Table Substance identity 2 XI Table Constituents 3 XI Table Impurities 3 XI




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CHEMICAL SAFETY REPORT




Substance Name: cadmium oxide

EC Number: 215-146-2

CAS Number: 1306-19-0

Registrant's Identity:

Table of Contents
Table 1. Substance identity 2 xi
Table 2. Constituents 3 xi
Table 3. Impurities 3 xi
Table 4. Overview of physico-chemical properties 3 xi
Table 5. Overview of quantities (in tonnes/year) 5 xi
Table 6. Uses by workers in industrial settings 7 xi
Table 7. Uses by professional workers 22 xi
Table 8. Freshwater BCF (L kg-1) reported in the EU risk assessment (ECB 2008; ) Table 3.2.34a) 35 xi
Table 9. BAF values for whole body vertebrates (L kg-1). (from the EU RA: Table 3.2.34b) 37 xi
Table 10. BAF values of some benthic organisms (from EU RA; table 3.2.40) 37 xi
Table 11. Overview of studies on aquatic bioaccumulation 37 xi
Table 12. bioaccumulation factors (BAF's) of soil dwelling organisms (from EU RA: table 3.2.37.). 43 xi
Table 13. Overview of studies on terrestrial bioaccumulation 44 xi
Table 14. Kidney concentration in mammals and predicted critical soil concentrations at which the renal threshold for toxicity may be exceeded (after linear extrapolation of the critical soil levels (values taken from the RA Cd, (ECB 2008)) 56 xi
Table 15. Ambient background concentrations in Europe according to FOREGS (2006). 57 xi
Table 16. Water solubility of the eight cadmium compounds covered in this assessment 58 xi
Table 17. Overview of selected experimental studies on acute toxicity after oral administration 60 xi
Table 18. Overview of selected experimental studies on acute toxicity after inhalation exposure 62 xi
Table 19. Overview of selected experimental studies on repeated dose toxicity after oral administration 67 xi
Table 20. Overview of selected experimental studies on repeated dose toxicity after inhalation exposure 69 xi
Table 21 . Overview of selected studies on repeated dose toxicity (other routes) 71 xi
Table 22. Thresholds for renal effects in recent/relevant studies in occupational settings (inhalation exposure) (adapted from ‘Recommendation from the Scientific Expert Group on Occupational Exposure Limits for Cd and its inorganic compounds’ SCOEL/SUM/136) 75 xi
Table 23. Overview of selected experimental in vitro genotoxicity studies 79 xi
Table 24. Overview of selected exposure-related observations on genotoxicity in humans 82 xi
Table 25. Overview of selected experimental studies on carcinogenicity after oral administration 88 xi
Table 26. Overview of selected experimental studies on carcinogenicity after inhalation exposure 88 xi
Table 27. Overview of selected experimental studies on carcinogenicity (other routes) 93 xi
Table 28. Overview of selected exposure-related observations on carcinogenicity in humans 95 xi
Table 29. Overview of selected experimental studies on male fertility and reproductive organs (oral route) 107 xi
Table 30. Overview of selected experimental studies on female fertility and reproductive organs (oral route) 110 xi
Table 31. Overview of selected exposure-related observations on toxicity to reproduction / fertility in humans 113 xi
Table 32. Overview of selected experimental studies on developmental toxicity 117 xi
Table 33. Overview of selected exposure-related observations developmental toxicity in humans 120 xi
Table 34. Available dose-descriptor(s) per endpoint for water-soluble cadmium compounds (cadmium nitrate, chloride and sulphate) 125 xi
Table 35. Available dose-descriptor(s) per endpoint for slightly soluble cadmium compounds (i.e. cadmium metal, oxide, hydroxide and carbonate) 127 xi
Table 36. Derivation of cadmium DNEL biomonitoring for workers 129 xi
Table 37. Derivation of cadmium DNEL general population based on animal data 131 xi
Table 38. Derivation of cadmium DNEL general population based on general population monitoring data 131 xi
Table 39. Overview of information on oxidising potential 132 xi
Table 40. Acute aquatic toxicity of cadmium by species as a function of pH and hardness. 135 xi
Table 41. Lowest acute aquatic toxicity data observed for cadmium 136 xi
Table 42. 'Case-by-case”- selected NOEC data of effects of Cd in freshwater and case-by-case calculation of 'geometric mean NOEC's. Bold, underlined data are selected for the HC5 calculation. (after table 3.2.9C of the EU risk assessment). 137 xi
Table 43. Endpoints selected for use in SSD for the derivation of marine PNEC for Cd. 141 xi
Table 44. Summary statistics for the SSD on chronic NOEC values for cadmium in saltwater (n=50). 143 xi
Table 45. Results of field experiments made on phytoplankton communities coming from various natural sea waters 144 xi
Table 46. Overview of short-term effects on fish 144 xi
Table 47. Overview of long-term effects on fish 147 xi
Table 48. Overview of short-term effects on aquatic invertebrates 153 xi
Table 49. Overview of long-term effects on aquatic invertebrates 156 xii
Table 50. Overview of effects on algae and aquatic plants 174 xii
Table 51. Overview of long-term effects on sediment organisms 179 xii
Table 52. Overview of short-term effects on other aquatic organisms 180 xii
Table 53. PNEC water 187 xii
