmus subspicatus (reported as

Scenedesmus subspicatus) (algae)

freshwater

static

OECD Guideline 201 (Alga, Growth

Inhibition Test)

EC50 (72 h): > 100 mg/L


on: growth rate

NOEC (72 h): >= 100 mg/L


on: measured fluorescence

before growth rate

calculation (Concentrations

above the water solubility;

tested as dilutions of a

filtered leachate)

EC10 (72 h): > 100 mg/L


on: growth rate

2 (reliable with

restrictions)

key study

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

BASF AG (2000b)

Desmodesmus subspicatus (reported as

Scenedesmus subspicatus) (algae)

EC50 (72 h): > 100 mg/L


on: growth rate

2 (reliable with

restrictions)

BASF AG (2000c)




freshwater

static

OECD Guideline 201 (Alga, Growth

Inhibition Test)

NOEC (72 h): 50 mg/L test


measured fluorescence

before growth rate

calculation (Concentrations

above the water solubility;

tested as dilutions of a

filtered leachate)

EC10 (72 h): > 100 mg/L


on: growth rate

supporting study

experimental result

Test material:

Sicomin Rot L 2922

Discussion

Effects on algae / cyanobacteria

Two guideline studies on the acute toxicity of C. I. Pigment Yellow 34 to the aquatic alga Desmodesmus

subspicatus are available (OECD 201, 1984, reliability 2, acceptable restrictions). The test substance was not

prepared according to the OECD 29 dissolution protocol (07/2001). It was prepared by stirring 125 mg C. I.

pigment Yellow 34 per liter for 24 hours and filtration over 0.2 micrometer. The concentrations of dissolved

metals in the eluate were determined. The eluate contents for dissolved chromium, lead and barium were 0.008 -

0.0011 mg chromium/l, 0.005 mg lead/l, and 1.7 - 2.0 mg Ba per liter. No dose-related effects on the growth rate

were observed (see attached graphs). The 72h-EC50 for Desmodesmus subspicatus was above the loading rate

of 100 mg C. I. Pigment Yellow 34 per liter. The 72h-NOEC for Desmodesmus subspicatus was at or above the

loading rate of 50 and 100 mg C. I. Pigment Yellow 34 per liter (BASF AG, 2000).

The following information is taken into account for effects on algae / cyanobacteria for the derivation of PNEC:

No dose-related effects on the growth rate of Desmodesmus subspicata were observed after 72 h exposure to test

concentrations up to 100 mg C. I. Pigment Yellow 34/l. Therefore the LC50 is above the loading rate of 100 mg

test substance/liter and the NOEC is at or above 50 mg/l.

Value used for CSA:

EC50/LC50 for freshwater algae: 100 mg/L

EC10/LC10 or NOEC for freshwater algae: 50 mg/L

7.1.4. Sediment organisms


Table 44. Long-term effects on sediment organisms


Hediste diversicolor

saltwater

long-term toxicity (laboratory study)

static

Rag worms were collected and fed on

organic matter in sediment. Lead

concentrations were determined

LC50 (10 d): 48 mg/L test


mortality (size class 20-30

mm)




mm)



2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance: lead

(II) nitrate

Bat L, Guendogdu

A, Akbulut M,

Culha M, Satilmis

HH (2001)





mm)




mm)

Mytilus edulis

saltwater

short-term toxicity (laboratory study)

static

The bioaccumulation of Cr (III) and

Cr(VI) in phytoplankton was

investigated by exposing phytoplanton

species to different concentrations of

crhomium. Cell growth and

accumulated Cr was measured

periodically.

The dry weight

concentration factors (DCF)

calculated for the

phytoplankton decreased

with cell growth. The DCFs

for CrIII was generally

higher than the DCF for

CrVI (DCF CrIII: 104 -105;

CR VI 2 -5 102).

The Cr assimilation of

mussels did not vary

between the different

sediments (of different

organic matter content) but

different with the ingested

phytoplankton species.

Mussels rapidly egested Cr.

The uptake rate of Cr VI

from the dissolved phase

was three times higher than

that of CrIII. The efflux rate

constant was 0.011 d-1 for

mussels following 7 d

dissolved uptake of Cr(VI)

and 0.010 d-1 following 8 d

ingestion of Cr(III)-labeled

diatoms.

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance: Cr

(III), Cr (VI)

Wang W_X,

Griscom SB,

Fisher NS (1997)

Discussion

The effect of the test substance on the sediment compartment and sediment organisms was not tested. C. I.

Pigment Yellow 34 and C. I. Pigment Red 104 are very stable in the environment but a low proportion of the

substance may dissociate and release chromate and lead ions. The bioavailability of these ions is assumed to be

very low. It depends on sediment pH, the amount of organic matter or mineral particles and alkalinity (chapter

5.4). Therefore, the bioavailability of dissociating chromate and lead ions is presumably limited.

However, data on the influence of chromate and lead demonstrate that both metals have detrimental effects on

sediment organisms.

In a study on lead uptake from sediment by river crabs accumulation of lead was determined. Smaller crabs had

a higher lead concentration as larger crabs (mean 72.6 +/- 59 µg/g and 3.6 +/- 1.3 µg/g respectively) (Reinecke

et al. 2003). Comparable results were demonstrated by a second study on lead uptake by polychaetes. The

sensitivity of smaller animals was higher compared to larger individuals. After 28 days of exposure a LC50 of

19 mg/l was determined for smaller polychaetes whereas for larger animals a LC50 (28 d) of 28 mg/l was

detected (Bat et al. 2001). The bioaccumulation of chromium in phytoplankton and mussels was investigated

using radio labeled chromium (III) and chromium (VI) (Wang et al.1997). Chromium (III) and, to a smaller

extent, chromium (VI) was concentrated by phytoplankton (DCF Cr(III): 12000 -130000; DCF Cr(VI): 190 -

500). Comparable concentration rates were measured for mussels.

7.1.5. Other aquatic organisms




7.2. Terrestrial compartment

Data on the effect of C. I. Pigment Yellow 34 and C. I. Pigment Red 104 on terrestrial organisms are not

available. Generally the substances are very stable in the environment. However, a low proportion of the

substance may dissociate and release chromate and lead ions to the environment. The bioavailability of these

ions depends on factors like pH and the presence of organic matter or mineral particles c. f. chapter 5.4. Thus,

the availability of lead and chromate ions released by the substance is probably very limited.

Results on the toxicity of lead and chromate on terrestrial organisms indicate that both ions have detrimental

effects on terrestrial flora and fauna. Both moieties of the pigments are taken up by earthworms. EC50 values

that are only available for chromium predict a mortality rate of 50 % at a concentration of 20 mg Cr/l.

7.2.1. Toxicity to soil macro-organisms


Table 45. Effects on soil macro-organisms


Lubricus terrestris and Aporectodea

spec. (annelids)

long-term toxicity (field study)

Substrate: natural soil

In a first experiment the metal

concentrations of earthworms from soil

treated with sewage sludge containing

heavy metals was tested. In the second

experiment the long-term effects of

heavy metal addition were tested. The

addition of sewage sludge to the test

field occured several years before the

tested earthworms were sampled.

2 (reliable with

restrictions)

key study

read-across from



or surrogate)


Beyer WN,

Chaney RL,

Mulhern BM

(1982)

Pheretina posthuma (annelids)



Earthworms were exposed to soil

mixed with potassium dichromate.

The results observed in the

three experimental sets are

inconsistent. Mortalities

decreased with increasing

chromium concentrations.

However, earthworms seem

to be intolerant to

chromium (VI). Regarding

the effect of chromium (VI)

on reproduction very

heterogeneous results were

detected and no linear

relationship can be

determined.

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

potassium

dichromate

Soni R and Abbasi

SA (1981)

Folsomia candida (Collembola (soil-

dwelling springtail))


Collembola were exposed to lead

contaminated soil. The test was

replicated at two different pH.

Surviving adults and produced

juveniles were counted

EC50 (4 wk): EC50 test


reproduction (pH 6)



reproduction (pH 5)



2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Sandifer RD and

Hopkin SP (1996)




mortality (pH 4.5) Test substance: Lead

nitrate

Discussion of effects on soil macro-organisms except arthropods

Data on the toxicity of C. I. Pigment Yellow 34 to soil macro-organisms are not available. The substance is

generally assumed to be not bioavailable to terrestrial organisms due to its low solubility and its stability. As

stated in chapter 5.0 Chromate (CrO42-

) and lead ions (Pb²+) may dissociate from the substance. Test on the

toxicity of both ions to earthworms indicate that lead and chromium ions are taken up by earthworms. A study

conducted by Beyer et al. (1982) demonstrated that lead was taken up by earthworms but was not concentrated

by the animals. Comparable results were determined for chromium. At a concentration of 20 mg/l a mortality

rate of 50 % was determined after 28 days of exposure (Soni and Abbasi, 1981).

Discussion of effects on soil dwelling arthropods

Since C. I. Pigment Yellow 34 and C. I. Pigment Red 104 are highly insoluble, exposure of terrestrial organisms

to the substance is not expected. Therefore, no data exist on the toxicity of the substance to terrestrial

arthropods. However, a minor part of C. I. Pigment Yellow 34 may dissolve and release lead and chromium

ions. The toxicity of chromium to the fig moth was investigated in a feeding test. Trivalent and hexavalent

chromium had little effect on fecundity and survival of fig moths. However, for hexavalent chromium lethal

mutations were detected at concentrations of 150 and 200 mg Cr/ kg food (Al-Hakkak and Hussain 1990). The

toxicity of lead was tested in a study on the survival and reproduction of Collembola. The animals were exposed

to lead via soil at different pH. After 4 weeks of exposure an EC50 (reproduction) of 2970µg lead/g soil of pH 6

was detected (Sandifer and Hopkin 1996).

7.2.2. Toxicity to terrestrial plants


Table 46. Effects on terrestrial plants


Zea mays (Monocotyledonae

(monocots))

long-term toxicity (field study)

seedling emergence toxicity /

vegetative vigour test


Zea mays was grown in soil treated

with lead acetate. Seedling emergence,

lead concentrations of plants and yield

were determined.

Neither germination nor

plant height and yield were

affected by lead addition to

soil. Lead was taken up by

the plants. Lead was

absorbed by the roots and

translocated in the plant.

However, no increased lead

concentrations were

detected in the corn grain.

2 (reliable with

restrictions)

key study

read-across from



or surrogate)


acetate

Baumhardt GR

and Welch IF

(1972)

Lycopersicon esculentum

(Dicotyledonae (dicots))

Lactuca sativa (Dicotyledonae

(dicots))

(Monocotyledonae (monocots))


seedling emergence toxicity test

Lactuca sativa: NOEC (2

wk): 0.35 mg/kg soil dw


on: growth (loam)

Lactuca sativa: EC50 (2

wk): 1.8 mg/kg soil dw test


growth (loam)

Lycopersicon esculentum:

NOEC (2 wk): 3.2 test mat.

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Potassium

Adema DMM and

Henzen L (1989)




Substrate: artificial soil


Guideline 208 (Terrestrial Plants Test:

Seedling Emergence and Seedling

Growth Test)

(nominal) based on: growth

(loam)

Lycopersicon esculentum:

EC50 (2 wk): 6.8 mg/kg

soil dw test mat. (nominal)

based on: growth (loam)

Avena sativa: NOEC (2

wk): 3.5 mg/kg soil dw test


growth (loam)

Avena sativa: EC50 (2 wk):

7.4 mg/kg soil dw test mat.

(nominal) based on: growth

bichromate


seedling emergence toxicity /

vegetative vigour test


The test substance was added to soil,

subsequently test plants were sown.

Phytotoxical effects of the test

substance on plant development were

recorded.

Effect of

Potassiumdichromate on

plant species. EC50 values

are given in mg/kg soil

Sinapis alta: 100

Brassica napus: 10

Brassica rapa: 10

Brassica chinensis: 10

Raphanus sativus: 100

Vicia sativa: 100

Phaseolus aureus: 100

Trifolium pratense: 10

Trinelis mellotus-coerulea:

100

Lolium perenne: 100

Avena sativa: 100

Triticum aestivum: 100

Sorghum vulgare: 100

Lepidium sativum: 10

Lactuca sativa: 10

The emergence and

germination of all plant

species were reduced by

100 % at 1000 mg/kg soil

exept for Avena sativa.

Potassiumdichromate

strongly reduced growth of

Avena sativa at an early

developmental stage.

2 (reliable with

restrictions)

supporting study

read-across from



or surrogate)

Test substance:

Potassium

dichromate

Pestemer W,

Auspurg B,

Günther P (1987)

Discussion

Since no data on the toxicity of C. I. Pigment Yellow 34 or C. I. Pigment Red 104 to terrestrial plants are

available. The toxicity of Chromate (CrO42-

) and lead ions (Pb²+) that may dissociate from the substance was

examined. Both ions are taken up by plants. Baumhardt and Welch (1972) detected uptake and translocation of

lead in maize plants but determined no effect on seedling germination and plant growth. In a guideline study

comparable to OECD 208 seedling emergence and growth of Avena sativa, Lycopersicon esculentum and

Lactuca sativa in presence of chromium were investigated. Lactuca sativa was the most susceptible plant species

regarding chromium addition; a NOEC (14 d) of 0.35 mg/kg soil dw was determined for Lettuce. For Avena

sativa and Lycopersicon esculentum a NOEC of 3.5 and 3.2 respectively was determined. EC50 (14 d) values

for all three plant species ranged from 1.8 - 7.4 mg/kg soil dw (Adema and Henzen 1989). A comparable study

was conducted by Pestemer et al. (1987). The study focused on the effect of chromium on seedling emergence



and shoot wet weight of several plant species. For Avena sativa an EC50 of 100 mg/kg soil was determined.

Thus the EC50 value was appr. 100 times higher compared to the study by Adema and Henzen (1989), however

strong reduction of the early growth of Avena sativa was reported by both studies.

7.2.3. Toxicity to soil micro-organisms


Table 47. Effects on soil micro-organisms


Species/Inoculum: soil

The community composition of

microorganisms from soil samples

collected at different distances from a

secondary Pb semlter was analysed.

Total number of

microorganisms increased

with increasinf distance

from the smelter

2 (reliable with

restrictions)

key study

read-across from



or surrogate)


Bisessar S (1982)

Species/Inoculum: soil

Organic amendments were added to

soil that was previously treated with

potassium chromate. CO2 evolution

was determined as a measure of

microbial activity. In a second

experimetn the effect of organic matter

on reduction of hexavalent chromium

to chromium III and the effect of

chromium III on microbial activity was

tested. In a third experiment the effect

of chromium on the composition of the

microorganism communitiy in soil was

tested

CO2 evolution was slightly

decreased at 20 mg/l and

decreased further at 50 and

100 mg/l.

Chromium VI was rapidly

reduced to chromium III,

the reduction was increased

in treatments with organic

amendments.

The total number of

microorganisms was not

affected by chromium

addition, however the

composition of microbial

community was affected.

The number of fungi

increased whereas the

number of actinomycetes

decreased.

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Potassium chromate

Ueda K,

Kobayashi M,

Takahashi E

(1988)

Discussion

Due to the low solubility of C. I. Pigment Yellow 34 and C. I. Pigment Red 104, significant exposure of soil

microorganisms to the substance is not expected. However, since a small fraction of the substance may dissolve

and chromium and lead ions may dissociate from the substance, the toxicity of these two ions to soil

microorganisms is considered here. The toxicity of chromium to soil microorganisms was evaluated by

measuring CO2 evolution of soil exposed to Potassium chromate for 28 days. Furthermore the composition of

the microbial community was determined. Chromium did not affect total numbers but caused a shift towards a

fungi dominated microbial community. CO2 evolution was decreased by chromium addition. The reduction was

detectable at a concentration of 20 mg/l and increased further at higher concentrations (Ueda et al. 1987). A

study investigating the community composition of microorganisms in increasing distance from a secondary Pb

smelter detected a notable decrease in the total numbers of Bacteria, Actinomycetes and Fungi with decreasing

distance from the smelter (Bisessar 1982). Thus both ions trigger a decrease in total numbers and in the overall

community composition of soil microorganisms.

7.2.4. Toxicity to other terrestrial organisms




Table 48. Effects on terrestrial arthropods


Application method: oral

Ephestia cautella (Lepidoptera)


Moth eggs were hatched and larvae

were reared on a diet mixed with

chromium salts

Both chromium salts had

little effect on femal

fecundity and mean age of

male and female animals.

Trivalent chromium has no

mutagenic effect, whereas

hexavalent chromium had

mutagnic activity at

concentrations of 150 and

200 mg/kg. The level of

dominant lethal mutations

was increased by the

substance

2 (reliable with

restrictions)

key study

read-across from



or surrogate)

Test substance:

Chromic sulfate,

Potassium

dichromate

Al-Hakkak ZS and

Hussain AF (1990)

Discussion

Please refer to Chapter 7.2.1 Toxicity to soil macro-organisms.

7.3. Atmospheric compartment


7.4. Microbiological activity in sewage treatment systems


Table 49. Effects on micro-organisms


Pseudomonas putida

freshwater

static

Oxygen consumption according to

ROBRA

EC10 (30 min): > 10000

mg/L test mat. (nominal)

based on: respiration rate

EC50 (30 min): > 10000



2 (reliable with

restrictions)

weight of evidence

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

BASF AG (1988b)

Pseudomonas putida

freshwater

static

Oxygen consumption according to

ROBRA

EC10 (30 min): > 10000



EC50 (30 min): > 10000



2 (reliable with

restrictions)

weight of evidence

experimental result

Test material

(IUPAC name):

lead sulfochromate

yellow

BASF AG (1988c)

Discussion

The results of two toxicity tests on respiration inhibition induced by C. I. Pigment Yellow 34 in Pseudomonas

putida indicate that the substance does not inhibit the activiy of microorganisms. The EC50 determined in both



sutdies was > 10000 mg/l (BASF AG, 1988).

7.5. Non compartment specific effects relevant for the food chain

(secondary poisoning)

7.5.1. Toxicity to birds

Data waiving

Information requirement: Toxicity to birds


Justification: long-term or reproductive toxicity tests on birds do not need to be conducted due to the facts

that

- a mammalian dataset is available

- direct exposure to soil is unlikely

7.5.2. Toxicity to mammals


7.6. PNEC derivation and other hazard conclusions To perform the environmental risk assessment, the pigment and its transformation products were taken into

account. PNECs were therefore derived for Lead, Chromium (VI) and C.I. Pigment Red 104, and summarized in

the tables below.

Table 50. Hazard assessment conclusion for the environment - Lead

Compartmen

t

Hazard conclusion Remarks/Justification

Freshwater PNEC aqua

(freshwater): 2.7

µg/L

Assessment factor: 3

Extrapolation method: statistical extrapolation

Lead: Statistical extrapolation has been used for the PNEC derivation as

the database for lead fulfills the requirements stipulated in the REACH

guidance with respect to input data, taxonomic groups, number of data,

treatment of multiple data for the same species and fit to distribution.

The derived HC5 was reported as 8.0 µg/L based on species means. AF

of 3 was applied to the HC5 taking into account the remaining

uncertainty. There are some limitations to the data set as discussed in the

EU RAR. Use of AF of 3 and the HC5 of 8.0 µg/L results in a PNEC of

2.7 µg/L for dissolved lead. In the vRAR PNEC of 4.0 ug/L dissolved

lead was used as well in the risk characterisation due to the use of AF of

2.

Marine water PNEC aqua (marine

water): 0.27 µg/L



Lead: A PNEC for the marine environment was not proposed in the

vRAR. A conservative approach has been selected for the purpose of this

hazard assessment using PNEC freshwater with AF 10. For a tier 2

assessment, an indicative HC5-50 value of 6.1 ug/L dissolved lead was

derived from the combined saltwater – freshwater dataset in the vRAR.

This dataset fulfilled the requirements outlined in the REACH guidance

for the use of a sensitivity distribution method with the main uncertainty

relating to the limited availability of marine ecotoxicity data as discussed

in the vRAR. The REACH guidance recommends an AF between 1 and



Compartmen

t


5 to be applied on the HC5-50. Application of AF 5 to take into account

this uncertainty would result in PNEC marine water of 1.2 ug/L.

Intermittent

releases to

water

PNEC aqua

(intermittent

releases): 2.7 µg/L



Lead: PNEC for intermittent releases was not derived in the vRAR.

Therefore the PNEC derived for the aquatic freshwater compartment has

been used as well as PNEC for intermittent releases. It should be realized

that this is a worst case approach as this PNEC is based on long term

studies, whereas in the case of intermittent releases the environmental

exposure will be limited in time.

Sediments

(freshwater)

PNEC sediment

(freshwater): 174

mg/kg sediment dw



Lead: The PNEC is based on the species sensitivity distribution of long

term experimental data for sediment organisms covering various

endpoints, habitats and feeding habits (dry weight normalised). HC5-

50% of 522 mg/kg dw was derived from the SSD on the basis of long

term sediment toxicity data (expressed as total lead). This HC5 and AF

of 3 resulted in the PNEC sediment of 174 mg total lead/kg sediment dw.

Alternatively, the most conservative PNEC derived in vRAR was based

on the lowest long term NOEC and an assessment factor. This PNEC

was not used in the risk characterisation of the vRAR - it was at the level

of the background concentrations: PNEC = 57.3 mg/kg dw, based on

lowest long term NOEC and AF of 10.

Sediments

(marine water)

PNEC sediment

(marine water): 17.4

mg/kg sediment dw



Lead: PNEC sediment (marine water) was not discussed in the vRAR. In

the absence of data for marine sediment species the default approach of

the REACH guidance has been used. An additional factor of 10 has been

applied to the PNECsediment (freshwater) to take into account the larger

species diversity in the marine environment. Comparison of freshwater

and marine toxicity data revealed that there were no indications of

marine species being consistently more sensitive than fresh water

species. The difference in metal chemistry in the marine and freshwater

environment has not been taken into account. Alternatively,

Sewage

treatment

plant

PNEC STP: 0.1

mg/L


Extrapolation method: assessment factor

Lead: The PNEC was derived from the lowest observed NOEC/L(E)C10

in the database for micro-organisms in STPs. The NOEC of 1.06 mg/L

dissolved Pb for inhibition of respiration and AF of 10 resulted in PNEC

= 0.1 mg/L for dissolved lead in effluent.

Soil PNEC soil: 166

mg/kg soil dw



Lead: Reliable experimental terrestrial toxicity data were available for

plants (n=18), invertebrates (n=12) and microflora (n=18). A

leaching/aging correction factor of 4.2 was applied to the NOECs

determined in laboratory studies to take into account difference in Pb

toxicity between spiked soils and field contaminated soils. The log-



Compartmen

t


normal distribution of the SSD (based on species mean) resulted in HC5

of 333 mg/kg. The PNEC of 166 mg/kg was derived from the HC5 and

AF of 2.

Air No hazard identified: Lead: Effects due to exposure of organisms to lead in air, airborne

particulates and aerosols are not expected because of the low

atmospheric emissions from the production and uses of lead in the

vRAR. This applies as well to the emissions of lead from the production

and uses of C.I. pigment Red 104 and C.I. Pigment Yellow 34.

Contribution to abiotic effects such as global warming, ozone depletion

in the stratosphere, ozone formation in the troposphere or acidification is

not expected.

Secondary

poisoning

PNEC oral: 0.5

mg/kg food


Lead: Application of AF of 300 to the lowest NOEC for mammals (150

mg/kg food, Rattus sp., ref Kao & Forbes, 1973)) resulted in PNECoral

of 0.5 mg/kg for mammals. It should be noted that the latter value is in

the range of natural background concentrations. The SCHER also

discusses the use of lead concentrations in blood and an SSD approach

but concludes that more work is required before a proper assessment of

the risk of secondary poisoning could be conducted.

Table 51. Hazard assessment conclusion for the environment – Chromium (VI)

Compartmen

t



(freshwater): 3.4

µg/L



Chromium(VI): Statistical extrapolation was used for the PNEC

derivation as the database for chromium (VI) fulfills the requirements

stipulated in the REACH guidance with respect to input data, taxonomic

groups, number of data, treatment of multiple data for the same species

and fit to distribution. The derived HC5-50% was reported as 10.2 µg/L.

AF of 3 was applied to the HC5 taking into account that there are some

limitations to the data set as discussed in the EU RAR. The PNEC refers

to the added dissolved concentration of Cr (VI). Chromium(III):

PNECaqua(freshwater = 4.7 µg/l, Extrapolation method. Since acute and

long term toxicity data are available for the three taxonomic groups (fish,

invertebrates, algae), AF of 10 has been applied to the lowest available

NOEC (invertebrates). The PNEC of 4.7 µg/L applies to soft water. A

PNEC of 13 µg/L would be derived from the NOEC determined in the

same invertebrate study at a hardness of 100 mg/L, suggesting that

toxicity may be reduced at greater hardness levels. The PNEC refers to

the added dissolved water concentrations. It should be noted that water

soluble forms of chromium (III) have been tested in the experimental

studies, whereas chromium (VI) will be reduced to forms of chromium

(III) with limited water solubility associated predominantly with

particulates in the environment.


water): 3.4 µg/L



Chromium(VI): The comparison of the toxicity data for freshwater and

saltwater species in the EU RAR revealed that freshwater species are

more sensitive than saltwater species. At very low salinity (< 2%) the



Compartmen

t


sensitivity appears to become comparable with that of freshwater

species. Therefore no separate PNEC was proposed for marine species in

the EU RAR. The PNEC for freshwater has been used as a worst case for

the marine environment as well. Chromium(III): PNECaqua-marine =

4.7 ug/l. PNEC was not derived separately for marine species in the EU

RAR. The PNEC freshwater (soft water) of chromium (III) is considered

to be protective for the marine environment as well because the available

data suggest that chromium (III) is less toxic in hard water and saltwater

than in soft water.

Intermittent

releases to

water

PNEC aqua

(intermittent

releases): 3.4 µg/L



Chromium(VI): A separate PNEC for intermittent releases was not

proposed in the EU RAR. Therefore the PNEC derived for the aquatic

freshwater compartment has been used as well as PNEC for intermittent

releases. It should be realized that this is a worst case approach as this

PNEC is based on long term studies, whereas in the case of intermittent

releases the environmental exposure will be limited in time.

Chromium(III): PNECaqua-intermittent = 4.7 ug/l. A separate PNEC for

intermittent releases was not proposed in the EU RAR. Therefore the

PNEC derived for the aquatic freshwater compartment has been used as

well as PNEC for intermittent releases. It should be realized that this is a

worst case approach as this PNEC is based on long term studies, whereas

in the case of intermittent releases the environmental exposure will be

limited in time.

Sediments

(freshwater)

PNEC sediment

(freshwater): 0.7

mg/kg sediment dw

Extrapolation method: partition coefficient

Chromium(VI): PNEC sediment (freshwater) is derived from PNEC

freshwater, dissolved (3.4 µg/L) using the equilibrium partitioning

method and the experimentally determined Ksuspended matter. For the

calculations a distinction has been made between the Ksuspended matter

for acidic conditions (Kp 500) and the Kpsuspended matter for other

conditions (Kp 5000). Hence two PNECs have been derived as

representative for different environmental conditions: PNECsediment-

freshwater-acid = 1.5 mg/kg ww ~ 7 mg/kg dw and PNECsediment-

freshwater-other conditions = 0.15 mg/kg ww ~ 0.7 mg/kg dw

Chromium(III): PNECsediment (freshwater) = 31 mg/kg ww for acidic

conditions and 307 mg/kg ww for other conditions. Converted to dry

weight this is 143 mg/kg dw for acidic conditions and 1412 mg/kg dw

for other conditions. PNEC sediment (fresh water) is derived from PNEC

freshwater, dissolved (4.7 µg/L) using the equilibrium partitioning

method and the experimentally determined Ksuspended matter. For the

calculations a distinction has been made between the Ksuspended matter

for acidic conditions (Kp 7500) and the Kpsuspended matter for neutral

and alkaline conditions (Kp 75000). Hence two PNECs have been

derived as representative for different environmental conditions.

Sediments

(marine water)

PNEC sediment

(marine water): 0.7

mg/kg sediment dw

Chromium(VI): The comparison of the toxicity data for freshwater and

saltwater species in the RAR revealed that freshwater species are more

sensitive than saltwater species. At very low salinity (< 2%) the

sensitivity appears to become comparable with that of freshwater

species. Therefore no separate PNEC was proposed for marine species in

the EU RAR. Here we use the PNEC freshwater sediment for ‘other

conditions’ for the marine environment as these conditions reflect the

marine environment as well. (Chromium(III): PNECsediment-marine =

307 mg/kg ww ~ 1412 mg/kg dw. PNEC was not derived separately for

marine species in the EU RAR. The PNEC freshwater sediment for



Compartmen

t


neutral and alkaline conditions has been selected as being most

representative of salt water.

