SVHC-11 六溴环十二烷 HBCCD_publication(PBT 生物累积性与毒性)

SVHC SUPPORT DOCUMENT Substance name: Hexabromocyclododecane and all major diastereoisomers identified EC number: 247-148-4 and 221-695-9 CAS number: 25637-99-4 and 3194-55-6 Names of the major diastereoisomers identified: alpha-hexabromocyclododecane CAS No 134237-50-6 beta-hexabromocyclododecane CAS No 134237-51-7 gamma-hexabromocyclododecane CAS No 134237-52-8 MEMBER STATE COMMITTEE SUPPORT DOCUMENT FOR IDENTIFICATION OF HEXABROMOCYCLODODECANE AND ALL MAJOR DIASTEREOISOMERS IDENTIFIED AS A SUBSTANCE OF VERY HIGH CONCERN Adopted on 8 October 2008 SVHC SUPPORT DOCUMENT 1 CONTENTS JUSTIFICATION .........................................................................................................................................................5 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .................................5 1.1 Name and other identifiers of the substance ...................................................................................................5 1.2 Composition of the substance .........................................................................................................................5 1.3 Physico-chemical properties ...........................................................................................................................7 2 CLASSIFICATION AND LABELLING ...............................................................................................................9 2.1 Classification in Annex I of Directive 67/548/EEC........................................................................................9 2.2 Self classification(s) .......................................................................................................................................9 3 ENVIRONMENTAL FATE PROPERTIES...........................................................................................................10 3.1 Degradation ....................................................................................................................................................10 3.1.1 Biodegradation ....................................................................................................................................10 3.1.1.1 Screening tests.......................................................................................................................10 3.1.1.2 Simulation tests .....................................................................................................................10 3.1.2 Summary and discussion of persistence ..............................................................................................13 3.2 Environmental distribution .............................................................................................................................14 3.2.1 Adsorption/desorption .........................................................................................................................14 3.2.2 Volatilisation .......................................................................................................................................14 3.2.3 Distribution modelling ........................................................................................................................14 3.3 Bioaccumulation.............................................................................................................................................16 3.3.1 Aquatic bioaccumulation.....................................................................................................................16 3.3.1.1 Bioaccumulation estimation ..................................................................................................16 3.3.1.2 Measured bioaccumulation data ............................................................................................16 3.3.2 Terrestrial bioaccumulation.................................................................................................................17 3.3.3 Others ..................................................................................................................................................18 3.3.4 Summary and discussion of bioaccumulation .....................................................................................23 3.4 Secondary poisoning.......................................................................................................................................23 4 HUMAN HEALTH HAZARD ASSESSMENT.....................................................................................................25 4.1 Toxicokinetics (absorption, metabolism, distribution and elimination) .........................................................25 4.2 Acute toxicity .................................................................................................................................................25 4.2.1 Acute toxicity: oral ..............................................................................................................................25 4.2.2 Acute toxicity: inhalation ....................................................................................................................25 4.2.3 Acute toxicity: dermal .........................................................................................................................25 4.2.4 Summary and discussion of acute toxicity. .........................................................................................25 4.3 Irritation..........................................................................................................................................................26 4.4 Corrosivity......................................................................................................................................................26 4.5 Sensitisation....................................................................................................................................................26 4.6 Repeated dose toxicity....................................................................................................................................26 SVHC SUPPORT DOCUMENT 2 4.6.1 Repeated dose toxicity: oral ................................................................................................................26 4.6.2 Repeated dose toxicity: inhalation.......................................................................................................28 4.6.3 