Table Substance identity 2 VII Table Constituents 3 VII Table Impurities 3 VII




НазваниеTable Substance identity 2 VII Table Constituents 3 VII Table Impurities 3 VII
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CHEMICAL SAFETY REPORT




Substance Name: zinc sulphide

EC Number: 215-251-3

CAS Number: 1314-98-3

Registrant's Identity:

Table of Contents
Table 1. Substance identity 2 vii
Table 2. Constituents 3 vii
Table 3. Impurities 3 vii
Table 4. Overview of physico-chemical properties 4 vii
Table 5. Overview of quantities (in tonnes/year) 6 vii
Table 6. Uses by workers in industrial settings 8 vii
Table 7. Uses by professional workers 36 vii
Table 8. Uses by consumers 47 vii
Table 9. (taken from the RA zinc, ECB 2008): Possible chemical forms (speciation) of dissolved zinc in seawater (Cleven et al., 1993). 58 vii
Table 10. Overview of studies on aquatic bioaccumulation 61 vii
Table 11. Overview of studies on terrestrial bioaccumulation 62 vii
Table 12 : transformation/dissolution of zinc sulphide tested at pH 6 and 8 (ECTX 2010). 66 vii
Table 13: transformation/dissolution of zinc sulphide tested at pH 6 and 8(ECTX 2010bis). 67 vii
Table 14. Water solubility values of the eleven zinc compounds covered in this CSR 69 vii
Table 15. Grouping based on water solubility 70 vii
Table 16. Dermal absorption of Zn (% of dose) through pig skin in vitro within 72 hours 71 vii
Table 17. Deposition fractions for oral breathers and for oronasal augmenters, using a polydisperse particle distribution (MMAD 15.2 m, GSD 4.0) 76 vii
Table 18. Assumptions used for estimating the inhalation absorption 77 vii
Table 19. Percentage estimations for inhalation absorption of soluble, slightly soluble and insoluble zinc compounds 77 vii
Table 20. Elimination data obtained following thirty humans dosed with 18 to 900 moles of 65Zn 79 vii
Table 21. Overview of experimental studies on acute toxicity after oral administration according to decreasing water solubility of zinc compounds 81 vii
Table 22. Re-calculation of oral LD50 rat values 83 vii
Table 23. Overview of experimental studies on acute toxicity after inhalation exposure according to decreasing water solubility of zinc compounds 83 vii
Table 24. Overview of experimental studies on acute toxicity after dermal exposure 84 vii
Table 25. Overview of experimental studies on skin irritation according to decreasing water solubility of zinc compounds 88 vii
Table 26. Overview of experimental studies on eye irritation according to decreasing water solubility of zinc compounds 89 vii
Table 27. Overview of experimental studies on skin sensitisation according to decreasing water solubility of zinc compounds 91 vii
Table 28. Overview of experimental studies on repeated dose toxicity after oral administration 93 vii
Table 29. Overview of experimental studies on repeated dose toxicity after inhalation 96 vii
Table 30. Overview of experimental in vitro genotoxicity studies according to decreasing water solubility 103 vii
Table 31. Overview of experimental in vivo genotoxicity studies according to decreasing water solubility 106 vii
Table 32. Overview of experimental studies on fertility 112 vii
Table 33. Overview of experimental studies on developmental toxicity 115 vii
Table 34. Overview of experimental studies on immunotoxicity 118 vii
Table 35. OELs for zinc chloride 120 vii
Table 36. OELs for zinc oxide 120 vii
Table 37. Available dose-descriptor(s) per endpoint for water soluble zinc compounds (i.e., zinc chloride, zinc sulphate, zinc bis(dihydrogen phosphate), diammonium tetrachlorozincate and triammonium pentachlorozincate). 121 vii
Table 38. Available dose-descriptor(s) per endpoint for sparingly or insoluble soluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal, zinc sulphide) 124 vii
Table 39. Summary of absorption rates through different routes of exposure 126 vii
Table 40. Assessment factors (AF) for zinc compounds 127 vii
Table 41. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for workers 129 vii
