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Chloroform Risk Assessment EU RISK ASSESSMENT – C HLOROFORM CAS 67-66-3 COVER CHLOROFORM CAS-No.: 67-66-3 EINECS-No.: 200-663-8 RISK ASSESSMENT Final Report (2007) France Rapporteur for the risk evaluation of chloroform is the Ministry for the Protection of Nature and the Environment as well as the Ministry of Employment and Social Affairs in co-operation with the Ministry of Public Health. Responsible for the risk evaluation and subsequently for the contents of this report is the rapporteur. The scientific work on this report has been prepared by the National Institute for Research and Security (INRS) as well as the National Institute for Industrial Environment and Risks (INERIS), by order of the rapporteur. Contact point: INERIS INRS DRC/ECOT SCP Parc Technologique ALATA 30, rue Olivier Noyer BP N° 2 75680 Paris CEDEX 14 60550 Verneuil en Halatte FRANCE FRANCE RAPPORTEUR F RANCE I ESR R EPORT DRAFT OF JUNE 2007 EU RISK ASSESSMENT – C HLOROFORM CAS 67-66-3 COVER Foreword to Draft Risk Assessment Reports This Draft Risk Assessment Report is carried out in accordance with Council Regulation (EEC) 793/93 1 on the evaluation and control of the risks of “existing” 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) 1488/94 2 which is supported by a technical guidance document 3. 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 to the Competent Group of Member State experts for endorsement. Observers from Industry, Consumer Organisations, Trade Unions, Environmental Organisations and certain International Organisations are also invited to attend the meetings. The Risk Assessment Report is then peer-reviewed by the Scientific Committee on Toxicity, Eco-toxicity and the Environment (SCTEE) which gives its opinion to the European Commission on the quality of the risk assessment. This Draft Risk Assessment Report is currently under discussion in the Competent Group of Member State experts with the aim of reaching consensus. In doing so, the scientific interpretation of the underlying information may change, more information may be included and even the conclusions reached in this draft may change. Competent Group of Member State experts seek as wide a distribution of these drafts as possible, in order to assure as complete and accurate an information basis as possible. The information contained in this Draft Risk Assessment Report therefore does not necessarily provide a sound basis for decision making regarding the hazards, exposures or the risks associated with the priority substance. This Draft Risk Assessment Report is the responsibility of the Member State rapporteur. In order to avoid possible misinterpretations or misuse of the findings in this draft, anyone wishing to cite, quote or copy this report must obtain the permission of the Member State rapporteur beforehand. 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] RAPPORTEUR F RANCE II ESR R EPORT DRAFT OF JUNE 2007 EU RISK ASSESSMENT – C HLOROFORM CAS 67-66-3 COVER Contact Details of the Rapporteur Rapporteur: France Contact (environment): Institut National de l’Environnement Industriel et des Risques (INERIS) Direction des Risques Chroniques Unité Evaluation des Risques Ecotoxicologiques Parc Technologique ALATA BP n°2 60550 Verneuil-en-Halatte France RAPPORTEUR F RANCE III ESR R EPORT DRAFT OF JUNE 2007 EU RISK ASSESSMENT – C HLOROFORM CAS 67-66-3 COVER 0. OVERALL RESULTS OF THE RISK ASSESSMENT CAS Number: 67-66-3 EINECS Number: 200-663-8 IUPAC Name : Chloroform Environment This risk assessment has been performed with site-specific data when available and the exposure assessment is therefore only valid for the sites considered in this evaluation. