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Draft Support Document Substance 1,6,7,8,9,14,15,16,17,17,18,18- Name: Dodecachloropentacyclo[12.2.1.16,9. 02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) [covering any of its individual anti- and syn- isomers or any combination thereof] EC Numbers: 236-948-9; -; - CAS Numbers: 13560-89-9; 135821-74-8; 135821- 03-3 MEMBER STATE COMMITTEE SUPPORT DOCUMENT FOR IDENTIFICATION OF 1,6,7,8,9,14,15,16,17,17,18,18- DODECACHLOROPENTACYCLO[12.2.1.16,9.02,13.05,10]O CTADECA-7,15-DIENE (“DECHLORANE PLUS”TM) [COVERING ANY OF ITS INDIVIDUAL ANTI- AND SYN-ISOMERS OR ANY COMBINATION THEREOF] AS A SUBSTANCE OF VERY HIGH CONCERN BECAUSE OF ITS vPvB1 PROPERTIES (ARTICLE 57(E)) Adopted on 30 November 2017 1 vPvB means very persistent and very bioaccumulative SVHC SUPPORT DOCUMENT - DECHLORANE PLUS TM CONTENTS IDENTIFICATION OF A SUBSTANCE OF VERY HIGH CONCERN ON THE BASIS OF THE CRITERIA SET OUT IN REACH ARTICLE 57 ..................................................... 5 JUSTIFICATION .................................................................................................... 7 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES ....... 8 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE .............................................. 8 1.3 IDENTITY AND COMPOSITION OF DEGRADATION PRODUCTS/METABOLITES RELEVANT FOR THE SVHC ASSESSMENT .............................................................................................. 12 1.4 IDENTITY AND COMPOSITION OF STRUCTURALLY RELATED SUBSTANCES (USED IN A BENCHMARKING OR READ-ACROSS APPROACH) ............................................................ 16 1.5 PHYSICOCHEMICAL PROPERTIES ......................................................................... 22 2 HARMONISED CLASSIFICATION AND LABELLING ............................................ 25 3 ENVIRONMENTAL FATE PROPERTIES ............................................................... 25 3.1 DEGRADATION ............................................................................................... 25 3.1.1 Abiotic degradation ............................................................................ 25 3.1.2 Biodegradation ................................................................................... 26 3.1.3 Other data .......................................................................................... 31 3.1.4 Summary and discussion of degradation ............................................ 31 3.2 ENVIRONMENTAL DISTRIBUTION ........................................................................ 32 3.2.1 Adsorption/desorption ....................................................................... 32 3.2.2 Volatilisation ...................................................................................... 32 3.2.3 Distribution modelling ........................................................................ 33 3.3 DATA INDICATING POTENTIAL FOR LONG-RANGE TRANSPORT ..................................... 33 3.4 BIOACCUMULATION......................................................................................... 35 3.4.1 Bioaccumulation in aquatic organisms (pelagic & sediment organisms) ................................................................................................................... 35 3.4.2 Bioaccumulation in terrestrial organisms (soil dwelling organisms, vertebrates) ................................................................................................ 49 3.4.4 Summary and discussion of bioaccumulation ..................................... 57 4 HUMAN HEALTH HAZARD ASSESSMENT ....................................................... 59 4.1 TOXICOKINETICS (ABSORPTION, METABOLISM, DISTRIBUTION AND ELIMINATION) ......... 59 5 ENVIRONMENTAL HAZARD ASSESSMENT ......................................................... 61 6 CONCLUSIONS ON THE SVHC PROPERTIES ...................................................... 62 6.1 CMR ASSESSMENT .......................................................................................... 62 6.2 PBT AND VPVB ASSESSMENT ............................................................................ 62 6.2.1 Assessment of PBT/vPvB properties .................................................. 62 6.2.1.3.1 Fulfilment of the T criterion based on human health classification67 6.2.1.3.2 Fulfilment of the T criterion based on ecotoxicity data ............. 67 6.2.2 Summary and overall conclusions on the PBT and vPvB properties .... 69 REFERENCES FOR MAIN REPORT AND APPENDICES ........................................... 71 APPENDIX 1 DETAILED SUMMARIES OF DATA CITED IN THE MAIN REPORT …….86 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES ..88 2 CLASSIFICATION AND LABELLING................................................................... 