Table Substance identity 2 VII Table Constituents 2 VII Table Overview of physico-chemical properties 3 VII




НазваниеTable Substance identity 2 VII Table Constituents 2 VII Table Overview of physico-chemical properties 3 VII
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CHEMICAL SAFETY REPORT




Substance Name: Slags, lead-zinc smelting

EC Number: 297-907-9

CAS Number: 93763-87-2

Registrant's Identity:

Table of Contents
Table 1. Substance identity 2 vii
Table 2. Constituents 2 vii
Table 3. Overview of physico-chemical properties 3 vii
Table 4. Overview of quantities (in tonnes/year) 5 vii
Table 5. Uses by workers in industrial settings 7 vii
Table 6. Classification according to Directive 67/548/EEC criteria 13 vii
Table 7. (taken from the RA zinc, ECB 2008): Possible chemical forms (speciation) of dissolved zinc in seawater (Cleven et al., 1993). 17 vii
Table 8. Overview of studies on aquatic bioaccumulation 20 vii
Table 9. Overview of studies on terrestrial bioaccumulation 21 vii
Table 10. Summary of the measured metal concentration after 7-day T/D testing of slags, lead-zinc smelting under standard T/D protocol conditions. 24 vii
Table 11. Overview of experimental studies on acute toxicity after oral administration 27 vii
Table 12. Overview of experimental studies on acute toxicity after dermal administration 27 vii
Table 13. Overview of experimental studies on skin irritation 28 vii
Table 14. Overview of experimental studies on eye irritation 28 vii
Table 15. Overview of experimental in vitro genotoxicity studies 28 vii
Table 16. Water solubility values of the eleven zinc compounds covered in this CSR 29 vii
Table 17. Grouping based on water solubility 30 vii
Table 18. Dermal absorption of Zn (% of dose) through pig skin in vitro within 72 hours 31 vii
Table 19. Deposition fractions for oral breathers and for oronasal augmenters, using a polydisperse particle distribution (MMAD 15.2 m, GSD 4.0) 36 vii
Table 20. Assumptions used for estimating the inhalation absorption 37 vii
Table 21. Percentage estimations for inhalation absorption of soluble, slightly soluble and insoluble zinc compounds 37 vii
Table 22. Elimination data obtained following thirty humans dosed with 18 to 900 moles of 65Zn 39 vii
Table 23. Overview of experimental studies on acute toxicity after oral administration according to decreasing water solubility of zinc compounds 41 vii
Table 24. Re-calculation of oral LD50 rat values 43 vii
Table 25. Overview of experimental studies on acute toxicity after inhalation exposure according to decreasing water solubility of zinc compounds 43 vii
Table 26. Overview of experimental studies on acute toxicity after dermal exposure 45 vii
Table 27. Overview of experimental studies on skin irritation according to decreasing water solubility of zinc compounds 48 vii
Table 28. Overview of experimental studies on eye irritation according to decreasing water solubility of zinc compounds 49 vii
Table 29. Overview of experimental studies on skin sensitisation according to decreasing water solubility of zinc compounds 52 vii
Table 30. Overview of experimental studies on repeated dose toxicity after oral administration 54 vii
Table 31. Overview of experimental studies on repeated dose toxicity after inhalation 56 vii
Table 32. Overview of experimental in vitro genotoxicity studies according to decreasing water solubility 63 vii
Table 33. Overview of experimental in vivo genotoxicity studies according to decreasing water solubility 66 vii
Table 34. Overview of experimental studies on fertility 72 vii
Table 35. Overview of experimental studies on developmental toxicity 75 vii
Table 36. Overview of experimental studies on immunotoxicity 78 vii
Table 37. OELs for zinc chloride 80 vii
Table 38. OELs for zinc oxide 80 vii
Table 39. 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). 81 vii
Table 40. 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) 84 vii
Table 41. Summary of absorption rates through different routes of exposure 86 vii
Table 42. Assessment factors (AF) for zinc compounds 87 vii
Table 43. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for workers 89 vii
Table 44. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for consumers 89 vii