Table 54. PNEC sediment 197 xii
Table 55. Summary table of species geometric mean NOECs for the most sensitive endpoints of plants and invertebrates used in the SSD. New species to the ones mentioned in the RA or species for which new information was found are highlighted in bold. The newly added individual NOECs are underlined in the last column. 200 xii
Table 56. Overview of effects on soil macro-organisms 202 xii
Table 57. Overview of effects on terrestrial plants 206 xii
Table 58. Overview of effects on soil micro-organisms 212 xii
Table 59. Summary statistics for the SSD on chronic NOEC values for cadmium in soil 216 xii
Table 60. Phytotoxicity of Cd salts in field trials (from Cd RA, 2008) 218 xii
Table 61. Chronic long term field NOEC values taken from table 57. 218 xii
Table 62. PNEC soil 219 xii
Table 63. Overview of effects on micro-organisms 220 xii
Table 64. PNEC sewage treatment plant 220 xii
Table 65. Overview of effects on birds 221 xii
Table 66. PNEC oral 223 xii
Table 67. Generic exposure scenarios for cadmium oxide 226 xii
Table 68. Identified uses for CdO and corresponding Generic Exposure Scenario (GES) 227 xii
Table 69. GES CdO-0 228 xii
Table 70. Environmental risk characterisation for the scenario “industrial manufacture of CdO” 233 xii
Table 71. Occupational exposure data for production of CdO 235 xii
Table 72. GES CdO-1 236 xii
Table 73. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of preparations for further downstream use. 242 xii
Table 74. Exposure assessment for the industrial use of Cd0 for the manufacture of wet or dry preparations, based on recently reported exposure data. 244 xii
Table 75. Occupational exposure data for the Industrial formulation of dry or wet preparations/mixtures by mixing thoroughly CdO with the other starting materials, with possible pressing, pelletising, sintering and packaging of the preparations/mixtures. 245 xii
Table 76. GES CdO-2 247 xii
Table 77. Environmental risk characterisation for the scenario “industrial use of CdO for the manufacture of other cadmium compounds” (GES 2 CdO) 252 xii
Table 78. Exposure assessment for the industrial use of CdO for the manufacture of other Cd-compounds, based on recently reported exposure data. 253 xii
Table 79. Occupational exposure data from the industrial use of CdO for the manufacture of other Cd compounds in the battery and pigment manufacturing industry. 254 xii
Table 80. GES CdO-3 255 xii
Table 81. Environmental release factors for the manufacture of different Cd compounds, to be used for industrial laboratories 262 xii
Table 82. Exposure assessment and risk characterisation for the industrial and professional use of CdO in laboratory. 262 xii
Table 83. Modelling* of occupational exposure data and risk characterisation for the Industrial and professional use of CdO and other Cd-compounds in the laboratory. 263 xii
Table 84. GES CdO-4 264 xii
Table 85. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of dry preparations (solid blends) for further downstream use. 271 xii
Table 86. Exposure assessment for the industrial use of CdO for the manufacture of dry preparations (solid blends), based on recently reported exposure data. 272 xii
Table 87. Occupational exposure data for the Industrial formulation of dry preparations/mixtures by mixing thoroughly CdO with the other starting materials. 274 xii
Table 88. GES CdO-5 275 xii
Table 89. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of liquid preparations for further downstream use. 282 xii
Table 90. Exposure assessment for the industrial use of CdO for the manufacture of wet preparations, based on recently reported exposure data. 283 xii
Table 91. Occupational exposure data for the Industrial formulation of wet preparations/mixtures by mixing thoroughly CdO with the other starting materials,. 285 xiii
Table 92. GES CdO-7 287 xiii
Table 93. Environmental risk characterisation for the Industrial and professional use of liquid substrates containing less than 25% w/w of CdO. 293 xiii
Table 94. Occupational exposure data for the Industrial and professional use of liquid substrates containing less than 25%w/w of CdO. 294 xiii
Table 95. Summary and conclusions of scenarios of potential consumer exposure (after the EU RA, ECB 2008). Uses indicated in italics indicate applications that have been stopped/changed or are new, as compared to the RA 297 xiii
Table 96. Average Cd in ambient air concentrations (µg/m3) measured in the surroundings of Cd-producing plants in the EU (2003-2006). 299 xiii
Table 97. Biological indicators of Cd-exposure, measured on the general population living in the surroundings of a CdO producers (“central zone”), and a control group (“peripheral zone”) 299 xiii
Table 98. Estimated daily Cd uptake (µgCd/person.day) in children and adults through environmental exposure in areas at ambient Cd concentrations (scenario’s 0-2) and near point sources (scenario 3). Data based on the EU RA, but updates were made for ambient air levels in urban area and in the surroundings of point sources. 302 xiii
Table 99. Conversion of Cd daily intake in Cd-U for individuals indirectly exposed via the environment. 303 xiii
Table 100. Overall Cd emissions to surface water and air (t/y). 304 xiii
