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CHEMICAL SAFETY REPORT

Substance Name: diantimony trioxide

EC Number: 215-175-0

CAS Number: 1309-64-4

Registrant's Identity: Campine NV Lead Registrant of Diantimony

trioxide- JS ATO- i2a

Final Report

5th Revision

August 2014

EC number: Diantimony trioxide CAS number:

215-175-0 1309-64-4

Table of Contents

CHEMICAL SAFETY REPORT ........................................................................................................................... 1 Table of Contents..................................................................................................................................................ii List of Tables ......................................................................................................................................................... 9 List of figures ...................................................................................................................................................... 12 1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES ........................... 13

1.1. Name and other identifiers of the substance .............................................................................................. 13 1.2. Composition of the substance .................................................................................................................... 14 1.3. Physico-chemical properties ...................................................................................................................... 15

2. MANUFACTURE AND USES ....................................................................................................................... 19 2.1. Manufacture............................................................................................................................................... 19 2.2. Identified uses............................................................................................................................................ 19 2.3. Uses advised against .................................................................................................................................. 39

3. CLASSIFICATION AND LABELLING ......................................................................................................... 40 3.1. Classification and labelling according to CLP / GHS................................................................................ 40 3.2. Classification and labelling according to DSD / DPD ............................................................................... 49

3.2.1. Classification and labelling in Annex I of Directive 67/548/EEC ...................................................... 49 3.2.2. Self classification(s)............................................................................................................................ 54 3.2.3. Other classification(s) ......................................................................................................................... 54

4. ENVIRONMENTAL FATE PROPERTIES .................................................................................................... 55 4.1. Degradation ............................................................................................................................................... 57

4.1.1. Abiotic degradation ............................................................................................................................ 57 4.1.1.1. Hydrolysis.................................................................................................................................... 57 4.1.1.2. Phototransformation/photolysis ................................................................................................... 57

4.1.1.2.1. Phototransformation in air .................................................................................................... 57 4.1.1.2.2. Phototransformation in water................................................................................................ 57 4.1.1.2.3. Phototransformation in soil ................................................................................................... 57

4.1.2. Biodegradation.................................................................................................................................... 57 4.1.2.1. Biodegradation in water ............................................................................................................... 57

4.1.2.1.1. Estimated data....................................................................................................................... 57 4.1.2.1.2. Screening tests ...................................................................................................................... 57 4.1.2.1.3. Simulation tests (water and sediments)................................................................................. 57

4.1.2.2 Biodegradation in sediments......................................................................................................... 58 4.1.2.3. Summary and discussion of biodegradation in water and sediment ............................................ 58 4.1.2.4. Biodegradation in soil .................................................................................................................. 58

4.1.3. Summary and discussion of degradation ............................................................................................ 58 4.2. Environmental distribution ........................................................................................................................ 58

4.2.1. Adsorption/desorption ........................................................................................................................ 58 4.2.2. Volatilisation ...................................................................................................................................... 71 4.2.3. Distribution modelling........................................................................................................................ 71 4.2.4. Summary and discussion of environmental distribution ..................................................................... 71 4.2.5 Calculated and measured concentrations ............................................................................................. 71

4.2.5.1 Reasonable worst case ambient concentration .............................................................................. 72 4.2.5.2 Measured levels ............................................................................................................................ 72

4.2.5.2.1 Levels in surface water .......................................................................................................... 72 4.2.5.2.2 Levels in marine water........................................................................................................... 82 4.2.5.2.3 Levels in sediment ................................................................................................................. 84 4.2.5.2.4 Levels in marine sediments.................................................................................................... 90 4.2.5.2.5 WWTP levels ......................................................................................................................... 91 4.2.5.2.6 Levels in soil .......................................................................................................................... 92 4.2.5.2.7 Levels in air ......................................................................................................................... 107 4.2.5.3 Summary of the RWC-ambient concentration........................................................................ 109

4.3. Bioaccumulation ...................................................................................................................................... 110 4.3.1. Aquatic bioaccumulation .................................................................................................................. 110 4.3.2. Terrestrial bioaccumulation .............................................................................................................. 112 4.3.3. Summary and discussion of bioaccumulation................................................................................... 114

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4.4. Secondary poisoning................................................................................................................................ 117 5. HUMAN HEALTH HAZARD ASSESSMENT ............................................................................................ 118

5.1. Toxicokinetics (absorption, metabolism, distribution and elimination)................................................... 118 5.1.1. Non-human information ................................................................................................................... 118 5.1.2. Human information........................................................................................................................... 128 5.1.3. Summary and discussion of toxicokinetics....................................................................................... 134

5.2. Acute toxicity........................................................................................................................................... 138 5.2.1. Non-human information ................................................................................................................... 138

5.2.1.1. Acute toxicity: oral .................................................................................................................... 138 5.2.1.2. Acute toxicity: inhalation........................................................................................................... 139 5.2.1.3. Acute toxicity: dermal ............................................................................................................... 140 5.2.1.4. Acute toxicity: other routes........................................................................................................ 141