Sewage

treatment

plant

PNEC STP: 0.21

mg/L



Chromium(VI): PNEC was not derived separately for marine species in

the EU RAR. The PNEC freshwater sediment for neutral and alkaline

conditions has been selected as being most representative of salt water.

Chromium(III): PNEC = 10 mg/l, Extrapolation with assessment factor

1. Chromium III seems to be much less toxic to micro-organisms than

Chromium VI. Some growth inhibition was observed at test

concentrations of 100 mg/L, while growth rates higher than controls

were observed for some species at test concentrations of 10 mg/L for

Chromium III. In the absence of further relevant data, a PNEC of 10

mg/L was used in the EU RAR.

Soil PNEC soil: 0.035

mg/kg soil dw


Chromium(VI): The PNEC is based on experimental data for terrestrial

organisms. Long term terrestrial toxicity tests are available for plants,

earthworms and soil processes (soil micro-organisms) with plants being

the most sensitive organisms. The PNEC was derived from the lowest

NOEC plant of around 0.35 mg/kg dw of soil for plants and AF of 10.

Chromium(III): PNECsoil = 3.2 mg/kg dw. Extrapolation method with

AF 10. The PNEC is based on experimental data for terrestrial

organisms. Long term terrestrial toxicity tests are available for plants,

earthworms and soil processes (soil micro-organisms) with plants being

the most sensitive organisms. The PNEC was derived from the lowest

NOEC earthworm of 32 mg/kg dw of soil and AF of 10. It should be

noted that the PNEC for chromium (III) is based on experimental studies

where a highly soluble (and thus bio available) form of chromium III has

been tested, whereas chromium VI is likely to be reduced to forms

chromium (III) with low solubility and bioavailability.

Air No hazard identified: Chromium(VI) and Chromium(III): Effects due to exposure of organisms

to chromium in air, airborne particulates and aerosols are not expected

because of the low atmospheric emissions arising from the production

and uses of chromium according to the EU RAR. This applies as well to

the emissions of chromium arising from the uses of C.I. Pigment Yellow

34 and C.I. Pigment Red 104. Contribution to abiotic effects such as

global warming, ozone depletion in the stratosphere, ozone formation in

the troposphere or acidification is not expected.

Secondary

poisoning

PNEC oral: 17

mg/kg food


Chromium(VI): The very low bioconcentration factors for fish (BCF

usually around 1 L/kg) do not trigger the evaluation of secondary

poisoning. However since chromium (VI) uptake from water, sediment

and soil has been reported for a wide range of organisms, the PNECoral

derived in the EU RAR has been used here as well. The PNEC is based

on the lowest available chronic NOAEL (20 mg Cr VI/kg body weight/

day for effects on the testes in mice by exposure via oral gavage) and the

lowest available chronic LOAEL (20 mg Cr VI/kg body weight/ day for

developmental effects in mice via the drinking water route). Converting

this value of 20 mg/kg with conversion factor 8.3 gives a NOECfood of

166 mg/kg. Application of an AF of 10 results in the PNECoral of 16.6

mg chromium VI / kg food. Chromium(III): PNEC oral was not derived

in EU RAR (2005) because of the absence of a review of mammalian

data for chromium (III). In the toxicity studies used for the PNECoral for



Compartmen

t


chromium (VI), organisms were exposed through gavage or drinking

water. Therefore little conversion of chromium (VI) to chromium (III)

was expected (according to the EU RAR).

Table 52. Hazard assessment conclusion for the environment – C.I. Pigment Yellow 34

Compartmen

t



(freshwater): 0.1

mg/L



The calculation of the PNEC aqua (marine waters) is based on the

nominal results (loading) for C.I. Pigment Yellow 34 obtained in a study

testing the acute toxicity to Daphnia magna (EC50 >100 mg/l).


water): 0.01 mg/L






Intermittent

releases to

water

PNEC aqua

(intermittent

releases): 1 mg/L






Sediments

(freshwater)

No data available:

testing technically

not feasible

The risk characterisation will be performed for lead.

Sediments

(marine water)

No data available:

testing technically

not feasible


Sewage

treatment

plant

PNEC STP: 1000

mg/L



The calculation of the PNEC STP is based on an EC50 >10000 assessed

in toxicity testing using Pseudomonas putida as test organism.

Soil No data available:

testing technically

not feasible


Air No hazard identified:

Secondary

poisoning

PNEC oral: Due to the fact that the substance is not bioaccumulative, it is unlikely

that a secondary poisoning risk will occur by this substance. Therefore

and for reasons of animal welfare, the assessment of secondary

poisoning of this substance will be based on mammalian data.

Environmental classification justification

C. I. Pigment Yellow 34 is not acutely toxic to aquatic organisms, as an inorganic substance not biodegradable

and has no relevant bioaccumulation potential. Nevertheless the official EU classification which has been

derived from lead and chromate toxicities accounts to N, R50/53. In order to avoid discrepancies the official



classification will be maintained.

General discussion

In the environment C. I. Pigment Yellow 34 and C. I. Pigment Red 104 may release small amounts of Pb2+

and

CrO42-

under certain conditions.

The PNECs for lead have been extracted from the Voluntary RAR (vRAR) of lead and lead compounds (2008).

The lead vRAR was produced by industry on the basis of the principles applied in the Existing Substances

Regulation. The lead vRAR has been reviewed by the Technical Committee on New and Existing substances

(TC NES) in 2008.

In the environment C. I. Pigment Yellow 34 and C. I. Pigment Red 104 may release small amounts of Pb2+

and

CrO42-

under certain conditions. The hexavalent chromates yield dissolved chromate and dichromate ions in the

environment, with the equilibrium depending on pH. Since chromium (VI) can be reduced to chromium (III) in

the environment, the possible effects of chromium (III) have been addressed as well. This is especially

important for the soil and sediment compartment where the majority of chromium will be converted to

chromium (III). It should be noted that chromium (III) is an essential element in animal nutrition and for some

microbes, whereas it is not considered essential for plant growth. The toxicity of chromium (III) to aquatic

organisms is briefly summarised in the EU RAR (2005). From the available data, it can be seen that chromium

(III) appears generally to be less toxic than chromium (VI) in waters of medium hardness (>50 mg CaCO3).

The PNECs for chromium have been extracted from the EU Risk Assessment Report (RAR) on chromium

trioxide, sodium chromate, sodium dichromate, ammonium dichromate and potassium dichromate (2005). The

chromium RAR was produced in the context of EU Existing Substances Regulation EEC no 793/93 by the UK

Rapporteur, agreed by the Technical Committee on New and Existing substances and published by the European

Communities in 2005.



8. PBT AND vPvB ASSESSMENT

8.1.1. PBT/vPvB criteria and justification

Not applicable.

8.1.2. Summary and overall conclusions on PBT or vPvB properties

Overall conclusion:

PBT assessment does not apply.

Justification:

C. I. Pigment Yellow 34 is an inorganic substance and therefore PBT and vPvB criteria do not apply to the

substance.



9. EXPOSURE ASSESSMENT (and related risk

characterisation)

9.0. Introduction

9.0.1. Overview of uses and Exposure Scenarios

Tonnage information:

Assessed tonnage: 3000.0 tonnes/year based on:

3000 tonnes/year imported

This tonnage is the total combined tonnage for C.I. Pigment Yellow 34 and C.I. Pigment Red 104, as the

environmental assessment for these substances is conducted in the same way and should be combined to give a

complete overview of the exposure and risk characterisation for these substances.

In order to assess the aggregated worker health risk associated with the use of the pigment in the socio-

economic analysis (SEA) the tonnage of 2100 tonnes per year was used, as this is the tonnage of C.I. Pigment

Yellow 34 for which authorization is requested. This is not relevant for the CSA of the substance as a CSA has a

clear focus on the health impact for individual workers. For an individual worker the amount of substance

handled per day, the concentration of the pigments in mixtures and the particle size of exposure determines the

health effect and not the total tonnage handles within the EU. However as the SEA refers to this CSR, the

information was included in Table 53.

Tonnage used for the environmental assessment:

Paints and coatings (PC 9a: Coatings and Paints, Thinners, paint removers): 1200 tonnes/year for the

environmental assessment (40% of the total tonnage of C.I. Pigment Yellow 34 and C.I. Pigment Red 104,

which is 3000 tonnes/year). For the environmental assessment it is assumed that the entire volume is used in

each step of the life cycle stage. This is the most conservative approach.

Colouration of plastic or plasticised articles (PC 32: Polymer Preparations and Compounds; PC 34: Textile dyes,

finishing and impregnating products; including bleaches and other processing aids): 1800 tonnes/year for the

environmental assessment (60% of the total tonnage of C.I. Pigment Yellow 34 and C.I. Pigment Red 104,

which is 3000 tonnes/year). For the environmental assessment it is assumed that the entire volume is used in

each step of the life cycle stage, except for the professional use stage (500 tonnes/year). This is in general the

most conservative approach.

Tonnage used for the aggregated worker risk (SEA monetization):

Paints and coatings

For the worker assessment in the formulation stage, 840 tonnes/year was used to determine the aggregated risk

(40% of the total tonnage of C.I. Pigment Yellow 34, which is 2100 tonnes/year). For the human health

assessment in the SEA an assessment was made of which volume will be used in which life cycle stage, based

on the information gathered in the supply chain. It is assumed that 80% of the volume can be assigned to

industrial use and 20% to professional use. For the service life, 10% of the formulated volume is assumed to be

serviced per year. 20% of this volume is serviced in an industrial setting and 80% in a professional setting.

Plastics

For the worker assessment in the formulation stage, 1260 tonnes/year was used to determine the aggregated risk

(60% of the total tonnage of C.I. Pigment Yellow 34, which is 2100 tonnes/year). For the human health

assessment in the SEA an assessment was made of which volume will be used in which life cycle stage, based

on the information gathered in the supply chain. It is assumed that 80% of the volume can be assigned to

industrial use and 20% to professional use. For the service life, 10% of the formulated volume is assumed to be

serviced per year. 20% of this volume is serviced in an industrial setting and 80% in a professional setting.

The table below lists all the exposure scenarios (ES) assessed in this CSR, including the applicable volumes.

Table 53. Overview of exposure scenarios and contributing scenarios



Identifiers Market

Sector

Titles of exposure scenarios and the related

contributing scenarios Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)

ES1 - F1 PC 9a Formulation - Distribution and mixing pigment

powder in an industrial environment into solvent-

based paints for non-consumer use. Pigment

choice depends on product specifications on

visibility, shade and colour, durability, other

requirements and Regulations.

- Distribution and mixing pigment powder in an

industrial environment into solvent-based paints

for non-consumer use (ERC 2)

- Delivery, storage and handling of closed bags

with pigment powder (PROC 3)

- Pigment powder quality control / lab work

(PROC 15)

- Manual dosing of pigment powder (PROC 8a)

- Automated dosing of pigment powder (PROC

8b)

- Re-packaging of pigment powder (PROC 9)

- Mixing of pigment paste (PROC 5)

- Storage of pigment paste / Transfer of pigment

paste through closed piping (PROC 2)

- Manual cleaning / scraping of mixing vessels,

equipment and lids (PROC 21)

- Cleaning of vessel with solvent (PROC 10)

- Pigment paste testing by smearing (PROC 10)

- Pigment paste charging/discharging by gravity

or manual handling (PROC 8a)

- Pigment paste charging/discharging using a

dedicated installation (PROC 8b)

- Pigment paste filling into drums/cans at a filling

line (PROC 9)

- Mixing colour paste in closed drum mixing

machine with automated dosing of paste (PROC

2)

- Mixing colour paste into paint in closed mixing

vessel (PROC 3)

- Pigment paint filling into drums/cans at a filling

line (PROC 9)

- Pigment paint charging/discharging using a


- Equipment cleaning: scraping and brushing

(PROC 10)

- Dried pigment paint cleaning (PROC 21)

- Spray testing of pigment paint in industrial

booth (PROC 7)

- Pigment paint testing by brushing/rolling

(PROC 10)

- Pigment paste or paint laboratory operations

(PROC 15)

1200 840

ES2 - IW1 PC 9a Use at industrial site - Industrial application of

paints on metal surfaces (machines, vehicles, 1200 672



Identifiers Market

Sector


contributing scenarios

Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)

structures, signs, road furniture, coil coating).

Pigment choice is governed by end product

specifications on visibility, colour, durability,

other technical requirements and Regulations.

- Industrial application of paints on metal

surfaces (machines, vehicles, structures, signs,

road furniture, coil coating) (ERC 5)

- Laboratory handling of pigment paste and/or

paints (PROC 15)

- Handling of packaged colour paste and/or paint,

including distribution (PROC 2)

- Mixing colour paste with paint in closed mixing


3)

- Equipment cleaning: scraping, brushing and

wiping (PROC 10)

- Dried pigment paste and/or paint cleaning

(PROC 21)

- Mixing of paste and/or coating with extra

solvents or additives before use (PROC 5)

- Filling of equipment with pigment paint (PROC

8a)

- Filling of spray equipment with pigment paints

in dedicated settings (PROC 8b)

- Transfer of pigment paint to/from drums/cans

e.g. at a filling line before application (PROC 9)

- Automated pigment paint spray application in

an industrial booth (PROC 7)

- Manual pigment paint spray application in an

industrial booth (PROC 7)

- Handling and manipulation of dried painted

articles (PROC 21)

- Pigment paint testing by brushing/rolling

(PROC 10)

- Pigment paint application and heat curing

(PROC 6)

‣ Related subsequent service life: ES4; ES5

ES3 - PW1 PC 9a Use by professional worker - Professional, non-

consumer application of paints on metal surfaces

(machines, vehicles, structures, signs, road

furniture) or as road marking. Pigment choice is

governed by requirements on visibility, colour,

durability, technical performance and

Regulations.

- Professional, non-consumer application of

paints on metal surfaces (machines, vehicles,

structures, signs, road furniture) or as road

marking (ERC 8f)

- Handling of packaged colour paste and/or paint,


- Dosing of colour paste into paint premix

1200 168



Identifiers Market

Sector



Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)

(PROC 9)

- Mixing colour paste with paint in closed mixing


3)

- Filling of spray equipment with colour paints

(PROC 9)

- Pigment paint spray application in a make-shift

booth on location (PROC 11)

- Pigment paint spray application in a

professional spray booth (PROC 11)

- Mixing of pigment paint in an open vessel

(PROC 5)

- Pigment paint application by rolling/brushing

(PROC 10)

- Cleaning of wet pigment paint on equipment by

wiping and brushing (PROC 10)

- Cleaning of dried pigment paint on equipment

by wiping, brushing, scraping etc. (PROC 21)

- Manipulation of pigment painted articles (dry)

(PROC 21)


ES4 - SL-IW1 PC 9a Service life (worker at industrial site) - Service

life of coated articles. Performance and longevity

depend on the pigment quality for bright lasting

colours improving visibility and safety, light and

weather fastness (durability), chemical fastness,

impact resistance and heat stability.

- Sanding of painted/coated articles (ERC 12b)

- Cutting painted metal sheet (dry) (PROC 21)

- Sanding of dried paint on machines, vehicles,

other metal articles etc. (PROC 24)

- Welding, torchcutting of painted metal (dry)

(PROC 25)

1200 16.8

ES5 - SL-PW1 PC 9a Service life (professional worker) - Service life

of coated articles. Performance and longevity

depend on the pigment quality for bright lasting

colours improving visibility and safety, light and

weather fastness (durability), chemical fastness,

impact resistance and heat stability.

- Leaching from painted metal surfaces

(machines, vehicles, structures, signs, road

furniture, coil coating) during service life (ERC

10b)

- Sanding of painted/coated articles (ERC 10b)

- Leaching from painted road marking during

service life (ERC 10b)

- Cutting painted metal sheet (dry) (PROC 21)

- Sanding of dried paint on machines, vehicles,

other articles etc. (PROC 24)

- Welding, torchcutting of painted metal (dry)

1200 67.2



Identifiers Market

Sector



Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)

(PROC 25)

ES6 - F2 PC 32; PC

34

Formulation - Distribution and mixing pigment

powder in an industrial environment into liquid

or solid premix to colour plastic/plasticised

articles. Pigment choice depends on product

specifications on visibility, colour, heat stability,

durability and Regulations.

- Distribution and mixing pigment powder in an

industrial environment into a premix or pre-

compound to add colour to plastic or plasticised

articles (ERC 3)

- Delivery, storage and handling of closed paper

bags with pigment powder (PROC 3)

- Pigment powder quality control / lab work

(PROC 15)

- Manual dosing of pigment powder (PROC 8a)

- Automated dosing of pigment powder (PROC

8b)

- Mixing of pigment with resins and additives to

form a liquid pre-mix/pre-compound (PROC 5)

- Storage of premix/pre-compound / Transfer of

pre-mix/pre-compound through closed piping

(PROC 2)

- Premix/pre-compound charging/discharging by

gravity or manual handling (PROC 8a)

- Premix/pre-compound charging/discharging

using a dedicated installation (PROC 8b)

- Premix/pre-compound filling into drums/cans at

a filling line (PROC 9)

- Manual cleaning / scraping of mixing vessels,


- Cleaning of vessel with resin (PROC 10)

- Premix/pre-compound quality control / lab

work (PROC 15)

- Production of coloured plastic granules or

masterbatch by extrusion, compression and/or

pelletisation (PROC 14)

- Mixing pigment powder or premix/pre-

compound into matrix in closed mixing vessel

(PROC 3)

- Production of plastic articles by extrusion,

injection moulding and other processes (PROC

14)

- Quality control / lab work with coloured

plastics (PROC 15)

- Handling of articles and single coloured

granules (PROC 21)

- Handling of mixed coloured granules and

articles (PROC 21)

- Transfer of articles and single coloured granules

(PROC 8a)

1800 1260



Identifiers Market

Sector



Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)


(PROC 8b)

- Transfer of mixed coloured granules and

articles (PROC 8a)


articles (PROC 8b)

- Pigment powder dosing before mixing (PROC

8b)

- Mixing of pigment powder with other solid

additives (PROC 3)

- Filling of small packages with pigment powder

(PROC 9)

- Manual handling of pigment contained in small

sealed plastic bags (<1 kg) (PROC 1)

- Pigment powder manual cleaning, wiping,

scraping etc. (PROC 19)

ES7 - IW2 PC 32; PC

34

Use at industrial site - Use of colour premixes

and pre-compounds to colour plastic or

plasticised articles for non-consumer use.

Pigment choice depends on product

specifications on visibility, colour, heat stability,

chemical fastness, durability and Regulations.

- Use of colour premixes and pre-compounds to

colour plastic or plasticized articles for non-

consumer use (ERC 5)

- Delivery, storage and handling of coloured

plastic granules (PROC 3)

- Delivery, storage and handling of packed plastic

premix or pre-compound (PROC 3)


(PROC 8a)


(PROC 8b)


articles (PROC 8a)


articles (PROC 8b)

- Charging/discharging of coloured plastic

granules (PROC 9)

- Mixing coloured plastic granules in closed

mixing vessel (PROC 3)

- Production of plastic articles by extrusion and

injection moulding or other processes (PROC 14)


premix or pre-compound (PROC 8a)



- Roll application and heat curing of coloured

plastic paste (PROC 6)

- Handling and manipulation of pigment plastic

articles and plastic coated textiles (PROC 21)

1800 1008



Identifiers Market

Sector



Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)


ES8 - PW2 PC 32; PC

34

Use by professional worker - Use of colour

premixes and pre-compounds in the application

of hotmelt road marking. Pigment choice

depends on end product specifications on

visibility & night time reflectivity, colour, heat

stability, durability, chemical fastness and

Regulations.

- Use of colour premixes and pre-compounds in

the application of hotmelt road marking (ERC 8f)

- Charging/discharging premix or pre-compound

(PROC 8a)

- Storage and mixing of plastic compounds in an

open vessel before application (PROC 5)

- Application of hotmelt road marking (plastic

compound) to road pavement (PROC 10)

- Handling and manipulation of coloured road

marking (PROC 21)

- High energy manipulation/removal of coloured

road marking using abrasive techniques like

grinding, drilling or sanding (PROC 24)


500 252

ES9 - SL-IW2 PC 32; PC

34

Service life (worker at industrial site) - Service

life of coloured plastic or plasticised articles.

Performance and longevity depend on pigment

quality, for bright lasting colours improving

visibility and safety, heat stability, durability,

other technical specifications and Regulations.

- Industrial service life of coloured plastic or

plasticised articles, including hotmelt road

marking (ERC 12a)


articles, plastic coated textiles and coloured road

marking (PROC 21)

- High energy manipulation of pigment plastic


marking using abrasive techniques like

mechanical cutting, grinding, drilling or sanding

(PROC 24)

1800 25.2

ES10 - SL-PW2 PC 32; PC

34

Service life (professional worker) - Service life

of coloured plastic or plasticised articles.

Performance and longevity depend on pigment

quality, for bright lasting colours improving

visibility and safety, heat stability, durability,

other technical specifications and Regulations.

- Service life of coloured plastic and plasticised

articles, including hotmelt road marking

(leaching) (ERC 10b)

- Removal of hotmelt road marking (ERC 10b)


1800 100.8



Identifiers Market

Sector



Tonnage used

in

environmental

assessment

(tonnes per

year)

Tonnage

used in

assessment

of aggregate

worker risk

(tonnes per

year)


marking (PROC 21)

- High energy manipulation of pigment plastic


marking using abrasive techniques like

mechanical cutting, grinding, drilling or sanding

(PROC 24)

Manufacture: M-#, Formulation: F-#, Industrial end use at site: IW-#, Professional end use: PW-#,

Consumer end use: C-#, Service life (by workers in industrial site): SL-IW-#, Service life (by professional

workers): SL-PW-#, Service life (by consumers): SL-C-#.)

Manufacture: M-#, Formulation: F-#, Industrial end use at site: IW-#, Professional end use: PW-#,

Consumer end use: C-#, Service life (by workers in industrial site): SL-IW-#, Service life (by professional

workers): SL-PW-#, Service life (by consumers): SL-C-#.)

9.0.2. Introduction to the assessment

9.0.2.1. Environment

Scope and type of assessment

The scope of exposure assessment and type of risk characterisation required for the environment are described

in the following table based on the hazard conclusions presented in section 7.

Table 54. Type of risk characterisation required for the environment

Protection target Type of risk characterisation Hazard conclusion (see section 7)

Freshwater Quantitative PNEC aqua (freshwater) = 2.23 µg/L

Sediment (freshwater) Quantitative PNEC sediment (freshwater) = 174

mg/kg sediment dw

Marine water Quantitative PNEC aqua (marine water) = 0.27

µg/L

Sediment (marine water) Quantitative PNEC sediment (marine water) = 17.4

mg/kg sediment dw

Sewage treatment plant Quantitative PNEC STP = 0.1 mg/L

Air Not needed No hazard identified

Agricultural soil Quantitative PNEC soil = 162 mg/kg soil dw

Predator Not conducted (see explanation below) No or insufficient data available at

present

Comments on assessment approach:

After release of C.I. Pigment Yellow 34 and/or C.I. Pigment Red 104 into the environment, a small fraction

consisting of chromate ions (CrO42-


) will dissociate from the solids and partition to the

environmental compartments. Both lead and chromium may bioaccumulate in fish and other organisms. The

relatively high Kd-values for lead and chromium indicate that both moieties may adsorb to suspended particles

and soil.



Chromium and lead

The metals chromium and lead are ubiquitously present in the environment due to both natural and

anthropogenic processes, resulting in background concentrations in all environmental compartments including

biota. The levels of these metals in the environment can vary widely due to differences in natural background

concentrations and historical emissions. Different approaches dealing with background concentrations have

been used in the EU RAR for chromium and the vRAR for lead.

The EU RAR for chromium focussed on the added contribution of industrial activities. The measured data

indicated a large spread in ambient environmental concentrations and it was judged that a plausible

representative background concentration could not be derived. Therefore the added risk approach was used as a

pragmatic solution to have an understanding of the importance of the industrial emissions. With the added risk

approach, Clocal (modelled according to the REACH guidance/EUSES) is compared to 'PNECadded' derived in

the EU RAR for chromium, thus the risk characterisation is based on the ratio Clocal/PNECadded. In the EU

RAR for chromium, a risk characterisation for the regional scale has not been performed.

The risk characterisation in the vRAR for lead was based on the conventional comparison of PEC with PNEC.

Alternative – higher tier – approaches were elaborated in the vRAR as well including for example a

bioavailability correction for sediment (use of AVS/SEM concept).

C.I. Pigment Yellow 34 and C.I. Pigment Red 104

For the risk assessment of C.I. Pigment Yellow 34 and C.I. Pigment Red 104, lead was identified as the lead

substance indicator. The content of lead in the pigments is higher than the chromium content by a factor of 4,

the dissolution from the pigments is higher by a factor of 4 to 100 and the PNECs for lead were generally lower.

PNECs and PECregional for lead were taken from the vRAR for lead. Conservative PNECs have been selected

if there was still some debate concerning various PNECs by EU Member States with respect to the most recent

publicly available vRAR.

Risk characterisation for lead

According to the REACh guidance, PEClocal is calculated as Clocal + PECregional. For lead, PECregional was

based on modelled data or the median of large datasets of ambient measured concentrations. The selected

PECregional values (vRAR lead) are presented in table Chapter 10. An initial screening of the regional

concentrations showed that the background level of lead is significant as compared to the PNECs. In that case,

according to the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Appendix

R.7.13-2 (Metals and metal compounds) the 'added risk approach' can be used. Therefore, PNEC is corrected for

the background levels in the test medium (PNECadd) and compared to the estimated PEClocal without addition

of the earlier established background concentration (see Scope and type of assessment above for the

PNECadded values used). The calculations were performed using EUSES (in CHESAR). The use volume of the

pigments was converted to represent the content of lead ion in the substance (60%).

Calculation of PEClocal

During/after use, pigment powder may be released to the environment. However, only a small fraction of the

lead in the pigment will be transformed and diluted into the water phase. The calculations focus on the fate and

behaviour of the dissolved lead. The results of the Transformation/Dissolution study showed that at low

concentrations (1 mg/l) up to 10% of the lead content in the pigments is dissolved. Without any further

correction, the concentrations of lead in effluent would be overestimated by a factor of 10 and subsequently this

is also the case for the concentrations in surface water, sediment and fish. This is illustrated in the below figure,

where for the sake of the illustration 167 g pigment was discharged to the STP, equalling 100 g pigment-bound

lead.



Illustration of the correction for transformation/dissolution of lead from C.I. Pigment Red 104 and C.I. Pigment

Yellow 34

Since the concentration in the effluent is lower, the amount going to the sludge will be somewhat higher and

subsequently, the concentration in agricultural soil is higher. The transformation/dissolution of the pigments will

also occur in the soil, and then the transformed/dissolved lead will partition between pore water and the soil

solids. With pigment concentrations in the range of 10 mg/l, the transformation/dissolution would be circa 2%.

As shown in the figure, without correction, the pore water concentration for lead would also be overestimated by

a factor of circa 10. The correction for the limited transformation/dissolution from the pigments to lead (10%),

as well as for the lead content (60%) has been included in the calculations directly at the start by reducing the

use volume of lead entering the environment by two reduction factors. This is visible in each contributing

scenario under the heading Conditions of use – Product (article) characteristics; as well as in the difference

between the initial release factor and the final release factor.

Secondary poisoning

The PNECoral for lead as included in section 7.6 has been derived according to the ECHA guidance. However,

already in the vRAR it was recognised that this PNECoral would result in the prediction of risk well below the

lead background concentrations. It was concluded that the generic recommended method to derive a PNECoral

was not suitable and that more research was needed (Pb RAR, draft of January 2006). In addition, it was

concluded that the generic approach to base the assessment on exposure concentrations in food was not suitable,

but that an assessment based on internal concentrations was more appropriate (e.g., blood lead levels). This

approach cannot be modelled with the current tools. Therefore the assessment of secondary poisoning has not

been performed.

9.0.2.2. Man via environment


In the vRAR, indirect exposure of man through the environment was based on measured concentrations food,

water, air, soil and dust, products in addition to their occupational exposure.

As indicated above and under section 10.2.1.2 the modelling of sections including the regional compartment are



of limited value. This affects also the modelling of food chain exposure. Moreover, the predictions for the lead

concentrations in crops and milk are developed for organic chemicals and in this assessment probably Kd-values

for soil/sediment are used for the predictions (e.g. uptake from air in leaves). This implies that any prediction of

human indirect exposure based on these predictions has no value. Therefore an assessment of the risk of indirect

exposure of man through the environment has not been performed.

9.0.2.3. Workers


The scope of exposure assessment and type of risk characterisation required for workers are described in the

following table based on the hazard conclusions presented in section 5.11.