Table 42. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for consumers 129 vii
Table 43. Overview of short-term effects on fish 132 vii
Table 44. Overview of short-term effects on aquatic invertebrates 133 vii
Table 45. Overview of effects on algae and aquatic plants 134 vii
Table 46. Overview of effects on other aquatic organisms: communities 135 viii
Table 47. PNEC water 137 viii
Table 48. PNEC sediment 138 viii
Table 49. PNEC soil 141 viii
Table 50. PNEC sewage treatment plant 142 viii
Table 51. PNEC oral 143 viii
Figure 1. Base case total zinc removal from the water column using EUSES model parameters. The initial total zinc concentration in the water column (C0) is 413 μg/L. The horizontal dashed line represents C/C0 = 0.3 or 70% removal of zinc (from Mutch Associates 2010b). 68 viii
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 2
1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES 2
1.1. Name and other identifiers of the substance 2
Table 1. Substance identity 2
1.2. Composition of the substance 2
Table 2. Constituents 3
Table 3. Impurities 3
1.3. Physico-chemical properties 3
Table 4. Overview of physico-chemical properties 4
2. MANUFACTURE AND USES 6
Table 5. Overview of quantities (in tonnes/year) 6
2.1. Manufacture 6
2.2. Identified uses 7
Table 6. Uses by workers in industrial settings 8
Table 7. Uses by professional workers 36
Table 8. Uses by consumers 47
2.3. Uses advised against 51
3. CLASSIFICATION AND LABELLING 52
3.1. Classification and labelling according to CLP / GHS 52
3.2. Classification and labelling according to DSD / DPD 54
3.2.1. Classification and labelling in Annex I of Directive 67/548/EEC 54
3.2.2. Self classification(s) 54
Classification according to Directive 67/548/EEC criteria 54
4. ENVIRONMENTAL FATE PROPERTIES 55
4.1. Degradation 56
4.1.1. Abiotic degradation 56
4.1.1.1. Hydrolysis 56
4.1.1.2. Phototransformation/photolysis 57
4.1.1.2.1. Phototransformation in air 57
4.1.1.2.2. Phototransformation in water 57
4.1.1.2.3. Phototransformation in soil 57
4.1.2. Biodegradation 57
4.1.2.1. Biodegradation in water 57
4.1.2.1.1. Estimated data 57
4.1.2.1.2. Screening tests 57
4.1.2.1.3. Simulation tests (water and sediments) 57
4.1.2.1.4. Summary and discussion of biodegradation in water and sediment 57
4.1.2.2. Biodegradation in soil 57
4.1.3. Summary and discussion of degradation 58
4.2. Environmental distribution 58
4.2.1. Adsorption/desorption 59
4.2.2. Volatilisation 60
4.2.3. Distribution modelling 60
4.2.4. Summary and discussion of environmental distribution 60
4.3. Bioaccumulation 61
4.3.1. Aquatic bioaccumulation 61
Table 10. Overview of studies on aquatic bioaccumulation 61
4.3.2. Terrestrial bioaccumulation 62
Table 11. Overview of studies on terrestrial bioaccumulation 62
4.3.3. Summary and discussion of bioaccumulation 63
4.4. Secondary poisoning 64
4.5. Natural background 64
4.6. Additional information on environmental fate and distribution 65
5. HUMAN HEALTH HAZARD ASSESSMENT 69
5.1. Toxicokinetics 70
5.1.1. Non-human information 70
5.1.2. Human information 74
5.1.3. Summary and discussion of toxicokinetics 80
5.2. Acute toxicity 81
5.2.1. Non-human information 81
5.2.1.1. Acute toxicity: oral 81
5.2.1.2. Acute toxicity: inhalation 83
5.2.1.3. Acute toxicity: dermal 84
5.2.1.4. Acute toxicity: other routes 85
5.2.2. Human information 85
5.2.3. Summary and discussion of acute toxicity 87
5.3. Irritation 87
5.3.1. Skin 88
5.3.1.1. Non-human information 88
5.3.1.2. Human information 89
5.3.2. Eye 89
5.3.2.1. Non-human information 89
5.3.2.2. Human information 90
5.3.3. Respiratory tract 90
5.3.3.1. Non-human information 90
5.3.3.2. Human information 90
5.3.4. Summary and discussion of irritation 91
5.4. Corrosivity 91
5.4.1. Non-human information 91
5.4.2. Human information 91
5.4.3. Summary and discussion of corrosion 91
5.5. Sensitisation 91
5.5.1. Skin 91
5.5.1.1. Non-human information 91
5.5.1.2. Human information 93
5.5.2. Respiratory system 93