Table 101. Annual Cd input into agricultural soils from the use of sludge on agricultural soils. 306 xiii
Table 102. Input data and results of the regional exposure assessment 308 xiii
Table 103. Monitored Cd concentrations in regional waters in EU countries (90P values); After table 3.3.3. of the Cd RA, ECB 2008. 310 xiii
Table 104. Monitored dissolved cadmium concentrations (µg Cd/l) in coastal waters and open sea of the Netherlands (2007-2009) 310 xiii
Table 105. Monitored dissolved cadmium concentrations (µg Cd/l) in coastal waters and open sea of Belgium (1995-1998) 311 xiii
Table 106. Monitored sediment concentrations (mg Cd/kg dwt) in the Netherlands (2000, 2003 and 2006) 311 xiii
Table 107. Monitored sediment concentrations (mg Cd/kg dwt) in Belgium 312 xiii
Table 108. Monitored soil concentrations (mg Cd/kg dry wt) in Europe (EU RA (ECB 2008), table 3.3.7.) 313 xiii
Table 109. Regional cadmium concentrations in the environment (predicted vs measured) 314 xiii
Table 110. Risk characterization for the general population 317 xiii
Table 111. Modelled PECadd values and risk characterisation for cadmium in the regional analysis. 319 xiii
Table 112. Monitored PEC add values and risk characterisation for the EU freshwater 319 xiii
Table 113. Monitored PEC add values and risk characterisation for EU marine waters 320 xiii
Table 114. Monitored PEC add values and risk characterisation for EU sediment (freshwater and marine) 320 xiii
Table 115. Monitored PECvalues and risk characterisation for EU agricultural soils (arable land and grassland) 320 xiii
Figure 1. The BCF values (L kg-1) of fish or fish tissues as a function of the Cd concentration in water (µg L-1). Data collated from experiments where solution Cd was artificially increased (Figure 3.2.10 of the EU risk assessment, ECB 2008) 36 xiii
Figure 2. The bioaccumulation factors (BAF kg kg-1) of earthworms as a function of the Cd concentration in soil (mg kg-1)(taken from the EU RA, figure 3.2.11) 44 xiii
Figure 3. Cumulative frequency of the critical soil Cd concentration at which the critical kidney Cd concentration (400µg/gDW) may be exceeded in the average population of different wildlife species (log-logistic curve fitting) 57 xiii
Figure 4. Illustration of Eurometaux/ICdA medical supervision guidance (2006)
(BI: biological indicators; C: creatinine) 130 xiii
Figure 5. Species sensitivity distribution of selected chronic marine Cd endpoints (n=47) 143 xiii
Figure 6. The cumulative frequency distribution of the NOEC values of Cd toxicity tests of data quality group and RI 1-3 used to calculate the HC5 (case-by-case geometric mean calculation; n = 44). Selected data and logistic distribution curve fitted on the data (figure taken from the RA Cd/CdO, ECB 2008). 183 xiii
Figure 7. Species diversity in the marine environment (from ECETOC 2001). The stars highlight taxonomic groups represented in the cadmium marine database. 186 xiii
Figure 8. Belgian Monitoring stations in the North Sea for coastal and open sea areas 312 xiii
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 3
Table 2. Constituents 3
Table 3. Impurities 3
1.3. Physico-chemical properties 3
Table 4. Overview of physico-chemical properties 3
2. MANUFACTURE AND USES 5
Table 5. Overview of quantities (in tonnes/year) 5
2.1. Manufacture 6
2.2. Identified uses 6
Table 6. Uses by workers in industrial settings 7
Table 7. Uses by professional workers 22
2.3. Uses advised against 26
3. CLASSIFICATION AND LABELLING 26
3.1. Classification and labelling according to CLP / GHS 26
3.2. Classification and labelling according to DSD / DPD 29
3.2.1. Classification and labelling in Annex I of Directive 67/548/EEC 29
3.2.2. Self classification(s) 30
3.2.3. Other classification(s) 30
4. ENVIRONMENTAL FATE PROPERTIES 30
4.1. Degradation 31
4.1.1. Abiotic degradation 31
4.1.1.1. Hydrolysis 31
4.1.1.2. Phototransformation/photolysis 31
4.1.1.2.1. Phototransformation in air 31
4.1.1.2.2. Phototransformation in water 31
4.1.1.2.3. Phototransformation in soil 32
4.1.2. Biodegradation 32
4.1.2.1. Biodegradation in water 32
4.1.2.1.1. Estimated data 32
4.1.2.1.2. Screening tests 32
4.1.2.1.3. Simulation tests (water and sediments) 32
4.1.2.1.4. Summary and discussion of biodegradation in water and sediment 32
4.1.2.2. Biodegradation in soil 32
4.1.3. Summary and discussion of degradation 32
4.2. Environmental distribution 33
4.2.1. Adsorption/desorption 34
4.2.2. Volatilisation 34
4.2.3. Distribution modelling 34
4.2.4. Summary and discussion of environmental distribution 35
4.3. Bioaccumulation 35
4.3.1. Aquatic bioaccumulation 35
Table 8. Freshwater BCF (L kg-1) reported in the EU risk assessment (ECB 2008; ) Table 3.2.34a) 35
Table 9. BAF values for whole body vertebrates (L kg-1). (from the EU RA: Table 3.2.34b) 37
Table 10. BAF values of some benthic organisms (from EU RA; table 3.2.40) 37
Table 11. Overview of studies on aquatic bioaccumulation 37
4.3.2. Terrestrial bioaccumulation 43
Table 12. bioaccumulation factors (BAF's) of soil dwelling organisms (from EU RA: table 3.2.37.). 43
Table 13. Overview of studies on terrestrial bioaccumulation 44
4.3.3. Summary and discussion of bioaccumulation 53