Table 45. Overview of information on explosivity 91 viii
Table 46. Overview of information on flammability 91 viii
Table 47. Overview of short-term effects on fish 93 viii
Table 48. Overview of short-term effects on aquatic invertebrates 95 viii
Table 49. Overview of long-term effects on aquatic invertebrates 95 viii
Table 50. Overview of effects on algae and aquatic plants 96 viii
Table 51. Overview of effects on other aquatic organisms: communities 97 viii
Table 52. PNEC water 99 viii
Table 53. PNEC sediment 100 viii
Table 54. Overview of effects on soil macro-organisms 101 viii
Table 55. Overview of effects on terrestrial plants 102 viii
Table 56. PNEC soil 103 viii
Table 57. Overview of effects on micro-organisms 104 viii
Table 58. PNEC sewage treatment plant 105 viii
Table 59. PNEC oral 106 viii
Figure 1. Transformation /dissolution results for slags, lead-zinc smelting at pH 6. 25 viii
Figure 2. 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). 26 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 2
1.3. Physico-chemical properties 3
Table 3. Overview of physico-chemical properties 3
2. MANUFACTURE AND USES 5
2.1. Manufacture 5
Table 4. Overview of quantities (in tonnes/year) 5
2.2. Identified uses 6
Table 5. Uses by workers in industrial settings 7
2.3. Uses advised against 10
3. CLASSIFICATION AND LABELLING 11
3.1. Classification and labelling according to CLP / GHS 11
3.2. Classification and labelling according to DSD / DPD 13
3.2.1. Classification and labelling in Annex I of Directive 67/548/EEC 13
3.2.2. Self classification(s) 13
3.2.3. Other classification(s) 14
4. ENVIRONMENTAL FATE PROPERTIES 14
4.1. Degradation 15
4.1.1. Abiotic degradation 15
4.1.1.1. Hydrolysis 15
4.1.1.2. Phototransformation/photolysis 15
4.1.1.2.1. Phototransformation in air 15
4.1.1.2.2. Phototransformation in water 16
4.1.1.2.3. Phototransformation in soil 16
4.1.2. Biodegradation 16
4.1.2.1. Biodegradation in water 16
4.1.2.1.1. Estimated data 16
4.1.2.1.2. Screening tests 16
4.1.2.1.3. Simulation tests (water and sediments) 16
4.1.2.1.4. Summary and discussion of biodegradation in water and sediment 16
4.1.2.2. Biodegradation in soil 16
4.1.3. Summary and discussion of degradation 17
4.2. Environmental distribution 17
4.2.1. Adsorption/desorption 18
4.2.2. Volatilisation 19
4.2.3. Distribution modelling 19
4.2.4. Summary and discussion of environmental distribution 19
4.3. Bioaccumulation 20
4.3.1. Aquatic bioaccumulation 20
Table 8. Overview of studies on aquatic bioaccumulation 20
4.3.2. Terrestrial bioaccumulation 21
Table 9. Overview of studies on terrestrial bioaccumulation 21
4.3.3. Summary and discussion of bioaccumulation 22
4.4. Secondary poisoning 23
4.5. Natural background 23
4.6. Additional information on environmental fate and distribution 24
Table 10. Summary of the measured metal concentration after 7-day T/D testing of slags, lead-zinc smelting under standard T/D protocol conditions. 24
Loading @ pH 6 24
100 mg/L zinc Waelz slag 24
5. HUMAN HEALTH HAZARD ASSESSMENT 27
Table 11. Overview of experimental studies on acute toxicity after oral administration 27
Table 12. Overview of experimental studies on acute toxicity after dermal administration 27
Table 13. Overview of experimental studies on skin irritation 28
Table 14. Overview of experimental studies on eye irritation 28
Table 15. Overview of experimental in vitro genotoxicity studies 28
5.1. Toxicokinetics 30
5.1.1. Non-human information 30
5.1.2. Human information 34
5.1.3. Summary and discussion of toxicokinetics 40
5.2. Acute toxicity 41
5.2.1. Non-human information 41
5.2.1.1. Acute toxicity: oral 41
5.2.1.2. Acute toxicity: inhalation 43
5.2.1.3. Acute toxicity: dermal 45
5.2.1.4. Acute toxicity: other routes 45
5.2.2. Human information 45
5.2.3. Summary and discussion of acute toxicity 47
5.3. Irritation 48
5.3.1. Skin 48
5.3.1.1. Non-human information 48
5.3.1.2. Human information 49
5.3.2. Eye 49
5.3.2.1. Non-human information 49
5.3.2.2. Human information 50
5.3.3. Respiratory tract 50
5.3.3.1. Non-human information 50
5.3.3.2. Human information 51
5.3.4. Summary and discussion of irritation 51
5.4. Corrosivity 51
5.4.1. Non-human information 51
5.4.2. Human information 51
5.4.3. Summary and discussion of corrosion 51
5.5. Sensitisation 51
5.5.1. Skin 51