Table 55. Type of risk characterisation required for workers

Route Type of effect Type of risk characterisation Hazard conclusion (see section 5.11)

Inhalatio

n

Systemic Long Term

(neurodevelopmental

damage)

Semi-quantitative DMEL (Derived Minimum Effect Level) =

5.8 µg/m³

Systemic Acute Not needed No hazard identified

Local Long Term Qualitative High hazard (no threshold derived)

Local Acute Not needed No hazard identified

Systemic Long Term

(carcinogenicity,

lung)


2.96 µg/m³

Dermal

Systemic Long Term

(neurodevelopmental

damage)


5 mg/kg bw/day

Systemic Acute Not needed No hazard identified

Local Long Term Qualitative Medium hazard (no threshold derived)

Local Acute Not needed No hazard identified

Oral

Systemic Long Term

(carcinogenicity,

intestinal)

Quantitative DNEL (Derived No Effect Level) = 1.47

µg/kg bw/day

Eye Local Not needed No hazard identified

Comments on assessment approach and general information on risk management related to toxicological

hazard:

The worker risk assessment requires both a qualitative and a semi-quantitative approach. The qualitative

assessment is required because of the local (long term) skin and respiratory sensitisation properties based on

read across to hexavalent chromium compounds, for which no DNEL can be derived based upon the available

information. Please note that this is a worst-case approach as the likelihood of respiratory sensitization of C.I.

Pigment Yellow 34 and C.I. Pigment Red 104 is considered very low due to very poor bioavailability.

The semi-quantitative assessment is required because of the presence of Lead and Chromium-VI in the pigment,

even though both have a very limited bio-availability based upon the low solubility of the substance. The semi-

quantitative assessment starts with a qualitative assessment and is followed by an exposure estimation and a

comparison to a DMEL or DNEL if derived. As two different effects have been identified via inhalation, two

inhalation long term systemic DMELs have been derived.

Carcinogenicity

The inhalation DMEL for carcinogenicity effects is derived in accordance with the current EU classification for

C.I. Pigment Yellow 34 and C.I. Pigment Red 104, which was based on read across from other more soluble



hexavalent chromium compounds, although the likelihood of carcinogenicity risk is considered very low due to

very poor bioavailability of these two substances. The inhalation DMEL that was derived for the effect of lung

cancer is related to the presence of Chromium(VI) in the pigment and was set at 2.96 µg/m3 for the respirable

fraction. This DMEL is determined at such a level that if a worker is exposed at a respirable concentration of

2.96 µg/m3 for 40 hours per week and 40 week per year, for his entire working career, the excess lung cancer

risk equals 4*10-5

.

The models used in the exposure estimation provide the inhalable fraction. The Exposure / DMEL Ratio (EDR)

was calculated using this exposure estimate. In the uses listed in this Chemical Safety Report the respirable

fraction varies from 2.2%1 for the powders to 12%2 for the spraying of paint. The value of 12% was used in the

calculation of the excess lung cancer risk in all scenarios, using the following formula:

Excess lung cancer risk = EDR x 4*10-5

x 0.12

In this manner the worst case excess risk was calculated as the non-respirable fraction is not related to the effect

of lung cancer. For the non-respirable fraction there is a theoretical risk from muco-cilliary clearance into the

gastro-intestinal system. Therefore an oral risk assessment was included, based on the conversion of the airborne

exposure to a workday oral dose in μg/kg bw/day. In this calculation it was assumed that the total estimated

airbone concentration in each contributing scenario leads to an oral exposure. Technical risk management

measures and respiratory protection are included in the assessment. The organizational RMMslike daily time

reduction are only used if needed. This will be listed in the scenarios. This results in an overestimation as the

respirable dose is not available for muco-cilliary clearance. The concentration is multiplied with the assumed

inhaled volume per 8-hour shift (10 m3) and divided by the assumed worker body weight (70 kg) to calculate the

oral dose in μg/kg bw/day. This value was used to calculate the oral RCR and demonstrate that the oral RCR is

below 1 for all of the uses listed. If below 1 this indicates that the risk is controlled, meaning that there is no

excess risk of intestinal cancer due to exposure to pigment via the oral route.

Neurodevelopmental effects

The inhalation and dermal DMELs for neurodevelopmental effects are derived from blood Lead levels equalling

the 1-percentile of the Confidence Interval of the Benchmark response of an IQ deficit of 1 IQ point. It should

be noted that even though the DMEL based upon the neurodevelopmental effects associated with the presence

of Lead is technically a minimal effect level, this DMEL is by definition of the Benchmark response the effect

level below which there is no toxicological significance. Risk management measures (RMM) are introduced to

ensure a combined inhalation and dermal Exposure / DMEL Ratio (hereafter referred to as EDR) below 1. This

means that no neurodevelopmental damage will occur through the use of PY.34 and PR.104, as described in the

uses applied for authorisation.The EDRs are presented as Exposure/DMEL in this CSR, whilst the combined

EDR for the two routes is presented as Ʃ(Exposure/DMEL).

Qualitative assessment

The qualitative risk assessment was performed according to “Guidance on information requirements and

chemical safety assessment”, Part E: Risk Characterisation, Version 2.0 November 2012. The hazard bands

were established using Table E 3-1 of this document. The results are indicated per route below, the established

hazard bands are highlighted in bold.

Inhalation, systemic, long-term: High hazard, based on read across to the carcinogenic properties of

hexavalent chromium compounds, which is a worst-case approach as the likelihood of carcinogenicity

risk of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 is considered very low due to very poor

bioavailability. The presence of Lead leads to the same conclusion, but is based on the associated

neurodevelopmental damage.

Inhalation, local, long-term: High hazard, based on read across to the respiratory sensitization caused

by the Chromium VI presence, which is a worst-case approach as the likelihood of respiratory

sensitization of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 is considered very low due to very

1 Value calculated based on the dustiness studies performed in order to document the particle size distribution field in the IUCLID dossier.

2.2% is the 95% percentile tolerance upper limit, with a reliability of 70% as calculated using the Non-Central Student, tolerance limit Tuggle NVvA/BOHS method of calculation, for the pigment with the highest respirable / inhalable fraction ratio

2 Size Distribution of Chromate Paint Aerosol Generated in a Bench-Scale Spray Booth. RANIA A. SABTY-DAILY (Health Science

Program, 5151 State University Drive, California State University, Los Angeles, CA 90032-8171), USA, WILLIAM C. HINDS,and JOHN

R. FROINES (both from Center for Occupational and Environmental Health, School of Public Health, 650 Charles E. Young Drive South, University of California, Los Angeles, CA 90095-1772, USA). Annals of occupational Hygiene, Vol. 49, No. 1, pp. 33–45, 2005. ©2004

British Occupational Hygiene Society.



poor bioavailability. Even though the number of reported occupational asthma cases arising from CrVI

is small, the risk is considered to be high because of the severity of the effect.

Dermal, systemic, long-term: High hazard, based on read across to the developmental damage caused

by the presence of Lead in the pigment.

Dermal, local, long-term: Moderate hazard, based on read across to the dermal sensitization caused

by the Chromium VI presence.

The following general risk management measures are needed based upon the result of the quantitative

assessment:

A strict application of the hierarchy of control;

Use of high level containment whenever feasible;

The use of equipment that functions under negative pressure if needed;

Control of staff entry to work area;

High standard of industrial hygiene practices including

o Regular cleaning of equipment and work area

o Good standard of personal hygiene (no eating, drinking or smoking in the work area, washing of

hands before eating, drinking, smoking or using the toilet)

o Management supervision in order to ensure proper use of RMM

o Regular training of staff on good practice

o Procedures and training for emergency decontamination and disposal

o Recording of near miss situations

o Recording of task performed and frequency of use per worker (2004/37/EC)

o Without prejudice to relevant national legislation, pre-employment screening and appropriate

health surveillance

o Annual fit testing program if respirators are needed.

Based on the qualitative risk assessment of the substance, the use of a respirator with a minimum assigned

protection factor (APF) of 10 is required unless:

The scenario prescribes that the pigment is contained/handled in a closed environment (e.g. closed system,

package material, fume cupboard);

The pigment is included in a non-dusty matrix in the scenario (e.g. paste, granules and articles) and handled

in a non-abrasive manner;

The scenario includes complete segregation with ventilation and filtration of air as a risk management

measure and the RCR is below 0.1.

The minimum APF (as mentioned in European standard EN 529, Respiratory protective devices -

Recommendations for selection, use, care and maintenance - Guidance document) for the substance is 10 (90%

efficiency of RMM) in order to prevent the use of class P1 filters, as they are deemed inappropriate for pigment

substances.

The qualitative risk assessment furthermore requires dermal protection with a high level of protection, the use of

full skin coverage with appropriate barrier material and chemical goggles. The use of a face shield is optional.

Quantitative and semi-quantitative assessment

The operational conditions under which the substance is used and the risk management used within the supply

chain were gathered by means of a number of site visits in different member states. This information was used

as a starting point in the exposure estimations. It should be noted that any operational condition that impacts the

result of the exposure estimation is to be seen as a risk management measure.

The worker inhalatory exposure was estimated using the Advanced REACH Tool (version 1.5) for almost all of

the identified uses. The 90th

percentile of the estimation was used in our calculations. For a limited number of

uses the ART model does not allow for a valid assessment; in those cases the MEASE tool was used. As the

ART model does not estimate dermal exposure, the ECETOC TRA tool (version 3) as incorporated into

CHESAR was used to assess the dermal exposure.

The substance is used as a powder for formulation, in a paste or viscous liquid (paint) and in granules (plastics).

In all of the end uses the substance will be part of a more or less complex matrix. The substance has no vapour

pressure meaning that it will not evaporate from a liquid or a solid. Consequently the temperature of the process

in which the substance is used is not relevant for the exposure. As the substance itself is not volatile, the

tendency to become airborne was established based upon the potential for the generation of particles or aerosols

during the activity. For the dermal assessment in CHESAR, the dustiness was set on high for powdered PR.104

use and medium for powdered PY.34 use. The dustiness was set to low for all other scenarios (paste, liquid,



granules, articles), although it has no actual effect on the dermal exposure calculation in ECETOC TRA. When

modelling exposure in the Advanced REACH Tool for contributing scenarios in which the pigment is used as a

powder, the dustiness level selected in the model was based on the actual measured value of a continuous drop

test according to EN 15051-3 (“fine dust” for PR.104 and “coarse dust” for PY.34). A limited fraction of the

inhalable concentration associated with the worker contributing scenarios is respirable (2.2%1 for all

contributing scenarios but up to 12%Error! Bookmark not defined.

for the spraying of paint). As mentioned above the

value of 12%2 was selected in order to calculate the individual workers excess lung cancer risk. This is results in

an overestimation of the workers risks.

For the contributing scenarios in which the substance is incorporated into a paste, the potential of aerosol

generation is zero. For the contributing scenarios in which the pigment is incorporated into a liquid (paint,

premix/pre-compound) a medium viscosity was selected.

Most of the contributing scenarios are modelled as indoor activities to ensure a worst case estimation of the

exposure. This means that in general the outdoor use – if applicable for that use – is considered to be safe as

well. For all uses where exposure is expected to occur and risk management measures (RMM) are needed, the

RMM were selected according to the hierarchy of control as prescribed in the following Council Directives,

taking into account the results of the qualitative assessment:

Directive on the protection of the health and safety of workers from the risks related to chemical agents at

work (98/24/EC) ‘Chemical Agents Directive’;

Directive on the protection of workers from the risks related to exposure to carcinogens and mutagens at

work (2004/37/EC).

In the case of carcinogenic or mutagenic substances, substitution is mandatory if technically feasible under the

rules of the Chemical Agents Directive. The socio-economic analysis as included in the application for

authorisation establishes that substance substitution is not technically and economically feasible for the uses

covered in the authorisation request.

Exposure / DMEL Ratios (EDRs) are calculated for the two inhalation DMELs and the dermal DMEL. The

EDR based on the inhalation DMEL associated with the (systemic) carcinogenicity of the substance (due to the

presence of Chromium VI) is calculated and assessed separately as this effect is entirely independent from the

(systemic) neurodevelopmental effect (due to the presence of Lead). Based on the EDR the additional risk of a

worker to die due to lung cancer, while performing the task for his entire working career, is calculated and

presented in the conclusion on risk characterisation.

The EDRs of the inhalation and dermal DMEL related to developmental damage are added up, resulting in the

calculation of the combined EDR for this effect. This combined EDR is only applicable to female workers of

childbearing age and for lactating females. It should be stressed that even though the DMEL for the

neurodevelopmental damage is technically a minimal effect level, this DMEL is by definition of the Benchmark

response the effect level below which there is no toxicological significance (deficit of <1 IQ point). The

operational conditions and risk management measures as described in the contributing scenarios ensure a

combined inhalation and dermal EDR below 1. This means that no neurodevelopmental damage will occur

through the use of PY.34 and PR.104, as described in the uses applied for authorisation.

In a number of scenarios respiratory protection (based on assigned protection factors as listed in EN 529) and/or

time reduction were applied to the assessment (linear correction to both inhalation and dermal exposure). These

measures were applied based onknowledge of the current practise (gained through site visits) in companies

working with pigments throughout the supply chain. When in a contributing scenario respiratory protective

equipment is used, the concentration is adapted linearly using the assigned protection factors (and not the

nominal protection factors) as listed in Annex C of EN 529 standard on respiratory protection. This is

sufficiently conservative as (in Annex C) the APF is defined as “the level of respiratory protection that can

realistically be expected to be achieved in the workplace by 95% of adequately trained and supervised

employees wearing it. This is based on the assumption that the employee is using a properly functioning and

correctly fitted respiratory protective device and on the 5thpercentile of the Workplace Protection Factor

(WPF) data”.

In the table below an overview is provided of the assigned protection factors (APFs) that are used in the CSA.

For each of the APFs, the types of respiratory protection equipment that can achieve that particular APF are

listed. We have listed country specific information for those countries for which appendix C of EN 529 provides

and overview of APFs.

Currently, there is no harmonised approach within the EU on the appropriate application of APFs for

Respiratory Protective Equipment (RPE). Each user of the pigments will have to verify with its supplier which



RPE can provide the APF needed in their jurisdiction. As the UK generally lists the lowest APF, the use of this

value is advised if no other APF is established within a given jurisdiction.

Table 56 Type of respiratory protection for which the APF meets or exceeds the APF used in the CSA

Assigned

protection factor

used in CSA

Type of RPE that as a minimum meets the used APF as listed in appendix C

of EN 529

Country Standard Description of RPE Class

10 Fin, D, I, S, UK EN 149 Filtering half mask FF P2

Fin, D, I, S, UK EN 140 Half mask and quarter mask with filter P2

30 D, I EN 149 Filtering half mask FF P3

D, I EN 140 Half mask and quarter mask with filter P2

Fin, D, I, S EN 12942 Powered assisted filtering device

incorporating full face mask, half

mask or quarter mask

TM2

UK EN 12942 Powered assisted filtering device



TM3

Fin, D, I, S, UK EN 136 Full face mask (all classes) P3

40 Fin, D, I, S, UK EN 136 Full face mask (all classes) P3

Fin, D, I, S, UK EN 12941 Powered filtering device incorporating

a hood or a helmet

TH3

Fin, D, I, S, UK EN 12942 Powered assisted filtering device



TM3

Fin, D, I, S, UK EN 138 Fresh air hose breathing apparatus Full

face

mask

100 Fin, D, I, S EN 136 Full face mask (all classes) P3

Fin, D, I, S EN 12941 Powered filtering device incorporating

a hood or a helmet

TH3

Fin, D, I, S EN 138 Fresh air hose breathing apparatus Full

face

mask

UK EN 137 Self-contained open circuit

compressed air breathing apparatus

Positive

pressure

demand

200

Fin, D, I, S EN 136 Full face mask (all classes) P3

Fin, I, S EN 12941 Powered filtering device incorporating

a hood or a helmet

TH3


face

mask



Positive

pressure

demand

400 Fin, D, I, S EN 136 Full face mask (all classes) P3

Fin, D, I, S EN 12942 Powered assisted filtering device



TM3

Fin, D, I, S EN

14593-1

Compressed air line breathing

apparatus with demand valve - Part 1:

Apparatus with a full face mask

-



Assigned

protection factor

used in CSA

Type of RPE that as a minimum meets the used APF as listed in appendix C

of EN 529

Country Standard Description of RPE Class


face

mask



Positive

pressure

demand

1000 Fin, S EN 12942 Powered assisted filtering device



TM3

Fin, D, I, S EN

14593-1

Compressed air line breathing

apparatus with demand valve - Part 1:

Apparatus with a full face mask

-

D EN 138 Fresh air hose breathing apparatus Full

face

mask

D, I, UK EN 137 Self-contained open circuit


Positive

pressure

demand

Comments on assessment approach and information on risk management related to physicochemical

hazard:

Not applicable, as pigments have no physicochemical hazard.

9.0.2.4. Consumers

Exposure assessment is not applicable as there are no consumer-related uses for the substance.

9.0.2.5. Waste management

At the end of their service life, articles painted with paint containing C.I. Pigment Yellow 34 or C.I. Pigment

Red 104 or plastic articles containing the pigments will become waste and need to be dealt with in line with the

relevant EU Waste Legislation. In general the EU Waste Legislation consists of three layers:

a. Framework legislation on waste;

b. Legislation on waste management operations;

c. Legislation on specific waste streams.

Ad a. Framework waste legislation

The Framework waste legislation describes three distinctive topics, namely:

Waste Framework Directive or Directive 2008/98/EC of the European Parliament and of the Council of 19

November 2008 on waste. It provides for a general framework of waste management requirements and sets

the basic waste management definitions for the EU. The Directive only states in article 11 the obligation to

separate plastic waste (to certain degrees) for the purpose of reuse and recycling;

European Waste Catalogue (EWC) or Decision 2000/532/EC establishing a list of wastes. This Decision

establishes the classification system for wastes, including a distinction between hazardous and non-

hazardous wastes. It is closely linked to the list of the main characteristics which render waste hazardous

contained in Annex III to the Waste Framework Directive above; the Catalogue is used to derive a code (six

numbers in 3 sets of 2) that adequately describes the waste being transported, handled or treated. These

codes carry three categories - absolute non-hazardous, mirror entries and absolute hazardous. Where a

waste is hazardous by its very composition, the EWC is followed by an Asterix (*). The EWC contains

numerous categories of plastic(ized) waste originating from roughly twenty economic activities, e.g. 17 02

03 (plastic from construction & demolition waste), 17 02 04* (glass, plastic and wood containing or



contaminated with dangerous substances), 12 01 16 (waste blasting material containing dangerous

substances);

Waste Shipment Regulation (WSR), or Regulation (EC) No 1013/2006 of the European Parliament and of

the Council of 14 June 2006 on shipments of waste. This Regulation specifies under which conditions waste

can be shipped between countries. The Regulation contains in Annex V several, with lead contaminated

plastics that are subject to export prohibition e.g. A2 (Waste containing principally inorganic constituents,

which may contain metals and inorganic materials).

Generally, to a certain degree all three framework regulations are applicable for end-of-life painted and coloured

plastic or plasticized articles.

Ad b. Waste management operations legislation

EU legislation on waste management operations consists of three distinctive directives on:

Landfill, Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste. The Landfill Directive

does not yet include a landfill ban for plastic waste, but nine EU countries already banned dumping of

plastic waste on landfills and currently the plastics manufacturers are pushing for an EU-wide ban on the

disposal of plastics in landfills, arguing that Europe needs tougher recycling requirements to stop an

important raw material from being thrown away;

Incineration, Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on

the incineration of waste. Although waste plastics are widely incinerated (or landfilled) in the EU, the

Incineration Directive does not contain specific provisions for plastic waste. Indirectly however the

incineration of chloride containing plastic waste (e.g. PVC) is prohibited in order to limit the emissions of

dioxins;

Port reception facilities, Directive 2000/59/EC of the European Parliament and of the Council of 27

November 2000 on port reception facilities for ship-generated waste and cargo residues - Commission

declaration. This Directive does not have any provisions for plastic waste.

So generally speaking, EU waste management operations legislation is not (directly) applicable in this case.

Ad c. Specific waste streams legislation

European Union legislation on specific waste streams consists of seven directives for the following waste

streams:

Waste from titanium dioxide industry: Council Directive 78/176/EEC of 20 February 1978 on waste from

the titanium dioxide industry; Council Directive 82/883/EEC of 3 December 1982 on procedures for the

surveillance and monitoring of environments concerned by waste from the titanium dioxide industry;

Council Directive 92/112/EEC of 15 December 1992 on procedures for harmonizing the programmes for

the reduction and eventual elimination of pollution caused by waste from the titanium dioxide industry;

Sewage sludge for agricultural use, Council Directive 86/278/EEC of 12 June 1986 on the protection of the

environment, and in particular of the soil, when sewage sludge is used in agriculture;

Batteries and accumulators, Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators

containing certain dangerous substances, and repealing Directive 91/157/EEC;

Packaging and packaging waste, European Parliament and Council Directive 94/62/EC of 20 December

1994:

o Commission Decision 97/129/EC of 28 January 1997 on the identification system for packaging

materials; Commission Decision 97/138/EC of 3 February 1997 establishing the formats relating to the

database system; Commission Decision 1999/42/EC of 22 December 1998 confirming the measures

notified by Austria pursuant to Article 6(6) of Directive 94/62/EC; Commission Decision 1999/177/EC

of 8 February 1999 establishing the conditions for a derogation for plastic crates and plastic pallets in

relation to the heavy metal concentration levels established in Directive 94/62/EC; Commission

Decision 1999/652/EC of 15 September 1999 confirming the measures notified by Belgium pursuant to

Article 6(6) of Directive 94/62/EC; Commission Decision 1999/823/EC confirming the measures

notified by the Netherlands pursuant to Article 6(6) of Directive 94/62/EC

o EU Member States must ensure that packaging placed on the market complies with the essential

requirement to reduce the content of hazardous substances and materials in the packaging material and

its components. Article 11 of the packaging waste directive (94/62/EC) on concentration levels of



heavy metals present in packaging states that Member States shall ensure that the sum of concentration

levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging

components shall not exceed certain thresholds.

Polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT), Council Directive 96/59/EC of 16

September 1996 on the disposal of polychlorinated biphenyls and polychlorinated terphenyls (PCB/PCT);

End-of-life vehicles (ELV), Directive 2000/53/EC of the European Parliament and of the Council of 18

September 2000 on end-of life vehicles

Waste electrical and electronic equipment (WEEE), Directive 2002/96/EC of the European Parliament and

of the Council of 27 January 2003 on waste electrical and electronic equipment (WEEE), recasted by new

WEEE Directive 2012/19/EU and The Restriction of Hazardous Substances Directive 2002/95/EC (RoHS)

short for Directive on the Restriction of the Use of certain Hazardous Substances in electrical and electronic

equipment, amended by the RoHS 2 directive (2011/65/EU) is an evolution of the original directive and

took effect 2 January 2013. Annex II of this Directive contains maximum concentration values tolerated by

weight in homogeneous materials, e.g. for lead: 0.1%. This also applies for coating or plastic insulation of

waste metal cables containing or contaminated with lead.

Most of these directives are not applicable to painted articles or plastic/plasticized articles. C.I. Pigment Yellow

34 and C.I. Pigment Red 104 are not expected to be used in colouring of packaging materials. However,

depending on the application of these pigments for plastics or plasticized articles used in vehicles and electrical

or electronic equipment or the use of paint on vehicles, the regulations for End-of-life Vehicles and RoHS may

be relevant.



9.1. Exposure scenario 1: Formulation - Distribution and mixing

pigment powder in an industrial environment into solvent-based paints

for non-consumer use. Pigment choice depends on product specifications

on visibility, shade and colour, durability, other requirements and

Regulations

Market sector: Paints and coatings

Distribution and formulation of C.I.Pigment Yellow 34 and C.I.Pigment Red 104 powder into paste/dispersions

and solvent-based coloured paints with specific functions for industrial or professional use on non-consumer

articles. Examples of coated objects are high grade steel based products e.g. piping for the (petro)chemical

industry, crane arms, agricultural machinery, street furniture and markings, steel bridges, construction arches,

steel skips, coil coated products (e.g. roofing).High quality of the coating is crucial for the long-term functioning

and protection of the objects,i.e. where fading of the colour could endanger public or worker safety,where

regular repainting could create difficult or risky situations (steel bridges, traffic jams) or where idle time of

specialty equipment would incur high costs.

Pigment choice is based on requirements for the end application related to: VISIBILITY & SAFETY - Based on

their bright, vivid, durable colours, these pigments are used when visibility and safety are important,especially

in regulated applications like road marking; DURABILITY - The pigments respond to the demand for high

performance pigments, e.g. in aggressive atmospheric conditions in industrialized areas,providing excellent light

and weather fastness,preventing applications to darken or fade if exposed to light and humidity; excellent

resistance to sulfur dioxide, preventing discolouration (greyness) and loss of gloss, required for exterior

applications; SHADE FUNCTIONALITY - Their colour covers a wide range from green to red shade yellow

and yellow to blue shade red; COLOURISTIC & TECHNICAL PERFORMANCE - Within the listed colour

range, these pigments provide clean, vivid colours (chroma); excellent opacity or hiding power; excellent

weather fastness. The perceived colour remains the same regardless of the light source (no metamerism). They

also provide excellent rheology in coatings; excellent non-bleeding properties, non-migration properties and

impact resistance in coatings.

PC 9a: Coatings and Paints, Thinners, paint removers

Environment contributing scenario(s):

Distribution and mixing pigment powder in an industrial environment into solvent-based

paints for non-consumer use

ERC 2

Worker contributing scenario(s):

Delivery, storage and handling of closed bags with pigment powder PROC 3

Pigment powder quality control / lab work PROC 15

Manual dosing of pigment powder PROC 8a

Automated dosing of pigment powder PROC 8b

Re-packaging of pigment powder PROC 9

Mixing of pigment paste PROC 5

Storage of pigment paste / Transfer of pigment paste through closed piping PROC 2

Manual cleaning / scraping of mixing vessels, equipment and lids PROC 21

Cleaning of vessel with solvent PROC 10

Pigment paste testing by smearing PROC 10

Pigment paste charging/discharging by gravity or manual handling PROC 8a

Pigment paste charging/discharging using a dedicated installation PROC 8b

Pigment paste filling into drums/cans at a filling line PROC 9



Mixing colour paste in closed drum mixing machine with automated dosing of paste PROC 2

Mixing colour paste into paint in closed mixing vessel PROC 3

Pigment paint filling into drums/cans at a filling line PROC 9

Pigment paint charging/discharging using a dedicated installation PROC 8b

Equipment cleaning: scraping and brushing PROC 10

Dried pigment paint cleaning PROC 21

Spray testing of pigment paint in industrial booth PROC 7

Pigment paint testing by brushing/rolling PROC 10

Pigment paste or paint laboratory operations PROC 15

Description of the activities and technical processes covered in the exposure scenario:

Pigment powders are typically delivered by truck in bags on pallets. The pallets are stored inside. Order picking

is usually performed manually, internal transport with hand pallet truck or forklift.

A colour paste consists of a mixture containing up to 70% pigment, prepared in a dedicated mixing vessel.

Before the pigment powder is dosed, the mixing vessel already contains the carrier. Dosing of pigment powder

is done manually or automated by cutting the bags and emptying the contents into the mixing vessels. Mixing is

done in vessels of varying sizes.

The pigment is dispersed to the required specifications. The vessels are closed during mixing and dispersing

operations. The surface area of the mixing vessels varies and is between 1-3 m2 for the smaller containers and

over 3 m2 for the large containers. Local exhaust ventilation is present. Good housekeeping practices are

present. The mixing room is ventilated by means of good natural ventilation or by mechanical room ventilation.

The pigment as such is embedded in a matrix.

This colour paste is transferred to a storage container either using fixed piping or by flexible hose, gravity and/or

air pressure.

Base paints are formulated separately by mixing ingredients such as binder, filler, hardener and/or solvent in a

closed, controlled batch process. The colour pastes are added to the base paint and subsequently mixed in a

closed container. For quality control purposes a sample can be taken from the coloured paint. During Quality

Control (QC) the paint is either spread manually or sprayed in a dedicated spray booth. Testing on dried paints

include low speed mechanical abrasion. Powdered pigment is used during QC and product development in small

quantities inside fume cupboards.

An operator, formulating a full day, typically handles 1,000 kg of pigment powder per shift.

During activities where exposure to pigment powder is to be expected the workers use respiratory protection, a

coverall, gloves and goggles.

Equipment is cleaned using solvents. The stirrer is cleaned by scraping followed by soft spraying with the

organic solvent of the paste. These solvents are either dosed into a product or collected and recycled. No water

is used to clean mixing vessels, piping and other equipment. Spills are collected, using absorbent if needed, the

material is disposed of as hazardous waste. If water is used during cleanup of spills, it is collected and disposed

of as hazardous waste. Emptied bags of pigment powder are collected and disposed of as hazardous waste. The

production area is a contained area with liquid-proof floors.