4.4. Secondary poisoning 55
Table 14. Kidney concentration in mammals and predicted critical soil concentrations at which the renal threshold for toxicity may be exceeded (after linear extrapolation of the critical soil levels (values taken from the RA Cd, (ECB 2008)) 56
4.5. Natural background 57
Table 15. Ambient background concentrations in Europe according to FOREGS (2006). 57
5. HUMAN HEALTH HAZARD ASSESSMENT 58
5.1. Toxicokinetics (absorption, metabolism, distribution and elimination) 59
5.2. Acute toxicity 60
5.2.1. Non-human information 60
5.2.1.1. Acute toxicity: oral 60
5.2.1.2. Acute toxicity: inhalation 61
5.2.1.3. Acute toxicity: dermal 63
5.2.1.4. Acute toxicity: other routes 63
5.2.2. Human information 63
5.2.3. Summary and discussion of acute toxicity 64
5.3. Irritation 65
5.3.1. Skin 65
5.3.1.1. Non-human information 65
5.3.1.2. Human information 65
5.3.2. Eye 65
5.3.3. Respiratory tract 65
5.3.4. Summary and discussion of irritation 65
5.4. Corrosivity 65
5.5. Sensitisation 65
5.5.1. Skin 65
5.5.1.1. Non-human information 66
5.5.1.2. Human information 66
5.5.2. Respiratory system 66
5.5.3. Summary and discussion of sensitisation 66
5.6. Repeated dose toxicity 67
5.6.1. Non-human information 67
5.6.1.1. Repeated dose toxicity: oral, inhalation and other 67
5.6.1.2. Repeated dose toxicity: dermal 74
5.6.2. Human information 74
5.6.3. Summary and discussion of repeated dose toxicity 78
5.7. Mutagenicity 79
5.7.1. Non-human information 79
5.7.1.1. In vitro data 79
Table 23. Overview of selected experimental in vitro genotoxicity studies 79
5.7.1.2. In vivo data 82
5.7.2. Human information 82
5.7.3. Summary and discussion of mutagenicity 86
5.8. Carcinogenicity 87
5.8.1. Non-human information 87
5.8.1.1. Carcinogenicity: oral 87
5.8.1.2. Carcinogenicity: inhalation 88
5.8.1.3. Carcinogenicity: dermal 92
5.8.1.4. Carcinogenicity: other routes 92
5.8.2. Human information 94
5.8.3. Summary and discussion of carcinogenicity 106
5.9. Toxicity for reproduction 107
5.9.1. Effects on fertility 107
5.9.1.1. Non-human information 107
5.9.1.2. Human information 113
5.9.2. Developmental toxicity 117
5.9.2.1. Non-human information 117
5.9.2.2. Human information 120
5.9.3. Summary and discussion of reproductive toxicity 123
5.10. Other effects 123
5.10.1. Non-human information 123
5.10.1.1. Neurotoxicity 123
5.10.1.2. Immunotoxicity 123
5.10.1.3. Specific investigations: other studies 124
5.10.2. Human information 124
5.10.3. Summary and discussion of specific investigations 124
5.11. Derivation of DNEL(s) / DMEL(s) 125
5.11.1. Overview of typical dose descriptors for all endpoints 125
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 129
6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES 132
6.1. Explosivity 132
6.2. Flammability 132
6.3. Oxidising potential 132
Table 39. Overview of information on oxidising potential 132
7. ENVIRONMENTAL HAZARD ASSESSMENT 133
7.1. Aquatic compartment (including sediment) 134
7.1.1. Toxicity test results 134
Table 42. 'Case-by-case”- selected NOEC data of effects of Cd in freshwater and case-by-case calculation of 'geometric mean NOEC's. Bold, underlined data are selected for the HC5 calculation. (after table 3.2.9C of the EU risk assessment). 137
Table 43. Endpoints selected for use in SSD for the derivation of marine PNEC for Cd. 141
Table 44. Summary statistics for the SSD on chronic NOEC values for cadmium in saltwater (n=50). 143
Table 45. Results of field experiments made on phytoplankton communities coming from various natural sea waters 144
7.1.1.1. Fish 144
7.1.1.1.1. Short-term toxicity to fish 144
Table 46. Overview of short-term effects on fish 144
7.1.1.1.2. Long-term toxicity to fish 147
Table 47. Overview of long-term effects on fish 147
7.1.1.2. Aquatic invertebrates 153
7.1.1.2.1. Short-term toxicity to aquatic invertebrates 153
Table 48. Overview of short-term effects on aquatic invertebrates 153
7.1.1.2.2. Long-term toxicity to aquatic invertebrates 156
Table 49. Overview of long-term effects on aquatic invertebrates 156
7.1.1.3. Algae and aquatic plants 174
Table 50. Overview of effects on algae and aquatic plants 174
7.1.1.4. Sediment organisms 179
Table 51. Overview of long-term effects on sediment organisms 179
7.1.1.5. Other aquatic organisms 180
Table 52. Overview of short-term effects on other aquatic organisms 180
7.1.2. Calculation of Predicted No Effect Concentration (PNEC) 182
7.1.2.1. PNEC freshwater 182
7.1.2.2. PNEC water Marine 184
Table 53. PNEC water 187
7.1.2.3. PNEC sediment 188
Table 54. PNEC sediment 197
7.2. Terrestrial compartment 198
7.2.1. Toxicity test results 198
7.2.1.1. Toxicity to soil macro-organisms 202
Table 56. Overview of effects on soil macro-organisms 202
7.2.1.2. Toxicity to terrestrial plants 206
Table 57. Overview of effects on terrestrial plants 206
7.2.1.3. Toxicity to soil micro-organisms 212
Table 58. Overview of effects on soil micro-organisms 212
7.2.1.4. Toxicity to other terrestrial organisms 215
7.2.2. Calculation of Predicted No Effect Concentration (PNEC soil) 215
Table 59. Summary statistics for the SSD on chronic NOEC values for cadmium in soil 216
7.3. Atmospheric compartment 219
7.4. Microbiological activity in sewage treatment systems 219
