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Rips) Led by the European Commission Services, Involving Stakeholders from Member States, Industry and Non-Governmental Organisations Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint specific guidance May 2008 Guidance for the implementation of REACH 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. 2 CHAPTER R.7A – ENDPOINT SPECIFIC GUIDANCE PREFACE This document describes the information requirements under REACH with regard to substance properties, exposure, uses 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/about/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 20061. 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 CHAPTER R.7A – ENDPOINT SPECIFIC GUIDANCE Convention for citing the REACH regulation Where the REACH regulation is cited literally, this is indicated by text in italics between quotes. Table of Terms and Abbreviations See Chapter R.20 Pathfinder The figure below indicates the location of part R.7(a) within the Guidance Document 4 CHAPTER R.7A – ENDPOINT SPECIFIC GUIDANCE CONTENTS TABLE OF CONTENTS R.7 ENDPOINT SPECIFIC GUIDANCE ....................................................................... 13 Introduction .................................................................................................................................................................... 13 R.7.1 Physico-chemical properties; adsorption/desorption .................................................................................... 17 R.7.1.1 Introduction ............................................................................................................................................... 17 R.7.1.1.1 Information requirements on physico-chemical properties ............................................................. 18 R.7.1.1.2 Available information on physico-chemical properties ................................................................... 18 R.7.1.1.3 Evaluation of available information on physico-chemical properties ............................................. 26 R.7.1.1.4 General testing strategy for physico-chemical properties ................................................................ 33 R.7.1.1.5 General assessment of the available information on physico-chemical properties .......................... 37 R.7.1.1.6 Overall consistency of the physico-chemical profile ....................................................................... 38 R.7.1.1.7 References for introduction of Physico-Chemical properties .......................................................... 44 R.7.1.2 MELTING/FREEZING POINT ............................................................................................................... 46 R.7.1.2.1 Information requirements on melting/freezing point ....................................................................... 47 R.7.1.2.2 Available information on melting/freezing point ............................................................................ 47 R.7.1.2.3 Evaluation of available information on melting/freezing point ....................................................... 49 R.7.1.2.4 Conclusions on melting/freezing point ............................................................................................ 51 R.7.1.2.5 Integrated testing strategy (ITS) for melting/freezing point ............................................................ 51 R.7.1.2.6 References on melting/freezing point .............................................................................................. 51 R.7.1.3 BOILING POINT ..................................................................................................................................... 53 R.7.1.3.1 Information requirements on boiling point ...................................................................................... 53 R.7.1.3.2 Available information on boiling point ........................................................................................... 53 R.7.1.3.3 Evaluation of available information on boiling point ...................................................................... 54 R.7.1.3.4 Conclusions on boiling point ........................................................................................................... 56 R.7.1.3.5 Integrated testing strategy (ITS) for boiling point ........................................................................... 56 R.7.1.3.6 References on boiling point ............................................................................................................. 57 R.7.1.4 RELATIVE DENSITY ............................................................................................................................. 59 R.7.1.4.1 Information requirements on relative density .................................................................................. 59 R.7.1.4.2 Available information on relative density ....................................................................................... 59 R.7.1.4.3 Evaluation of available information for relative density ................................................................. 60 R.7.1.4.4 Conclusions on relative density ....................................................................................................... 62 R.7.1.4.5 Integrated testing strategy (ITS) for relative density ....................................................................... 62 R.7.1.4.6 References for relative density ........................................................................................................ 62 R.7.1.5 VAPOUR PRESSURE ............................................................................................................................. 64 R.7.1.5.1 Information requirements on vapour pressure ................................................................................. 65 R.7.1.5.2 Available information on vapour pressure ...................................................................................... 65 R.7.1.5.3 Evaluation of available information on vapour pressure ................................................................. 65 R.7.1.5.4 Conclusions on vapour pressure ...................................................................................................... 71 R.7.1.5.5 Integrated testing strategy (ITS) for vapour pressure ...................................................................... 72 R.7.1.5.6 References on vapour pressure ........................................................................................................ 74 R.7.1.6 SURFACE TENSION .............................................................................................................................. 76 R.7.1.6.1 Information Requirements on surface tension ................................................................................. 78 R.7.1.6.2 Available Information on surface tension ....................................................................................... 78 R.7.1.6.3 Evaluation of available information on surface tension .................................................................. 79 R.7.1.6.4 Conclusions on surface tension ....................................................................................................... 80 R.7.1.6.5 Integrated testing strategy (ITS) for surface tension ....................................................................... 80 R.7.1.6.6 References on surface tension ........................................................................................................
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