5.2.2. Human information........................................................................................................................... 141 5.2.3. Summary and discussion of acute toxicity........................................................................................ 141

5.3. Irritation ................................................................................................................................................... 143 5.3.1. Skin................................................................................................................................................... 143

5.3.1.1. Non-human information ............................................................................................................ 143 5.3.1.2. Human information.................................................................................................................... 143

5.3.2. Eye.................................................................................................................................................... 147 5.3.2.1. Non-human information ............................................................................................................ 147 5.3.2.2. Human information.................................................................................................................... 148

5.3.3. Respiratory tract ............................................................................................................................... 148 5.3.3.1. Non-human information ............................................................................................................ 148 5.3.3.2. Human information.................................................................................................................... 149

5.3.4. Summary and discussion of irritation ............................................................................................... 149 5.4. Corrosivity ............................................................................................................................................... 151

5.4.1 Non-human information .................................................................................................................... 151 5.4.2 Human information............................................................................................................................ 151 5.4.3 Summary and discussion of corrosion ............................................................................................... 151

5.5. Sensitisation............................................................................................................................................. 151 5.5.1. Skin................................................................................................................................................... 151

5.5.1.1. Non-human information ............................................................................................................ 151 5.5.1.2. Human information.................................................................................................................... 152

5.5.2. Respiratory system ........................................................................................................................... 153 5.5.2.1. Non-human information ............................................................................................................ 153 5.5.2.2. Human information.................................................................................................................... 153

5.5.3. Summary and discussion of sensitisation ......................................................................................... 153 5.6. Repeated dose toxicity ............................................................................................................................. 154

5.6.1. Non-human information ................................................................................................................... 154 5.6.1.1. Repeated dose toxicity: oral....................................................................................................... 154 5.6.1.2. Repeated dose toxicity: inhalation ............................................................................................. 156 5.6.1.3. Repeated dose toxicity: dermal.................................................................................................. 158 5.6.1.4 Repeated dose toxicity: other routes ........................................................................................... 158

5.6.2. Human information........................................................................................................................... 158 5.6.3. Summary and discussion of repeated dose toxicity .......................................................................... 167

5.7. Mutagenicity ............................................................................................................................................ 169 5.7.1. Non-human information ................................................................................................................... 169

5.7.1.1. In vitro data................................................................................................................................ 169 5.7.1.2. In vivo data ................................................................................................................................ 171

5.7.2. Human information........................................................................................................................... 173 5.7.3. Summary and discussion of mutagenicity ........................................................................................ 174

5.8. Carcinogenicity........................................................................................................................................ 174 5.8.1. Non-human information ................................................................................................................... 174

5.8.1.1. Carcinogenicity: oral.................................................................................................................. 174 5.8.1.2. Carcinogenicity: inhalation........................................................................................................ 175 5.8.1.3. Carcinogenicity: dermal............................................................................................................. 175 5.8.1.4. Carcinogenicity: other routes ..................................................................................................... 176

5.8.2. Human information........................................................................................................................... 176 5.8.3. Summary and discussion of carcinogenicity..................................................................................... 177

5.9. Toxicity for reproduction......................................................................................................................... 178

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5.9.1. Effects on fertility ............................................................................................................................. 178 5.9.1.1. Non-human information ............................................................................................................ 178 5.9.1.2. Human information.................................................................................................................... 183

5.9.2. Developmental toxicity..................................................................................................................... 183 5.9.2.1. Non-human information ............................................................................................................ 183 5.9.2.2. Human information.................................................................................................................... 186

5.9.3. Summary and discussion of reproductive toxicity ............................................................................ 186 5.10. Other effects........................................................................................................................................... 187

5.10.1. Non-human information ................................................................................................................. 187 5.10.1.1. Neurotoxicity ........................................................................................................................... 187 5.10.1.2. Immunotoxicity........................................................................................................................ 188 5.10.1.3. Specific investigations: other studies ....................................................................................... 188

5.10.2. Human information......................................................................................................................... 188 5.11. Derivation of DNEL(s) .......................................................................................................................... 190

5.11.1. Overview of typical dose descriptors for all endpoints................................................................... 190 5.11.2. Selection of the critical DNEL(s) ................................................................................................... 191

6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICO-CHEMICAL PROPERTIES...................... 195 6.1. Explosivity............................................................................................................................................... 195 6.2. Flammability............................................................................................................................................ 195 6.3. Oxidising potential................................................................................................................................... 196

7. ENVIRONMENTAL HAZARD ASSESSMENT.......................................................................................... 197 7.1. Aquatic compartment (including sediment)............................................................................................. 197

7.1.1. Toxicity test results........................................................................................................................... 197 7.1.1.1. Fish ............................................................................................................................................ 198