7.4.1. Toxicity to aquatic micro-organisms 220
7.4.2. PNEC for sewage treatment plant 220
7.5. Non compartment specific effects relevant for the food chain (secondary poisoning) 221
7.5.1. Toxicity to birds 221
Table 65. Overview of effects on birds 221
7.5.2. Toxicity to mammals 222
7.5.3. Calculation of PNECoral (secondary poisoning) 223
Table 66. PNEC oral 223
7.6. Conclusion on the environmental hazard assessment and on classification and labelling 223
8. PBT AND VPVB ASSESSMENT 223
8.1. Assessment of PBT/vPvB Properties 223
8.1.1. Summary and overall conclusions on PBT or vPvB properties 225
9. EXPOSURE ASSESSMENT (with local risk characterisation) 225
9.1. Local scenarios 226
9.1.1. GES CdO-0: Industrial use of primary or secondary cadmium-bearing raw material in the manufacture of CdO by several pyro-or hydrometallurgical processes, collection of the substance produced and packaging. 227
Table 70. Environmental risk characterisation for the scenario “industrial manufacture of CdO” 233
Table 71. Occupational exposure data for production of CdO 235
9.1.2 GES CdO-1: Industrial use of CdO in the formulation of preparations by mixing thoroughly, dry or in a solvent, the starting materials with potential process steps like coating, pressing, pelletizing, drying or sintering and packaging process steps 236
Table 72. GES CdO-1 236
Table 73. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of preparations for further downstream use. 242
Table 74. Exposure assessment for the industrial use of Cd0 for the manufacture of wet or dry preparations, based on recently reported exposure data. 244
Table 75. Occupational exposure data for the Industrial formulation of dry or wet preparations/mixtures by mixing thoroughly CdO with the other starting materials, with possible pressing, pelletising, sintering and packaging of the preparations/mixtures. 245
9.1.3. GES CdO-2: Industrial use of cadmium oxide or CdO-formulations in the manufacturing of other inorganic cadmium substances through different process routes, with potentially drying, calcining and packaging. 247
Table 77. Environmental risk characterisation for the scenario “industrial use of CdO for the manufacture of other cadmium compounds” (GES 2 CdO) 252
Table 78. Exposure assessment for the industrial use of CdO for the manufacture of other Cd-compounds, based on recently reported exposure data. 253
Table 79. Occupational exposure data from the industrial use of CdO for the manufacture of other Cd compounds in the battery and pigment manufacturing industry. 254
9.1.4. GES CdO-3: Industrial and professional use of CdO as active laboratory reagent in aqueous or organic media, for analysis or synthesis. 255
Table 81. Environmental release factors for the manufacture of different Cd compounds, to be used for industrial laboratories 262
Table 82. Exposure assessment and risk characterisation for the industrial and professional use of CdO in laboratory. 262
Table 83. Modelling* of occupational exposure data and risk characterisation for the Industrial and professional use of CdO and other Cd-compounds in the laboratory. 263
9.1.5. GES CdO-4: Industrial use of CdO or CdO-formulations as component for the manufacture of solid blends and matrices for further downstream use. 264
Table 85. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of dry preparations (solid blends) for further downstream use. 271
Table 86. Exposure assessment for the industrial use of CdO for the manufacture of dry preparations (solid blends), based on recently reported exposure data. 272
Table 87. Occupational exposure data for the Industrial formulation of dry preparations/mixtures by mixing thoroughly CdO with the other starting materials. 274
9.1.6. GES CdO-5: Industrial use of CdO or CdO-formulations as component for the manufacture of dispersions, pastes or other viscous or polymerized matrices for further downstream use. 275
Table 88. GES CdO-5 275
Table 89. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of liquid preparations for further downstream use. 282
Table 90. Exposure assessment for the industrial use of CdO for the manufacture of wet preparations, based on recently reported exposure data. 283
Table 91. Occupational exposure data for the Industrial formulation of wet preparations/mixtures by mixing thoroughly CdO with the other starting materials,. 285
9.1.7. GES CdO-6: Industrial and professional use of solid substrates containing less than 25%w/w of CdO. 286
9.1.8. GES CdO-7: Industrial and professional use of dispersions, pastes and polymerised substrates containing less than 5%w/w of CdO. 286
Table 93. Environmental risk characterisation for the Industrial and professional use of liquid substrates containing less than 25% w/w of CdO. 293
Table 94. Occupational exposure data for the Industrial and professional use of liquid substrates containing less than 25%w/w of CdO. 294
9.2. Consumer exposure 295
Table 95. Summary and conclusions of scenarios of potential consumer exposure (after the EU RA, ECB 2008). Uses indicated in italics indicate applications that have been stopped/changed or are new, as compared to the RA 297
9.3. Indirect exposure of humans via the environment 297