5.5.1.1. Non-human information 51
5.5.1.2. Human information 53
5.5.2. Respiratory system 53
5.5.2.1. Non-human information 53
5.5.2.2. Human information 53
5.5.3. Summary and discussion of sensitisation 53
5.6. Repeated dose toxicity 53
5.6.1. Non-human information 53
5.6.1.1. Repeated dose toxicity: oral 54
5.6.1.2. Repeated dose toxicity: inhalation 56
5.6.1.3. Repeated dose toxicity: dermal 58
5.6.1.4. Repeated dose toxicity: other routes 58
5.6.2. Human information 58
5.6.3. Summary and discussion of repeated dose toxicity 62
5.7. Mutagenicity 63
5.7.1. Non-human information 63
5.7.1.1. In vitro data 63
5.7.1.2. In vivo data 66
5.7.2. Human information 68
5.7.3. Summary and discussion of mutagenicity 68
5.8. Carcinogenicity 69
5.8.1. Non-human information 69
5.8.1.1. Carcinogenicity: oral 69
5.8.1.2. Carcinogenicity: inhalation 70
5.8.1.3. Carcinogenicity: dermal 70
5.8.1.4. Carcinogenicity: other routes 70
5.8.2. Human information 70
5.8.3. Summary and discussion of carcinogenicity 72
5.9. Toxicity for reproduction 72
5.9.1. Effects on fertility 72
5.9.1.1. Non-human information 72
5.9.1.2. Human information 74
5.9.2. Developmental toxicity 75
5.9.2.1. Non-human information 75
5.9.2.2. Human information 76
5.9.3. Summary and discussion of reproductive toxicity 77
5.10. Other effects 78
5.10.1. Non-human information 78
5.10.1.1. Neurotoxicity 78
5.10.1.2. Immunotoxicity 78
5.10.1.3. Specific investigations: other studies 78
5.10.2. Human information 79
5.10.3. Summary and discussion of specific investigations 79
5.11. Derivation of DNEL(s) / DMEL(s) 80
5.11.1. Overview of typical dose descriptors for all endpoints 80
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 86
5.11.3. Selection of the critical DNEL(s) for critical health effects 90
6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES 91
6.1. Explosivity 91
Table 45. Overview of information on explosivity 91
6.2. Flammability 91
Table 46. Overview of information on flammability 91
6.3. Oxidising potential 92
7. ENVIRONMENTAL HAZARD ASSESSMENT 92
7.1. Aquatic compartment (including sediment) 93
7.1.1. Toxicity test results 93
7.1.1.1. Fish 93
7.1.1.1.1. Short-term toxicity to fish 93
Table 47. Overview of short-term effects on fish 93
7.1.1.1.2. Long-term toxicity to fish 94
7.1.1.2. Aquatic invertebrates 95
7.1.1.2.1. Short-term toxicity to aquatic invertebrates 95
Table 48. Overview of short-term effects on aquatic invertebrates 95
7.1.1.2.2. Long-term toxicity to aquatic invertebrates 95
Table 49. Overview of long-term effects on aquatic invertebrates 95
7.1.1.3. Algae and aquatic plants 96
Table 50. Overview of effects on algae and aquatic plants 96
7.1.1.4. Sediment organisms 96
7.1.1.5. Other aquatic organisms 97
Table 51. Overview of effects on other aquatic organisms: communities 97
7.1.2. Calculation of Predicted No Effect Concentration (PNEC) 99
7.1.2.1. PNEC water 99
Table 52. PNEC water 99
7.1.2.2. PNEC sediment 100
Table 53. PNEC sediment 100
7.2. Terrestrial compartment 101
7.2.1. Toxicity test results 101
7.2.1.1. Toxicity to soil macro-organisms 101
Table 54. Overview of effects on soil macro-organisms 101
7.2.1.2. Toxicity to terrestrial plants 102
Table 55. Overview of effects on terrestrial plants 102
7.2.1.3. Toxicity to soil micro-organisms 103
7.2.1.4. Toxicity to other terrestrial organisms 103
7.2.2. Calculation of Predicted No Effect Concentration (PNEC soil) 103
Table 56. PNEC soil 103
7.3. Atmospheric compartment 104
7.4. Microbiological activity in sewage treatment systems 104
7.4.1. Toxicity to aquatic micro-organisms 104
Table 57. Overview of effects on micro-organisms 104
7.4.2. PNEC for sewage treatment plant 105
Table 58. PNEC sewage treatment plant 105
7.5. Non compartment specific effects relevant for the food chain (secondary poisoning) 105
7.5.1. Toxicity to birds 105
7.5.2. Toxicity to mammals 106
7.5.3. Calculation of PNECoral (secondary poisoning) 106
Table 59. PNEC oral 106
7.6. Conclusion on the environmental hazard assessment and on classification and labelling 106
8. PBT AND VPVB ASSESSMENT 107
8.1. Assessment of PBT/vPvB Properties 107
8.1.1. Summary and overall conclusions on PBT or vPvB properties 107
9. EXPOSURE ASSESSMENT 107
10. RISK CHARACTERISATION 107
REFERENCES 108