Repeated dose toxicity: dermal ...........................................................................................................28 4.6.4 Summary and discussion of repeated dose toxicity: ............................................................................28 4.7 Mutagenicity...................................................................................................................................................28 4.8 Carcinogenicity...............................................................................................................................................28 4.8.1 Carcinogenicity: oral ...........................................................................................................................28 4.8.2 Carcinogenicity: inhalation .................................................................................................................28 4.8.3 Carcinogenicity: dermal ......................................................................................................................28 4.8.4 Carcinogenicity: human data ...............................................................................................................29 4.8.5 Summary and discussion of carcinogenicity .......................................................................................29 4.9 Toxicity for reproduction................................................................................................................................29 5 ENVIRONMENTAL HAZARD ASSESSMENT ..................................................................................................30 5.1 Aquatic compartment (including sediment)....................................................................................................31 5.1.1 Toxicity test results .............................................................................................................................31 5.1.1.1 Fish........................................................................................................................................31 Short-term toxicity to fish .....................................................................................................31 Long-term toxicity to fish......................................................................................................31 5.1.1.2 Aquatic invertebrates.............................................................................................................32 Short-term toxicity to aquatic invertebrates ..........................................................................32 Long-term toxicity to aquatic invertebrates...........................................................................32 5.1.1.3 Algae and aquatic plants........................................................................................................32 5.1.1.4 Sediment organisms ..............................................................................................................34 5.1.1.5 Other aquatic organisms........................................................................................................35 5.2 Terrestrial compartment..................................................................................................................................35 5.2.1 Toxicity test results .............................................................................................................................35 5.2.1.1 Toxicity to soil macro organisms ..........................................................................................35 5.2.1.2 Toxicity to terrestrial plants ..................................................................................................36 5.2.1.3 Toxicity to soil micro-organisms...........................................................................................36 5.3 Atmospheric compartment..............................................................................................................................36 5.4 Microbiological activity in sewage treatment systems ...................................................................................36 5.4.1 Toxicity to aquatic micro-organisms...................................................................................................36 5.5 Conclusion on the environmental classification and labelling........................................................................37 6 PBT, VPVB AND EQUIVALENT LEVEL OF CONCERN ASSESSMENT.......................................................38 6.1 Comparison with criteria from annex XIII .....................................................................................................38 6.2 PBT/vPvB Assessment/Assessment of substances of an equivalent level of concern....................................38 6.3 Conclusion of PBT and vPvB or equivalent level of concern assessment......................................................38 REFERENCES .............................................................................................................................................................40 TABLES Table1-1: Summary of physico- chemical properties ...................................................................................................7 SVHC SUPPORT DOCUMENT 3 Table1-2 Summary of the results of valid water solubility studies using generator column method, as evaluated by European Commission (2007) ......................................................................................................................................7 Table 3-1 Estimated primary degradation half-lives of HBCDD derived from the results of the degradation simulation tests of Davis et al. (2004) for the EU risk assessment (EU RAR, 2008). ....................................................................11 Table 3-2 Measured environmental concentrations of HBCDD in remote Arctic areas (bird data excluded)..............15 Table 3-3 Calculated half-distances for HBCDD, PBDEs and POPs in the North Pacific based on skipjack tuna monitoring (compiled in Ueno et al., 2006)..................................................................................................................16 Table 3-4 Concentration of HBCDD in soil and earthworm tissue after 28 day of exposure and corresponding bioaccumulation factors (BAF) at different levels of exposure. ...................................................................................17 Table 3-5 Concentration of α-, β- and