Table 96. Average Cd in ambient air concentrations (µg/m3) measured in the surroundings of Cd-producing plants in the EU (2003-2006). 299
Table 97. Biological indicators of Cd-exposure, measured on the general population living in the surroundings of a CdO producers (“central zone”), and a control group (“peripheral zone”) 299
Table 98. Estimated daily Cd uptake (µgCd/person.day) in children and adults through environmental exposure in areas at ambient Cd concentrations (scenario’s 0-2) and near point sources (scenario 3). Data based on the EU RA, but updates were made for ambient air levels in urban area and in the surroundings of point sources. 302
Table 99. Conversion of Cd daily intake in Cd-U for individuals indirectly exposed via the environment. 303
9.4. Regional exposure concentrations 303
9.4.1. Modelling approach: diffuse source analysis 304
Continental and regional releases and PEC calculations 304
Table 100. Overall Cd emissions to surface water and air (t/y). 304
Table 101. Annual Cd input into agricultural soils from the use of sludge on agricultural soils. 306
Table 102. Input data and results of the regional exposure assessment 308
9.4.2. Measured regional data in the environment 308
Table 106. Monitored sediment concentrations (mg Cd/kg dwt) in the Netherlands (2000, 2003 and 2006) 311
Table 107. Monitored sediment concentrations (mg Cd/kg dwt) in Belgium 312
Table 108. Monitored soil concentrations (mg Cd/kg dry wt) in Europe (EU RA (ECB 2008), table 3.3.7.) 313
9.4.3. Comparison of measured and calculated regional cadmium concentrations 313
Table 109. Regional cadmium concentrations in the environment (predicted vs measured) 314
10. RISK CHARACTERISATION 315
10.1. Local scenarios 315
10.1.1. Human health 315
10.1.1.1. Workers 315
10.1.1.2. Consumers 315
10.1.1.3. Indirect exposure of humans via the environment 316
Table 110. Risk characterization for the general population 317
10.1.2. Environment 318
10.2. Overall exposure (combined for all relevant emission/release sources) 318
10.2.1. Human health (combined for all exposure routes) 318
10.2.2. Environment (combined for all emission sources) 318
10.2.2.1. Risk characterisation based on modelled exposure 319
Table 111. Modelled PECadd values and risk characterisation for cadmium in the regional analysis. 319
10.2.2.2. Risk characterisation based on measured data 319
Table 112. Monitored PEC add values and risk characterisation for the EU freshwater 319
Table 113. Monitored PEC add values and risk characterisation for EU marine waters 320
Table 114. Monitored PEC add values and risk characterisation for EU sediment (freshwater and marine) 320
Table 115. Monitored PECvalues and risk characterisation for EU agricultural soils (arable land and grassland) 320
REFERENCES 322


List of Tables
Table 1. Substance identity 2
Table 2. Constituents 3
Table 3. Impurities 3
Table 4. Overview of physico-chemical properties 3
Table 5. Overview of quantities (in tonnes/year) 5
Table 6. Uses by workers in industrial settings 7
Table 7. Uses by professional workers 22
Table 8. Freshwater BCF (L kg-1) reported in the EU risk assessment (ECB 2008; ) Table 3.2.34a) 35
Table 9. BAF values for whole body vertebrates (L kg-1). (from the EU RA: Table 3.2.34b) 37
Table 10. BAF values of some benthic organisms (from EU RA; table 3.2.40) 37
Table 11. Overview of studies on aquatic bioaccumulation 37
Table 12. bioaccumulation factors (BAF's) of soil dwelling organisms (from EU RA: table 3.2.37.). 43
Table 13. Overview of studies on terrestrial bioaccumulation 44
Table 14. Kidney concentration in mammals and predicted critical soil concentrations at which the renal threshold for toxicity may be exceeded (after linear extrapolation of the critical soil levels (values taken from the RA Cd, (ECB 2008)) 56
Table 15. Ambient background concentrations in Europe according to FOREGS (2006). 57
Table 16. Water solubility of the eight cadmium compounds covered in this assessment 58
Table 17. Overview of selected experimental studies on acute toxicity after oral administration 60
Table 18. Overview of selected experimental studies on acute toxicity after inhalation exposure 62
Table 19. Overview of selected experimental studies on repeated dose toxicity after oral administration 67
Table 20. Overview of selected experimental studies on repeated dose toxicity after inhalation exposure 69
Table 21 . Overview of selected studies on repeated dose toxicity (other routes) 71
Table 22. Thresholds for renal effects in recent/relevant studies in occupational settings (inhalation exposure) (adapted from ‘Recommendation from the Scientific Expert Group on Occupational Exposure Limits for Cd and its inorganic compounds’ SCOEL/SUM/136) 75
Table 23. Overview of selected experimental in vitro genotoxicity studies 79
Table 24. Overview of selected exposure-related observations on genotoxicity in humans 82
Table 25. Overview of selected experimental studies on carcinogenicity after oral administration 88
Table 26. Overview of selected experimental studies on carcinogenicity after inhalation exposure 88
Table 27. Overview of selected experimental studies on carcinogenicity (other routes) 93