5.5.2.1. Non-human information 93
5.5.2.2. Human information 93
5.5.3. Summary and discussion of sensitisation 93
5.6. Repeated dose toxicity 93
5.6.1. Non-human information 93
5.6.1.1. Repeated dose toxicity: oral 93
5.6.1.2. Repeated dose toxicity: inhalation 96
5.6.1.3. Repeated dose toxicity: dermal 98
5.6.1.4. Repeated dose toxicity: other routes 98
5.6.2. Human information 98
5.6.3. Summary and discussion of repeated dose toxicity 102
5.7. Mutagenicity 103
5.7.1. Non-human information 103
5.7.1.1. In vitro data 103
5.7.1.2. In vivo data 106
5.7.2. Human information 108
5.7.3. Summary and discussion of mutagenicity 108
5.8. Carcinogenicity 109
5.8.1. Non-human information 109
5.8.1.1. Carcinogenicity: oral 109
5.8.1.2. Carcinogenicity: inhalation 109
5.8.1.3. Carcinogenicity: dermal 109
5.8.1.4. Carcinogenicity: other routes 109
5.8.2. Human information 109
5.8.3. Summary and discussion of carcinogenicity 111
5.9. Toxicity for reproduction 112
5.9.1. Effects on fertility 112
5.9.1.1. Non-human information 112
5.9.1.2. Human information 114
5.9.2. Developmental toxicity 114
5.9.2.1. Non-human information 114
5.9.2.2. Human information 116
5.9.3. Summary and discussion of reproductive toxicity 116
5.10. Other effects 117
5.10.1. Non-human information 117
5.10.1.1. Neurotoxicity 117
5.10.1.2. Immunotoxicity 118
5.10.1.3. Specific investigations: other studies 118
5.10.2. Human information 119
5.10.3. Summary and discussion of specific investigations 119
5.11. Derivation of DNEL(s) / DMEL(s) 119
5.11.1. Overview of typical dose descriptors for all endpoints 120
5.11.2. Correction of dose descriptors if needed (for example route-to-route extrapolation), application of assessment factors and derivation of the endpoint specific DN(M)EL 126
5.11.3. Selection of the critical DNEL(s) for critical health effects 130
6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES 130
6.1. Explosivity 130
6.2. Flammability 131
6.3. Oxidising potential 131
7. ENVIRONMENTAL HAZARD ASSESSMENT 132
7.1. Aquatic compartment (including sediment) 132
7.1.1. Toxicity test results 132
7.1.1.1. Fish 132
7.1.1.1.1. Short-term toxicity to fish 132
Table 43. Overview of short-term effects on fish 132
7.1.1.1.2. Long-term toxicity to fish 133
7.1.1.2. Aquatic invertebrates 133
7.1.1.2.1. Short-term toxicity to aquatic invertebrates 133
Table 44. Overview of short-term effects on aquatic invertebrates 133
7.1.1.2.2. Long-term toxicity to aquatic invertebrates 134
7.1.1.3. Algae and aquatic plants 134
Table 45. Overview of effects on algae and aquatic plants 134
7.1.1.4. Sediment organisms 135
7.1.1.5. Other aquatic organisms 135
Table 46. Overview of effects on other aquatic organisms: communities 135
7.1.2. Calculation of Predicted No Effect Concentration (PNEC) 136
7.1.2.1. PNEC water 137
Table 47. PNEC water 137
7.1.2.2. PNEC sediment 138
Table 48. PNEC sediment 138
7.2. Terrestrial compartment 138
7.2.1. Toxicity test results 139
7.2.1.1. Toxicity to soil macro-organisms 139
7.2.1.2. Toxicity to terrestrial plants 140
7.2.1.3. Toxicity to soil micro-organisms 140
7.2.1.4. Toxicity to other terrestrial organisms 141
7.2.2. Calculation of Predicted No Effect Concentration (PNEC soil) 141
Table 49. PNEC soil 141
7.3. Atmospheric compartment 141
7.4. Microbiological activity in sewage treatment systems 141
7.4.1. Toxicity to aquatic micro-organisms 141
7.4.2. PNEC for sewage treatment plant 142
Table 50. PNEC sewage treatment plant 142
7.5. Non compartment specific effects relevant for the food chain (secondary poisoning) 142
7.5.1. Toxicity to birds 143
7.5.2. Toxicity to mammals 143
7.5.3. Calculation of PNECoral (secondary poisoning) 143
Table 51. PNEC oral 143
7.6. Conclusion on the environmental hazard assessment and on classification and labelling 144
8. PBT AND VPVB ASSESSMENT 144
8.1. Assessment of PBT/vPvB Properties 144
8.1.1. Summary and overall conclusions on PBT or vPvB properties 144
9. EXPOSURE ASSESSMENT 144
10. RISK CHARACTERISATION 144
REFERENCES 146