7.1.1.1.1. Short-term toxicity to fish................................................................................................... 198 7.1.1.1.2. Long-term toxicity to fish ................................................................................................... 201

7.1.1.2. Aquatic invertebrates ................................................................................................................. 204 7.1.1.2.1. Short-term toxicity to aquatic invertebrates ........................................................................ 204 7.1.1.2.2. Long-term toxicity to aquatic invertebrates ........................................................................ 209

7.1.1.3. Algae and aquatic plants ............................................................................................................ 211 7.1.1.4. Sediment organisms................................................................................................................... 215 7.1.1.5. Other aquatic organisms ............................................................................................................ 220

7.1.2. Calculation of Predicted No Effect Concentration (PNEC).............................................................. 220 7.1.2.1. PNEC water ............................................................................................................................... 220 7.1.2.2. PNEC sediment.......................................................................................................................... 221

7.2. Terrestrial compartment........................................................................................................................... 222 7.2.1. Toxicity test results........................................................................................................................... 222

7.2.1.1. Toxicity to soil macro-organisms .............................................................................................. 222 7.2.1.2. Toxicity to terrestrial plants ....................................................................................................... 231 7.2.1.3. Toxicity to soil micro-organisms ............................................................................................... 239 7.2.1.4. Toxicity to other terrestrial organisms ....................................................................................... 244

7.2.2. Calculation of Predicted No Effect Concentration (PNEC soil) ....................................................... 244 7.3. Atmospheric compartment....................................................................................................................... 245 7.4. Microbiological activity in sewage treatment systems ............................................................................ 245

7.4.1. Toxicity to aquatic micro-organisms ................................................................................................ 245 7.4.2. PNEC for sewage treatment plant..................................................................................................... 246

7.5. Non compartment specific effects relevant for the food chain (secondary poisoning) ............................ 247 7.5.1. Toxicity to birds................................................................................................................................ 247 7.5.2. Toxicity to mammals ........................................................................................................................ 247 7.5.3. Calculation of PNECoral (secondary poisoning).............................................................................. 247

7.6. Conclusion on the environmental hazard assessment and on classification and labelling ....................... 247 8. PBT AND VPVB ASSESSMENT ................................................................................................................. 249

8.1 Assessment of PBT/vPvB properties – comparison with the criteria of Annex XIII................................ 249 8.1.1 Persistence assessment....................................................................................................................... 250 8.1.2 Bioaccumulation assessment ............................................................................................................. 250 8.1.3 Toxicity assessment ........................................................................................................................... 250 8.1.4 Summary and overall conclusions on PBT or vPvB.......................................................................... 250

8.2 Emission characterisation ......................................................................................................................... 250 9. EXPOSURE ASSESSMENT ......................................................................................................................... 251

9.0.1 Methodology – occupational exposure .............................................................................................. 251

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9.0.1.1 Measured data ............................................................................................................................. 251 9.0.1.1.1 Inhalation exposure data ...................................................................................................... 251 9.0.1.1.2 Assessment of data quality and percentiles to be used......................................................... 252 9.0.1.1.3 Analysis of air monitoring data............................................................................................ 253

9.0.1.2 Analogous data ........................................................................................................................... 253 9.0.1.3 Modelled exposure...................................................................................................................... 254

9.0.2 Methodology - environmental exposure ............................................................................................ 254 9.0.3 Methodology – consumer exposure ................................................................................................... 256 9.0.4 Methodology - indirect exposure via the environment ...................................................................... 256

9.0.4.1 General remark ........................................................................................................................... 256 9.0.4.1. Source of literature and evaluation thereof .......................................................................... 257 9.0.4.2. Exposure from food ............................................................................................................. 258 9.0.4.3. Exposure via mother´s milk ................................................................................................. 258 9.0.4.4. Exposure via drinking water ................................................................................................ 259 9.0.4.5. Exposure via ambient air...................................................................................................... 259

9.1. Use of antimony metal in the production of diantimony trioxide ............................................................ 262 9.1.1. Exposure scenario............................................................................................................................. 262 9.1.2. Exposure estimation.......................................................................................................................... 267

9.1.2.1 Indirect exposure of humans via the environment (local) ........................................................... 267 9.1.2.2 Environmental exposure ............................................................................................................. 267

9.2. Use of diantimony trioxide in PET (films/fibres, resin) production ........................................................ 268 9.2.1. Exposure scenario............................................................................................................................. 268 9.2.2. Exposure estimation.......................................................................................................................... 274

9.2.2.1 Indirect exposure of humans via the environment (local)........................................................... 274 9.2.2.2 Environmental exposure ............................................................................................................. 275

9.3. Industrial use of diantimony trioxide in the plastics and rubber industry ................................................ 276 9.3.1. Exposure scenario............................................................................................................................. 276 9.3.2. Exposure estimation.......................................................................................................................... 282


