PBT Assessment - REACh

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2 LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contents of this document. © European Chemicals Agency, 2008 Reproduction is authorised provided the source is acknowledged.
PREFACE CHAPTER R11 – <strong>PBT</strong> ASSESSMENT This document describes the information requirements under REACH with regard to substance properties, exposure, use and risk management measures, and the chemical safety assessment. It is part of a series of guidance documents that are aimed to help all stakeholders with their preparation for fulfilling their obligations under the REACH regulation. These documents cover detailed guidance for a range of essential REACH processes as well as for some specific scientific and/or technical methods that industry or authorities need to make use of under REACH. The guidance documents were drafted and discussed within the REACH Implementation Projects (RIPs) led by the European Commission services, involving stakeholders from Member States, industry and non-governmental organisations. These guidance documents can be obtained via the website of the European Chemicals Agency (http://echa.europa.eu/reach_en.asp). Further guidance documents will be published on this website when they are finalised or updated. This document relates to the REACH Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 1 1 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006); amended by Council Regulation (EC) No 1354/2007 of 15 November 2007 adapting Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) by reason of the accession of Bulgaria and Romania (OJ L 304, 22.11.2007, p. 1). 3
Page 1: Guidance on information requirement
Page 5 and 6: CONTENTS CHAPTER R11 - PBT ASSESSME
Page 7 and 8: R.11 PBT AND VPVB ASESSMENT CHAPTER
Page 9 and 10: CHAPTER R11 - PBT ASSESSMENT condit
Page 11 and 12: CHAPTER R11 - PBT ASSESSMENT in the
Page 13 and 14: Table R. 11-1: PBT and vPvB criteri
Page 15 and 16: R.11.1.3 Assessment of PBT/vPvB pro
Page 17 and 18: CHAPTER R11 - PBT ASSESSMENT level
Page 19 and 20: CHAPTER R11 - PBT ASSESSMENT A flow
Page 21 and 22: Conclusion on the endpoint: ITS for
Page 23 and 24: Conclusion on Persistency - Explana
Page 25 and 26: R.11.1.3.2 Bioaccumulation assessme
Page 27 and 28: Further data CHAPTER R11 - PBT ASSE
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Page 31 and 32: CHAPTER R11 - PBT ASSESSMENT Howeve
Page 33 and 34: R.11.1.3.3 Toxicity assessment (T)
Page 35 and 36: Use of QSAR data CHAPTER R11 - PBT
Page 37 and 38: CHAPTER R11 - PBT ASSESSMENT Table
Page 39 and 40: CHAPTER R11 - PBT ASSESSMENT Accord
Page 41 and 42: STEP 3 vPvB Assessment for substanc
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Page 45 and 46: R.11.1.4.2 Assessment of multi cons
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Page 49 and 50: R.11.1.5 Summary and overall conclu
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CHAPTER R11 - PBT ASSESSMENT In the
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CHAPTER R11 - PBT ASSESSMENT R.11.2
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CHAPTER R11 - PBT ASSESSMENT substa
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CHAPTER R11 - PBT ASSESSMENT exposu
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CHAPTER R11 - PBT ASSESSMENT Meylan
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APPENDICES CHAPTER R11 - PBT ASSESS
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Discussion CHAPTER R11 - PBT ASSESS
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Mechanisms of absorption CHAPTER R1
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CHAPTER R11 - PBT ASSESSMENT While
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CHAPTER R11 - PBT ASSESSMENT EU PBT
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CHAPTER R11 - PBT ASSESSMENT Lipid
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CHAPTER R11 - PBT ASSESSMENT Loonen
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log BCF 5.5 5.0 4.5 4.0 3.5 3.0 2.5
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Appendix R.11-1 Annex 2 CHAPTER R11
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Calculation of the 3D Dimension of
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Example R. 11-3 Example R. 11-4 IND
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1. Examples for Assessment of Subst
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CHAPTER R11 - PBT ASSESSMENT substa
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CHAPTER R11 - PBT ASSESSMENT Table
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CHAPTER R11 - PBT ASSESSMENT Exampl
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CHAPTER R11 - PBT ASSESSMENT other
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CHAPTER R11 - PBT ASSESSMENT OECD,
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CHAPTER R11 - PBT ASSESSMENT Howeve
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