Guidance on information requirements and chemical safety assessment

Echa — European Chemicals Agency

Description

Guidance for the implementation of REACHVOL 4Endpoint specific guidance for physico-chemical properties and human health
Chemical industry
Industrial policy
Public health
Target audience: Specialised/Technical

Sujets

• Guide
• Chemical industry
• Public health

Informations

• Publié par: ECHA-EUROPEAN-CHEMICALS-AGENCY
• Nombre de lectures: 178
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

ED-30-08-004-EN-C


Guidance on
information requirements
and chemical safety assessment
Volume 4: Endpoint specific guidance for
physico-chemical properties and human health
Contains Chapter R7a

May 2008



Guidance for the implementation of REACH



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
1and of the Council of 18 December 2006 .




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 ical 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 meng 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 .......................................................................