9.1.1. Environmental contributing scenario 1: Distribution and mixing pigment powder

in an industrial environment into solvent-based paints for non-consumer use

9.1.1.1. Conditions of use

Product (article) characteristics

• Correction for Pb content of pigment (60%): Correction applicable (The pigment contains 60% lead)

[Effectiveness Water: 40%; Air: 40%]

• Correction for water solubility of Pb in pigment (10%): Correction applicable (Transformation/dissolution

tests were carried out with the pigment. Based on the results of these tests, 10% dissolution is applied as a

worst-case.) [Effectiveness Water: 90%]

Amount used, frequency and duration of use (or from service life)



• Daily use at site: <= 5 tonnes/day

Worst-case tonnage per site per day based on formulators questionnaire

• Annual use at a site: <= 120 tonnes/year

Worst-case tonnage per site per year based on formulators questionnaire

• Percentage of tonnage used at regional scale: = 100 %

• Emission days per year: = 24 days/year

Number of emission days per year used for worst-case volume calculations. Scaling may be applied to increase

the number of emission days, as long as the daily use at the site and related release to environmental

compartments remains below the numbers mentioned in this scenario.

Technical and organisational conditions and measures

• Waste water treatment: If any process waste water is generated, this should be treated as hazardous waste

In general, no water is used in the process. If any process waste water is generated, this should be treated as

hazardous waste and should not be released to the waste water leaving the site.

• Relevant RMM to achieve emission reduction to air: Direct air emissions should be reduced by implementing

RMM

To reduce the emissions to air, one or more of the following RMM may be applied:

• Fabric or bag filters

• Wet scrubbers

• Electrostatic precipitators

• Wet electrostatic precipitators

• Cyclones as primary collector

• Ceramic and metal mesh filters

• Efficiency of raw material use: Process optimized for highly efficient use of raw materials

Conditions and measures related to sewage treatment plant

• Municipal STP: Yes [Effectiveness Water: 100%]

• Discharge rate of STP: >= 2E3 m3/d

• Application of the STP sludge on agricultural soil: Yes

Conditions and measures related to treatment of waste (including article waste)

• Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment

demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal

according to national/local legislation is sufficient.)

Other conditions affecting environmental exposure

• Receiving surface water flow rate: >= 1.8E4 m3/d

9.1.1.2. Releases

The local releases to the environment are reported in the following table.

Table 57. Local releases to the environment

Release Release factor estimation

method

Explanation / Justification

Water Release factor

(Site-specific information)

Initial release factor: 0%

Final release factor: 0%

Local release rate: 0 kg/day

Explanation / Justification: During the formulation of solvent-

based paints and coatings using C.I. Pigment Yellow 34 and C.I.

Pigment Red 104 no water is used. If any waste water is




method


generated, this is treated as hazardous waste.

Air Release factor

(SpERC CEPE 2.1c.v1 /

Eurometaux 2.2b.v2.1)

Initial release factor: 0.01%

Final release factor: 0.006%

Local release rate: 0.291 kg/day

Explanation / Justification: Release fraction from CEPE SpERC

2.1c.v1 - formulation - organic solvent borne coatings and inks –

solids. Based on Emission Scenario Document on Coatings

Industry (Paints, Lacquers and Varnishes), OECD, July 2009

[http://www.oecd.org/officialdocuments/displaydocumentpdf?cote

=ENV/JM/MONO(2009)24&doclanguage=en]. No direct dust

emissions to the air are expected. Initial loss from handling of

solid substances is captured by air extraction devices. This release

fraction is supported by SpERC Eurometaux 2.2b.v2 -

Formulation of metal compounds in pigments, paints and coating

industry sector, in which a release fraction of 0.005% is provided.

Soil Release factor

(SpERC CEPE 2.1c.v1 /

Eurometaux 2.2b.v2.1)


Explanation / Justification: No release to soil takes place during

formulation of solvent-based paints and coatings. This is

supported by SpERCs CEPE 2.1c.v1 and Eurometaux 2.2b.v2.1.

Releases to waste

Release factor to waste from the process: 1%

Information from Emission Scenario Document on Coatings Industry (Paints, Lacquers and Varnishes), OECD,

July 2009

[http://www.oecd.org/officialdocuments/displaydocumentpdf?cote=ENV/JM/MONO(2009)24&doclanguage=e

n].

9.1.1.3. Exposure and risks for the environment and man via the environment

The exposure concentrations and risk characterisation ratios (RCR) are reported in the following table.

Table 58. Exposure concentrations and risks for the environment

Protection target Exposure concentration Risk characterisation

Freshwater Local PEC: 0 mg/L RCR < 0.01

Sediment (freshwater) Local PEC: 0 mg/kg dw RCR < 0.01

Marine water Local PEC: 0 mg/L RCR < 0.01

Sediment (marine water) Local PEC: 0 mg/kg dw RCR < 0.01

Sewage treatment plant Local PEC: 0 mg/L RCR < 0.01

Agricultural soil Local PEC: 3.915E-4 mg/kg dw RCR < 0.01

Conclusion on risk characterisation

Under the conditions of this contributing scenario, the local concentrations and associated risk characterisation

ratios due to the use of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are orders of magnitude lower than

the background concentrations of lead for all environmental compartments assessed.

9.1.2. Worker contributing scenario 1: Delivery, storage and handling of closed bags

with pigment powder (PROC 3)




Method


• Substance product type: Powders, granules or pelletised material External Tool (Advanced

REACH Tool v1.5)

• Dustiness: 1006 mg/kg for inhalable fraction (Measured according to EN 15051)

Corresponding dustiness category in Advanced REACH Tool: "Coarse dust".

External Tool (Advanced

REACH Tool v1.5)

• Moisture Content of the product: Dry product (<5 % moisture content) External Tool (Advanced

REACH Tool v1.5)

• Concentration of substance in mixture: Substance as such External Tool (Advanced

REACH Tool v1.5)

• Concentration of substance in mixture: Substance as such TRA Worker v3

Amount used (or contained in articles), frequency and duration of use/exposure

• Duration of activity: < 8 hours TRA Worker v3


• Surface Contamination/Fugitive Emission Sources: The process is not fully

enclosed or the integrity of that enclosure is not regularly monitored but

demonstrable and effective housekeeping practices are in place (Demonstrable and

effective housekeeping practices (examples include daily cleaning using

appropriate methods (eg vacuum), preventive maintenance of machinery and

control measures, and use of protective clothing that will repel spills and reduce

personal cloud).)


REACH Tool v1.5)

• Dispersion - Indoors: Ventilation rate of the general ventilation system in the

work area: 3 ACH (ACH = air changes per hour.)


REACH Tool v1.5)

• Containment: Closed batch process with occasional controlled exposure TRA Worker v3

• Occupational Health and Safety Management System: Advanced TRA Worker v3

Conditions and measures related to personal protection, hygiene and health evaluation

• Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with

specific activity training) [Effectiveness Dermal: 95%]

TRA Worker v3

Other conditions affecting workers exposure

• Handling of Contaminated Solid Objects or Paste - Activity: Handling of

apparently clean objects (Examples: Drums coming out of a cleaning machine)


REACH Tool v1.5)

• Handling of Contaminated Solid Objects or Paste: Careful handling, involves

workers showing attention to potential danger, error or harm and carrying out the

activity in a very exact and thorough (or cautious) manner


REACH Tool v1.5)

• Dispersion - Indoor: Room size of the work area: Any size workroom External Tool (Advanced

REACH Tool v1.5)

• Skin surface potentially exposed: One hand face only (240 cm2) TRA Worker v3

9.1.2.2. Exposure and risks for workers


Table 59. Exposure concentrations and risks for workers

Route of exposure and type of

effects

Exposure concentration Risk characterisation

Inhalation, systemic, long-term

(neurodevelopmental damage)

2.5E-03 mg/m³ (External Tool (Advanced

REACH Tool v1.5))

Exposure/DMEL = 0.431

Qualitative risk characterisation

(see below)




effects


Inhalation, local, long-term Qualitative (see below)

Dermal, systemic, long-term


0.034 mg/kg bw/day (TRA Worker v3) Exposure/DMEL = 0.007


(see below)

Dermal, local, long-term Qualitative (see below)

Combined routes, systemic,

long-term (neurodevelopmental

damage)

Ʃ(Exposure/DMEL) = 0.438


(carcinogenicity, lung)


REACH Tool v1.5))



(see below)

Oral, systemic, long-term

(carcinogenicity, intestinal)

0.357 µg/kg bw/day (calculated from

exposure value for: Inhalation, systemic,

long-term)

RCR = 0.244

Remarks on exposure data

External Tool (Advanced REACH Tool v1.5)

Inhalation, systemic, long-term:

ART calculation: The inter-quartile confidence interval is 0.0013 mg/m³ to 0.0054 mg/m³. The predicted

90th percentile long-term exposure is 0.0025 mg/m³.

Conclusion on risk characterisation Semi-quantitative risk characterisation

Carcinogenicity:

Performing this specific activity for an entire working career leads to excess lung cancer mortality of 4.05E-06,

which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on

information requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this

specific activity.

Neurodevelopmental damage:

The performance of this task prior to and during pregnancy and lactation leads to a predicted loss in the IQ of

the offspring of less than one IQ point (= combined RCR for lead <1). As this number of loss is considered

toxicologically insignificant, the risk on neurodevelopmental damage caused by pigment use is deemed

controlled.

Please refer to section 9.0.2.3 for an additional explanation on the risk characterization of the carcinogenicity

and neurodevelopmental effect.


The operational conditions and risk management measures are in line with the qualitative risk assessment as

described in section 9.0.2.3 of the CSR.

9.1.3. Worker contributing scenario 2: Pigment powder quality control / lab work

(PROC 15)


For example QC at shipment receival.



Method


• Substance product type: Powders, granules or pelletised material

Applicable to transfer activity.


REACH Tool v1.5)

• Moisture Content of the product: Dry product (<5 % moisture content)

Applicable to activities with powder.


REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)











personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)

• General Control Measures: Local exhaust ventilation (LEV) - Enclosing hoods -

Fume cupboard (Any form of permanent encapsulation or encasing of the source of

which maximally one side is open with a well designed local exhaust ventilation

system (e.g. laminar air flow). The design of both the enclosure and the ventilation

system is such that the influence of worker behaviour is minimal (e.g. an alarm

system prevents the worker from using the fume cupboard in case the system is not

working properly).)

Effectiveness of RMM: 99%.


REACH Tool v1.5)

• Containment: No TRA Worker v3





TRA Worker v3


• Activity class (solids): Transfer of powders, granules or pelletised material -

Falling of powders, granules or pelletised material (Activities where a stream of

powder is transferred from one reservoir (or container, vessel) to the receiving

vessel. The product may either fall due to gravity from a high to a lower point

(dumping of powders), be transferred horizontally (scooping of powders) or is

transferred through a hose or tube with pressure (vacuum transfer). Example

Activities: Bagging solids Dumping solids in mixers Loading barges with minerals

or cereals Scooping Scattering Filling of bottles)


REACH Tool v1.5)

• Transferring of Powders, Granules or Pelletised Material - Activity: Transferring

10 – 100 gram/minute (Examples: Small-scale scooping for sampling)


REACH Tool v1.5)

• Falling of Powders, Granules or Pelletised Material - Drop height: Drop height <

0.5 m


REACH Tool v1.5)

• Falling of Powders, Granules or Pelletised Material - level of containment of the

process: Handling that reduces contact between product and adjacent air (Note:


REACH Tool v1.5)



Method

This does not include processes that are fully contained by localised controls (see

next questions). Example situation: Contained sieving of big bags with only small

opening )

• Falling of Powders, Granules or Pelletised Material - Type of handling: Careful

transfer involves workers showing attention to potential danger, error or harm and

carrying out the activity in a very exact and thorough (or cautious) manner e.g.

careful weighing in laboratory


REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5)) Exposure/DMEL = 0.257


(see below)





long-term)

RCR = 0.074







Carcinogenicity:






specific activity.





controlled.






9.1.4. Worker contributing scenario 3: Manual dosing of pigment powder (PROC 8a)


Manual discharge of bags of pigment, for example in hoppers, in facilities with general protection measures.

Removal of empty bags is included.

Method


• Substance product type: Powders, granules or pelletised material External Tool (Extended

ART v1.5)

• Moisture Content of the product: Dry product (<5 % moisture content) External Tool (Extended

ART v1.5)



External Tool (Extended

ART v1.5)

• Concentration of substance in mixture: Substance as such External Tool (Extended

ART v1.5)











personal cloud).)


ART v1.5)




ART v1.5)

• General Control Measures: Local exhaust ventilation (LEV) - Capturing hoods -

Fixed capturing hood (Fixed capturing hoods located in close proximity of and

directed at the source of emission. The design is such that the work is performed in

the capture zone of the ventilation system and the capture is indicated at the

workplace.)



ART v1.5)




Method



• Respiratory protection according to EN 529:2005 (APF only): Minimum APF of

100 [Effectiveness Inhal: 99%]


ART v1.5)



TRA Worker v3











ART v1.5)


10 – 100 kg/minute (Examples: Manual dumping of powders)


ART v1.5)


0.5 m


ART v1.5)





opening )


ART v1.5)






ART v1.5)

• Dispersion - Indoor: Room size of the work area: Any size workroom External Tool (Extended

ART v1.5)

• Skin surface potentially exposed: Two hands (960 cm2) TRA Worker v3





effects




0.002 mg/m³ (External Tool (Extended

ART v1.5))



(see below)






(see below)


Combined routes, systemic, Ʃ(Exposure/DMEL) = 0.534




effects



damage)




ART v1.5))



(see below)





long-term)

RCR = 0.224


External Tool (Extended ART v1.5)


ART calculation: The inter-quartile confidence interval is 0.11 mg/m³ to 0.48 mg/m³. The predicted 90th

percentile long-term exposure is 0.23 mg/m³. The result of the ART calculation was corrected by applying

respiratory protection with APF 100 (99% effectiveness).


Semi-quantitative risk characterisation

Carcinogenicity:




specific activity.





controlled.






9.1.5. Worker contributing scenario 4: Automated dosing of pigment powder (PROC

8b)


Automated discharge of bags of pigment, for example in hoppers, in facilities with high level of protection

protective measures. Bag is placed on conveyor belt using a vacuum transporter. The bag is cut and emptied

within the machine. Machine is in isolated room, which is underpressured.

Method



REACH Tool v1.5)



Method


REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)











personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)





workplace.)



REACH Tool v1.5)

• Containment - no extraction: Medium level containment (Physical containment or

enclosure of the source of emission. The air within the enclosure is not actively

ventilated or extracted. The enclosure is not opened during the activity. The

material transfer is enclosed with the receiving vessel being docked or sealed to the

source vessel. Examples include sealing heads, transfer containers and multiple o-

rings. Inflatable packing head with continuous liner ensures a seal is maintained

during the powder transfer and the continuous plastic liner prevents direct contact

with the product. The correct type of tie off must be used.) [Effectiveness Inhal:

99%]


REACH Tool v1.5)

• Containment: Semi-closed process with occasional controlled exposure TRA Worker v3





TRA Worker v3











REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)



Method






REACH Tool v1.5)


process: Open process


REACH Tool v1.5)


REACH Tool v1.5)

• Segregation of the emission source from the work environment: Complete

segregation with ventilation and filtration of recirculated air (Sources are

completely segregated from the work environment by isolating the source in a fully

enclosed and separate room (incl. closed doors & windows). The air within the

separate area is actively ventilated and the recirculated air is filtered or there is no

air recirculation. The segregated area is generally not entered by the worker during

a given activity or working shift.)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.032




ART calculation (far field exposure only): The inter-quartile confidence interval is 0.00016 mg/m³ to

0.0007 mg/m³. The predicted 90th percentile long-term exposure is 0.00033 mg/m³.





Carcinogenicity:

Performing this specific activity for an entire working career leads to excess lung cancer cases of 5.35E-07,



specific activity.





controlled.






9.1.6. Worker contributing scenario 5: Re-packaging of pigment powder (PROC 9)


Method



ART v1.5)


ART v1.5)




ART v1.5)


ART v1.5)











personal cloud).)


ART v1.5)




ART v1.5)








ART v1.5)



Method



99%]


segregation without ventilation (Sources are completely segregated from the work

environment by isolating the source in a fully enclosed and separate room (incl.

closed doors & windows). This segregated area is generally not entered by the

worker during a given activity or working shift. The air within the separate area is

not ventilated.)



ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)


1 – 10 kg/minute (Examples: Scooping activities)


ART v1.5)


0.5 m


ART v1.5)




ART v1.5)






ART v1.5)


ART v1.5)

• Skin surface potentially exposed: Two hands face (480 cm2) TRA Worker v3





effects




3.3E-4 mg/m³ (External Tool (Extended

ART v1.5)) Exposure/DMEL = 0.057


(see below)




effects







(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.024





90th percentile long-term exposure is 0.0033 mg/m³. The result of the ART calculation was corrected by

applying respiratory protection with APF 10 (90% effectiveness).



Carcinogenicity:



information requirements R.8.





controlled.






9.1.7. Worker contributing scenario 6: Mixing of pigment paste (PROC 5)


Mixing and blending in mixing vessel with loose fitting cover.

Method



Method


• Concentration of substance in mixture: >25% TRA Worker v3

• Solid in solid mixtures: Yes TRA Worker v3

• Substance product type: Paste, slurry or clearly (soaked) wet powder (not

containing volatile liquid components)


REACH Tool v1.5)




ART v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)

• Containment - no extraction: Low level containment (Physical containment or



process is contained with a loose lid or cover, which is not air tight. This includes

tapping molten metal through covered launders and placing a loose lid on a ladle.

This class also includes bags or liners fitted around transfer points from source to

receiving vessel. These include Muller seals, Stott head and single bag, and

associated clamps and closures.) [Effectiveness Inhal: 90%]


REACH Tool v1.5)




TRA Worker v3



• Activity Class: Handling of contaminated objects (Handling of solid objects that

are treated or contaminated with the liquid of interest.)


REACH Tool v1.5)




REACH Tool v1.5)

• Handling of Contaminated Solid Objects or Paste: Normal handling, involves

regular work procedures


REACH Tool v1.5)


REACH Tool v1.5)





effects





effects




0 mg/m³ (External Tool (Advanced

REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)



0 µg/kg bw/day (calculated from exposure

value for: Inhalation, systemic, long-term)

RCR = 0




ART calculation (far field exposure only): The inter-quartile confidence interval is 0 mg/m³ to 0 mg/m³.

The predicted 90th percentile full-shift exposure is 0 mg/m³.



Carcinogenicity:

Performing this specific activity for an entire working career leads to excess lung cancer mortality of 0, which is

lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on information

requirements R.8. For intestinal cancer there is no excess morbidity as the RCR is below 1 for this specific

activity.





controlled.






9.1.8. Worker contributing scenario 7: Storage of pigment paste / Transfer of pigment

paste through closed piping (PROC 2)




Handling of closed packagings of pigment paste: delivery, storage, transport etc. Sampling for QC.

Method







REACH Tool v1.5)




ART v1.5)


• Containment: Closed continuous process with occasional controlled exposure TRA Worker v3








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)










REACH Tool v1.5)




TRA Worker v3






REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)







effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.





controlled.






9.1.9. Worker contributing scenario 8: Manual cleaning / scraping of mixing vessels,





Method



ART v1.5)

TRA Worker v3



ART v1.5)

• Dustiness: Granules, flakes or pellets (Granules or flakes may fall apart and

crumble, resulting in only a very limited amount of fine particles. Handling the

product does not result in a visible dust cloud; e.g., fertilizer, garden peat, animal

pellets. Inhalable fraction: 101 - 500 mg/kg)


ART v1.5)

• Moisture Content of the product: 5 - 10 % moisture content External Tool (Extended

ART v1.5)




ART v1.5)










personal cloud).)


ART v1.5)




ART v1.5)




TRA Worker v3




ART v1.5)


• Skin surface potentially exposed: Two hands and forearms (1980 cm2) TRA Worker v3

• Activity class (solids): Compressing of powders, granules or pelletised material

(Activities where powders, granules or pelletised material are compressed due to

compaction or crushing. Example Activities: (Steam) rolling Compacting

Tabletting Granulation Pelletisation)


ART v1.5)

• Compressing of Powders, Granules or Pelletised Material - Activity:

Compressing 10 – 100 gram/minute


ART v1.5)

• Compressing of Powders, Granules or Pelletised Material - level of containment

of the process: Open process


ART v1.5)


ART v1.5)







effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.244









Carcinogenicity:




specific activity.





controlled.








9.1.10. Worker contributing scenario 9: Cleaning of vessel with solvent (PROC 10)


Cleaning of vessel with solvent, either manual or automated.

Method


• Substance product type: Powders dissolved in a liquid or incorporated in a liquid

matrix


ART v1.5)

• Liquid Weight Fraction: Substantial (10 - 50%) [Effectiveness Inhal: 50%] External Tool (Extended

ART v1.5)

• Viscosity: Liquids with medium viscosity (like oil) External Tool (Extended

ART v1.5)






ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)





40 [Effectiveness Inhal: 97.5%]


ART v1.5)



TRA Worker v3



Method


• Activity Class: Spreading of liquid products (Activities where a liquid product is

directly spread on surfaces using e.g. a roller, brush or wipe.)


ART v1.5)

• Spreading of Liquid Products - Activity: Spreading of liquids at surfaces or work

pieces 1 - 3 m² / hour (Examples: Degreasing machines Painting of walls)


ART v1.5)


ART v1.5)






effects




9E-4 mg/m³ (External Tool (Extended

ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.088






applying respiratory protection with APF 40 (97.5% effectiveness).



Carcinogenicity:






specific activity.





controlled.






9.1.11. Worker contributing scenario 10: Pigment paste testing by smearing (PROC 10)


Method







REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)




TRA Worker v3



• Activity Class: Handling of contaminated objects (Handling of solid objects that External Tool (Advanced



Method

are treated or contaminated with the liquid of interest.) REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.







controlled.






9.1.12. Worker contributing scenario 11: Pigment paste charging/discharging by gravity

or manual handling (PROC 8a)


Method







REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)




TRA Worker v3






REACH Tool v1.5)

• Handling of Contaminated Solid Objects or Paste - Activity: Handling of External Tool (Advanced



Method

apparently clean objects (Examples: Drums coming out of a cleaning machine) REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.







controlled.






9.1.13. Worker contributing scenario 12: Pigment paste charging/discharging using a



Method







REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)




TRA Worker v3






REACH Tool v1.5)




REACH Tool v1.5)

• Handling of Contaminated Solid Objects or Paste: Normal handling, involves External Tool (Advanced



Method

regular work procedures REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.







controlled.






9.1.14. Worker contributing scenario 13: Pigment paste filling into drums/cans at a

filling line (PROC 9)


Filling half product in containers for sale or further use at a filling line where the liquid/paste is dosed

automatically from the machine into the container, whereafter the container is closed.

Method







REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)




TRA Worker v3






REACH Tool v1.5)




REACH Tool v1.5)

• Handling of Contaminated Solid Objects or Paste: Normal handling, involves External Tool (Advanced



Method

regular work procedures REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.







controlled.






9.1.15. Worker contributing scenario 14: Mixing colour paste in closed drum mixing

machine with automated dosing of paste (PROC 2)


Mixing to colour of pastes, paints or paint components by dosing colour paste from a dedicated machine in a

drum which is subsequently closed with a lid and shaken by the machine.

Method


• Concentration of substance in mixture: 5-25% TRA Worker v3





REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)










REACH Tool v1.5)




TRA Worker v3



Method






REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:






activity.





controlled.






9.1.16. Worker contributing scenario 15: Mixing colour paste into paint in closed



Mixing to colour of pastes, paints or paint components by dosing colour paste in a vessel closed with a lid.

Occasional sampling.

Method




REACH Tool v1.5)



matrix


REACH Tool v1.5)

• Viscosity: Liquids with medium viscosity (like oil) External Tool (Advanced

REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)



Method









99%]


REACH Tool v1.5)




TRA Worker v3



• Activity Class: Activities with open liquid surfaces or open reservoirs - Activities

with agitated surfaces (Handling of a liquid product in a bath or other reservoir.

The liquid may either be relatively undisturbed (e.g. manual stirring, dipping in

bath) or agitated (e.g. gas bubbling, mechanical mixing in vessel).)


REACH Tool v1.5)

• Open Surface: Surface 1 - 3 m² External Tool (Advanced

REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0.5


(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)

Oral, systemic, long-term 0.414 µg/kg bw/day (calculated from RCR = 0.282




effects


(carcinogenicity, intestinal) exposure value for: Inhalation, systemic,

long-term)








Carcinogenicity:




specific activity.





controlled.






9.1.17. Worker contributing scenario 16: Pigment paint filling into drums/cans at a

filling line (PROC 9)


Filling endproduct in containers for sale at a filling line where the liquid/paste is dosed automatically from the

machine into the container, whereafter the container is closed.

Method



matrix


ART v1.5)


ART v1.5)



ART v1.5)





Method



ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)





workplace.)



ART v1.5)







ART v1.5)



TRA Worker v3


• Activity Class: Transfer of liquid products - Falling liquids (Activities where a

stream of liquid product is transferred from one reservoir to the next. The stream

may either fall or glide from high to a lower point (falling liquids) or is transferred

with pressure (pressurized transfer: e.g. bottom loading).)


ART v1.5)

• Falling Liquids - Activity: Transfer of liquid product with flow of: 10 - 100

l/minu (Examples: (Re)fuelling cars Manual topping up Manual calibration of fuel

pump)


ART v1.5)

• Falling Liquids - Level of containment of the process: Open process External Tool (Extended

ART v1.5)

• Transfer Loading Type: Splash loading, where the liquid dispenser remains at the

top of the reservoir and the liquid splashes freely


ART v1.5)


ART v1.5)

• Segregation of the emission source from the work environment: Partial

segregation with ventilation and filtration of recirculated air (Sources are partially

segregated from the work environment by isolating the source in a separate room

(with open doors and/or windows). This segregated area is generally not entered by

the worker during a given activity or working shift. The air within the separate area

is actively ventilated and the recirculated air is filtered or there is no air


ART v1.5)



Method

recirculation.)







effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.011




ART calculation (far field exposure): The inter-quartile confidence interval is 0.0005 mg/m³ to 0.0027

mg/m³. The predicted 90th percentile long-term exposure is 0.0011 mg/m³. The result of the ART

calculation was corrected by applying respiratory protection with APF 10 (90% effectiveness).



Carcinogenicity:




specific activity.







controlled.






9.1.18. Worker contributing scenario 17: Pigment paint charging/discharging using a



Charging and discharging liquid paint containing pigment under controlled conditions.

Method



matrix


ART v1.5)


ART v1.5)

• Concentration of substance in mixture: 5-25% External Tool (Extended

ART v1.5)

TRA Worker v3





ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)





workplace.)



ART v1.5)





Method





ART v1.5)



TRA Worker v3







ART v1.5)


l/minute (Examples: Filling of drums)


ART v1.5)

• Falling Liquids - Level of containment of the process: Handling that reduces

contact between product and adjacent air (Note: This does not include processes

that are fully contained by localised controls (see next questions). Example

situation: Transfer of liquid through a small filling opening (e.g. refuelling of

vehicles) )


ART v1.5)




ART v1.5)


ART v1.5)







recirculation.)



ART v1.5)






effects





ART v1.5))



(see below)






(see below)




effects





damage)





ART v1.5))



(see below)





long-term)

RCR = 0.010









Carcinogenicity:




specific activity.





controlled.






9.1.19. Worker contributing scenario 18: Equipment cleaning: scraping and brushing

(PROC 10)


Scraping or brushing of mixing vessels and other equipment of liquid paint product.

Method


• Substance product type: Powders dissolved in a liquid or incorporated in a liquid External Tool (Extended



Method

matrix ART v1.5)

• Liquid Weight Fraction: Minor (5 - 10%) [Effectiveness Inhal: 90%] External Tool (Extended

ART v1.5)


ART v1.5)






ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)







ART v1.5)



TRA Worker v3





ART v1.5)




ART v1.5)


ART v1.5)








effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.034









Carcinogenicity:




specific activity.





controlled.








9.1.20. Worker contributing scenario 19: Dried pigment paint cleaning (PROC 21)


Cleaning by scraping, wiping, brushing surfaces with dried paint containing pigment, with a brush or spatula.

The pigment is bound into the coating or paste or polymer matrix.

Method



ART v1.5)






ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)

• Solid in solid mixtures: Yes External Tool (Extended

TRA Workers v3)


• Duration of use: 2 hours/week [Effectiveness Inhal: 95%; Dermal: 95%] External Tool (Extended

ART v1.5)


TRA Workers v3)








personal cloud).)


