European Union Risk Assessment Report Vol. 35, 2nd priority list: 1, 2-benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich and di-isononyl phthalate (DINP)

302 Pages·7.111 MB·English

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European Union Risk Assessment Report
1,2-BENZENEDICARBOXYLIC ACID, DI-C8-10-BRANCHED ALKYL
ESTERS, C9-RICH
AND
DI-“ISONONYL” PHTHALATE
(DINP)
CAS Nos: 68515-48-0 and 28553-12-0
EINECS Nos: 271-090-9 and 249-079-5
RISK ASSESSMENT
LEGAL NOTICE
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Cataloguing data can be found at the end of this publication

Luxembourg: Office for Official Publications of the European Communities, 2003

© European Communities, 2003
Reproduction is authorised provided the source is acknowledged.
Printed in Italy
1,2-BENZENEDICARBOXYLIC ACID, DI-C8-10-BRANCHED ALKYL
ESTERS, C9-RICH
AND
DI-“ISONONYL” PHTHALATE
(DINP)
CAS Nos: 68515-48-0 and 28553-12-0
EINECS Nos: 271-090-9 and 249-079-5
RISK ASSESSMENT

Final Report, 2003

France

The French rapporteur for the risk evaluation of 1,2-Benzenedicarboxylic acid, di-C8-10-
branched alkyl esters, C9-rich and di-“isononyl” phthalate, is the Ministry of the Environment
and the Ministry of Employment and Solidarity.
The scientific work on this report has been prepared by:
Institut National de Recherche et de Sécurité (INRS)
Département Risques chimiques et biologiques
30, rue Olivier Noyer
75680 Paris Cedex 14
France
INERIS
Direction des Risques Chroniques
Parc Technologique ALATA - BP n° 2
60550 Verneuil-en-Halatte
France
Centre Anti-poison de Lille
5, avenue Oscart Lambret
59037 Lille Cedex
France
Date of Last Literature Search: 2001
Review of report by MS Technical Experts finalised: 2001
Final report: 2003
Foreword
We are pleased to present this Risk Assessment Report which is the result of in-depth work
carried out by experts in one Member State, working in co-operation with their counterparts in
the other Member States, the Commission Services, Industry and public interest groups.
The Risk Assessment was carried out in accordance with Council Regulation (EEC) 793/931 on
the evaluation and control of the risks of “existing” substances. “Existing” substances are
chemical substances in use within the European Community before September 1981 and listed in
the European Inventory of Existing Commercial Chemical Substances. Regulation 793/93
provides a systematic framework for the evaluation of the risks to human health and the
environment of these substances if they are produced or imported into the Community in
volumes above 10 tonnes per year.
There are four overall stages in the Regulation for reducing the risks: data collection, priority
setting, risk assessment and risk reduction. Data provided by Industry are used by Member
States and the Commission services to determine the priority of the substances which need to be
assessed. For each substance on a priority list, a Member State volunteers to act as “Rapporteur”,
undertaking the in-depth Risk Assessment and recommending a strategy to limit the risks of
exposure to the substance, if necessary.
The methods for carrying out an in-depth Risk Assessment at Community level are laid down in
Commission Regulation (EC) 1488/942, which is supported by a technical guidance document3.
Normally, the “Rapporteur” and individual companies producing, importing and/or using the
chemicals work closely together to develop a draft Risk Assessment Report, which is then
presented at a Meeting of Member State technical experts for endorsement. The Risk Assessment
Report is then peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the
Environment (CSTEE) which gives its opinion to the European Commission on the quality of the
risk assessment.
If a Risk Assessment Report concludes that measures to reduce the risks of exposure to the
substances are needed, beyond any measures which may already be in place, the next step in the
process is for the “Rapporteur” to develop a proposal for a strategy to limit those risks.
The Risk Assessment Report is also presented to the Organisation for Economic Co-operation
and Development as a contribution to the Chapter 19, Agenda 21 goals for evaluating chemicals,
agreed at the United Nations Conference on Environment and Development, held in Rio de
Janeiro in 1992.
This Risk Assessment improves our knowledge about the risks to human health and the
environment from exposure to chemicals. We hope you will agree that the results of this in-depth
study and intensive co-operation will make a worthwhile contribution to the Community
objective of reducing the overall risks from exposure to chemicals.

1 O.J. No L 084, 05/04/199 p.0001 – 0075
2 O.J. No L 161, 29/06/1994 p. 0003 – 0011
3 Technical Guidance Document, Part I – V, ISBN 92-827-801 [1234]
V

Explanatory note: 3 DINPs, one risk assessment report

There are 3 different DINPs. DINP 1 (CAS 68515-48-0) is manufactured by the “Polygas”
process. DINP 2 (CAS 28553-12-0) is n-butene based. DINP 3 (also CAS 28553-12-0) is n- and
iso-butene based (see Figure 1.1). Chemical structures consequently differ. Thus, these 3 DINPs
could have different physico-chemical and toxicological properties, and should be dealt with
separately. However it was not possible to separate for the following reasons:
Firstly, the manufacture of DINP 3 was stopped in 1995. A risk assessment for this substance is
therefore not justified. Relevant data are however presented in this report when it helps to better
understand some aspects of physico-chemical or toxicological properties.
Secondly, before 1995, the 3 DINPs have been submitted to different physico-chemical and
toxicological tests, but detailed sample compositions were not always available and references
sometimes vague (such as “DINP”) or provided only under coded references (e.g. MRD 94-996,
R 1218), rarely traceable to well-defined samples. Even when a CAS number was indicated for
the sample being tested, sample composition may not be warranted, since DINP 2 and DINP 3,
although different, were attributed the same CAS number. In addition, some DINPs seem to have
been produced by specific processes and may be still different although having the same CAS
number (e.g. Hoechst's Genomoll 150, CAS 28553-12-0, which contains di-(3,5,5-
trimethylhexyl)-phthalate as a main constituent; Hoechst (1973)).
Thirdly, a “pure” DINP sample is a rather complex mixture, and its physico-chemical properties
may be more or less well characterised. Moreover, the 3 DINPs may share common constituents.
They cannot be differentiated through their physico-chemical properties.
It is concluded that only one risk assessment report may usefully be presented. Proper
identification of the sample being dealt with (mentioning, in decreasing order of preference:
DINP 1, 2 or 3; CAS number; sample code; “DINP” or other denominations or attributes, as
indicated in the report) has been made inasmuch as possible.

VII