88 3 ENVIRONMENTAL FATE PROPERTIES ............................................................... 88 3.1 DEGRADATION ......................................................................................... 88 3.1.1 Abiotic degradation ...................................................................... 88 3.1.2 Biodegradation ............................................................................. 90 3.2 ENVIRONMENTAL DISTRIBUTION ................................................................... 96 3.2.1 Adsorption/desorption ................................................................. 96 2 SVHC SUPPORT DOCUMENT - DECHLORANE PLUS TM 3.2.2 Volatilisation ................................................................................ 97 3.3 POTENTIAL FOR LONG RANGE TRANSPORT ........................................................ 97 3.4 BIOACCUMULATION ................................................................................. 103 3.4.1 Bioaccumulation in aquatic organisms (pelagic and sediment organisms) ................................................................................................ 103 3.4.2 Bioaccumulation in terrestrial organisms (soil-dwelling organisms, vertebrates) .............................................................................................. 147 4 HUMAN HEALTH HAZARD ASSESSMENT RELEVANT FOR THE PBT ASSESSMENT .................................................................................................... 163 4.1 TOXICOKINETICS .................................................................................... 163 4.2 REPEATED DOSE TOXICITY ......................................................................... 163 4.2.1 Repeated dose toxicity: oral ....................................................... 163 4.2.2 Repeated dose toxicity: inhalation ............................................. 164 4.2.3 Repeated dose toxicity: dermal .................................................. 164 4.2.4 Summary and discussion of repeated dose toxicity .................... 164 4.3 MUTAGENICITY ...................................................................................... 165 4.3.1 In vitro data ............................................................................... 165 4.3.2 In vivo data ................................................................................ 165 4.3.3 Summary and discussion of mutagenicity .................................. 165 4.4 CARCINOGENICITY .................................................................................. 166 4.4.1 Summary and discussion of carcinogenicity ............................... 166 4.5 TOXICITY TO REPRODUCTION ..................................................................... 166 4.5.1 Effects on fertility and development ........................................... 166 4.5.2 Summary and discussion of toxicity to reproduction .................. 166 4.6 SUMMARY OF MAMMALIAN TOXICITY ............................................................ 166 5 ENVIRONMENTAL HAZARD ASSESSMENT .................................................. 167 5.1 AQUATIC COMPARTMENT (INCLUDING SEDIMENT) ........................................... 167 5.1.1 Pelagic toxicity ........................................................................... 167 5.1.2 Sediment organisms ................................................................... 180 5.2 TERRESTRIAL COMPARTMENT ..................................................................... 181 5.3 ATMOSPHERIC COMPARTMENT .................................................................... 185 5.4 MICROBIOLOGICAL ACTIVITY IN SEWAGE TREATMENT SYSTEMS ........................... 185 5.4.1 Toxicity to aquatic micro-organisms .......................................... 185 5.5 NON COMPARTMENT SPECIFIC EFFECTS RELEVANT FOR THE FOOD CHAIN (SECONDARY POISONING) ..................................................................................................... 185 5.5.1 Toxicity to birds ......................................................................... 185 5.5.2 Toxicity to mammals .................................................................. 188 6 MONITORING DATA .................................................................................. 188 ANNEX LITERATURE SEARCH ................................................................. 189 APPENDIX 2 TRANSFORMATION PRODUCTS ........................................... 196 APPENDIX 3 MEASURED CONCENTRATIONS OF DECHLORANE PLUS IN BIOTA ASSOCIATED WITH THE AQUATIC ENVIRONMENT ................................. 205 APPENDIX 4 MEASURED CONCENTRATIONS OF DECHLORANE PLUS IN BIOTA ASSOCIATED WITH THE TERRESTRIAL ENVIRONMENT ..................................... 233 APPENDIX 5 OTHER EUROPEAN MONITORING STUDIES ..........................
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