ART v1.5)




ART v1.5)

• Containment: No External Tool (Extended

TRA Workers v3)

• Occupational Health and Safety Management System: Advanced External Tool (Extended

TRA Workers v3)





ART v1.5)



Method




TRA Workers v3)







ART v1.5)




ART v1.5)




ART v1.5)


ART v1.5)

• Skin surface potentially exposed: Two hands and forearms (1980 cm2) External Tool (Extended

TRA Workers v3)





effects





ART v1.5))



(see below)




0.004 mg/kg bw/day (External Tool

(Extended TRA Workers v3))

Exposure/DMEL = 8.5E-4


(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.623







percentile long-term exposure is 0.064 mg/m³. The result of the ART calculation was corrected by

applying respiratory protection with APF 10 (90% effectiveness) and a factor 20 for the duration of use (2

hours/week).

External Tool (Extended TRA Workers v3)

Dermal, systemic, long-term:

The result of the ECETOC TRA calculation was corrected by applying a factor 20 for the duration of use

(2 hours/week).



Carcinogenicity:




specific activity.





controlled.






9.1.21. Worker contributing scenario 20: Spray testing of pigment paint in industrial

booth (PROC 7)


Application of paint by spraying for quality check and R&D purposes in an industrial setting. A dedicated spray

booth, general protective measures and PPE are in place.

Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)


TRA Workers v3)





Method

ART v1.5)


TRA Workers v3)








personal cloud).)


ART v1.5)

• Dispersion - Spray room: Cross-flow spray room (The spray room must meet the

following conditions: The spray room is a fully enclosed, unidirectional spray

room of volume between 30 and 1000 m³ with at least 10 air changes per hour. The

spray room has been designed by a competent ventilation engineer, the airflow

performance is regularly checked and the ventilation system is maintained. The

spray room needs to run under negative pressure (i.e. so any air leakage is inward).

The workers in the spray room must be properly trained in correctly using the room

(e.g. operation of the ventilation system, good positioning of the worker relative to

the source and the ventilation, knowing the ventilation clearance time of the

room).)



ART v1.5)


TRA Workers v3)


TRA Workers v3)





ART v1.5)




TRA Workers v3)


• Activity Class: Spray application of liquids - Surface spraying of liquids

(Activities used to atomise liquids into droplets for dispersion on surfaces (surface

spraying) or into air (space spraying). Spraying techniques may be used for

dispersion of e.g. pesticides, biocides, and paints.)


ART v1.5)

• Application rate: Moderate application rate (0.3 - 3 l/minute) External Tool (Extended

ART v1.5)

• Spray direction: Only horizontal or downward spraying External Tool (Extended

ART v1.5)

• Spray Technique: Spraying with no or low compressed air use External Tool (Extended

ART v1.5)

• Skin surface potentially exposed: Two hands and upper wrists (1500 cm2) External Tool (Extended

TRA Workers v3)







effects





ART v1.5))



(see below)








(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.828




ART calculation: The inter-quartile confidence interval is 0.75 mg/m³ to 4 mg/m³. The predicted 90th


respiratory protection with APF 200 (99.5% effectiveness) and a factor 5 for the duration of use (1

day/week).



The result of the ECETOC TRA calculation was corrected by applying a factor 5 for the duration of use (1

day/week).



Carcinogenicity:




specific activity.







controlled.






9.1.22. Worker contributing scenario 21: Pigment paint testing by brushing/rolling

(PROC 10)


Application by brush or roller of pigment coating for QC or R&D purposes.

Method



matrix


REACH Tool v1.5)


REACH Tool v1.5)

• Concentration of substance in mixture: 5-25% External Tool (Advanced

REACH Tool v1.5)

TRA Worker v3





REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)







working properly).)



REACH Tool v1.5)





Method




TRA Worker v3





REACH Tool v1.5)


pieces 0.3 - 1 m² / hour (Painting of casings using a roller or brush Gluing e.g. shoe

soles Degreasing or cleaning small machines/tools)


REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))

Exposure/DMEL = 0.5


(see below)






(see below)




damage)



(carcinogenicity, oral)

2.90E-3mg/m³ (External Tool (Advanced

REACH Tool v1.5))



(see below)





long-term)

RCR = 0.282










Carcinogenicity:




specific activity.





controlled.






9.1.23. Worker contributing scenario 22: Pigment paste or paint laboratory operations

(PROC 15)


Method



matrix


REACH Tool v1.5)


REACH Tool v1.5)

TRA Worker v3

TRA Worker v3


REACH Tool v1.5)



• Duration of activity: < 8 hours External Tool (Advanced

REACH Tool v1.5)

TRA Worker v3








working properly).)



REACH Tool v1.5)




REACH Tool v1.5)



Method






TRA Worker v3






Duration of activity: 120 minutes (total duration 8 hours).


REACH Tool v1.5)

• Falling Liquids - Activity: Transfer of liquid product with flow of: < 0.1 l/minute

(Examples: Transfer of small amounts in laboratory)


REACH Tool v1.5)

• Falling Liquids - Level of containment of the process: Open process External Tool (Advanced

REACH Tool v1.5)




REACH Tool v1.5)







REACH Tool v1.5)

• Open Surface: Surface < 0.1 m² (Examples: Manual stirring in paint can Storage

of laboratory samples)


REACH Tool v1.5)





REACH Tool v1.5)


pieces 0.1 - 0.3 m² / hour (Examples: Spot degreasing (small objects like knifes)

Gluing stickers and labels)


REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)





effects






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.014




ART calculation: The inter-quartile confidence interval is 0.000062 mg/m³ to 0.00033 mg/m³. The

predicted 90th percentile long-term exposure is 0.00014 mg/m³.



Carcinogenicity:




specific activity.





controlled.








9.2. Exposure scenario 2: Use at industrial site - Industrial application of

paints on metal surfaces (machines, vehicles, structures, signs, road

furniture, coil coating). Pigment choice is governed by end product

specifications on visibility, colour, durability, other technical



Industrial application of coating containing C.I. Pigment Yellow 34 and C.I. Pigment Red 104 on metal surfaces

of non-consumer articles. Examples of coated objects are high grade steel based products e.g. piping for the

(petro)chemical industry, crane arms, agricultural machinery, road furniture, steel bridges, construction arches,

steel skips, coil coated products (e.g. roofing). The high quality of the coating is crucial for the long-term

functioning and protection of the objects, i.e. where fading of the colour could jeopardise public or worker

safety, where regular repainting could create difficult or dangerous situations (steel bridges, traffic jams) or

where idle time of specialty equipment would incur high costs.

The selection of a coating containing these pigments is governed by requirements for the end application related

to: VISIBILITY AND SAFETY - Based on their bright, vivid, durable colours, these pigments are used when

visibility and safety play an important role, sometimes prescribed by Regulations. DURABILITY - The

pigments respond to the demand for high performance pigments, e.g. in aggressive atmospheric conditions in

industrialized areas, providing excellent light and weather fastness, preventing applications to darken or fade if

exposed to light and humidity; excellent resistance to sulfur dioxide, preventing discolouration (greyness) and

loss of gloss, required for exterior applications; SHADE FUNCTIONALITY - Their colour covers a wide range

from green to red shade yellow and yellow to blue shade red; COLOURISTIC AND TECHNICAL

PERFORMANCE - Within the listed colour range, these pigments provide clean, vivid colours (chroma);

excellent opacity or hiding power; excellent weather fastness. The perceived colour remains the same regardless

of the light source, i.e. does not exhibit metamerism. They also provide excellent rheology in coatings; excellent

non-bleeding properties, non-migration properties and impact resistance in coatings.



Industrial application of paints on metal surfaces (machines, vehicles, structures, signs,

road furniture, coil coating)

ERC 5


Laboratory handling of pigment paste and/or paints PROC 15

Handling of packaged colour paste and/or paint, including distribution PROC 2

Mixing colour paste with paint in closed mixing machine with automated dosing of paste PROC 3

Equipment cleaning: scraping, brushing and wiping PROC 10

Dried pigment paste and/or paint cleaning PROC 21

Mixing of paste and/or coating with extra solvents or additives before use PROC 5

Filling of equipment with pigment paint PROC 8a

Filling of spray equipment with pigment paints in dedicated settings PROC 8b

Transfer of pigment paint to/from drums/cans e.g. at a filling line before application PROC 9

Automated pigment paint spray application in an industrial booth PROC 7

Manual pigment paint spray application in an industrial booth PROC 7

Handling and manipulation of dried painted articles PROC 21

Pigment paint testing by brushing/rolling PROC 10

Pigment paint application and heat curing PROC 6



Subsequent service life exposure scenario(s):

ES4: Service life (worker at industrial site) - Service life of coated articles. Performance and longevity depend

on the pigment quality for bright lasting colours improving visibility and safety, light and weather fastness

(durability), chemical fastness, impact resistance and heat stability.

ES5: Service life (professional worker) - Service life of coated articles. Performance and longevity depend on

the pigment quality for bright lasting colours improving visibility and safety, light and weather fastness



The solvent-based coating or paint are used in the industrial and coil coatings market. The paint is prepared for

application and applied as a spray paint in spray booths. Examples of painted or coated objects are, but not

limited to, high grade steel based products such as piping for the (petro)chemical industry, crane arms,

agricultural machinery, road furniture, steel bridges or construction arches and steel skips. Another application

is in a coil coating process e.g. for roofing. The high quality of the paint/coating is crucial for the long-term

functioning and the longevity of the objects.

9.2.1. Environmental contributing scenario 1: Industrial application of paints on metal

surfaces (machines, vehicles, structures, signs, road furniture, coil coating)





• Correction for water solubility of Pb in paint (0.5%): Correction applicable (Transformation/dissolution tests

were carried out with paints containing the pigment. These tests show 0.2% dissolution. Based on the results of

these tests, 0.5% dissolution is applied as a worst-case.) [Effectiveness Water: 99.5%]


• Daily use at site: <= 0.15 tonnes/day

Worst-case based on 5 workers using 30 kg/day of pigment at one site


Worst-case tonnage per site based on worst-case daily use and emission days/year



Based on industry knowledge, industrial spray painting takes place on all working days. SpERCs CEPE

5.1a.v1, ECCA 5.1a.v1 and ACEA 5.1.b.v4 use 225, 220 and 300 days/year respectively. A worst-case of 200

days/year is assumed.






RMM



• Wet scrubbers

















9.2.1.2. Releases




method



(SpERC CEPE 5.1a.v1 )




Explanation / Justification: During the industrial use of solvent-

based paints and coatings containing C.I. Pigment Yellow 34 and

C.I. Pigment Red 104 no water is used. . If any waste water is

generated, this is treated as hazardous waste. This is supported by

CEPE SpERC 5.1a.v1 - application - industrial - spraying - indoor

use – solids in which a release factor of 0% is provided with the

explanation that there is no emission to water during application

and drying.

Air Release factor





Explanation / Justification: Release fraction from CEPE SpERC

5.1a.v1 - application - industrial - spraying - indoor use – solids.

Based on Emission Scenario Document on Coatings Industry

(Paints, Lacquers and Varnishes), OECD, July 2009


=ENV/JM/MONO(2009)24&doclanguage=en]. A proportion of

the solid phase will be contained in overspray.

Soil Release factor



Explanation / Justification: According to CEPE SpERC 5.1a.v1

- application - industrial - spraying - indoor use – solids there is

no deposition to soil from the industrial application of solvent-

based paints and coatings. This is supported by other SpERCs

concerning industrial application of paints, e.g. ECCA 5.1a.v1 and

ACEA 5.1.b.v4.












Agricultural soil Local PEC: 0.02 mg/kg dw RCR < 0.01





9.2.2. Worker contributing scenario 1: Laboratory handling of pigment paste and/or

paints (PROC 15)


Any handling of pigment paste or paints in their wet form in an industrial laboratory.

Method




REACH Tool v1.5)



matrix


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)










working properly).)


REACH Tool v1.5)



Method





REACH Tool v1.5)




TRA Worker v3









REACH Tool v1.5)




REACH Tool v1.5)

• Falling Liquids - Level of containment of the process: Open process External Tool (Advanced

REACH Tool v1.5)




REACH Tool v1.5)







REACH Tool v1.5)




REACH Tool v1.5)





REACH Tool v1.5)





REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)




effects







(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.014








Carcinogenicity:




specific activity.





controlled.






9.2.3. Worker contributing scenario 2: Handling of packaged colour paste and/or paint,



Handling of closed packagings of pigment paste or paint in delivery, storage, transport. Sampling for QC.



Method




REACH Tool v1.5)



matrix


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)









99%]


REACH Tool v1.5)




TRA Worker v3




with undisturbed surfaces (no aerosol formation) (Handling of a liquid product in a

bath or other reservoir. The liquid may either be relatively undisturbed (e.g.

manual stirring, dipping in bath) or agitated (e.g. gas bubbling, mechanical mixing

in vessel).)


REACH Tool v1.5)

• Open Surface: Surface 0.3 - 1 m² External Tool (Advanced



Method

REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.003





predicted 90th percentile full-shift exposure is 0.000033 mg/m³.



Carcinogenicity:




specific activity.







controlled.






9.2.4. Worker contributing scenario 3: Mixing colour paste with paint in closed mixing



Mixing to colour of pastes with paints or paint components by dosing colour paste from a dedicated machine in

a drum which is subsequently closed with a lid and shaken by the machine.

Method



matrix


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)

TRA Worker v3





REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)









99%]


REACH Tool v1.5)



Method






not ventilated.)



REACH Tool v1.5)






TRA Worker v3



REACH Tool v1.5)






REACH Tool v1.5)

• Open Surface: Surface 0.1 - 0.3 m² External Tool (Advanced

REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)




effects






long-term)

RCR = 0.004





0.0001 mg/m³. The predicted 90th percentile full-shift exposure is 0.000044 mg/m³.



Carcinogenicity:




specific activity.





controlled.






9.2.5. Worker contributing scenario 4: Equipment cleaning: scraping, brushing and

wiping (PROC 10)


Scraping, brushing or wiping of mixing vessels and other equipment of liquid paint product.

Method




ART v1.5)



matrix


ART v1.5)


ART v1.5)




Method



ART v1.5)










personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)




TRA Worker v3




ART v1.5)






ART v1.5)




ART v1.5)


ART v1.5)





effects





ART v1.5))





effects



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.034









Carcinogenicity:




specific activity.





controlled.






9.2.6. Worker contributing scenario 5: Dried pigment paste and/or paint cleaning

(PROC 21)




Cleaning by scraping, wiping, brushing surfaces with dried paint containing pigment, with a brush or spatula.

The pigment is bound into the coating or paste or polymer matrix.

Method



ART v1.5)






ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3





ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)







ART v1.5)



TRA Worker v3







ART v1.5)




ART v1.5)



Method




ART v1.5)


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.156









Carcinogenicity:




specific activity.







controlled.






9.2.7. Worker contributing scenario 6: Mixing of paste and/or coating with extra

solvents or additives before use (PROC 5)


Method



matrix

Applicable to activity with agitated liquid surface.


ART v1.5)


ART v1.5)

• Liquid Weight Fraction: Minor (5 - 10%) [Effectiveness Inhal: 90%] External Tool (Extended

ART v1.5)



Applicable to handling of contaminated objects activity. Not contaminated with

powder.


ART v1.5)






ART v1.5)








personal cloud).)


ART v1.5)





ART v1.5)

• Containment - no extraction: Low level containment (Physical containment or External Tool (Extended



Method









ART v1.5)






Applicable to all activities.


ART v1.5)



TRA Worker v3



ART v1.5)







ART v1.5)

• Open Surface: Surface 1 - 3 m² External Tool (Extended

ART v1.5)

• Activity class (solids): Handling of contaminated solid objects or paste (Handling

or transport of surfaces, objects or pastes that are(potentially) contaminated with

powders or granules. For this activity class, exposure is estimated to the

contamination on the surface, object or paste. Example Activities: Sorting Stacking

Carrying Picking / collecting objects Packaging Paving Wrapping Disposal of

empty bags Plastering Kneading Modeling of product Bending metal tubes)



ART v1.5)




ART v1.5)




ART v1.5)






effects





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.107









Carcinogenicity:




specific activity.





controlled.






9.2.8. Worker contributing scenario 7: Filling of equipment with pigment paint (PROC



8a)


Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3



• Duration of activity: < 8 hours External Tool (Extended

ART v1.5)

TRA Worker v3



enclosed or the integrity of that enclosure is not regularly monitored and no

demonstrable and effective housekeeping practices are in place but general

housekeeping practices are in place (General good housekeeping practices.)


ART v1.5)




ART v1.5)







ART v1.5)



TRA Worker v3



ART v1.5)






ART v1.5)

• Falling Liquids - Activity: Transfer of liquid product with flow of: 1 - 10 l/minute

(Examples: Filling of bottles, filling of paint gun)


ART v1.5)





vehicles) )


ART v1.5)



Method




ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.076








Carcinogenicity:

Performing this specific activity for an entire working career leads to excess lung cancer mortality of 1.26E-06

, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on


specific activity.







controlled.






9.2.9. Worker contributing scenario 8: Filling of spray equipment with pigment paints

in dedicated settings (PROC 8b)


Method




ART v1.5)



matrix


ART v1.5)


ART v1.5)




ART v1.5)









ART v1.5)




ART v1.5)




TRA Worker v3




ART v1.5)




ART v1.5)



Method






ART v1.5)




ART v1.5)





vehicles) )


ART v1.5)

• Transfer Loading Type: Submerged loading, where the liquid dispenser remains

below the fluid level reducing the amount of aerosol formation


ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.025











Carcinogenicity:




specific activity.





controlled.






9.2.10. Worker contributing scenario 9: Transfer of pigment paint to/from drums/cans

e.g. at a filling line before application (PROC 9)


Method




ART v1.5)



matrix


ART v1.5)


ART v1.5)




ART v1.5)









ART v1.5)




ART v1.5)

• General Control Measures: Local exhaust ventilation (LEV) - Capturing hoods - External Tool (Extended



Method




workplace.)


ART v1.5)







recirculation.)



ART v1.5)




TRA Worker v3




ART v1.5)




ART v1.5)






ART v1.5)



pump)


ART v1.5)


ART v1.5)




ART v1.5)





effects





ART v1.5))



(see below)





effects






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.011





0.0027 mg/m³. The predicted 90th percentile long-term exposure is 0.0011 mg/m³. The result of the ART




Carcinogenicity:




specific activity.





controlled.






9.2.11. Worker contributing scenario 10: Automated pigment paint spray application in

an industrial booth (PROC 7)


Method



Method



matrix


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)


TRA Worker v3)


TRA Worker v3)



TRA Worker v3)


REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)










REACH Tool v1.5)

• Personal enclosure of the worker from the emission source: Complete personal

enclosure with ventilation (Worker resides inside an enclosed cabin or room (door

and/or windows closed) for the entire duration of the activity. The air within the

personal enclosure is actively ventilated and filtered and a positive pressure is

maintained inside the personal enclosure.)



REACH Tool v1.5)




REACH Tool v1.5)


TRA Worker v3)


TRA Worker v3)





TRA Worker v3)



Method







REACH Tool v1.5)

• Application rate: Low application rate (0.03 - 0.3 l/minute) External Tool (Advanced

REACH Tool v1.5)

• Spray direction: Only horizontal or downward spraying External Tool (Advanced

REACH Tool v1.5)

• Spray Technique: Spraying with no or low compressed air use External Tool (Advanced

REACH Tool v1.5)


REACH Tool v1.5)


TRA Worker v3)





effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 1


(see below)





long-term)

RCR = 0.360








calculation was corrected by applying a factor 1.25 for the duration of use (32 hours/week).



The result of the ECETOC TRA calculation was corrected by applying a factor 1.25 for the duration of

use (32 hours/week).



Carcinogenicity:




specific activity.





controlled.






9.2.12. Worker contributing scenario 11: Manual pigment paint spray application in an

industrial booth (PROC 7)


Method



TRA Worker v3)


ART v1.5)


TRA Worker v3)


matrix


ART v1.5)


ART v1.5)



TRA Worker v3)


ART v1.5)



Method



TRA Worker v3)


TRA Worker v3)







personal cloud).)


ART v1.5)










room).)



ART v1.5)





TRA Worker v3)




ART v1.5)



TRA Worker v3)






ART v1.5)


ART v1.5)


ART v1.5)


ART v1.5)


ART v1.5)







effects





ART v1.5))



(see below)






(see below)




damage)




2.55E-03mg/m³ (External Tool (Extended

ART v1.5))

Exposure/DMEL =

0.861


(see below)





long-term)

RCR = 0.414






respiratory protection with APF 400 (99.75% effectiveness) and a factor 1.66 for the duration of use (24

hours/week).







Carcinogenicity:




specific activity.







controlled.






9.2.13. Worker contributing scenario 12: Handling and manipulation of dried painted

articles (PROC 21)


Method



ART v1.5)

• Dustiness: Firm granules, flakes or pellets (Product does not result in dust

emission without intentional breakage of products: e.g., firm polymer granules,

granules covered with a layer of wax, a woodblock, a brick). Inhalable fraction: ≤

100 mg/kg)


ART v1.5)


ART v1.5)


TRA Worker v3)


ART v1.5)


TRA Worker v3)



TRA Worker v3)


ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)


TRA Worker v3)


TRA Worker v3)



Method





TRA Worker v3)





ART v1.5)




ART v1.5)




ART v1.5)


ART v1.5)


TRA Worker v3)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.020










Carcinogenicity:




specific activity.





controlled.






9.2.14. Worker contributing scenario 13: Pigment paint testing by brushing/rolling

(PROC 10)


Method



ART v1.5)

TRA Worker v3



matrix


ART v1.5)


ART v1.5)




ART v1.5)











ART v1.5)



Method

personal cloud).)




ART v1.5)







working properly).)



ART v1.5)




TRA Worker v3




ART v1.5)






ART v1.5)





ART v1.5)


ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





effects





ART v1.5))



(see below)





long-term)

RCR = 0.020









Carcinogenicity:




specific activity.





controlled.






9.2.15. Worker contributing scenario 14: Pigment paint application and heat curing

(PROC 6)


Rolling paint onto a surface such as sheet metal or sheet materials and subsequent curing. Industrial installation

with measures in place.

Method




ART v1.5)





Method

matrix ART v1.5)


ART v1.5)




ART v1.5)










personal cloud).)


ART v1.5)




ART v1.5)




TRA Worker v3




ART v1.5)







in vessel).)


ART v1.5)


ART v1.5)


ART v1.5)





effects





ART v1.5))






effects


(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.032





90th percentile full-shift exposure is 0.0033 mg/m³. The result of the ART calculation was corrected by




Carcinogenicity:




specific activity.





controlled.








9.3. Exposure scenario 3: Use by professional worker - Professional, non-

consumer application of paints on metal surfaces (machines, vehicles,

structures, signs, road furniture) or as road marking. Pigment choice is

governed by requirements on visibility, colour, durability, technical

performance and Regulations


Professional application of coating containing C.I. Pigment Yellow 34 and C.I. Pigment Red 104 on non-

consumer articles. Examples include painted road marking on public roads and airports, as well as small scale

repair activities on damaged coating layers containing these specific pigments on high grade equipment, for

protection and to maintain the replacement value. The high quality of the coating is crucial for the long-term

functioning of road or airport marking as fading of the colour could jeopardise public or worker safety; regular

repainting could create dangerous situations (traffic jams); frequent temporary closing of airport operations

would incur high costs.

The selection of a coating containing these pigments is governed by requirements for the end application related

to: VISIBILITY AND SAFETY - Based on their bright, vivid, durable colours, these pigments are used when

visibility and safety play an important role. In particular for road/airport markings, various national regulations

require the use of precisely these pigments. DURABILITY - The pigments respond to the demand for high

performance pigments, e.g. in aggressive atmospheric conditions in industrialized areas, providing excellent

light and weather fastness, preventing applications to darken or fade if exposed to light and humidity; excellent

resistance to sulfur dioxide, preventing discolouration (greyness) and loss of gloss, required for exterior

applications; SHADE FUNCTIONALITY - Their colour covers a wide range from green to red shade yellow

and yellow to blue shade red; COLOURISTIC AND TECHNICAL PERFORMANCE - Within the listed colour

range, these pigments provide clean, vivid colours (chroma); excellent opacity or hiding power; excellent

weather fastness. The perceived colour remains the same regardless of the light source, i.e. does not exhibit

metamerism. They also provide excellent rheology in coatings; excellent non-bleeding properties, non-migration

properties and impact resistance in coatings.



Professional, non-consumer application of paints on metal surfaces (machines, vehicles,

structures, signs, road furniture) or as road marking

ERC 8f, ERC 8c


Handling of packaged colour paste and/or paint, including distribution PROC 2

Dosing of colour paste into paint premix PROC 9

Mixing colour paste with paint in closed mixing machine with automated dosing of paste PROC 3

Filling of spray equipment with colour paints PROC 9

Pigment paint spray application in a make-shift booth on location PROC 11

Pigment paint spray application in a professional spray booth PROC 11

Mixing of pigment paint in an open vessel PROC 5

Pigment paint application by rolling/brushing PROC 10

Cleaning of wet pigment paint on equipment by wiping and brushing PROC 10

Cleaning of dried pigment paint on equipment by wiping, brushing, scraping etc. PROC 21

Manipulation of pigment painted articles (dry) PROC 21




ES4: Service life (worker at industrial site) - Service life of coated articles. Performance and longevity depend

on the pigment quality for bright lasting colours improving visibility and safety, light and weather fastness


ES5: Service life (professional worker) - Service life of coated articles. Performance and longevity depend on

the pigment quality for bright lasting colours improving visibility and safety, light and weather fastness



The solvent-based paint or coating is prepared for application and applied as a spray paint in road marking

machines, spray booths, by roller application or brushing. Examples of activities are the painting of road marks

on public roads and in dedicated areas such as airports and car parks and the maintenance and repair of the

coating on high value steel-based objects such as piping for the (petro)chemical industry, crane arms,

agricultural machinery, road furniture, steel bridges, construction arches and steel skips.

9.3.1. Environmental contributing scenario 1: Professional, non-consumer application

of paints on metal surfaces (machines, vehicles, structures, signs, road furniture) or as

road marking









• Daily wide dispersive use: <= 6.6E-4 tonnes/day



• Municipal STP: Yes [Effectiveness Water: 86.49%]









9.3.1.2. Releases




method


Water Release factor Initial release factor: 2%




method


(SpERC CEPE 8f.3a.v1) Final release factor: 0.006%

Local release rate: 3.96E-5 kg/day

Explanation / Justification: Worst-case emission to water

according to SpERC CEPE 8f.3a.v1 - application - professional -

spraying - outdoor use – solids. Also covers indoor spraying and

outdoor/indoor brushing and rolling as a worst case. During

application of coatings outdoors, a proportion of the applied

coating can be deposited into water (no OECD – industry data).

Air Release factor

(SpERC CEPE 8f.3a.v1)



Explanation / Justification: Worst-case emission to water

according to SpERC CEPE 8f.3a.v1 - application - professional -

spraying - outdoor use – solids. Also covers indoor spraying and

outdoor/indoor brushing and rolling as a worst case. Based on

Emission Scenario Document on Coatings Industry (Paints,

Lacquers and Varnishes), OECD, July 2009


=ENV/JM/MONO(2009)24&doclanguage=en]. A proportion of

the solid phase will be contained in overspray.

Soil Release factor

(SpERC CEPE 8f.2a.v1)


Explanation / Justification: During application of coatings

outdoors, a proportion of the applied coating can be deposited on

the soil below the area being painted. As SpERC CEPE 8f.3a.v1 -

application - professional - spraying - outdoor use – solids does

not provide a release factor, it is assumed that this release factor

will be similar to that determined for professional application by

brush or roller (SpERC CEPE 8f.2a.v1 - application - professional

- bush/roller - outdoor use - solids). Also covers indoor spraying

and brushing/rolling as a worst case.

Releases to waste


Information from Emission Scenario Document on Coatings Industry (Paints, Lacquers and Varnishes), OECD,

July 2009

[http://www.oecd.org/officialdocuments/displaydocumentpdf?cote=ENV/JM/MONO(2009)24&doclanguage=e

n].





Freshwater Local PEC: 4.928E-8 mg/L RCR < 0.01

Sediment (freshwater) Local PEC: 0.015 mg/kg dw RCR < 0.01

Marine water Local PEC: 4.928E-9 mg/L RCR < 0.01

Sediment (marine water) Local PEC: 0.001 mg/kg dw RCR < 0.01




Sewage treatment plant Local PEC: 2.674E-6 mg/L RCR < 0.01






9.3.2. Worker contributing scenario 1: Handling of packaged colour paste and/or paint,



Handling of closed packagings of colour paste or paint in delivery, storage, transport. Sampling for QC.

Method




REACH Tool v1.5)



matrix


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)



• Occupational Health and Safety Management System: Basic TRA Worker v3







personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)








REACH Tool v1.5)



Method



99%]



basic employee training) [Effectiveness Dermal: 90%]

TRA Worker v3







in vessel).)


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.003







predicted 90th percentile full-shift exposure is 0.000033 mg/m³.



Carcinogenicity:




specific activity.





controlled.