9.4. Industrial use of diantimony trioxide in the manufacture of flame retarded textiles ............................... 284 9.4.1. Exposure scenario............................................................................................................................. 284 9.4.2. Exposure estimation.......................................................................................................................... 290


9.5. Industrial use of diantimony trioxide in the production of glass, enamels, functional ceramics and semi

conductors....................................................................................................................................................... 292 9.5.1. Exposure scenario............................................................................................................................. 292 9.5.2. Exposure estimation.......................................................................................................................... 300


9.6. Industrial use of diantimony trioxide in the production of pigments, paints, coatings, ceramics, brake pads and production and formulation of fine chemicals ......................................................................................... 301

9.6.1. Exposure scenario............................................................................................................................. 301 9.6.2. Exposure estimation.......................................................................................................................... 308


9.7. Industrial use of diantimony trioxide in wood adhesives......................................................................... 309 9.7.1. Exposure scenario............................................................................................................................. 309 9.7.2. Exposure estimation.......................................................................................................................... 313


9.8. Professional uses of diantimony trioxide preparations ............................................................................ 314 9.8.1. Exposure scenario............................................................................................................................. 314 9.8.2. Exposure estimation.......................................................................................................................... 318


9.9. Professional uses of diantimony trioxide contained in articles ................................................................ 319 9.9.1. Exposure scenario............................................................................................................................. 319 9.9.2. Exposure estimation.......................................................................................................................... 323

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9.10 Service life/Use of articles with diantimony trioxide being embedded into the matrix .......................... 324 9.10.1 Exposure Scenario ........................................................................................................................... 324 9.10.2 Exposure estimation......................................................................................................................... 327

9.10.2.1 Indirect exposure of humans via the environment (local) ......................................................... 327 9.10.2.2 Environmental exposure ........................................................................................................... 328

9.11 Service life/Use of back-coated textiles.................................................................................................. 328 9.11.1 Exposure scenario............................................................................................................................ 328 9.11.2 Exposure estimation......................................................................................................................... 332


9.12 Service life/Use, wearing of articles made of PET/PES polymers.......................................................... 333 9.12.1 Exposure scenario............................................................................................................................ 333 9.12.2 Exposure estimation......................................................................................................................... 336


9.13 Service life/ Wearing of clothes containing antimony trioxide for fire resistance .................................. 338 9.13.1 Exposure scenario............................................................................................................................ 338 9.13.2 Exposure estimation......................................................................................................................... 340


9.14 Regional exposure concentrations .......................................................................................................... 341 9.14.1 Indirect exposure of humans via the environment (regional) .......................................................... 341 9.14.2 Regional environmental exposure ................................................................................................... 342

10. RISK CHARACTERISATION .................................................................................................................... 342 10.1. Use of antimony metal in the production of diantimony trioxide .......................................................... 342

10.1.1. Human Health................................................................................................................................. 342 10.1.1.1. Workers.................................................................................................................................... 342 10.1.1.2. Consumers ............................................................................................................................... 342 10.1.1.3. Indirect exposure to humans via the environment ................................................................... 342

10.1.2. Environment ................................................................................................................................... 343 10.1.2.1. Aquatic compartment (including sediment)............................................................................. 343 10.1.2.2. Terrestrial compartment........................................................................................................... 343 10.1.2.3. Atmospheric compartment....................................................................................................... 343 10.1.2.4. Microbiological activity in sewage treatment systems ............................................................ 343

10.2. Use of diantimony trioxide in PET (films/fibres, resin) production ...................................................... 343 10.2.1. Human Health................................................................................................................................. 343

10.2.1.1. Workers.................................................................................................................................... 343 10.2.1.2. Consumers ............................................................................................................................... 343 10.2.1.3. Indirect exposure to humans via the environment ................................................................... 343


10.3. Industrial use of diantimony trioxide in the plastics and rubber industry .............................................. 344 10.3.1. Human Health................................................................................................................................. 344



10.4. Industrial use of diantimony trioxide in the manufacture of flame retarded textiles ............................. 345 10.4.1. Human Health................................................................................................................................. 345

10.4.1.1. Workers.................................................................................................................................... 345 10.4.1.2. Consumers ............................................................................................................................... 345

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10.4.1.3. Indirect exposure to humans via the environment ................................................................... 345 10.4.2. Environment ................................................................................................................................... 345

10.4.2.1. Aquatic compartment (including sediment)............................................................................. 345 10.4.2.2. Terrestrial compartment........................................................................................................... 345 10.4.2.3. Atmospheric compartment....................................................................................................... 345 10.4.2.4. Microbiological activity in sewage treatment systems ............................................................ 345

10.5. Industrial use of diantimony trioxide in the production of glass, enamels, functional ceramics and semi

conductors....................................................................................................................................................... 345 10.5.1. Human Health................................................................................................................................. 345



10.6. Industrial use of diantimony trioxide in the production of pigments, paints, coatings, ceramics, brake

pads and production and formulation of fine chemicals ................................................................................. 346