List of Tables
Table 1. Substance identity 2
Table 2. Constituents 3
Table 3. Impurities 3
Table 4. Overview of physico-chemical properties 4
Table 5. Overview of quantities (in tonnes/year) 6
Table 6. Uses by workers in industrial settings 8
Table 7. Uses by professional workers 36
Table 8. Uses by consumers 47
Table 9. (taken from the RA zinc, ECB 2008): Possible chemical forms (speciation) of dissolved zinc in seawater (Cleven et al., 1993). 58
Table 10. Overview of studies on aquatic bioaccumulation 61
Table 11. Overview of studies on terrestrial bioaccumulation 62
Table 12 : transformation/dissolution of zinc sulphide tested at pH 6 and 8 (ECTX 2010). 66
Table 13: transformation/dissolution of zinc sulphide tested at pH 6 and 8(ECTX 2010bis). 67
Table 14. Water solubility values of the eleven zinc compounds covered in this CSR 69
Table 15. Grouping based on water solubility 70
Table 16. Dermal absorption of Zn (% of dose) through pig skin in vitro within 72 hours 71
Table 17. Deposition fractions for oral breathers and for oronasal augmenters, using a polydisperse particle distribution (MMAD 15.2 m, GSD 4.0) 76
Table 18. Assumptions used for estimating the inhalation absorption 77
Table 19. Percentage estimations for inhalation absorption of soluble, slightly soluble and insoluble zinc compounds 77
Table 20. Elimination data obtained following thirty humans dosed with 18 to 900 moles of 65Zn 79
Table 21. Overview of experimental studies on acute toxicity after oral administration according to decreasing water solubility of zinc compounds 81
Table 22. Re-calculation of oral LD50 rat values 83
Table 23. Overview of experimental studies on acute toxicity after inhalation exposure according to decreasing water solubility of zinc compounds 83
Table 24. Overview of experimental studies on acute toxicity after dermal exposure 84
Table 25. Overview of experimental studies on skin irritation according to decreasing water solubility of zinc compounds 88
Table 26. Overview of experimental studies on eye irritation according to decreasing water solubility of zinc compounds 89
Table 27. Overview of experimental studies on skin sensitisation according to decreasing water solubility of zinc compounds 91
Table 28. Overview of experimental studies on repeated dose toxicity after oral administration 93
Table 29. Overview of experimental studies on repeated dose toxicity after inhalation 96
Table 30. Overview of experimental in vitro genotoxicity studies according to decreasing water solubility 103
Table 31. Overview of experimental in vivo genotoxicity studies according to decreasing water solubility 106
Table 32. Overview of experimental studies on fertility 112
Table 33. Overview of experimental studies on developmental toxicity 115
Table 34. Overview of experimental studies on immunotoxicity 118
Table 35. OELs for zinc chloride 120
Table 36. OELs for zinc oxide 120
Table 37. Available dose-descriptor(s) per endpoint for water soluble zinc compounds (i.e., zinc chloride, zinc sulphate, zinc bis(dihydrogen phosphate), diammonium tetrachlorozincate and triammonium pentachlorozincate). 121
Table 38. Available dose-descriptor(s) per endpoint for sparingly or insoluble soluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal, zinc sulphide) 124
Table 39. Summary of absorption rates through different routes of exposure 126
Table 40. Assessment factors (AF) for zinc compounds 127
Table 41. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for workers 129
Table 42. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for consumers 129
Table 43. Overview of short-term effects on fish 132
Table 44. Overview of short-term effects on aquatic invertebrates 133
Table 45. Overview of effects on algae and aquatic plants 134
Table 46. Overview of effects on other aquatic organisms: communities 135
Table 47. PNEC water 137
Table 48. PNEC sediment 138
Table 49. PNEC soil 141
Table 50. PNEC sewage treatment plant 142
Table 51. PNEC oral 143



List of Figures
Figure 1. Base case total zinc removal from the water column using EUSES model parameters. The initial total zinc concentration in the water column (C0) is 413 μg/L. The horizontal dashed line represents C/C0 = 0.3 or 70% removal of zinc (from Mutch Associates 2010b). 68
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