9.3.3. Worker contributing scenario 2: Dosing of colour paste into paint premix (PROC

9)


Method







REACH Tool v1.5)




REACH Tool v1.5)











REACH Tool v1.5)



Method

personal cloud).)




REACH Tool v1.5)




TRA Worker v3






REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0










Carcinogenicity:




activity.





controlled.






9.3.4. Worker contributing scenario 3: Mixing colour paste with paint in closed mixing



Mixing to colour of pastes with paints or paint components by dosing colour paste from a dedicated machine in

a drum which is subsequently closed with a lid and shaken by the machine.

Method




REACH Tool v1.5)



matrix


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)




• Surface Contamination/Fugitive Emission Sources: The process is not fully External Tool (Advanced



Method






personal cloud).)

REACH Tool v1.5)




REACH Tool v1.5)









99%]


REACH Tool v1.5)






not ventilated.)



REACH Tool v1.5)




TRA Worker v3




REACH Tool v1.5)






REACH Tool v1.5)

• Open Surface: Surface 0.1 - 0.3 m² External Tool (Advanced

REACH Tool v1.5)





effects





REACH Tool v1.5))





effects



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.004





0.0001 mg/m³. The predicted 90th percentile full-shift exposure is 0.000044 mg/m³.



Carcinogenicity:




specific activity.





controlled.






9.3.5. Worker contributing scenario 4: Filling of spray equipment with colour paints

(PROC 9)




Method




ART v1.5)



matrix


ART v1.5)


ART v1.5)




ART v1.5)









ART v1.5)




ART v1.5)





workplace.)



ART v1.5)







recirculation.)



ART v1.5)




TRA Worker v3




ART v1.5)





Method


ART v1.5)






ART v1.5)



pump)


ART v1.5)


ART v1.5)




ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.011











Carcinogenicity:




specific activity.





controlled.






9.3.6. Worker contributing scenario 5: Pigment paint spray application in a make-shift

booth on location (PROC 11)


Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)


TRA Workers v3)



TRA Workers v3)


ART v1.5)

• Duration of use: 4 hours/day [Effectiveness Oral: 90%] External Tool (Extended

ART v1.5)








ART v1.5)



Method


personal cloud).)

• Dispersion - Outdoors: The source is located close to buildings External Tool (Extended

ART v1.5)


TRA Workers v3)

• Occupational Health and Safety Management System: Basic External Tool (Extended

TRA Workers v3)





ART v1.5)




TRA Workers v3)







ART v1.5)


ART v1.5)

• Spray direction: Spraying in any direction (including upwards) External Tool (Extended

ART v1.5)


ART v1.5)


TRA Workers v3)





effects





ART v1.5))



(see below)








(see below)








effects


damage)




ART v1.5))



(see below)





long-term, based on the maximum exposure

duration of 4 hours in a shift)

RCR = 0.877




ART calculation: The inter-quartile confidence interval is 6 mg/m³ to 76 mg/m³. The predicted 90th

percentile long-term exposure is 18 mg/m³. The result of the ART calculation was corrected by applying

respiratory protection with APF 1000 (99.9% effectiveness) and a factor 10 for the duration of use (4

hours/week).



The result of the ECETOC TRA calculation was corrected by applying a factor 10 for the duration of use

(4 hours/week).



Carcinogenicity:




specific activity, provided that the daily duration is below 4 hours.





controlled.






9.3.7. Worker contributing scenario 6: Pigment paint spray application in a professional

spray booth (PROC 11)


Method




Method


matrix


ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)


TRA Workers v3)



ART v1.5)


TRA Workers v3)








personal cloud).)


ART v1.5)










room).)



ART v1.5)


TRA Workers v3)

• Occupational Health and Safety Management System: Basic External Tool (Extended

TRA Workers v3)





ART v1.5)




TRA Workers v3)





ART v1.5)



Method




ART v1.5)


ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)





effects





ART v1.5))



(see below)








(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.414






respiratory protection with APF 400 (99.75% effectiveness) and a factor 5 the duration of use (8

hours/week).






hours/week).



Carcinogenicity:




specific activity.





controlled.






9.3.8. Worker contributing scenario 7: Mixing of pigment paint in an open vessel

(PROC 5)


Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)

TRA Worker v3








ART v1.5)



Method


personal cloud).)


work area: Only good natural ventilation


ART v1.5)







ART v1.5)



TRA Worker v3



ART v1.5)





in vessel).)


ART v1.5)

• Open Surface: Surface 0.3 - 1 m² External Tool (Extended

ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)




effects






long-term)

RCR = 0.039









Carcinogenicity:




specific activity.





controlled.






9.3.9. Worker contributing scenario 8: Pigment paint application by rolling/brushing

(PROC 10)


Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3





Method


ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)







working properly).)



ART v1.5)







ART v1.5)



TRA Worker v3





ART v1.5)





ART v1.5)


ART v1.5)






effects


Inhalation, systemic, long-term 2.9E-4 mg/m³ (External Tool (Extended Exposure/DMEL = 0.05




effects


(neurodevelopmental damage) ART v1.5)) Qualitative risk characterisation

(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.028









Carcinogenicity:




specific activity.





controlled.






9.3.10. Worker contributing scenario 9: Cleaning of wet pigment paint on equipment by

wiping and brushing (PROC 10)




Method



matrix


ART v1.5)

• Viscosity: Liquids with low viscosity (like water) External Tool (Extended

ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)







ART v1.5)



TRA Worker v3





ART v1.5)




ART v1.5)



Method


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.034









Carcinogenicity:




specific activity.







controlled.






9.3.11. Worker contributing scenario 10: Cleaning of dried pigment paint on equipment

by wiping, brushing, scraping etc. (PROC 21)


Cleaning, scraping, wiping, brushing of vessels and surfaces with dried paint containing pigment powder. The

pigment is bound into a matrix.

Method



ART v1.5)






ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)


TRA Workers v3)



ART v1.5)


TRA Workers v3)








personal cloud).)


ART v1.5)




ART v1.5)




Method

TRA Workers v3)


TRA Workers v3)





ART v1.5)




TRA Workers v3)







ART v1.5)




ART v1.5)




ART v1.5)


ART v1.5)


TRA Workers v3)





effects





ART v1.5))



(see below)








(see below)




damage)





ART v1.5))



(see below)





effects



long-term)






applying respiratory protection with APF 10 (90% effectiveness) and a factor 6.66 for the duration of use

(6 hours/week).




use (6 hours/week).



Carcinogenicity:




specific activity.





controlled.






9.3.12. Worker contributing scenario 11: Manipulation of pigment painted articles (dry)

(PROC 21)


Assembling, disassembling, packaging, handling machinery, vehicles, articles, gear painted with pigment

containing paint (dry) as part of a machinery, vehicle, article, gear production process.

Method



ART v1.5)

• Dustiness: Firm granules, flakes or pellets (Product does not result in dust External Tool (Extended



Method



100 mg/kg)

ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)







ART v1.5)



TRA Worker v3





ART v1.5)




ART v1.5)




ART v1.5)


ART v1.5)








effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.002









Carcinogenicity:




specific activity.





controlled.








9.4. Exposure scenario 4: Service life (worker at industrial site) - Service

life of coated articles. Performance and longevity depend on the pigment

quality for bright lasting colours improving visibility and safety, light

and weather fastness (durability), chemical fastness, impact resistance

and heat stability



Article categories: AC 1, Vehicles

AC 2, Machinery, mechanical appliances, electrical/electronic articles

AC 4, Stone, plaster, cement, glass and ceramic articles

AC 7, Metal articles


Sanding of painted/coated articles ERC 12b, ERC 12a


Cutting painted metal sheet (dry) PROC 21

Sanding of dried paint on machines, vehicles, other metal articles etc. PROC 24

Welding, torchcutting of painted metal (dry) PROC 25

Exposure scenario(s) of the uses leading to the inclusion of the substance into the article(s):

ES2: Use at industrial site - Industrial application of paints on metal surfaces (machines, vehicles, structures,

signs, road furniture, coil coating). Pigment choice is governed by end product specifications on visibility,

colour, durability, other technical requirements and Regulations.

ES3: Use by professional worker - Professional, non-consumer application of paints on metal surfaces

(machines, vehicles, structures, signs, road furniture) or as road marking. Pigment choice is governed by

requirements on visibility, colour, durability, technical performance and Regulations.


Painted/coated objects are high grade steel based articles such as piping for the (petro)chemical industry, crane

arms, agricultural machinery, road furniture such as road blocks, crash barriers and signs, steel bridges or

construction arches and steel skips and roofing. Other objects would include for example road markings. The

presence of the pigment contributes to industrial and/or public safety (i.e. visibility) and durability of the

paint/coating and the coated object (improving light and weather fastness (durability), impact resistance, gloss

retention, etc). The technical durability of the paint/coating is beneficial in situations where fading of the colours

could jeopardise public or worker safety, where regular maintenance and repainting could create difficult or

dangerous situations (e.g., steel bridges, or road work) or where idle time of specialty equipment would incur

high costs.

Paints and coatings containing C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are applied to ensure a long

service life of the coating of non-consumer articles. Significant direct contact with consumers or workers will

not take place and there is no release to the environment. Only in case of occasional maintenance or repair,

workers may carry out activities that may lead to exposure due to sanding, shot blasting, cutting, drilling or

welding operations.

After their service life, the painted/coated objects, being high grade steel based articles such as piping for the

(petro)chemical industry, crane arms, agricultural machinery, crash barriers, steel bridges, etc. will be collected

as scrap for recycling. During the recycling, due to the very high temperatures in the steel production process

(1100-1500ºC) contaminants are removed. The pigment structure will be broken and the chromium oxides are

expected to end up in the slags that find application in various other industrial processes, whereas the lead

oxides are expected to be filtered from the fly ash.

Painted road markings may wear down in time and paint particles wash down to the gutters along with other



traffic emissions; or during road reconstruction works they are collected along with the asphalt concrete road

material which is usually recycled.

9.4.1. Environmental contributing scenario 1: Sanding of painted/coated articles










Tonnage per day based on the following assumptions: Each painter can sand 100 m2/day. This produces ~4

liter of paint (of the 2.5 liter which was applied). This corresponds to 7.2 kg paint, when 10 painters are

working at the same time a worst-case of 80 kg/day of paint is therefore sanded off. Assuming a pigment

concentration in paint of 7.5%, this corresponds to 6 kg/day of pigment.

• Annual use at a site: <= 1.2 tonnes/year

Daily use * number of emission days per year



It is assumed that sanding as part of industrial service life takes place as a worst case 200 days/year


• Integrated LEV: Integrated LEV industrial (During the process, equipment with integrated local exhaust

ventilation is used) [Effectiveness Water: 84%; Air: 84%]











9.4.1.2. Releases




method


Water ERC based Initial release factor: 20%





method



Air ERC based Initial release factor: 20%



Soil ERC based Final release factor: 20%















9.4.2. Worker contributing scenario 1: Cutting painted metal sheet (dry) (PROC 21)


Method



ART v1.5)




100 mg/kg)


ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)



Method

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)







ART v1.5)



TRA Worker v3





ART v1.5)




ART v1.5)

• Handling of Contaminated Solid Objects or Paste: Handling that departs from

regular work procedures and involves large amounts of energy (e.g. rough handling

or throwing of bags)


ART v1.5)


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




effects





damage)





ART v1.5))



(see below)





long-term)

RCR = 0.001





predicted 90th percentile long-term exposure is 0.000076 mg/m³. The result of the ART calculation was

corrected by applying respiratory protection with APF 10 (90% effectiveness).



Carcinogenicity:




specific activity.





controlled.






9.4.3. Worker contributing scenario 2: Sanding of dried paint on machines, vehicles,

other metal articles etc. (PROC 24)


Method



MEASE 1.02.01)

TRA Worker v3



Method




MEASE 1.02.01)

TRA Worker v3


• Implemented RMMs: Integrated LEV (Lower confidence limit for efficiency)

[Effectiveness Inhal: 84%]


MEASE 1.02.01)







MEASE 1.02.01)



TRA Worker v3


• Process temperature (for solid): Ambient External Tool (Extended

MEASE 1.02.01)

• Pattern of use: Wide dispersive use External Tool (Extended

MEASE 1.02.01)

• Pattern of exposure control: Direct handling External Tool (Extended

MEASE 1.02.01)

• Contact level: Extensive External Tool (Extended

MEASE 1.02.01)






effects


Inhalation, systemic, long-term 0.002 mg/m³ (External Tool (Extended

MEASE 1.02.01))



(see below)


Dermal, systemic, long-term 0.028 mg/kg bw/day (TRA Worker v3) Exposure/DMEL = 0.006


(see below)




damage)





effects





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.208


External Tool (Extended MEASE 1.02.01)


The result of the MEASE calculation was corrected by applying respiratory protection with APF 30

(96.66% effectiveness).



Carcinogenicity:




specific activity.





controlled.






9.4.4. Worker contributing scenario 3: Welding, torchcutting of painted metal (dry)

(PROC 25)


Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3



Method





MEASE 1.02.01)







MEASE 1.02.01)



TRA Worker v3



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)






effects





MEASE 1.02.01))



(see below)




0.003 mg/kg bw/day (TRA Worker v3) Exposure/DMEL = 5.6E-4


(see below)




damage)





MEASE 1.02.01))



(see below)





effects



long-term)








Carcinogenicity:




specific activity.





controlled.








9.5. Exposure scenario 5: Service life (professional worker) - Service life

of coated articles. Performance and longevity depend on the pigment

quality for bright lasting colours improving visibility and safety, light

and weather fastness (durability), chemical fastness, impact resistance

and heat stability



Article categories: AC 1, Vehicles

AC 2, Machinery, mechanical appliances, electrical/electronic articles

AC 4, Stone, plaster, cement, glass and ceramic articles

AC 7, Metal articles


Leaching from painted metal surfaces (machines, vehicles, structures, signs, road

furniture, coil coating) during service life

ERC 10b, ERC 10a,

ERC 11a, ERC 11b

Sanding of painted/coated articles ERC 10b, ERC 10a,

ERC 11a, ERC 11b

Leaching from painted road marking during service life ERC 10b, ERC 10a,

ERC 11a, ERC 11b


Cutting painted metal sheet (dry) PROC 21

Sanding of dried paint on machines, vehicles, other articles etc. PROC 24

Welding, torchcutting of painted metal (dry) PROC 25


ES2: Use at industrial site - Industrial application of paints on metal surfaces (machines, vehicles, structures,

signs, road furniture, coil coating). Pigment choice is governed by end product specifications on visibility,

colour, durability, other technical requirements and Regulations.

ES3: Use by professional worker - Professional, non-consumer application of paints on metal surfaces

(machines, vehicles, structures, signs, road furniture) or as road marking. Pigment choice is governed by

requirements on visibility, colour, durability, technical performance and Regulations.


Painted/coated objects are high grade steel based articles such as piping for the (petro)chemical industry, crane

arms, agricultural machinery, road furniture such as road blocks, crash barriers and signs, steel bridges or

construction arches and steel skips and roofing. Other objects would include for example road markings. The

presence of the pigment contributes to industrial and/or public safety (i.e. visibility) and durability of the

paint/coating and the coated object (improving light and weather fastness (durability), impact resistance, gloss

retention, etc). The technical durability of the paint/coating is beneficial in situations where fading of the colours

could jeopardise public or worker safety, where regular maintenance and repainting could create difficult or

dangerous situations (e.g., steel bridges, or road work) or where idle time of specialty equipment would incur

high costs.

Paints and coatings containing C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are applied to ensure a long

service life of the coating of non-consumer articles. Significant direct contact with consumers or workers will

not take place and there is no release to the environment. Only in case of occasional maintenance or repair,

workers may carry out activities that may lead to exposure due to sanding, shot blasting, cutting, drilling or

welding operations.



After their service life, the painted/coated objects, being high grade steel based articles such as piping for the

(petro)chemical industry, crane arms, agricultural machinery, crash barriers, steel bridges, etc. will be collected

as scrap for recycling. During the recycling, due to the very high temperatures in the steel production process

(1100-1500ºC) contaminants are removed. The pigment structure will be broken and the chromium oxides are

expected to end up in the slags that find application in various other industrial processes, whereas the lead

oxides are expected to be filtered from the fly ash.

Painted road markings may wear down in time and paint particles wash down to the gutters along with other

traffic emissions; or during road reconstruction works they are collected along with the asphalt concrete road

material which is usually recycled.

9.5.1. Environmental contributing scenario 1: Leaching from painted metal surfaces

(machines, vehicles, structures, signs, road furniture, coil coating) during service life







Based on 1000 tonnes pigment / year on metal surfaces












9.5.1.2. Releases




method



(Test data)




Explanation / Justification: Transformation/dissolution tests

were carried out with paints containing the pigment. These tests

show 0.2% dissolution. Based on the results of these tests, 0.5%

dissolution, with release to both water and soil, is applied as a

worst-case.

Air Release factor Initial release factor: 0%




method


(Specific information) Final release factor: 0%

Explanation / Justification: Based on the low volatility of the

substance, no leaching to air is expected.

Soil Release factor

(Test data)



were carried out with paints containing the pigment. These tests

show 0.2% dissolution. Based on the results of these tests, 0.5%


worst-case.

Releases to waste


None of the leached material will enter the waste phase.















9.5.2. Environmental contributing scenario 2: Sanding of painted/coated articles










Based on 1000 tonnes pigment / year on metal surfaces





• Integrated LEV: Integrated LEV professional (During the process, equipment with integrated local exhaust












9.5.2.2. Releases




method
























9.5.3. Environmental contributing scenario 3: Leaching from painted road marking

during service life










Based on 200 tonnes pigment / year as road marking












9.5.3.2. Releases




method








Releases to waste



















9.5.4. Worker contributing scenario 1: Cutting painted metal sheet (dry) (PROC 21)


Method




ART v1.5)



ART v1.5)




100 mg/kg)


ART v1.5)


ART v1.5)




ART v1.5)










personal cloud).)


ART v1.5)



Method




ART v1.5)




TRA Worker v3




ART v1.5)






ART v1.5)




ART v1.5)





ART v1.5)


ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.001







predicted 90th percentile long-term exposure is 0.000076 mg/m³. The result of the ART calculation was

corrected by applying respiratory protection with APF 10 (90% effectiveness).



Carcinogenicity:




specific activity.





controlled.






9.5.5. Worker contributing scenario 2: Sanding of dried paint on machines, vehicles,

other articles etc. (PROC 24)


Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3


• Implemented RMMs (professional setting): Integrated LEV (Lower confidence

limit for efficiency) [Effectiveness Inhal: 80%]


MEASE 1.02.01)




• Respiratory protection according to EN 529:2005 (APF only): Minimum APF of External Tool (Extended



Method

30 [Effectiveness Inhal: 96.66%] MEASE 1.02.01)



TRA Worker v3



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)






effects


Inhalation, systemic, long-term 2.67E-03 mg/m³ (External Tool (Extended

MEASE 1.02.01))



(see below)




(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.260










Carcinogenicity:




specific activity.





controlled.






9.5.6. Worker contributing scenario 3: Welding, torchcutting of painted metal (dry)

(PROC 25)


Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3





MEASE 1.02.01)







MEASE 1.02.01)



TRA Worker v3



MEASE 1.02.01)


MEASE 1.02.01)



Method


MEASE 1.02.01)


MEASE 1.02.01)






effects


Inhalation, systemic, long-term 0.002 mg/m³ (External Tool (Extended

MEASE 1.02.01))



(see below)




(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.156





(99% effectiveness).



Carcinogenicity:




specific activity.







controlled.








9.6. Exposure scenario 6: Formulation - Distribution and mixing

pigment powder in an industrial environment into liquid or solid premix

to colour plastic/plasticised articles. Pigment choice depends on product

specifications on visibility, colour, heat stability, durability and

Regulations

Market sector: Colouration of plastic or plasticised articles

Distribution and formulation (compounding) of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 powder in an

industrial environment into a solid or liquid premix with other additives (masterbatch) to be used in the

conversion process for the colouration of plastic or plasticised articles for non-consumer use. Examples of

articles are technical specialty parts, canvas for truck trailer covers, safety covers on agricultural equipment, hot

melt road marking, safety signage, safety helmets, medical waste containers, etc. The high quality of the

pigments is crucial for the long-term integrity of the plastic material and the functioning of the article.

The choice for these pigments is based on end product specifications and requirements related to: VISIBILITY

AND SAFETY - Based on their bright, vivid, durable colours, these pigments are often used when visibility and

safety play an important role, in particular in regulated applications, e.g. hot melt road marking; DURABILITY

- The pigments respond to the demand for high performance pigments, e.g. in aggressive atmospheric conditions

in industrialized areas, providing excellent light and weather fastness, preventing applications to darken or fade

if exposed to light and humidity; excellent resistance to sulfur dioxide, preventing discolouration (greyness) as

required for exterior applications; SHADE FUNCTIONALITY - The pigments provide colour, covering a wide

range from green to red shade yellow and yellow to blue shade red; COLOURISTIC AND TECHNICAL

PERFORMANCE - Within the mentioned colour range, these pigments provide clean, vivid colours (chroma);

excellent opacity or hiding power; excellent weather fastness; superior dispersion properties and high heat

stability for processing in high temperature matrices. These pigments also provide excellent non-migration

properties in plastics.

PC 32: Polymer Preparations and Compounds; PC 34: Textile dyes, finishing and impregnating products;

including bleaches and other processing aids


Distribution and mixing pigment powder in an industrial environment into a premix or

pre-compound to add colour to plastic or plasticised articles

ERC 3


Delivery, storage and handling of closed paper bags with pigment powder PROC 3

Pigment powder quality control / lab work PROC 15

Manual dosing of pigment powder PROC 8a

Automated dosing of pigment powder PROC 8b

Mixing of pigment with resins and additives to form a liquid pre-mix/pre-compound PROC 5

Storage of premix/pre-compound / Transfer of pre-mix/pre-compound through closed

piping

PROC 2

Premix/pre-compound charging/discharging by gravity or manual handling PROC 8a

Premix/pre-compound charging/discharging using a dedicated installation PROC 8b

Premix/pre-compound filling into drums/cans at a filling line PROC 9

Manual cleaning / scraping of mixing vessels, equipment and lids PROC 21

Cleaning of vessel with resin PROC 10

Premix/pre-compound quality control / lab work PROC 15

Production of coloured plastic granules or masterbatch by extrusion, compression and/or

pelletisation

PROC 14



Mixing pigment powder or premix/pre-compound into matrix in closed mixing vessel PROC 3

Production of plastic articles by extrusion, injection moulding and other processes PROC 14

Quality control / lab work with coloured plastics PROC 15

Handling of articles and single coloured granules PROC 21

Handling of mixed coloured granules and articles PROC 21

Transfer of articles and single coloured granules PROC 8a

Transfer of articles and single coloured granules PROC 8b

Transfer of mixed coloured granules and articles PROC 8a

Transfer of mixed coloured granules and articles PROC 8b

Pigment powder dosing before mixing PROC 8b

Mixing of pigment powder with other solid additives PROC 3

Filling of small packages with pigment powder PROC 9

Manual handling of pigment contained in small sealed plastic bags (<1 kg) PROC 1

Pigment powder manual cleaning, wiping, scraping etc. PROC 19


Pigment powders are typically delivered by truck in bags on pallets. The pallets are stored inside. Order picking

is usually performed manually, internal transport with hand pallet truck or forklift. Some formulators only

repack into sealed plastic sachets with precautionary measures in place. The bags as delivered by the supplier

are cut manually or automated and the contents are emptied into a hopper that is connected to an automated

filling machine to fill and seal the plastic sachets. In a next formulation step the sealed sachets are manually

added to a large volume of hotmelt mixture.

A colour matrix (liquid or solid) consists of a mixture of resins, additives and up to 70% pigments, usually

prepared in dedicated equipment. Dosing of pigment powder is done manually or automated by cutting the bags

and emptying the contents into a hopper or directly into mixing vessels and blenders in order to generate a

premix or precompound. The mixing vessels and blenders at this stage normally contain other resins and

additives required to complete the formulation. Mixing is done in vessels of varying sizes. The surface area of

the mixing vessels varies and is between 1-3 m2 for the smaller containers and over 3 m2 for the large

containers. After premixing the colour premix or precompound is then normally processed further such as

packing for use or dispersed further using appropriate equipment such as extruders, three roll mills, beadmills

etc. The vessels are closed during the mixing and dispersing operations.

At the end of the process the final colour matrix has been dispersed and mixed to achieve the required

specification in terms of colour strength, hiding power/opacity, colour shade, brightness/chroma. The pigment as

such is fully embedded in the matrix.

Subsequent in plant process steps may be to mix the final colour matrix with other colour matrices or further

diluting the product with resins and additives to form plastic or road marking compounds. Several processing

techniques can be used such as tableting, compression, extrusion, pelletisation etc. This secondary processing

takes place in an industrial environment for products for industrial and non-consumer use.

During processing, local exhaust ventilation is present and good housekeeping practices are followed. The

mixing room is ventilated by means of good natural ventilation or by mechanical room ventilation.

For quality control purposes a sample can be taken from the coloured liquid or solid matrix. Powdered pigment

is used during Quality Control and product development in small quantities inside fume cupboards.

An operator, formulating a full day, typically handles 1,000 kg of pigment powder per shift. During activities

where exposure to pigment powder is to be expected the workers use respiratory protection, a coverall, gloves

and goggles.

Equipment is cleaned using solvents or resins as needed. The subsequent material is then dosed into a product,

or collected and recycled or treated as hazardous waste. No water is used to clean mixing vessels, piping and

other equipment. Spills are collected, using absorbent if needed, the material is disposed of as hazardous waste.

If water is used during cleanup of spills, it is collected and disposed of as hazardous waste. Emptied bags of

pigment powder are collected and disposed of as hazardous waste. The production area is a contained area with

liquid-proof floors.



9.6.1. Environmental contributing scenario 1: Distribution and mixing pigment powder

in an industrial environment into a premix or pre-compound to add colour to plastic or

plasticised articles





• Correction for water solubility of Pb in pigment (10%): Correction applicable (Transformation/dissolution

tests were carried out with the pigment. Based on the results of these tests, 10% dissolution is applied as a

worst-case.) [Effectiveness Water: 90%]


• Daily use at site: <= 4 tonnes/day

Worst-case tonnage per site per day based on formulators questionnaire


Worst-case tonnage per site per year based on formulators questionnaire



Number of emission days per year used for worst-case volume calculations






RMM



• Wet scrubbers















9.6.1.2. Releases






method







Explanation / Justification: During the formulation of premixes

and pre-compounds using C.I. Pigment Yellow 34 and C.I.

Pigment Red 104 no water is used. If any waste water is

generated, this is treated as hazardous waste.

Air Release factor

(SpERC Eurometaux 2.2a.v2.1 )




Explanation / Justification: Release fraction from Eurometaux

2.2a.v2.1 - Formulation of metal compounds in plastics and

rubber industry sector. Derived from a multi-metal background

database of measured site-specific release factors collected from

peer-reviewed EU Risk Assessment Reports under the former

Directive of New and Existing Substances and REACH 2010

registration dossiers. The specific release factor fort his SpERC is

the 90th percentile of reported site-specific release factors to air

for 15 sites. This release fraction is considered worst-case, as the

release to air is 0% according to Emission Scenario Document on

Plastic Additives, OECD, July 2009

[http://search.oecd.org/officialdocuments/displaydocumentpdf/?co

te=env/jm/mono(2004)8/rev1&doclanguage=en].

Soil Release factor

(SpERC Eurometaux 2.2a.v2.1 )


Explanation / Justification: No release to soil takes place during

formulation of premixes and pre-compounds. This is supported by

SpERC Eurometaux 2.2a.v2.1 and Emission Scenario Document

on Plastic Additives, OECD, July 2009


te=env/jm/mono(2004)8/rev1&doclanguage=en], which does not

consider any release to soil.

Releases to waste


In accordance with SpERC Eurometaux 2.2a.v2.1. The 90th percentile of reported site-specific release factors to

solid waste for 32 downstream user sites covering zinc, nickel, lead, antimony. This is supported by Emission

Scenario Document on Plastic Additives, OECD, July 2009

[http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2004)8/rev1&doclanguage=

en], which also takes into account 1% release to waste during raw material handling.


















9.6.2. Worker contributing scenario 1: Delivery, storage and handling of closed paper

bags with pigment powder (PROC 3)


Method



REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)











personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)

• Personal enclosure of the worker from the emission source: Complete personal

enclosure without ventilation (Worker resides inside an enclosed cabin or room

(door & windows closed) for the entire duration of the activity. The air within the

separate room is not actively ventilated.)

Applicable to far field exposure.


REACH Tool v1.5)




• Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with TRA Worker v3



Method






REACH Tool v1.5)





REACH Tool v1.5)


REACH Tool v1.5)






effects


Inhalation, systemic, long-term 2.5E-03 mg/m³ (External Tool (Advanced



(see below)




(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.244








Carcinogenicity:






specific activity.





controlled.