List of Tables
Table 1. Substance identity 2
Table 2. Constituents 2
Table 3. Overview of physico-chemical properties 3
Table 4. Overview of quantities (in tonnes/year) 5
Table 5. Uses by workers in industrial settings 7
Table 6. Classification according to Directive 67/548/EEC criteria 13
Table 7. (taken from the RA zinc, ECB 2008): Possible chemical forms (speciation) of dissolved zinc in seawater (Cleven et al., 1993). 17
Table 8. Overview of studies on aquatic bioaccumulation 20
Table 9. Overview of studies on terrestrial bioaccumulation 21
Table 10. Summary of the measured metal concentration after 7-day T/D testing of slags, lead-zinc smelting under standard T/D protocol conditions. 24
Table 11. Overview of experimental studies on acute toxicity after oral administration 27
Table 12. Overview of experimental studies on acute toxicity after dermal administration 27
Table 13. Overview of experimental studies on skin irritation 28
Table 14. Overview of experimental studies on eye irritation 28
Table 15. Overview of experimental in vitro genotoxicity studies 28
Table 16. Water solubility values of the eleven zinc compounds covered in this CSR 29
Table 17. Grouping based on water solubility 30
Table 18. Dermal absorption of Zn (% of dose) through pig skin in vitro within 72 hours 31
Table 19. Deposition fractions for oral breathers and for oronasal augmenters, using a polydisperse particle distribution (MMAD 15.2 m, GSD 4.0) 36
Table 20. Assumptions used for estimating the inhalation absorption 37
Table 21. Percentage estimations for inhalation absorption of soluble, slightly soluble and insoluble zinc compounds 37
Table 22. Elimination data obtained following thirty humans dosed with 18 to 900 moles of 65Zn 39
Table 23. Overview of experimental studies on acute toxicity after oral administration according to decreasing water solubility of zinc compounds 41
Table 24. Re-calculation of oral LD50 rat values 43
Table 25. Overview of experimental studies on acute toxicity after inhalation exposure according to decreasing water solubility of zinc compounds 43
Table 26. Overview of experimental studies on acute toxicity after dermal exposure 45
Table 27. Overview of experimental studies on skin irritation according to decreasing water solubility of zinc compounds 48
Table 28. Overview of experimental studies on eye irritation according to decreasing water solubility of zinc compounds 49
Table 29. Overview of experimental studies on skin sensitisation according to decreasing water solubility of zinc compounds 52
Table 30. Overview of experimental studies on repeated dose toxicity after oral administration 54
Table 31. Overview of experimental studies on repeated dose toxicity after inhalation 56
Table 32. Overview of experimental in vitro genotoxicity studies according to decreasing water solubility 63
Table 33. Overview of experimental in vivo genotoxicity studies according to decreasing water solubility 66
Table 34. Overview of experimental studies on fertility 72
Table 35. Overview of experimental studies on developmental toxicity 75
Table 36. Overview of experimental studies on immunotoxicity 78
Table 37. OELs for zinc chloride 80
Table 38. OELs for zinc oxide 80
Table 39. 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). 81
Table 40. 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) 84
Table 41. Summary of absorption rates through different routes of exposure 86
Table 42. Assessment factors (AF) for zinc compounds 87
Table 43. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for workers 89
Table 44. Corrected dose descriptor(s) per endpoint and endpoint-specific DNELs for consumers 89
Table 45. Overview of information on explosivity 91
Table 46. Overview of information on flammability 91
Table 47. Overview of short-term effects on fish 93
Table 48. Overview of short-term effects on aquatic invertebrates 95
Table 49. Overview of long-term effects on aquatic invertebrates 95
Table 50. Overview of effects on algae and aquatic plants 96
Table 51. Overview of effects on other aquatic organisms: communities 97
Table 52. PNEC water 99
Table 53. PNEC sediment 100
Table 54. Overview of effects on soil macro-organisms 101
Table 55. Overview of effects on terrestrial plants 102
Table 56. PNEC soil 103
Table 57. Overview of effects on micro-organisms 104
Table 58. PNEC sewage treatment plant 105
Table 59. PNEC oral 106

List of Figures
Figure 1. Transformation /dissolution results for slags, lead-zinc smelting at pH 6. 25
Figure 2. 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). 26
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