γ- HBCDD in soil and earthworm tissue after 28 day of exposure, and diastereomer specific bioaccumulation factors (BAF) at different levels of exposure. ................................................18 Table 3-6 Statistical overview of measured HBCDD concentrations in muscle of freshwater fish in the EU and Norway. The percentiles were calculated using weighted average at X(n+1)p (EU RAR, 2008). ..............................................19 Table 3-7 Median concentrations of HBCDD in marine mammals and fish muscle collected from specific European regions. As for marine mammals the concentration in blubber is reported conventionally, the data have been converted to whole body concentrations assuming a 1/3 lipid/whole body ratio (EU RAR, 2008). .............................................19 Table4-1 Summary of findings related to the liver and the thyroid system in the RdT studies. ...................................27 Table5-1 Acute and chronic ecotoxicity data, which are considered reliable according to EU RAR (2008) ...............30 FIGURES Figure 3-1 Stepwise dehalogenation of HBCDD (Davis et al., 2004). .........................................................................12 Figure 3-2 Concentration of HBCDD over time in guillemot (Uria aalge) eggs in the Baltic Sea (data from Sellström et al., 2003) .......................................................................................................................................................................21 Figure 3-3 Concentration of BDE-47, BDE-100, BDE-99 and HBCDD over time in guillemot (Uria aalge) eggs in the Baltic Sea (data from Swedish Museum of Natural History, 2007)..............................................................................22 SVHC SUPPORT DOCUMENT 4 Substance Name: Hexabromocyclododecane and all major diastereoisomers identified EC Number: 221-695-9, 247-148-4 CAS number: 3194-55-6, 25637-99-4 Names of the major diastereoisomers identified: alpha-hexabromocyclododecane CAS No 134237-50-6 beta-hexabromocyclododecane CAS No 134237-51-7 gamma-hexabromocyclododecane CAS No 134237-52-8 The substance is identified as a PBT according to Article 57 (d) of Regulation (EC) No 1907/2006 (REACH). Summary of the evaluation: Hexabromocyclododecane (HBCDD) fulfils both the B and the vB-criteria based on experimental data (BCF=18100) and measured data from biota. With a NOEC of 3.1 µg/l for Daphnia, the T- criterion is also met. The available soil degradation simulation data show that the half-life of HBCDD in aerobic soil is > 120 d and thus the P-criterion in soil is met. In addition, degradation sediment simulation tests and dated sediment cores are available indicating slow degradation rates of HBCDD thus supporting the P criterion in sediment. Furthermore, HBCDD is found to be ubiquitously present in remote areas in abiotic samples and biota providing evidence that the substance is persistent in the environment and undergoes long- range environmental transport. It is concluded that HBCDD is a PBT substance. Registration number(s) of the substance or of substances containing the substance: The substance has not yet been registered. This Annex XV dossier mainly builds on the agreed European Union Risk Assessment Report (RAR) on HBCDD performed under regulation EEC 793/93, and the corresponding European Union Risk Reduction Strategy (RRS). The PBT-assessment builds on the PBT-fact sheet agreed by the TC NES PBT-subgroup. Information from those documents is used in this support document without giving references in this support document. Thus, the reader is referred to the RAR and the RRS. New information and new studies not used in the RAR and RRS are given as full references in this document. SVHC SUPPORT DOCUMENT 5 JUSTIFICATION 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES 1.1 Name and other identifiers of the substance Chemical Name: Hexabromocyclododecane and 1,2,5,6,9,10-hexabromocyclododecane EC Number 247-148-4; this number refers to hexabromocyclododecane (without specifying the bromine positions) and is used by some industry for the commercial substance. 221-695-9a; this number refers to 1,2,5,6,9,10-hexabromocyclododecane and is thus the most correct one from a chemical point of view CAS Number: 25637-99-4; this number refers to hexabromocyclododecane (without specifying the bromine positions) and is used by some industry for the commercial substance 3194-55-6a ; this number refers to 1,2,5,6,9,10-hexabromocyclododecane and is thus the most correct one from a chemical point of view IUPAC Name: Hexabromocyclododecane a: The latter number is more specific in terms of the diastereomeric composition of the substance (1,2,5,6,9,10-HBCDD; see below). However, as the former numbers are used by industry (e.g., in SDS) for technical HBCDD,, the dossier need to cover both numbers. 1.2 Composition of the substance Chemical Name: Hexabromocyclododecane and 1,2,5,6,9,10-hexabromocyclododecane EC Number: 247-148-4; 221-695-9a CAS Number: 25637-99-4b ; 3194-55-6a IUPAC Name: Hexabromocyclododecane Molecular Formula: C12H18Br6 Structural Formula: structure formula for 1,2,5,6,9,10-HBCDD, i.e., CAS no 3194-55-6a Note that CAs no 25637-99-4 is also used for this substance, although not correct from a chemical point of view as this number is not specifying the positions of the bromine atoms. As additional information, the structures and CAS numbers for the diastereomers making up 1,2,5,6,9,10-HBCDD is given below, although these diastereomers always occur as mixtures in the technical product. Molecular Weight: 641.7 Synonyms Cyclododecane, hexabromo; HBCD; Bromkal 73-6CD; Nikkafainon CG 1; Pyroguard F 800; Pyroguard SR 103; Pyroguard SR 103A; Pyrovatex 3887; Great Lakes CD-75P™; Great Lakes CD-75; Great Lakes CD75XF; Great Br Br BrBr Br Br SVHC SUPPORT DOCUMENT 6 Lakes CD75PC (compacted); (Dead Sea Bromine Group Ground FR 1206 I- LM; Dead Sea Bromine Group Standard FR 1206 I-LM; Dead Sea Bromine Group Compacted FR 1206 I-CM)c; FR-1206; HBCD ILM; HBCD IHM Concentration range (% w/w): Depending on the producer, technical grade HBCDD consists of approximately 70-95 % γ-HBCDD and 3-30 % of α- and β-HBCDD due to its production method (European Commission, 2007). Two additional diastereoisomers, δ-HBCDD and ε–HBCDD have been found by Heeb et al. (2005) in commercial HBCDD in concentration of 0.5 % and 0.3 %, respectively. The only detailed information on composition available in the EU RAR (European Commission, 2007), concerns composite