9.6.3. Worker contributing scenario 2: Pigment powder quality control / lab work

(PROC 15)


For example QC at shipment receival.

Method


• Substance product type: Powders, granules or pelletised material

Applicable to transfer activity.


REACH Tool v1.5)

• Moisture Content of the product: Dry product (<5 % moisture content)

Applicable to activities with powder.


REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)











personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)







working properly).)



REACH Tool v1.5)



Method






TRA Worker v3











REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)





opening )


REACH Tool v1.5)






REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)








effects


damage)




REACH Tool v1.5))



(see below)





long-term)

RCR = 0.074









Carcinogenicity:




specific activity.





controlled.






9.6.4. Worker contributing scenario 3: Manual dosing of pigment powder (PROC 8a)


Manual discharge of bags of pigment, for example in hoppers, in facilities with general protection measures.

Removal of empty bags is included.

Method



ART v1.5)


ART v1.5)



Method




ART v1.5)


ART v1.5)











personal cloud).)


ART v1.5)




ART v1.5)





workplace.)



ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)




ART v1.5)


0.5 m


ART v1.5)





opening )


ART v1.5)






ART v1.5)



Method


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.224









Carcinogenicity:




specific activity.







controlled.






9.6.5. Worker contributing scenario 4: Automated dosing of pigment powder (PROC

8b)


Automated discharge of bags of pigment, for example in hoppers, in facilities with high level of protection

protective measures. Bag is placed on conveyor belt using a vacuum transporter. The bag is cut and emptied

within the machine. Machine is in isolated room, which is underpressured.

Method



REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)











personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)





workplace.)



REACH Tool v1.5)









REACH Tool v1.5)



Method


99%]






TRA Worker v3











REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)






REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)









REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)








effects



(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.032








Carcinogenicity:




specific activity.





controlled.






9.6.6. Worker contributing scenario 5: Mixing of pigment with resins and additives to

form a liquid pre-mix/pre-compound (PROC 5)


Mixing and blending in mixing vessel with loose fitting cover. A liquid is present in the mixing vessel before

the pigment is added.

Method



Method





matrix


ART v1.5)


ART v1.5)

• Liquid Weight Fraction: Main component (50 - 90%) [Effectiveness Inhal: 10%] External Tool (Extended

ART v1.5)




ART v1.5)










personal cloud).)


ART v1.5)



Applicable to activity with agitated liquid surfaces.


ART v1.5)









99%]


ART v1.5)




TRA Worker v3




ART v1.5)




ART v1.5)

• Activity Class: Activities with open liquid surfaces or open reservoirs - Activities External Tool (Extended



Method




ART v1.5)


ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.034









Carcinogenicity:




specific activity.







controlled.






9.6.7. Worker contributing scenario 6: Storage of premix/pre-compound / Transfer of

pre-mix/pre-compound through closed piping (PROC 2)


Handling of closed packagings of premix/pre-compound: delivery, storage, transport etc. Sampling for QC.

Method





matrix


REACH Tool v1.5)


REACH Tool v1.5)

• Liquid Weight Fraction: Main component (50 - 90%) [Effectiveness Inhal: 10%] External Tool (Advanced

REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)



Applicable to activity with agitated liquid surfaces.


REACH Tool v1.5)





REACH Tool v1.5)



Method






99%]




TRA Worker v3




REACH Tool v1.5)





in vessel).)


REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.008










Carcinogenicity:


hich is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on


specific activity.





controlled.






9.6.8. Worker contributing scenario 7: Premix/pre-compound charging/discharging by

gravity or manual handling (PROC 8a)


Method





matrix


ART v1.5)


ART v1.5)


ART v1.5)




ART v1.5)






Method






ART v1.5)




ART v1.5)










ART v1.5)




TRA Worker v3




ART v1.5)




ART v1.5)






ART v1.5)



pump)


ART v1.5)


ART v1.5)




ART v1.5)





effects





ART v1.5))



(see below)




effects







(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.234









Carcinogenicity:




specific activity.





controlled.






9.6.9. Worker contributing scenario 8: Premix/pre-compound charging/discharging

using a dedicated installation (PROC 8b)




Method





matrix


ART v1.5)


ART v1.5)


ART v1.5)




ART v1.5)









ART v1.5)




ART v1.5)










ART v1.5)




TRA Worker v3




ART v1.5)




ART v1.5)






ART v1.5)

• Falling Liquids - Activity: Transfer of liquid product with flow of: 10 - 100 External Tool (Extended



Method


pump)

ART v1.5)


ART v1.5)




ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.080









Carcinogenicity:






specific activity.





controlled.






9.6.10. Worker contributing scenario 9: Premix/pre-compound filling into drums/cans

at a filling line (PROC 9)


Filling premix/pre-compound in containers for sale or further use at a filling line where the premix/pre-

compound is dosed automatically from the machine into the container. Next, the container is closed.

Method





matrix


ART v1.5)


ART v1.5)


ART v1.5)




ART v1.5)









ART v1.5)




ART v1.5)





workplace.)


ART v1.5)



Method


segregation without ventilation (Sources are partially segregated from the work

environment by isolating the source in a separate room (e.g. with open doors

and/or windows to the adjacent area). This segregated area is generally not entered

by the worker during a given activity or working shift. The air within the separate

room is not actively ventilated.)


ART v1.5)




TRA Worker v3




ART v1.5)




ART v1.5)






ART v1.5)




ART v1.5)





vehicles) )


ART v1.5)




ART v1.5)





effects





ART v1.5))



(see below)






(see below)





effects




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.007









Carcinogenicity:




specific activity.





controlled.






9.6.11. Worker contributing scenario 10: Manual cleaning / scraping of mixing vessels,



Method



ART v1.5)




ART v1.5)



Method



• Moisture Content of the product: 5 - 10 % moisture content External Tool (Extended

ART v1.5)


ART v1.5)

• Concentration of substance in mixture: >25% External Tool (Extended

TRA Workers v3)


TRA Workers v3)



ART v1.5)


TRA Workers v3)








personal cloud).)


ART v1.5)




ART v1.5)


TRA Workers v3)


TRA Workers v3)





ART v1.5)




TRA Workers v3)







ART v1.5)




ART v1.5)




ART v1.5)


ART v1.5)



Method


TRA Workers v3)





effects





ART v1.5))



(see below)








(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.175







(32 hours/week).







Carcinogenicity:






specific activity.





controlled.






9.6.12. Worker contributing scenario 11: Cleaning of vessel with resin (PROC 10)


Cleaning of vessel with resin (e.g. polyethylene) either manual or automated.

Method



matrix


ART v1.5)


ART v1.5)

• Liquid Weight Fraction: Substantial (10 - 50%) [Effectiveness Inhal: 50%] External Tool (Extended

ART v1.5)


TRA Workers v3)


TRA Workers v3)



ART v1.5)


TRA Workers v3)








personal cloud).)


ART v1.5)




ART v1.5)




ART v1.5)



Method








TRA Workers v3)


TRA Workers v3)





ART v1.5)




TRA Workers v3)





ART v1.5)




ART v1.5)


ART v1.5)

• Skin surface potentially exposed: Two hands (960 cm2) External Tool (Extended

TRA Workers v3)





effects





ART v1.5))



(see below)








(see below)




damage)


Inhalation, systemic, long-term 0.001 mg/m³ (External Tool (Extended Exposure/DMEL = 0.473




effects


(carcinogenicity, lung) ART v1.5)) Qualitative risk characterisation

(see below)





long-term)

RCR = 0.341







(2 days/week).



The result of the ECETOC TRA calculation was corrected by applying a factor 2.5 for the duration of use

(16 hours/week).



Carcinogenicity:




specific activity.





controlled.






9.6.13. Worker contributing scenario 12: Premix/pre-compound quality control / lab

work (PROC 15)


Any other manipulations in the laboratory not otherwise specified in this CSR. For example QC at shipment

receival.

Method




Method


matrix


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)






REACH Tool v1.5)








working properly).)

Effectiveness of RMM: 99%. Only applicable to activity with agitated surface and

spreading of liquids.


REACH Tool v1.5)




REACH Tool v1.5)






TRA Worker v3








REACH Tool v1.5)




REACH Tool v1.5)





vehicles) )


REACH Tool v1.5)




REACH Tool v1.5)

• Activity Class: Activities with open liquid surfaces or open reservoirs - Activities External Tool (Advanced



Method





REACH Tool v1.5)




REACH Tool v1.5)





REACH Tool v1.5)





REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.091










Carcinogenicity:




specific activity.





controlled.






9.6.14. Worker contributing scenario 13: Production of coloured plastic granules or

masterbatch by extrusion, compression and/or pelletisation (PROC 14)


Premix/pre-compound is again mixed with other premixes/pre-compound, polymer and other additives to

produce another masterbatch, resulting in inclusion into a matrix.

Method



ART v1.5)




100 mg/kg)


ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)


TRA Workers v3)



ART v1.5)


TRA Workers v3)



Method








personal cloud).)


ART v1.5)




ART v1.5)


TRA Workers v3)


TRA Workers v3)





ART v1.5)




TRA Workers v3)







ART v1.5)


Compressing 1 – 10 kg/minute


ART v1.5)




ART v1.5)


ART v1.5)

• Skin surface potentially exposed: Two hands face (480 cm2) External Tool (Extended

TRA Workers v3)





effects





ART v1.5))



(see below)


Dermal, systemic, long-term 0.138 mg/kg bw/day (External Tool Exposure/DMEL = 0.028




effects


(neurodevelopmental damage) (Extended TRA Workers v3)) Qualitative risk characterisation

(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.175







(32 hours/week).







Carcinogenicity:




specific activity.





controlled.






9.6.15. Worker contributing scenario 14: Mixing pigment powder or premix/pre-

compound into matrix in closed mixing vessel (PROC 3)




Mixing to colour for plastics by dosing pigment powder or premix/pre-compound in a vessel closed with a lid.

Occasional sampling.

Method



TRA Worker v3)


TRA Worker v3)


matrix


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)



TRA Worker v3)


REACH Tool v1.5)


• Containment: Closed batch process with occasional controlled exposure External Tool (Extended

TRA Worker v3)


TRA Worker v3)







personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)









99%]


REACH Tool v1.5)





TRA Worker v3)



Method


• Skin surface potentially exposed: One hand face only (240 cm2) External Tool (Extended

TRA Worker v3)


REACH Tool v1.5)






REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)








(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.341










Carcinogenicity:




specific activity.





controlled.






9.6.16. Worker contributing scenario 15: Production of plastic articles by extrusion,

injection moulding and other processes (PROC 14)


Premix/pre-compound is mixed with polymer resulting in inclusion of the pigment into a matrix resulting in

formation of articles

Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)




Method








ART v1.5)









ART v1.5)







ART v1.5)



TRA Worker v3





ART v1.5)




ART v1.5)


ART v1.5)

• Process Temperature: Hot processed (50 - 150°C) External Tool (Extended

ART v1.5)






effects





ART v1.5))



(see below)








effects



(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.010









Carcinogenicity:




specific activity.





controlled.






9.6.17. Worker contributing scenario 16: Quality control / lab work with coloured

plastics (PROC 15)


Any other manipulations in the laboratory (of premix or pre-compound or other liquid mixture) not otherwise

specified in this CSR. For example QC at shipment receival.



Method



REACH Tool v1.5)

• Powder Weight Fraction: Main component (50 - 90%) [Effectiveness Inhal: 10%] External Tool (Advanced

REACH Tool v1.5)


REACH Tool v1.5)




100 mg/kg)


REACH Tool v1.5)





REACH Tool v1.5)

TRA Worker v3








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)

• General Control Measures: Local exhaust ventilation (LEV) - Other LEV systems

(In case the type of local exhaust ventilation system is unknown or not specified,

this default LEV category can be selected. Note that this default category results in

a low reduction of the estimated personal exposure level. An attempt should be

made to more specifically define the type of local exhaust ventilation.)



REACH Tool v1.5)






TRA Worker v3









REACH Tool v1.5)



Method






REACH Tool v1.5)


0.5 m


REACH Tool v1.5)






REACH Tool v1.5)





opening )


REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.263










Carcinogenicity:




specific activity.





controlled.






9.6.18. Worker contributing scenario 17: Handling of articles and single coloured

granules (PROC 21)


Packaging, transfer between containers, storage and any other manipulation with finished granules and articles

containing pigment in a matrix.

Method



ART v1.5)

• Powder Weight Fraction: Main component (50 - 90%) [Effectiveness Inhal: 10%] External Tool (Extended

ART v1.5)


ART v1.5)




100 mg/kg)


ART v1.5)








Method

ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)










ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)




ART v1.5)

• Falling of Powders, Granules or Pelletised Material - Drop height: Drop height < External Tool (Extended



Method

0.5 m ART v1.5)

• Falling of Powders, Granules or Pelletised Material - Type of handling: Routine

transfer


ART v1.5)




ART v1.5)


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.074









Carcinogenicity:






specific activity.





controlled.






9.6.19. Worker contributing scenario 18: Handling of mixed coloured granules and

articles (PROC 21)


Packaging, transfer between containers, storage and any other manipulation with finished granules and articles

containing pigment in a matrix.

Method




REACH Tool v1.5)



REACH Tool v1.5)




100 mg/kg)


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)










REACH Tool v1.5)



Method


personal cloud).)




REACH Tool v1.5)




TRA Worker v3






REACH Tool v1.5)




REACH Tool v1.5)





REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.074










Carcinogenicity:




specific activity.





controlled.






9.6.20. Worker contributing scenario 19: Transfer of articles and single coloured

granules (PROC 8a)


Method


• Concentration of substance in mixture: >25% TRA Workers v3

• Solid in solid mixtures: Yes TRA Workers v3


ART v1.5)


ART v1.5)


ART v1.5)




100 mg/kg)


ART v1.5)


• Duration of activity: < 8 hours TRA Workers v3


ART v1.5)



Method


• Containment: No TRA Workers v3

• Occupational Health and Safety Management System: Advanced TRA Workers v3







personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)




TRA Workers v3




ART v1.5)


• Skin surface potentially exposed: Two hands (960 cm2) TRA Workers v3










ART v1.5)




ART v1.5)


0.5 m


ART v1.5)






ART v1.5)




ART v1.5)




Method

ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.129









Carcinogenicity:




specific activity.





controlled.








9.6.21. Worker contributing scenario 20: Transfer of articles and single coloured

granules (PROC 8b)


Method





REACH Tool v1.5)


REACH Tool v1.5)




100 mg/kg)


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)









REACH Tool v1.5)



Method











REACH Tool v1.5)




TRA Worker v3












REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)






REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects




0.002 mg/m³ (External Tool (Advanced

REACH Tool v1.5))



(see below)





effects






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.224





mg/m³. The predicted 90th percentile long-term exposure is 0.0023 mg/m³.



Carcinogenicity:




specific activity.





controlled.






9.6.22. Worker contributing scenario 21: Transfer of mixed coloured granules and

articles (PROC 8a)


Method




Method



ART v1.5)



ART v1.5)


ART v1.5)




100 mg/kg)


ART v1.5)




ART v1.5)










personal cloud).)


ART v1.5)




ART v1.5)




TRA Worker v3




ART v1.5)












ART v1.5)




ART v1.5)



Method


0.5 m


ART v1.5)






ART v1.5)




ART v1.5)


ART v1.5)





effects





ART v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.224











Carcinogenicity:




specific activity.





controlled.






9.6.23. Worker contributing scenario 22: Transfer of mixed coloured granules and

articles (PROC 8b)


Method




REACH Tool v1.5)



REACH Tool v1.5)


REACH Tool v1.5)




100 mg/kg)


REACH Tool v1.5)




REACH Tool v1.5)










REACH Tool v1.5)



Method


personal cloud).)




REACH Tool v1.5)










REACH Tool v1.5)




TRA Worker v3












REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)






REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects





ART v1.5))





effects



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.224








Carcinogenicity:




specific activity.





controlled.






9.6.24. Worker contributing scenario 23: Pigment powder dosing before mixing (PROC

8b)




Method



ART v1.5)


ART v1.5)


ART v1.5)




ART v1.5)











personal cloud).)


ART v1.5)




ART v1.5)





workplace.)



ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)




ART v1.5)


0.5 m


ART v1.5)

• Falling of Powders, Granules or Pelletised Material - level of containment of the External Tool (Extended



Method




opening )

ART v1.5)






ART v1.5)


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.224







hours/week).





Carcinogenicity:




specific activity.





controlled.






9.6.25. Worker contributing scenario 24: Mixing of pigment powder with other solid

additives (PROC 3)


Relevant for mixing of small bags of pigment with polymers for hotmelt (road marking)

Method



ART v1.5)


ART v1.5)




ART v1.5)


ART v1.5)











personal cloud).)


ART v1.5)




ART v1.5)

• Containment - no extraction: High level containment (Physical containment or



substance is contained within a sealed and enclosed system. This class includes

metal smelting furnaces or atomisation units. The material transfer is entirely

enclosed with high containment valves (e.g. split butterfly valves and direct

couplings, which consist of two sections which connect together to allow the


ART v1.5)



Method

opening of the valve). At the end of the material transfer the two halves are

separated, forming a seal on both the process equipment and the material container.

The system is designed to minimise the surface area which can contact the material

or pairs of valves with wash space between them.) [Effectiveness Inhal: 99.9%]





workplace.)



ART v1.5)







ART v1.5)



TRA Worker v3



ART v1.5)

• Movement and Agitation of Powders, Granules or Pelletised Material - Activity:

Movement and agitation of 100 - 1000 kg (Examples: Cleaning large heaps of dust

or debris (after demolition) Sieving, mixing or blending in vessels)


ART v1.5)

• Movement and Agitation of Powders, Granules or Pelletised Material - Level of

agitation: Other handling with high level of agitation (Examples: Sweeping of

floors Sieving Mechanical mixing)


ART v1.5)


containment: Open process


ART v1.5)






effects







(see below)






(see below)




damage)





effects







(see below)





long-term)

RCR = 0.074




ART calculation (far field exposure only): The inter-quartile confidence interval is 0.0038 mg/m³ to 0.016





Carcinogenicity:




specific activity.





controlled.






9.6.26. Worker contributing scenario 25: Filling of small packages with pigment powder

(PROC 9)

9.6.26.1. Conditions of use Filling of smaller packagings (bags, boxes, containers) with pigment powder at a dedicated filling line using an

Method



ART v1.5)


ART v1.5)




ART v1.5)


ART v1.5)



Method











personal cloud).)


ART v1.5)




ART v1.5)





workplace.)



ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)




ART v1.5)


0.5 m


ART v1.5)





opening )


ART v1.5)






ART v1.5)


ART v1.5)








effects







(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.052









Carcinogenicity:




specific activity.





controlled.








9.6.27. Worker contributing scenario 26: Manual handling of pigment contained in

small sealed plastic bags (<1 kg) (PROC 1)


Method



REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)




REACH Tool v1.5)











personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)

• Containment: Closed system (minimal contact during routine operations) TRA Worker v3





TRA Worker v3





REACH Tool v1.5)




REACH Tool v1.5)





REACH Tool v1.5)


REACH Tool v1.5)








effects





REACH Tool v1.5))

Exposure/DMEL = 0.5


(see below)




0.002 mg/kg bw/day (TRA Worker v3) Exposure/DMEL = 3.4E-4


(see below)




damage)







(see below)





long-term)

RCR = 0.282





90th percentile full-shift exposure is 0.0029 mg/m³.



Carcinogenicity:




specific activity.





controlled.






9.6.28. Worker contributing scenario 27: Pigment powder manual cleaning, wiping,



scraping etc. (PROC 19)


Method



ART v1.5)




ART v1.5)


ART v1.5)


ART v1.5)


TRA Workers v3)



TRA Workers v3)








personal cloud).)


ART v1.5)




ART v1.5)


TRA Workers v3)


TRA Workers v3)





ART v1.5)




TRA Workers v3)



ART v1.5)

• Movement and Agitation of Powders, Granules or Pelletised Material - Activity:

Movement and agitation of 0.1 - 1 kg (Examples: Using brush and dustpan to clean

up small spills Manual sieving, mixing or blending)


ART v1.5)


agitation: Handling with low level of agitation (Examples: Manual mixing)


ART v1.5)


containment: Handling that reduces contact between product and adjacent air

(Note: This does not include processes that are fully contained by localised

controls. Example situation: Contained sieving of big bags with only small

opening)


ART v1.5)




Method

TRA Workers v3)





effects





ART v1.5))



(see below)








(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.740






respiratory protection with APF 100 (99% effectiveness) and a factor 5 for the duration of use (8

hours/week).




hours/week).



Carcinogenicity:




specific activity.







controlled.








9.7. Exposure scenario 7: Use at industrial site - Use of colour premixes

and pre-compounds to colour plastic or plasticised articles for non-

consumer use. Pigment choice depends on product specifications on

visibility, colour, heat stability, chemical fastness, durability and

Regulations


Industrial use of solid or liquid coloured premix containing C.I. Pigment Yellow 34 and C.I. Pigment Red 104

with other plastic compounds during the conversion into plastic or plasticised articles for non-consumer use.

Several processing techniques can be used including extrusion, moulding, calendering, spread or dip coating.

Examples of articles are technical specialty parts, canvas for truck trailer covers, safety covers on agricultural

equipment, safety signage, safety helmets, medical waste containers, etc. The high quality of the pigments is

crucial for the long-term integrity of the material and the functioning of the article.

The choice for a premix containing these pigments is based on end product specifications and requirements

related to: VISIBILITY AND SAFETY - Based on their bright, vivid, durable colours, these pigments are often

used when visibility and safety play an important role, in particular in regulated applications; DURABILITY -

The pigments respond to the demand for high performance pigments, e.g. in aggressive atmospheric conditions

in industrialized areas, providing excellent light and weather fastness, preventing applications to darken or fade

if exposed to light and humidity; excellent resistance to sulfur dioxide, preventing discolouration (greyness) as










Use of colour premixes and pre-compounds to colour plastic or plasticized articles for

non-consumer use

ERC 5


Delivery, storage and handling of coloured plastic granules PROC 3

Delivery, storage and handling of packed plastic premix or pre-compound PROC 3

Transfer of articles and single coloured granules PROC 8a

Transfer of articles and single coloured granules PROC 8b

Transfer of mixed coloured granules and articles PROC 8a

Transfer of mixed coloured granules and articles PROC 8b

Charging/discharging of coloured plastic granules PROC 9

Mixing coloured plastic granules in closed mixing vessel PROC 3

Production of plastic articles by extrusion and injection moulding or other processes PROC 14

Charging/discharging of coloured plastic premix or pre-compound PROC 8a

Charging/discharging of coloured plastic premix or pre-compound PROC 9

Roll application and heat curing of coloured plastic paste PROC 6

Handling and manipulation of pigment plastic articles and plastic coated textiles PROC 21




ES9: Service life (worker at industrial site) - Service life of coloured plastic or plasticised articles. Performance

and longevity depend on pigment quality, for bright lasting colours improving visibility and safety, heat

stability, durability, other technical specifications and Regulations.

ES10: Service life (professional worker) - Service life of coloured plastic or plasticised articles. Performance




Colour premixes or pre-compounds are used to colour plastic or plasticised articles for non-consumer use in an

industrial, controlled environment. There are numerous compounding and conversion techniques depending on

the matrix and the required characteristics of the final product, including extrusion, moulding, calendering,

spread or dip coating. Examples are technical specialty parts, canvas for truck trailer covers, safety signage and

road blocks, safety covers on agricultural equipment, safety helmets, medical waste containers. The high quality

of the pigments is crucial for the long-term integrity of the plastic material and/or the functioning of the product.

9.7.1. Environmental contributing scenario 1: Use of colour premixes and pre-

compounds to colour plastic or plasticized articles for non-consumer use





• Correction for water solubility of Pb in plastic (0.1%): Correction applicable (Transformation/dissolution tests

were carried out with plastics containing the pigment. These tests show <0.1% dissolution. Based on the results

of these tests, 0.1% dissolution is applied as a worst-case.) [Effectiveness Water: 99.9%]



Assumed worst-case daily use of pigment per site (corresponding to 10 tonnes/day plastic, based on worst-case

5% pigment concentration in plastic)


Assumed worst-case yearly use of pigment per site (corresponding to 2000 tonnes/year plastic, based on worst-

case 5% pigment concentration in plastic)



Based on SpERC Eurometaux 2.5-6a.v2.1 the number of emission days for industrial use of metal compounds

in the plastics and rubber industry sector is 216. This number was derived from a multi-metal background

database of measured site-specific release factors collected under the former Directive of New and Existing

Substances and REACH 2010 registration dossiers. For the current assessment a worst-case of 200 days/year

is assumed.






RMM





• Wet scrubbers















9.7.1.2. Releases




method







Explanation / Justification: During the industrial use of colour

premixes or pre-compounds containing C.I. Pigment Yellow 34

and C.I. Pigment Red 104 to colour plastic or plasticised articles

no water is used. If any waste water is generated, this is treated as

hazardous waste.

Air Release factor



Final release factor: 6E-4%


Explanation / Justification: Release fraction from Eurometaux

2.5-6a.v2.1 - Industrial use of metal compounds in plastics and

rubber industry sector. Derived from a multi-metal background

database of measured site-specific release factors collected from

peer-reviewed EU Risk Assessment Reports under the former

Directive of New and Existing Substances and REACH 2010

registration dossiers. The specific release factor fort his SpERC is

the 90th percentile of reported site-specific release factors to air

for 28 sites. This release fraction is considered worst-case, as the

release to air is 0% according to Emission Scenario Document on

Plastic Additives, OECD, July 2009


te=env/jm/mono(2004)8/rev1&doclanguage=en].

Soil Release factor Final release factor: 0%




method


(Site-specific information) Explanation / Justification: No release to soil takes place during

formulation of premixes and pre-compounds. This is supported by

SpERC Eurometaux 2.5-6a.v2.1 and Emission Scenario

Document on Plastic Additives, OECD, July 2009


te=env/jm/mono(2004)8/rev1&doclanguage=en], which does not

consider any release to soil.

Releases to waste


In accordance with SpERC Eurometaux 2.5-6a.v2.1. The 90th percentile of reported site-specific release factors

to solid waste for 32 downstream user sites covering zinc, nickel, lead, antimony.















9.7.2. Worker contributing scenario 1: Delivery, storage and handling of coloured

plastic granules (PROC 3)


Method



ART v1.5)




100 mg/kg)


ART v1.5)


ART v1.5)



Method


ART v1.5)





ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)






TRA Worker v3





ART v1.5)




ART v1.5)





ART v1.5)


ART v1.5)






effects





ART v1.5))






effects


(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.018







Carcinogenicity:

Performing this specific activity for an entire working career leads to excess lung cancer mortality of 2.92E-07

, which is lower than the indicative tolerable risk level for workers as mentioned in the REACH Guidance on


specific activity.





controlled.






9.7.3. Worker contributing scenario 2: Delivery, storage and handling of packed plastic





Method



matrix


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)





REACH Tool v1.5)

TRA Worker v3








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)

• Containment - no extraction: High level containment (Physical containment or



substance is contained within a sealed and enclosed system. This class includes

metal smelting furnaces or atomisation units. The material transfer is entirely

enclosed with high containment valves (e.g. split butterfly valves and direct

couplings, which consist of two sections which connect together to allow the

opening of the valve). At the end of the material transfer the two halves are

separated, forming a seal on both the process equipment and the material container.

The system is designed to minimise the surface area which can contact the material

or pairs of valves with wash space between them.) [Effectiveness Inhal: 99.9%]


REACH Tool v1.5)






TRA Worker v3



REACH Tool v1.5)




REACH Tool v1.5)



Method



in vessel).)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.001








Carcinogenicity:




specific activity.







controlled.






9.7.4. Worker contributing scenario 3: Transfer of articles and single coloured granules

(PROC 8a)


Transfer of ground pigment concentrate granules from one vessel or container to another (vessels, drums, bags,

machines) in a non-dedicated facility with general protection measures.

Method



ART v1.5)


ART v1.5)


ART v1.5)




100 mg/kg)


ART v1.5)





ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)




Method








ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)




ART v1.5)


0.5 m


ART v1.5)






ART v1.5)




ART v1.5)


ART v1.5)






effects





ART v1.5))






effects


(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.129









Carcinogenicity:




specific activity.





controlled.






9.7.5. Worker contributing scenario 4: Transfer of articles and single coloured granules

(PROC 8b)




Transfer of ground pigment concentrate granules from one vessel or container to another (vessels, drums, bags,

machines) in a dedicated facility with general protection measures.

Method



REACH Tool v1.5)


REACH Tool v1.5)




100 mg/kg)


REACH Tool v1.5)


REACH Tool v1.5)






REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)










REACH Tool v1.5)










REACH Tool v1.5)




Method





TRA Worker v3











REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)






REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)








effects


damage)




REACH Tool v1.5))



(see below)





long-term)

RCR = 0.224








Carcinogenicity:




specific activity.





controlled.