10.6.1. Human Health................................................................................................................................. 346 10.6.1.1. Workers.................................................................................................................................... 346 10.6.1.2. Consumers ............................................................................................................................... 347 10.6.1.3. Indirect exposure to humans via the environment ................................................................... 347


10.7. Industrial use of diantimony trioxide in wood adhesives....................................................................... 347 10.7.1. Human Health................................................................................................................................. 347



10.8. Professional uses of diantimony trioxide preparations .......................................................................... 348 10.8.1. Human Health................................................................................................................................. 348



10.9. Professional uses of diantimony trioxide containing articles ................................................................. 349 10.9.1. Human Health................................................................................................................................. 349



10.10. Service life/Use of articles with diantimony trioxide being embedded into the matrix ....................... 350 10.10.1. Human Health............................................................................................................................... 350

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10.10.1.1. Workers.................................................................................................................................. 350 10.10.1.2. Consumers ............................................................................................................................. 350 10.10.1.3. Indirect exposure to humans via the environment ................................................................. 350

10.10.2. Environment ................................................................................................................................. 350 10.10.2.1. Aquatic compartment (including sediment)........................................................................... 350 10.10.2.2. Terrestrial compartment......................................................................................................... 350 10.10.2.3. Atmospheric compartment..................................................................................................... 350 10.10.2.4. Microbiological activity in sewage treatment systems .......................................................... 350

10.11. Service life/Use of back-coated textiles............................................................................................... 350 10.11.1. Human Health............................................................................................................................... 350



10.12. Service life/Use, wearing of articles made of PET/PES polymers....................................................... 351 10.12.1. Human Health............................................................................................................................... 351



10.13. Service life/ Wearing of clothes containing antimony trioxide for fire resistance ............................... 352 10.13.1. Human Health............................................................................................................................... 352



10.14. Overall exposure (combined for all relevant emission/release sources) .............................................. 352 REFERENCES ................................................................................................................................................... 353 Abbreviations ..................................................................................................................................................... 376 Appendix I: Measured data on dietary intake of antimony................................................................................. 382 Appendix II: Literature search............................................................................................................................ 390

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List of Tables Table 1. Substance identity ..................................................................................................................................................13 Table 2. Constituents Diantimony trioxide (Representative sample) ...................................................................................14 Table 3. Impurities Diantimony trioxide (Representative sample) ......................................................................................14 Table 4. Constituents Diantimony trioxide - Composition medium PbO.............................................................................14 Table 5. Impurities Diantimony trioxide - Composition medium PbO ................................................................................14 Table 6. Constituents ...........................................................................................................................................................15 Table 7. Impurities...............................................................................................................................................................15 Table 8. Overview of physico-chemical properties..............................................................................................................15 Table 9. Uses by workers in industrial settings....................................................................................................................20 Table 10. Uses by professional workers .............................................................................................................................................................................................Erro r! Bookmark not defined. Table 11. Waste types, amounts and waste treatment processes for antimony from manufacturing .........................36

Table 13. Waste types, amounts and treatment of waste from service life sated subsequent to the identified uses for Table 12. Waste types, amounts and waste treatment processes for antimony from identified uses .........................37

antimony from identified uses...........................................................................................................................................37 Table 14:Overview of studies on adsorption/desorption ......................................................................................................58 Table 15: Concentrations of Sb in European stream water according to FOREGS http://www.gsf.fi/publ/foregsatlas/article.php?id=15...........................................................................................................72 Table 16:Measured antimony concentrations in European rivers. .......................................................................................73 Table 17:Measured antimony concentrations in European lakes. ........................................................................................77 Table 18: Measured antimony concentrations in European groundwaters. ..........................................................................79 Table 19:Measured antimony concentrations in European snow and rain water. ................................................................80 Table 20: Calculation of RWC-ambient PEC for antimony in freshwater. Country-specific 90P FOREGS data are included for comparative purposes only. ............................................................................................................................................81 Table 21: Measured antimony concentrations in marine waters adjacent to Europe............................................................82 Table 22: Concentrations of Sb in European stream sediment according to FOREGS

(http://www.gsf.fi/publ/foregsatlas/article.php?id=15). .......................................................................................................84 Table 23: Measured antimony concentrations in European sediments.................................................................................85 Table 24: Calculation of RWC-ambient PEC for antimony in freshwater sediments. Country specific 90P FOREGS data are included for comparative purposes only. .............................................................................................................................89 Table 25: Measured antimony concentrations in marine sediments.....................................................................................90 Table 26: Measured antimony concentrations in European wastewater treatment plants. ...................................................92 Table 27: Concentrations of Sb in European topsoil according to FOREGS

http://www.gsf.fi/publ/foregsatlas/article.php?id=15). ........................................................................................................92 Table 28: Concentrations of Sb in European subsoil according to FOREGS