Table 28. Overview of selected exposure-related observations on carcinogenicity in humans 95
Table 29. Overview of selected experimental studies on male fertility and reproductive organs (oral route) 107
Table 30. Overview of selected experimental studies on female fertility and reproductive organs (oral route) 110
Table 31. Overview of selected exposure-related observations on toxicity to reproduction / fertility in humans 113
Table 32. Overview of selected experimental studies on developmental toxicity 117
Table 33. Overview of selected exposure-related observations developmental toxicity in humans 120
Table 34. Available dose-descriptor(s) per endpoint for water-soluble cadmium compounds (cadmium nitrate, chloride and sulphate) 125
Table 35. Available dose-descriptor(s) per endpoint for slightly soluble cadmium compounds (i.e. cadmium metal, oxide, hydroxide and carbonate) 127
Table 36. Derivation of cadmium DNEL biomonitoring for workers 129
Table 37. Derivation of cadmium DNEL general population based on animal data 131
Table 38. Derivation of cadmium DNEL general population based on general population monitoring data 131
Table 39. Overview of information on oxidising potential 132
Table 40. Acute aquatic toxicity of cadmium by species as a function of pH and hardness. 135
Table 41. Lowest acute aquatic toxicity data observed for cadmium 136
Table 42. 'Case-by-case”- selected NOEC data of effects of Cd in freshwater and case-by-case calculation of 'geometric mean NOEC's. Bold, underlined data are selected for the HC5 calculation. (after table 3.2.9C of the EU risk assessment). 137
Table 43. Endpoints selected for use in SSD for the derivation of marine PNEC for Cd. 141
Table 44. Summary statistics for the SSD on chronic NOEC values for cadmium in saltwater (n=50). 143
Table 45. Results of field experiments made on phytoplankton communities coming from various natural sea waters 144
Table 46. Overview of short-term effects on fish 144
Table 47. Overview of long-term effects on fish 147
Table 48. Overview of short-term effects on aquatic invertebrates 153
Table 49. Overview of long-term effects on aquatic invertebrates 156
Table 50. Overview of effects on algae and aquatic plants 174
Table 51. Overview of long-term effects on sediment organisms 179
Table 52. Overview of short-term effects on other aquatic organisms 180
Table 53. PNEC water 187
Table 54. PNEC sediment 197
Table 55. Summary table of species geometric mean NOECs for the most sensitive endpoints of plants and invertebrates used in the SSD. New species to the ones mentioned in the RA or species for which new information was found are highlighted in bold. The newly added individual NOECs are underlined in the last column. 200
Table 56. Overview of effects on soil macro-organisms 202
Table 57. Overview of effects on terrestrial plants 206
Table 58. Overview of effects on soil micro-organisms 212
Table 59. Summary statistics for the SSD on chronic NOEC values for cadmium in soil 216
Table 60. Phytotoxicity of Cd salts in field trials (from Cd RA, 2008) 218
Table 61. Chronic long term field NOEC values taken from table 57. 218
Table 62. PNEC soil 219
Table 63. Overview of effects on micro-organisms 220
Table 64. PNEC sewage treatment plant 220
Table 65. Overview of effects on birds 221
Table 66. PNEC oral 223
Table 67. Generic exposure scenarios for cadmium oxide 226
Table 68. Identified uses for CdO and corresponding Generic Exposure Scenario (GES) 227
Table 69. GES CdO-0 228
Table 70. Environmental risk characterisation for the scenario “industrial manufacture of CdO” 233
Table 71. Occupational exposure data for production of CdO 235
Table 72. GES CdO-1 236
Table 73. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of preparations for further downstream use. 242
Table 74. Exposure assessment for the industrial use of Cd0 for the manufacture of wet or dry preparations, based on recently reported exposure data. 244
Table 75. Occupational exposure data for the Industrial formulation of dry or wet preparations/mixtures by mixing thoroughly CdO with the other starting materials, with possible pressing, pelletising, sintering and packaging of the preparations/mixtures. 245
Table 76. GES CdO-2 247
Table 77. Environmental risk characterisation for the scenario “industrial use of CdO for the manufacture of other cadmium compounds” (GES 2 CdO) 252
Table 78. Exposure assessment for the industrial use of CdO for the manufacture of other Cd-compounds, based on recently reported exposure data. 253
Table 79. Occupational exposure data from the industrial use of CdO for the manufacture of other Cd compounds in the battery and pigment manufacturing industry. 254
Table 80. GES CdO-3 255
Table 81. Environmental release factors for the manufacture of different Cd compounds, to be used for industrial laboratories 262
Table 82. Exposure assessment and risk characterisation for the industrial and professional use of CdO in laboratory. 262
Table 83. Modelling* of occupational exposure data and risk characterisation for the Industrial and professional use of CdO and other Cd-compounds in the laboratory. 263
Table 84. GES CdO-4 264
Table 85. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of dry preparations (solid blends) for further downstream use. 271