9.7.6. Worker contributing scenario 5: Transfer of mixed coloured granules and articles

(PROC 8a)


Transfer of plastic granules or articles containing pigment from one vessel or container to another (vessels,

drums, bags, machines) in a non-dedicated facility with general protection measures.

Method



ART v1.5)


ART v1.5)



Method




100 mg/kg)


ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)







ART v1.5)



TRA Worker v3











ART v1.5)




ART v1.5)


0.5 m


ART v1.5)





ART v1.5)



Method





ART v1.5)


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.224









Carcinogenicity:






specific activity.





controlled.






9.7.7. Worker contributing scenario 6: Transfer of mixed coloured granules and articles

(PROC 8b)


Transfer of plastic granules or articles containing pigment from one vessel or container to another (vessels,

drums, bags, machines) in a dedicated facility with general protection measures.

Method




REACH Tool v1.5)



REACH Tool v1.5)


REACH Tool v1.5)




100 mg/kg)


REACH Tool v1.5)




REACH Tool v1.5)










personal cloud).)


REACH Tool v1.5)



Method




REACH Tool v1.5)










REACH Tool v1.5)




TRA Worker v3












REACH Tool v1.5)




REACH Tool v1.5)


0.5 m


REACH Tool v1.5)






REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)





effects





REACH Tool v1.5))



(see below)




effects







(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.224








Carcinogenicity:




specific activity.





controlled.






9.7.8. Worker contributing scenario 7: Charging/discharging of coloured plastic

granules (PROC 9)


Transfer of ground pigment concentrate granules or resin/plastic granules containing pigment from one vessel or

container to another (vessels, drums, bags, machines) in a dedicated facility with general protection measures.



Method



ART v1.5)


ART v1.5)


ART v1.5)




100 mg/kg)


ART v1.5)






ART v1.5)








personal cloud).)


ART v1.5)




ART v1.5)





workplace.)



ART v1.5)







ART v1.5)



TRA Worker v3






ART v1.5)



Method









ART v1.5)


0.5 m


ART v1.5)





opening )


ART v1.5)






ART v1.5)


ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)







(see below)





long-term)

RCR = 0.052











Carcinogenicity:




specific activity.





controlled.






9.7.9. Worker contributing scenario 8: Mixing coloured plastic granules in closed



Method



matrix


REACH Tool v1.5)


REACH Tool v1.5)


REACH Tool v1.5)

TRA Worker v3





REACH Tool v1.5)





REACH Tool v1.5)



Method





personal cloud).)




REACH Tool v1.5)










REACH Tool v1.5)






TRA Worker v3



REACH Tool v1.5)






REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




effects





damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.146








Carcinogenicity:




specific activity.





controlled.






9.7.10. Worker contributing scenario 9: Production of plastic articles by extrusion and

injection moulding or other processes (PROC 14)


Pre-mix/pre-compound is mixed with other pre-mixes/pre-compounds, polymer and other additives to produce

plastic articles

Method





Method

matrix ART v1.5)


ART v1.5)


ART v1.5)

TRA Worker v3




ART v1.5)

TRA Worker v3








personal cloud).)


ART v1.5)




ART v1.5)










ART v1.5)









ART v1.5)







ART v1.5)



TRA Worker v3


• Activity Class: Spreading of liquid products (Activities where a liquid product is External Tool (Extended



Method

directly spread on surfaces using e.g. a roller, brush or wipe.) ART v1.5)




ART v1.5)


ART v1.5)

• Process Temperature: Hot processed (50 - 150°C) External Tool (Extended

ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.010









Carcinogenicity:






specific activity.





controlled.







premix or pre-compound (PROC 8a)


Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)






ART v1.5)







ART v1.5)




ART v1.5)








ART v1.5)



Method









ART v1.5)



TRA Worker v3



ART v1.5)






ART v1.5)



pump)


ART v1.5)


ART v1.5)




ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)


Inhalation, systemic, long-term 0.002 mg/m³ (External Tool (Extended Exposure/DMEL = 0.811




effects


(carcinogenicity, lung) ART v1.5)) Qualitative risk characterisation

(see below)





long-term)

RCR = 0.234









Carcinogenicity:




specific activity.





controlled.









Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)




Method





ART v1.5)







ART v1.5)




ART v1.5)





workplace.)


ART v1.5)








ART v1.5)







ART v1.5)



TRA Worker v3



ART v1.5)






ART v1.5)




ART v1.5)





vehicles) )


ART v1.5)

• Transfer Loading Type: Splash loading, where the liquid dispenser remains at the External Tool (Extended



Method

top of the reservoir and the liquid splashes freely ART v1.5)






effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.007









Carcinogenicity:




specific activity.







controlled.






9.7.13. Worker contributing scenario 12: Roll application and heat curing of coloured

plastic paste (PROC 6)


Rolling coloured plastic onto a surface such as textiles and subsequent curing. Industrial installation with

measures in place.

Method




Not contaminated with powder


REACH Tool v1.5)





REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)






TRA Worker v3





REACH Tool v1.5)




REACH Tool v1.5)

• Handling of Contaminated Solid Objects or Paste: Careful handling, involves External Tool (Advanced



Method



REACH Tool v1.5)


REACH Tool v1.5)






effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0





percentile full-shift exposure is 0 mg/m³.



Carcinogenicity:




activity.







controlled.






9.7.14. Worker contributing scenario 13: Handling and manipulation of pigment plastic

articles and plastic coated textiles (PROC 21)


Method





REACH Tool v1.5)






REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)






TRA Worker v3





REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)



Method



REACH Tool v1.5)






effects





REACH Tool v1.5))



(see below)






(see below)




damage)





REACH Tool v1.5))



(see below)





long-term)

RCR = 0.074








Carcinogenicity:




specific activity.







controlled.








9.8. Exposure scenario 8: Use by professional worker - Use of colour

premixes and pre-compounds in the application of hotmelt road

marking. Pigment choice depends on end product specifications on

visibility & night time reflectivity, colour, heat stability, durability,

chemical fastness and Regulations


Professional use of solid or liquid coloured premix containing C.I. Pigment Yellow 34 and C.I. Pigment Red

104 for the colouration of hotmelt road marking. Alternatively, sealed plastic sachets containing the pigment can

be added directly during the hotmelt conversion process. The high quality of the pigments is crucial for the long-

term integrity of the plastic material and the functioning of the road marking.

The choice for a premix containing these pigments is governed by end product specifications and requirements

and in particular also by national Regulations in various countries related to: VISIBILITY AND SAFETY -

Based on their bright, vivid, durable colours, these pigments are often used when visibility and safety play an

important role, in particular in regulated applications such as hot melt road marking; DURABILITY-The

pigments respond to the demand for high performance pigments, e.g. in aggressive atmospheric conditions in

industrialized areas, providing excellent light and weather fastness, preventing applications to darken or fade if

exposed to light and humidity; excellent resistance to sulfur dioxide, preventing discolouration (greyness) as










Use of colour premixes and pre-compounds in the application of hotmelt road marking ERC 8f, ERC 8c


Charging/discharging premix or pre-compound PROC 8a

Storage and mixing of plastic compounds in an open vessel before application PROC 5

Application of hotmelt road marking (plastic compound) to road pavement PROC 10

Handling and manipulation of coloured road marking PROC 21

High energy manipulation/removal of coloured road marking using abrasive techniques

like grinding, drilling or sanding

PROC 24


ES9: Service life (worker at industrial site) - Service life of coloured plastic or plasticised articles. Performance



ES10: Service life (professional worker) - Service life of coloured plastic or plasticised articles. Performance




Coloured premixes or pre-compounds containing the pigments, or alternatively, sealed sachets containing the

pigment, are used and applied in a professional setting, at elevated temperatures, such as hotmelt road markings.



The high quality of the pigments is crucial for the long-term integrity and visibility of the road markings and in

the interest of public safety.

Big bags of coloured premixes or pre-compounds containing pigment used for hotmelt road markings are

transported to road works and melted in open preheaters. The hot thermoplastic is applied to the road surfaces

by manual application, by mechanical extrusion, or by mechanical spray application from a closed pressurised

tank.

During road marking activities there will be no significant exposure of professional workers because the

pigment is packed in small closed bags and in the hotmelt itself, the pigment is embedded in a matrix.

Moreover, due to the high temperature any contact will be avoided.

9.8.1. Environmental contributing scenario 1: Use of colour premixes and pre-

compounds in the application of hotmelt road marking





















9.8.1.2. Releases




method



(Specific information)


Final release factor: 6E-6%


Explanation / Justification: Hot-melt hardens immediately when

applied as road marking. As a worst-case assumption 0.01%

release to water is used.

Air Release factor Initial release factor: 0.01%




method


(Specific information) Final release factor: 0.006%


applied as road marking. As a worst-case assumption 0.01%

release to air is used.

Soil Release factor




applied as road marking, therefore no release to soil can take

place.






Sediment (freshwater) Local PEC: 6.06E-6 mg/kg dw RCR < 0.01


Sediment (marine water) Local PEC: 6.06E-7 mg/kg dw RCR < 0.01







9.8.2. Worker contributing scenario 1: Charging/discharging premix or pre-compound

(PROC 8a)


Method



matrix


ART v1.5)


ART v1.5)


ART v1.5)








Method

ART v1.5)







ART v1.5)




ART v1.5)










ART v1.5)







ART v1.5)



TRA Worker v3



ART v1.5)






ART v1.5)



pump)


ART v1.5)


ART v1.5)




ART v1.5)





oute of exposure and type of

effects




oute of exposure and type of

effects





ART v1.5))



(see below)






(see below)




damage)





ART v1.5))



(see below)





long-term)

RCR = 0.234









Carcinogenicity:




specific activity.





controlled.






9.8.3. Worker contributing scenario 2: Storage and mixing of plastic compounds in an



open vessel before application (PROC 5)


Method





REACH Tool v1.5)






REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)






TRA Worker v3





REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)








effects





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.





controlled.






9.8.4. Worker contributing scenario 3: Application of hotmelt road marking (plastic

compound) to road pavement (PROC 10)




Method





REACH Tool v1.5)






REACH Tool v1.5)








personal cloud).)


REACH Tool v1.5)




REACH Tool v1.5)






TRA Worker v3





REACH Tool v1.5)




REACH Tool v1.5)




REACH Tool v1.5)


REACH Tool v1.5)






effects


Inhalation, systemic, long-term 0 mg/m³ (External Tool (Advanced Exposure/DMEL = 0




effects


(neurodevelopmental damage) REACH Tool v1.5)) Qualitative risk characterisation

(see below)






(see below)




damage)





REACH Tool v1.5))

Exposure/DMEL = 0


(see below)





RCR = 0








Carcinogenicity:




activity.





controlled.






9.8.5. Worker contributing scenario 4: Handling and manipulation of coloured road

marking (PROC 21)




Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3


• Implemented RMMs: No RMMs [Effectiveness Inhal: 0%] External Tool (Extended

MEASE 1.02.01)







MEASE 1.02.01)



TRA Worker v3



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)






effects





MEASE 1.02.01))



(see below)








effects



(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.097




The result of the MEASE calculation was corrected by applying respiratory protection with APF 10 (90%

effectiveness).



Carcinogenicity:




specific activity.





controlled.






9.8.6. Worker contributing scenario 5: High energy manipulation/removal of coloured

road marking using abrasive techniques like grinding, drilling or sanding (PROC 24)


Method





Method

MEASE 1.02.01)


TRA Workers v3)


TRA Workers v3)



TRA Workers v3)


MEASE 1.02.01)



MEASE 1.02.01)







MEASE 1.02.01)




TRA Workers v3)



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


TRA Workers v3)





effects





MEASE 1.02.01))



(see below)











effects


(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.390





(99% effectiveness) and a factor 1.66 for the duration of use (24 hours/week).







Carcinogenicity:




specific activity.





controlled.








9.9. Exposure scenario 9: Service life (worker at industrial site) - Service

life of coloured plastic or plasticised articles. Performance and longevity

depend on pigment quality, for bright lasting colours improving

visibility and safety, heat stability, durability, other technical

specifications and Regulations




Article categories: AC 13, Plastic articles


Industrial service life of coloured plastic or plasticised articles, including hotmelt road

marking

ERC 12a


Handling and manipulation of pigment plastic articles, plastic coated textiles and

coloured road marking

PROC 21

High energy manipulation of pigment plastic articles, plastic coated textiles and coloured

road marking using abrasive techniques like mechanical cutting, grinding, drilling or

sanding

PROC 24


ES7: Use at industrial site - Use of colour premixes and pre-compounds to colour plastic or plasticised articles

for non-consumer use. Pigment choice depends on product specifications on visibility, colour, heat stability,


ES8: Use by professional worker - Use of colour premixes and pre-compounds in the application of hotmelt

road marking. Pigment choice depends on end product specifications on visibility & night time reflectivity,

colour, heat stability, durability, chemical fastness and Regulations.


C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are applied in plastics or plasticised articles to provide

specified technical properties and meet requirements related to brightness, colour and colour shade, hiding

power, colour stability, heat stability, light and weather fastness (durability) and night time reflectivity.

The presence of these pigments contributes to the industrial and/or public safety due to their superior brightness

and opacity. Their high opacity causes them to have superior night time reflectivity which can be critical in road

marking colour matrices.

Examples of pigmented matrices include technical specialty parts, canvas for truck trailer covers, tennis courts,

road blocks, crash barriers, road markings and signals, safety covers on agricultural equipment, safety helmets,

medical waste containers, etc, that all have specific requirements related to the superior technical performance

characteristics of C.I. Pigment Yellow 34 or C.I. Pigment Red 104 such as high heat stability, high light and

weather fastness, superior hiding and opacity and superior brightness/cleanliness of colour and shade and night

time reflectivity.

Plastic or plasticised articles and hotmelt road marking are coloured to ensure a long service life of the non-

consumer articles. Significant direct contact with consumers or workers will not take place and there is no

release to the environment. Only in case of occasional maintenance or repair, professional workers may carry

out activities that may lead to exposure due to cutting, drilling or scraping operations.

After their service life, the plastic objects are to be collected for recycling or thermal destruction. Due to the

very high temperatures during incineration (800-1000ºC) the metals from the pigments will oxidise and the

chromium oxides are expected to end up in the slags that find application in various other industrial processes,

whereas the lead oxides are expected to be filtered from the fly ash. Plastic road marks may wear down in time



and particles may be washed down to the gutters along with other traffic emissions; or they may be scraped off

during road reconstruction works and properly disposed of or recycled; or they are collected along with the

asphalt concrete road material which is usually recycled.

9.9.1. Environmental contributing scenario 1: Industrial service life of coloured plastic

or plasticised articles, including hotmelt road marking










Assumed maximum daily tonnage per site for industrial processing of plastic and plasticised article, based on

ERC default of 20 emission days per year


Assumed maximum yearly tonnage per site for industrial processing of plastic and plasticised article



Default considering tonnage and ERC











9.9.1.2. Releases




method


Water ERC based Initial release factor: 2.5%



Air ERC based Initial release factor: 2.5%






method


Soil ERC based Final release factor: 2.5%





Freshwater Local PEC: 2.8E-5 mg/L RCR = 0.013

Sediment (freshwater) Local PEC: 8.263 mg/kg dw RCR = 0.047

Marine water Local PEC: 2.8E-6 mg/L RCR = 0.01

Sediment (marine water) Local PEC: 0.826 mg/kg dw RCR = 0.047

Sewage treatment plant Local PEC: 0.002 mg/L RCR = 0.015







articles, plastic coated textiles and coloured road marking (PROC 21)


Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3



MEASE 1.02.01)







MEASE 1.02.01)

• Dermal Protection: Yes (chemically resistant gloves conforming to EN374 with TRA Worker v3



Method




MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)






effects





MEASE 1.02.01))



(see below)






(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.097





effectiveness).





Carcinogenicity:




specific activity.





controlled.






9.9.3. Worker contributing scenario 2: High energy manipulation of pigment plastic

articles, plastic coated textiles and coloured road marking using abrasive techniques

like mechanical cutting, grinding, drilling or sanding (PROC 24)


Method



MEASE 1.02.01)


TRA Workers v3)


TRA Workers v3)



MEASE 1.02.01)


TRA Workers v3)





MEASE 1.02.01)


TRA Workers v3)


TRA Workers v3)





MEASE 1.02.01)




TRA Workers v3)



Method



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


TRA Workers v3)





effects





MEASE 1.02.01))



(see below)








(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.623





effectiveness) and a factor 2.5 for the duration of use (16 hours/week).





The result of the ECETOC TRA calculation was corrected by applying a factor 2.5 for the duration of use

(16 hours/week).



Carcinogenicity:




specific activity.





controlled.








9.10. Exposure scenario 10: Service life (professional worker) - Service

life of coloured plastic or plasticised articles. Performance and longevity

depend on pigment quality, for bright lasting colours improving

visibility and safety, heat stability, durability, other technical

specifications and Regulations




Article categories: AC 13, Plastic articles


Service life of coloured plastic and plasticised articles, including hotmelt road marking

(leaching)

ERC 10b, ERC 10a,

ERC 11a, ERC 11b

Removal of hotmelt road marking ERC 10b, ERC 10a,

ERC 11a, ERC 11b


Handling and manipulation of pigment plastic articles, plastic coated textiles and

coloured road marking

PROC 21

High energy manipulation of pigment plastic articles, plastic coated textiles and coloured

road marking using abrasive techniques like mechanical cutting, grinding, drilling or

sanding

PROC 24


ES7: Use at industrial site - Use of colour premixes and pre-compounds to colour plastic or plasticised articles

for non-consumer use. Pigment choice depends on product specifications on visibility, colour, heat stability,


ES8: Use by professional worker - Use of colour premixes and pre-compounds in the application of hotmelt

road marking. Pigment choice depends on end product specifications on visibility & night time reflectivity,

colour, heat stability, durability, chemical fastness and Regulations.


C.I. Pigment Yellow 34 and C.I. Pigment Red 104 are applied in plastics or plasticised articles to provide

specified technical properties and meet requirements related to brightness, colour and colour shade, hiding

power, colour stability, heat stability, light and weather fastness (durability) and night time reflectivity.

The presence of these pigments contributes to the industrial and/or public safety due to their superior brightness

and opacity. Their high opacity causes them to have superior night time reflectivity which can be critical in road

marking colour matrices.

Examples of pigmented matrices include technical specialty parts, canvas for truck trailer covers, tennis courts,

road blocks, crash barriers, road markings and signals, safety covers on agricultural equipment, safety helmets,

medical waste containers, etc, that all have specific requirements related to the superior technical performance

characteristics of C.I. Pigment Yellow 34 or C.I. Pigment Red 104 such as high heat stability, high light and

weather fastness, superior hiding and opacity and superior brightness/cleanliness of colour and shade and night

time reflectivity.

Plastic or plasticised articles and hotmelt road marking are coloured to ensure a long service life of the non-

consumer articles. Significant direct contact with consumers or workers will not take place and there is no

release to the environment. Only in case of occasional maintenance or repair, professional workers may carry

out activities that may lead to exposure due to cutting, drilling or scraping operations.

After their service life, the plastic objects are to be collected for recycling or thermal destruction. Due to the



very high temperatures during incineration (800-1000ºC) the metals from the pigments will oxidise and the

chromium oxides are expected to end up in the slags that find application in various other industrial processes,

whereas the lead oxides are expected to be filtered from the fly ash. Plastic road marks may wear down in time

and particles may be washed down to the gutters along with other traffic emissions; or they may be scraped off

during road reconstruction works and properly disposed of or recycled; or they are collected along with the

asphalt concrete road material which is usually recycled.

9.10.1. Environmental contributing scenario 1: Service life of coloured plastic and

plasticised articles, including hotmelt road marking (leaching)


















9.10.1.2. Releases




method



(Test data)





were carried out with plastics containing the pigment. These tests

show <0.1% dissolution. Based on the results of these tests, 0.1%


worst-case.

Air Release factor




Explanation / Justification: Based on the low volatility of the

substance, no leaching to air is expected.

Soil Release factor Final release factor: 0.1%




method


(Test data) Explanation / Justification: Transformation/dissolution tests

were carried out with plastics containing the pigment. These tests

show <0.1% dissolution. Based on the results of these tests, 0.1%


worst-case.

Releases to waste

















9.10.2. Environmental contributing scenario 2: Removal of hotmelt road marking










Based on a volume of 500 tonnes/year, the total volume of pigment used in hotmelt road marking



• Integrated LEV: Integrated LEV professional (During the process, equipment with integrated local exhaust














9.10.2.2. Releases




method








Releases to waste

Release factor to waste from on site treatment: 80%

Integrated LEV is used when removing hot-melt. The efficiency of this LEV is very conservatively assumed to

be 80%.


















articles, plastic coated textiles and coloured road marking (PROC 21)


Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3


• Implemented RMMs (professional setting): No RMMs [Effectiveness Inhal: 0%] External Tool (Extended

MEASE 1.02.01)







MEASE 1.02.01)



TRA Worker v3



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)






effects





MEASE 1.02.01))





effects



(see below)






(see below)




damage)





MEASE 1.02.01))



(see below)





long-term)

RCR = 0.097





effectiveness).



Carcinogenicity:




specific activity.





controlled.






9.10.4. Worker contributing scenario 2: High energy manipulation of pigment plastic

articles, plastic coated textiles and coloured road marking using abrasive techniques

like mechanical cutting, grinding, drilling or sanding (PROC 24)




Method



MEASE 1.02.01)

TRA Worker v3




MEASE 1.02.01)

TRA Worker v3





MEASE 1.02.01)







MEASE 1.02.01)



TRA Worker v3



MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)


MEASE 1.02.01)






effects





MEASE 1.02.01))



(see below)






effects


(neurodevelopmental damage) Qualitative risk characterisation

(see below)




damage)

Ʃ(Exposure/DMEL) = 0. 356




MEASE 1.02.01))



(see below)





long-term)

RCR = 0.195





effectiveness).



Carcinogenicity:




specific activity.





controlled.






C.I. Pigment Yellow 34 lead sulfo chromate


10. RISK CHARACTERISATION RELATED TO

COMBINED EXPOSURE

10.1. Human health

10.1.1. Workers

For both the carcinogenicity (lung cancer) and developmental effects, the effects of the pigment are linked to

long term average exposure and no acute effects are foreseen. Therefore the duration of use may be recalculated

from hours per week (as mentioned in this CSR) to hours per e.g. day or month, depending on the actual

situation at the workplace.

Regarding the hazard related to the potential oral intake of the non-respirable inhalable fraction, the absence of

risk is related to a maximum dose per day. To ensure flexibility in combining contributing scenarios for

workers, the duration per day was not used in calculating the (a.o. oral) RCR. Only for the worker contributing

scenario 5 “Pigment paint spray application in a make-shift booth on location” in theprofessional use stage for

paints duration per day was used specifically for the oral exposure assessment, as this was required with regard

to the risk (RCR was above 1). For this contributing scenario the duration per day cannot be adapted without the

implementation of additional risk management measures.

Most of the worker contributing scenarios have been assessed with duration of an entire working week (40

hours/week) and are therefore considered to be safe in any combination (up to 40 hours/week). For the

contributing scenarios where time reduction was applied it must be carefully assessed if a combination of

contributing scenarios is still safe by addition of the EDRs (Exposure/DMEL Ratios) provided for the respective

scenarios for both the carcinogenicity (lung cancer, EDR inhalation) effect and the neurodevelopmental effects

(EDR inhalation + EDR dermal). The combined EDR for lung cancermust be below 1 at all times in order for

the worker risk to be below 4*10-5

. The combined EDR for neurodevelopmental effects (inhalation+dermal)

must be below 1 for all female workers of childbearing age. The combined DNEL-oral must be below 1 in order

to eliminate the intestinal cancer risk related to the potential oral intake of the non-respirable inhalable fraction.

Please note that both the use of C.I. Pigment Yellow 34 and C.I. Pigment Red 104 should be considered

simultaneously at all times, due to the similar hazard profile of the pigment substances. This means that for most

uses e.g. 20 hours/week C.I. Pigment Red 104 and 20 hours/week C.I. Pigment Yellow 34 use is allowed (unless

time reduction has been applied for the respective activity), but 40 hours/week C.I. Pigment Red 104 and 10

hours/week C.I. Pigment Yellow 34 is not.

10.1.2. Consumer

There are no consumer uses reported for this substance and the substance should not be used as such.

10.2. Environment (combined for all emission sources)

10.2.1. All uses (regional scale)

10.2.1.1. Total releases

The total releases to the environment from all the exposure scenarios covered are presented in the table below.

This is the sum of the releases to the environments from all exposure scenarios addressed.

Where there is more than one contributing scenario scenarios for the environment for a given exposure scenario,

the highest release per route across all the contributing scenarios has been taken into account. This may lead to

overestimation of the PEC

Table 185. Total releases to the environment per year from all life cycle stages:

Release route Total releases per year

Water 4.894E3 kg/year



Release route Total releases per year

Air 1.016E6 kg/year

Soil 3.291E6 kg/year

10.2.1.2. Regional exposure

Environment

The regional risk characterisation in the vRAR for lead was performed with various approaches based on either

modelled or measured data. Selected regional PECs are shown in the following table.

Regional PECs for lead in the vRAR and comparison to regional PECs due to the use of C.I. Pigment Yellow 34

and C.I. Pigment Red 104

PECregional Remarks PNEC & RCR Calculated

PECregional

for pigment-

Pb

PECregional,

freshwater

0.61 µg/L Median measured ambient

concentration for EU

PNEC = 2.7 µg/l

RCR = 0.23

0.66 µg/L

PECregional, marine

water

0.046 µg/L Median measured ambient

concentration for Europe

0.13 µg/L

PECregional, sediment

(freshwater) scenario 1

55.4 mg/kg

dw

Modelled, no historic

contamination

PNEC = 174 mg/kg

dw

RCR = 0.32

389 mg/kg dw

PECregional, sediment

(freshwater) scenario 2

100.1 mg/kg

dw

Median measured ambient

concentration for Europe,

includes historic contamination

RCR = 0.58

PECregional, marine

sediment

53.2 mg/kg

dw


concentration for Europe

76 mg/kg dw

PECregional, natural

soil

28.3 mg/kg

dw

Modelled (PECtotal100 years) PNEC = 166 mg/kg

dw

RCR = 0.17

31 mg/kg dw

PECregional, air 20 ng/m3


concentration in EU countries

0.64 ng/m3

As C.I. Pigment Yellow 34 and C.I. Pigment Red 104 have been used for many years, the measured regional

PECs in the vRAR already include the fraction that is due to the use of the pigments.

The risk characterisation ratios for the measured background concentrations already fill a substantial part of the

risk ratio. This was the motivation to use the 'added risk approach', implying that only the Clocal is taken into

consideration.

The risk characterisation ratios for the regional PECs are higher by order(s) of magnitude than for the various

exposure scenarios (Clocal only) related to the use of the pigments.

Further consideration of the figures shows that the regional PECs for pigment-Pb are at the same level or higher

than the measured background concentration due to all applications of lead. Therefore the calculations are

considered as invalid, an anomaly of the regional model due to the fact that the EUSES model is designed for

organic chemicals. In particular the modelling of a steady state (regional) with no significant loss factor (half-

life time of the chemical is indefinite) leads to invalid predictions.

Man via environment

Exposure assessment and risk characterisation for man via the environment were not conducted. Please refer to

section 9.0.2.3 for more information.

10.2.2. Local exposure due to all wide dispersive uses

C.I. Pigment Yellow 34 Pigment Yellow 34


Environment

The predicted local environmental concentrations (PEC local) based on the releases from all widespread uses are

reported in the table below together with the risk characterisation ratio when a PNEC is available. Those

exposure estimates have been obtained with EUSES.

Where there is more than one contributing scenario scenarios for the environment for a given exposure scenario,

the highest release per route across all the contributing scenarios has been taken into account. This may lead to

overestimation of the PEC.



Table 186. Predicted environmental concentration and risk characterisation ratio for the environment

due to all wide dispersive uses

Protection target PEC local due to all wide dispersive uses RCR

Freshwater 2.834E-6 mg/L < 0.01

Sediment (freshwater) 0.836 mg/kg dw < 0.01

Marine water 2.834E-7 mg/L < 0.01

Sediment (marine water) 0.084 mg/kg dw < 0.01

Sewage treatment plant 1.538E-4 mg/L < 0.01

Agricultural soil 0.041 mg/kg dw < 0.01

Man via environment

Exposure assessment and risk characterisation for man via the environment were not conducted. Please refer to

section 9.0.2.3 for more information.

10.2.3. Local exposure due to combined uses at a site

The volume taken into account for the environmental exposure assessment and risk characterisation is the total

volume for C.I. Pigment Yellow 34 and C.I. Pigment Red 104. Therefore the combined use of both pigments,

for which the exposure assessment and risk characterization is driven by lead in both cases, is taken into account

in this CSR.



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