http://www.gsf.fi/publ/foregsatlas/article.php?id=15). ........................................................................................................92 Table 29: Measured antimony concentrations in European soils. ........................................................................................94 Table 30: Monitored concentrations of antimony in agricultural soils.................................................................................103 Table 31: Monitored concentrations of antimony in grazing soils .......................................................................................103 Table 32: Calculation of RWC-ambient PEC for antimony in soil. Country specific 90P FOREGS data are included for

comparative purposes only. .................................................................................................................................................106 Table 33: Measured antimony concentrations in European air. ...........................................................................................107 Table 34: Ambient background concentrations of antimony in the environment.................................................................109 Table 35: Overview of studies on aquatic bioaccumulation.................................................................................................110 Table 36: Overview of studies on terrestrial bioaccumulation .............................................................................................112 Table 37. Overview of experimental studies on absorption, metabolism, distribution and elimination ...............................118 Table 38. Overview of exposure-related observations on basic toxicokinetics and/or dermal absorption in humans..........128 Table 39. Overview of experimental studies on acute toxicity after oral administration .....................................................138 Table 40. Overview of experimental studies on acute toxicity after inhalation exposure ....................................................139 Table 41. Overview of experimental studies on acute toxicity after dermal administration ................................................140 Table 42. Overview of exposure-related observations on acute toxicity in humans ............................................................141 Table 43: Overview of experimental studies on skin irritation ............................................................................................143 Table 44. Overview of exposure-related observations on skin irritation in humans ............................................................143 Table 45. Overview of experimental studies on eye irritation .............................................................................................147 Table 46. Overview of exposure-related observations on eye irritation in humans .............................................................148 Table 47. Overview of exposure-related observations on respiratory irritation in humans..................................................149 Table 48. Overview of experimental studies on skin sensitisation.......................................................................................151 Table 49. Overview of exposure-related observations on skin sensitisation in humans.......................................................152 Table 50. Overview of experimental studies on repeated dose toxicity after oral administration ........................................154 Table 51. Overview of experimental studies on repeated dose toxicity after inhalation exposure .......................................156 Table 52. Overview of exposure-related observations on repeated dose toxicity in humans ...............................................159

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Table 53. Overview of experimental in vitro genotoxicity studies ......................................................................................169 Table 54. Overview of experimental in vivo genotoxicity studies .......................................................................................171 Table 55. Overview of exposure-related observations on genotoxicity in humans ..............................................................173 Table 56. Overview of experimental studies on carcinogenicity after inhalation exposure .................................................175 Table 57. Overview of exposure-related observations on carcinogenicity in humans .........................................................176 Table 58. Overview of experimental studies on fertility ......................................................................................................179 Table 59. Overview of experimental studies on developmental toxicity .............................................................................183 Table 60. Overview of exposure-related observations: endpoint not specified ....................................................................188 Table 61. Available dose-descriptor(s) per endpoint for the submission substance as a result of its hazard assessment .....190 Table 62. DNELs for workers..............................................................................................................................................191 Table 63. DNELs for the general population .......................................................................................................................193 Table 64: Overview of short-term effects on fish ................................................................................................................198 Table 65: Overview of long-term effects on fish .................................................................................................................201 Table 66: Overview of short-term effects on aquatic invertebrates .....................................................................................204 Table 67: Overview of long-term effects on aquatic invertebrates ......................................................................................209 Table 68: Overview of effects on algae and aquatic plants ..................................................................................................211 Table 69: Inhibition of the growth rate of Pseudokirchneriella subcapitata due to exposure to Sb2O3(LISEC, 2001). ......214 Table 70: Overview of long-term effects on sediment organisms........................................................................................215 Table 71: PNEC water .........................................................................................................................................................220 Table 72: PNEC sediment....................................................................................................................................................221 Table 73: Overview of effects on soil macro-organisms......................................................................................................222 Table 74: Overview of effects on terrestrial plants ..............................................................................................................231 Table 75: Overview of effects on soil micro-organisms ......................................................................................................239 Table 76: PNEC soil ............................................................................................................................................................245 Table 77: Overview of effects on micro-organisms .............................................................................................................246 Table 78: PNEC sewage treatment plant .............................................................................................................................246 Table 79: The criteria set out under REACH Annex XIII for determining whether a substance is PBT/vPvB. ..................249 Table 80: Quality assessment of measured data...................................................................................................................252 Table 81: Analysis of personal air monitoring measurements [mg Sb2O3/m³].....................................................................253 Table 82: Use of analogous data in occupational exposure scenarios for diantimony trioxide ............................................253 Table 83: Input parameters for environmental modelling of diantimony trioxide ...............................................................255 Table 84: Overview on exposure scenarios and coverage of substance life cycle ...............................................................260 Table 85: Concentration and risk characterization for local exposure of humans via the environment ...............................267 Table 86: Risk characterisation for the soil, sediment and water compartments .............................................................................................................................................................................................Erro r! Bookmark not defined. Table 87: Concentration and risk characterization for local exposure of humans via the environment ...............................274 Table 88: Risk characterisation for the soil, sediment and water compartments .............................................................................................................................................................................................Erro r! Bookmark not defined. Table 89: Concentration and risk characterization for local exposure of humans via the environment ...............................282 Table 90: Risk characterisation for the soil, sediment and water compartments..................................................................283 Table 91: Concentration and risk characterization for local exposure of humans via the environment ...............................290 Table 92: Risk characterisation for the soil, sediment and water compartments .............................................................................................................................................................................................Erro r! Bookmark not defined. Table 93: Concentration and risk characterization for local exposure of humans via the environment ...............................300 Table 94: Risk characterisation for the soil, sediment and water compartments .............................................................................................................................................................................................Erro r! Bookmark not defined. Table 95: Concentration and risk characterization for local exposure of humans via the environment ...............................308 Table 96: Risk characterisation for the soil, sediment and water compartments .............................................................................................................................................................................................Erro r! Bookmark not defined. Table 97: Concentration and risk characterization for local exposure of humans via the environment ...............................313 Table 98: Risk characterisation for the soil, sediment and water compartments..................................................................313 Table 99: Concentration and risk characterization for local exposure of humans via the environment ...............................318 Table 100: Risk characterisation for the soil, sediment and water compartments................................................................318 Table 101: Concentration and risk characterization for local exposure of humans via the environment .............................323 Table 102: Risk characterisation for the soil, sediment and water compartments................................................................323 Table 103: Concentration and risk characterization for local exposure of humans via the environment .............................327 Table 104: Risk characterisation for the soil, sediment and water compartments................................................................328 Table 105: Concentration and risk characterization for local exposure of humans via the environment .............................332 Table 106: Risk characterisation for the soil, sediment and water compartments................................................................332 Table 107: Concentration and risk characterization for local exposure of humans via the environment .............................336 Table 108: Risk characterisation for the soil, sediment and water compartments................................................................336 Table 109: Concentration and risk characterization for local exposure of humans via the environment .............................340



