European Union Risk Assessment Report
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European Chemicals Bureau Institute for Health and Consumer Protection European Union Risk Assessment Report European Chemicals CAS: 79-94-7 EINECS: 201-236-9 Bureau 2,2’,6,6’-tetrabromo-4,4’-isopropylidenediphenol Existing Substances (tetrabromobisphenol-A or TBBP-A) Part II – human health 2,2’,6,6’ EuropeanUnion Risk Assessment Report ( tetrabromobis -tetrabromo-4,4’-isopropylidenediphenol -tetrabromo-4,4’-isopropylidenediphenol Br Br p CH henol- 3 A or TBBP-A C OH HO CH3 ) Br Br CAS: EC: 201-236-9 79-94-7 4th Priority List Volume: 63 PL-4 EUR 22161 EN 63 European Union Risk Assessment Report 2,2’,6,6’-TETRABROMO-4,4’-ISOPROPYLIDENEDIPHENOL (TETRABROMOBISPHENOL-A or TBBP-A) Part II – Human Health CAS No: 79-94-7 EINECS No: 201-236-9 RISK ASSESSMENT LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa Server (http://europa.eu.int). Cataloguing data can be found at the end of this publication Luxembourg: Office for Official Publications of the European Communities, 2006 © European Communities, 2006 Reproduction is authorised provided the source is acknowledged. Printed in Italy 2,2’,6,6’-TETRABROMO-4,4’-ISOPROPYLIDENEDIPHENOL (TETRABROMOBISPHENOL-A or TBBP-A) Part II – Human Health CAS No: 79-94-7 EINECS No: 201-236-9 RISK ASSESSMENT Final Report, 2006 United Kingdom The rapporteur for the risk assessment of 2,2’,6,6’-tetrabromo-4,4’-isopropylidenediphenol (tetrabromobisphenol-A or TBBP-A) is the United Kingdom. Contact point: Human Health Health & Safety Executive Industrial Chemicals Unit Magdalen House Stanley Precinct Bootle, Merseyside L20 3QZ E-mail: [email protected] Fax: +44 (0)151 951 3308 Date of Last Literature Search: 2004 Review of report by MS Technical Experts finalised: 2005 Final report: 2006 0 OVERALL RESULTS OF THE RISK ASSESSMENT CAS Number: 79-94-7 EINECS Number: 201-236-9 IUPAC Name: 2,2’,6,6’-tetrabromo-4,4’-isopropylidenediphenol (tetrabromobisphenol-A or TBBP-A) Environment (to be added later). Human health No health effects of concern have been identified for TBBP-A. Workers Conclusion (ii) There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already. No health effects of concern to adults have been identified. Therefore conclusion (ii) is reached in relation to all endpoints and for all exposure scenarios. Consumer Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Given that consumer exposure is negligible conclusion (ii) is reached in relation to all endpoints. Humans exposed via the environment Regional exposures No health effects of concern to adults have been identified. Therefore, conclusion (ii) is reached for regional exposures. Local exposures No health effects of concern to adults have been identified. Therefore conclusion (ii) is reached for all local exposure scenarios. Infants MOS values of 210 and 106 have been obtained by comparing the NOAEL for nephrotoxicity in newborn rats with the highest environmental exposure estimate of an adult and the highest concentration of TBBP-A found in breast milk, respectively. These MOS values are considered to be sufficient to allow for interspecies and intraspecies differences, and therefore conclusion (ii) is reached. Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. VI Combined exposure Given that consumer exposures are negligible calculation of combined exposure is not necessary. Therefore conclusion (ii) is reached. Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. Human health (risks from physico-chemical properties) There are no significant risks from physico-chemical properties. Conclusion (ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already. VII CONTENTS 1 GENERAL SUBSTANCE INFORMATION.......................................................................................... 5 1.1 IDENTIFICATION OF THE SUBSTANCE.................................................................................. 5 1.2 PURITY/IMPURITIES, ADDITIVES............................................................................................ 5 1.2.1 Purities/impurities.................................................................................................................... 5 1.2.2 Additives.................................................................................................................................. 6 1.3 PHYSICO-CHEMICAL PROPERTIES ........................................................................................ 6 1.3.1 Physical state (at n.t.p)............................................................................................................. 7 1.3.2 Melting point ........................................................................................................................... 7 1.3.3 Boiling point............................................................................................................................ 7 1.3.4 Density..................................................................................................................................... 7 1.3.5 Vapour pressure....................................................................................................................... 7 1.3.6 Solubility ................................................................................................................................. 9 1.3.7 Octanol-water partition coefficient (log Kow)......................................................................... 11 1.3.8 Flash point ............................................................................................................................... 12 1.3.9 Autoignition............................................................................................................................. 12 1.3.10 Explosivity............................................................................................................................... 13 1.3.11 Oxidising properties................................................................................................................. 13 1.3.12 Granulometry........................................................................................................................... 13 1.3.13 Surface tension ........................................................................................................................ 13 1.3.14 Other physico-chemical properties .......................................................................................... 13 1.3.14.1 Henry’s law constant ................................................................................................. 13 1.3.14.2 Acid dissociation constant ......................................................................................... 14 1.3.15 Hazardous products formed under pyrolysis conditions.......................................................... 15 1.4 CLASSIFICATION .......................................................................................................................... 15 1.4.1 Current classification............................................................................................................... 15 1.4.2 Proposed classification ............................................................................................................ 15 2 GENERAL INFORMATION ON EXPOSURE..................................................................................... 17 2.1 PRODUCTION ................................................................................................................................. 17 2.2 CONSUMPTION AND USES.......................................................................................................... 17 2.2.1 Consumption, Import and Export ............................................................................................ 17 2.2.2 Uses ......................................................................................................................................... 23 2.2.2.1 Reactive flame retardants .......................................................................................... 24 2.2.2.2 Additive flame retardant............................................................................................ 26 2.2.2.3 Derivatives................................................................................................................. 27 2.2.2.3.1 Tetrabromobisphenol-A dimethyl ether.................................................... 27 2.2.2.3.2 Tetrabromobisphenol-A bis(2,3-dibromopropyl ether)............................. 27 2.2.2.3.3 Tetrabromobisphenol-A bis(allyl ether).................................................... 28 2.2.2.3.4 Tetrabromobisphenol-A bis(2-hydroxyethyl ether) .................................. 28 2.2.2.3.5 Tetrabromobisphenol-A brominated epoxy oligomer............................... 29 2.2.2.3.6 Tetrabromobisphenol-A carbonate