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

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

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

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