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Table 110: Risk characterisation for the soil, sediment and water compartments................................................................340 Table 111: Regional exposure concentrations .....................................................................................................................341 Table 112: Regional concentrations in food and drinking water and risk characterization for exposure of humans via the environment .........................................................................................................................................................................341 Table 113: Risk characterisation for the soil, sediment and water compartments................................................................342 Table 114: Literature on dietary intake of antimony............................................................................................................382



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List of figures

Figure 1: FOREGs map showing measured concentrations of Sb in European stream water

(http://www.gsf.fi/publ/foregsatlas/maps/Water/w_icpms_sb_edit.pdf)..............................................................................73 Figure 2: FOREGs map showing measured concentrations of Sb (mg/kg dw) in European stream sediment

(http://www.gsf.fi/publ/foregsatlas/maps/StreamSed/s_icpms_sb_edit.pdf)........................................................................85 Figure 3: FOREGs map showing measured concentrations of Sb (mg/kg dw) in European top soil (http://www.gsf.fi/publ/foregsatlas/maps/Topsoil/t_icpms_sb_edit.pdf). ............................................................................93 Figure 4: GEMAS map showing measured concentrations of Sb (mg/kg) in European agricultural soil ............................105 Figure 5: GEMAS map showing measured concentrations of Sb (mg/kg) in European grazing land soil ...........................106



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Part B

Introductory note: The scientific background of this chemical safety report has largely been adopted from the European Union Risk

Assessment Report for Diantimony trioxide which has been carried out in accordance with Council Regulation

(EEC) 793/93 on the evaluation and control of the risks of “existing” substances. The report was finalised in 2008 and is publicly available via the following link: (http://esis.jrc.ec.europa.eu/doc/existing

chemicals/risk_assessment/REPORT/datreport415.pdf)

1. IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL

PROPERTIES

1.1. Name and other identifiers of the substance

The substance diantimony trioxide is a mono constituent substance (origin: inorganic) having the following

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

The following public name is used: Diantimony trioxide.

Table 1. Substance identity

EC number: 215-175-0

EC name: diantimony trioxide

CAS number (EC inventory): 1309-64-4

CAS name: diantimony trioxide

IUPAC name: dioxodistiboxane

Description: white powder

Annex I index number: 051-005-00-X

Molecular formula: Sb2O3

Molecular weight range: 291.5182

Structural formula:


http://esis.jrc.ec.europa.eu/doc/existing


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1.2. Composition of the substance

Name: Diantimony trioxide (Representative sample)

Description: inorganic trivalent antimony compound

Degree of purity: > 98.0 — 98.0 —


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other impurities 97.0 — 97.0 — = 0.3 — < 2.5 % (w/w) Impurity is relevant for C&L of the substance.

other impurities


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Vapour pressure Antimony trioxide has a vapour pressure of

1mm Hg at 574° C.