Table 86. Exposure assessment for the industrial use of CdO for the manufacture of dry preparations (solid blends), based on recently reported exposure data. 272
Table 87. Occupational exposure data for the Industrial formulation of dry preparations/mixtures by mixing thoroughly CdO with the other starting materials. 274
Table 88. GES CdO-5 275
Table 89. Environmental risk characterisation for the Industrial use of CdO as component for the manufacture of liquid preparations for further downstream use. 282
Table 90. Exposure assessment for the industrial use of CdO for the manufacture of wet preparations, based on recently reported exposure data. 283
Table 91. Occupational exposure data for the Industrial formulation of wet preparations/mixtures by mixing thoroughly CdO with the other starting materials,. 285
Table 92. GES CdO-7 287
Table 93. Environmental risk characterisation for the Industrial and professional use of liquid substrates containing less than 25% w/w of CdO. 293
Table 94. Occupational exposure data for the Industrial and professional use of liquid substrates containing less than 25%w/w of CdO. 294
Table 95. Summary and conclusions of scenarios of potential consumer exposure (after the EU RA, ECB 2008). Uses indicated in italics indicate applications that have been stopped/changed or are new, as compared to the RA 297
Table 96. Average Cd in ambient air concentrations (µg/m3) measured in the surroundings of Cd-producing plants in the EU (2003-2006). 299
Table 97. Biological indicators of Cd-exposure, measured on the general population living in the surroundings of a CdO producers (“central zone”), and a control group (“peripheral zone”) 299
Table 98. Estimated daily Cd uptake (µgCd/person.day) in children and adults through environmental exposure in areas at ambient Cd concentrations (scenario’s 0-2) and near point sources (scenario 3). Data based on the EU RA, but updates were made for ambient air levels in urban area and in the surroundings of point sources. 302
Table 99. Conversion of Cd daily intake in Cd-U for individuals indirectly exposed via the environment. 303
Table 100. Overall Cd emissions to surface water and air (t/y). 304
Table 101. Annual Cd input into agricultural soils from the use of sludge on agricultural soils. 306
Table 102. Input data and results of the regional exposure assessment 308
Table 103. Monitored Cd concentrations in regional waters in EU countries (90P values); After table 3.3.3. of the Cd RA, ECB 2008. 310
Table 104. Monitored dissolved cadmium concentrations (µg Cd/l) in coastal waters and open sea of the Netherlands (2007-2009) 310
Table 105. Monitored dissolved cadmium concentrations (µg Cd/l) in coastal waters and open sea of Belgium (1995-1998) 311
Table 106. Monitored sediment concentrations (mg Cd/kg dwt) in the Netherlands (2000, 2003 and 2006) 311
Table 107. Monitored sediment concentrations (mg Cd/kg dwt) in Belgium 312
Table 108. Monitored soil concentrations (mg Cd/kg dry wt) in Europe (EU RA (ECB 2008), table 3.3.7.) 313
Table 109. Regional cadmium concentrations in the environment (predicted vs measured) 314
Table 110. Risk characterization for the general population 317
Table 111. Modelled PECadd values and risk characterisation for cadmium in the regional analysis. 319
Table 112. Monitored PEC add values and risk characterisation for the EU freshwater 319
Table 113. Monitored PEC add values and risk characterisation for EU marine waters 320
Table 114. Monitored PEC add values and risk characterisation for EU sediment (freshwater and marine) 320
Table 115. Monitored PECvalues and risk characterisation for EU agricultural soils (arable land and grassland) 320


List of Figures
Figure 1. The BCF values (L kg-1) of fish or fish tissues as a function of the Cd concentration in water (µg L-1). Data collated from experiments where solution Cd was artificially increased (Figure 3.2.10 of the EU risk assessment, ECB 2008) 36
Figure 2. The bioaccumulation factors (BAF kg kg-1) of earthworms as a function of the Cd concentration in soil (mg kg-1)(taken from the EU RA, figure 3.2.11) 44
Figure 3. Cumulative frequency of the critical soil Cd concentration at which the critical kidney Cd concentration (400µg/gDW) may be exceeded in the average population of different wildlife species (log-logistic curve fitting) 57
Figure 4. Illustration of Eurometaux/ICdA medical supervision guidance (2006)
(BI: biological indicators; C: creatinine) 130
Figure 5. Species sensitivity distribution of selected chronic marine Cd endpoints (n=47) 143
Figure 6. The cumulative frequency distribution of the NOEC values of Cd toxicity tests of data quality group and RI 1-3 used to calculate the HC5 (case-by-case geometric mean calculation; n = 44). Selected data and logistic distribution curve fitted on the data (figure taken from the RA Cd/CdO, ECB 2008). 183
Figure 7. Species diversity in the marine environment (from ECETOC 2001). The stars highlight taxonomic groups represented in the cadmium marine database. 186
Figure 8. Belgian Monitoring stations in the North Sea for coastal and open sea areas 312
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