Value used for CSA: 133 Pa at 574° C

Water solubility Dissolved concentration of 370 ± 37 µg/L

was obtained with a loading of 10 mg/L

after 7 days of exposure. Temperature

varied between 20.8° C (t=0; start of the

test) and 22.9° C (please refer to the

IUCLID endpoint study records for

additional information)

Granulometry Particle size 0.2-44µm

The median particle size of the test items

are (please refer to the IUCLID endpoint

study records for further information):

Antimony Trioxide "A": 5.8 µm

Antimony Trioxide "B": 1.2 µm

Antimony Trioxide "C": 0.8 µm

Diantimony trioxide "1": 3.1 µm





Data waiving

Information requirement: Surface tension

Reason: other justification

Justification: This study only needs to be conducted if based on the structure surface activity is expected or

can be predicted, which is not the case for this substance: diantimony trioxide is a solid inorganic substance

of very low water solubility, yielding dissociated antimony aqua-complexes. Neither the dissolved antimony

aqua complexes nor the anions are expected to exert any surface active properties. Furthermore, the study

does not need to be conducted if the water solubility is below 1 mg/L at 20°C (cf. Annex VII section 7.6

Column 2 of regulation (EC) 1907/2006).

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


Justification: This study does not need to be conducted for inorganic substances (cf. Annex VII section 7.8

Column 2 of regulation 1907/2006).

Information requirement: Flash point


Justification: This study is only relevant for liquids or low melting point solids, which is not the case for

this substance. Further, this study does not need to be conducted for inorganic substances (cf. Annex VII

section 7.9 Column 2 of regulation (EC) 1907/2006).

Information requirement: Flammability / pyrophoric properties

Reason: study scientifically unjustified

Justification: Testing diantimony trioxide for pyrophoric properties of solids is considered unwarranted,

since this substance is stable at ambient temperature and does not contain any chemical groups that might

lead to spontaneous ignition a short time after coming in contact with air at room temperature (circa 20°C).

Furthermore, long-term industrial experience in handling shows that the substance does not ignite in contact

with air (in accordance with section 1 of REACH Annex XI).



215-175-0 1309-64-4

Thus diantimony trioxide can be designated as non-flammable.

Information requirement: Flammability in contact with water


Justification: Testing for flammability in contact with water is not considered to be required, because the

substance does not contain groups that might lead to a reaction with water or damp air, leading to the

development of dangerous amounts of gas or gases which may be highly flammable. Furthermore, long-term

industrial experience in practical handling of the substance shows that it does not react with water, and

recent experimental testing for water solubility has also not reported any formation of gases (in accordance

with section 1 of REACH Annex XI).

Thus Diantimony trioxide can be designated as non-flammable.

Information requirement: Flammability: further reaction with oxygen


Justification: Diantimony trioxide is already in a high oxidation state (+III), so that further reaction with

oxygen in the sense of combustion that would be of relevance for flammability is highly unlikely.

Thus diantimony trioxide can be designated as non-flammable.

Information requirement: Explosive properties


Justification: This substance is void of any chemical structures commonly associated with explosive

properties, such as metal peroxides, peroxo-acid-anions, azides, and halogen oxides. Further, it is noted that

despite long-term industrial use of the substance, it is not classified for explosive properties according to UN

transport regulations (in accordance with section 1 of REACH Annex XI).

Diantimony trioxide exhibits no chemical groups indicating explosive properties (e. g. peroxide). Therefore,

diantimony trioxide can be designated as non explosive.

Information requirement: Self-ignition temperature


Justification: Self-ignition is not considered to be of relevance for this substance, since this would require

heat to be developed either by reaction of this substance with oxygen or by exothermic decomposition and

which is not lost rapidly enough to the surroundings. In conclusion, the conduct of further experimental

verification is not considered to be required (in accordance with section 1 of REACH Annex XI).

Information requirement: Oxidising properties


Justification: This test item does not contain a surplus of oxygen or any structural groups known to be

correlated with a tendency to react exothermally with combustible material (cf. Annex VII section 7.13 Column 2 of regulation 1907/2006).

Diantimony trioxide is a chemically inert substance. Based on the chemical structure it can be concluded that

oxygen is not released. Therefore diantimony trioxide can be designated as a non-oxidising substance.

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


Justification: This study does not need to be conducted for inorganic substances (cf. Annex IX section 7.15

Column 2 of regulation (EC) 1907/2006).



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Information requirement: Dissociation constant


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

The substance does not contain relevant functional groups for which an assessment of the dissociation

behaviour would provide information for risk assessment purposes. Therefore, the determination of a

dissociation constant is not considered to be required (Guidance on information requirements and chemical

safety assessment Chapter R.7a: Endpoint specific guidance, section R.7.1.17.1).

Information requirement: Viscosity


Justification: Viscosity is a property of fluids. Since diantimony trioxide is a solid at ambient temperature

(ca. 20° C) such a study does not need to be conducted for this substance (melting point:656° C) (in

accordan

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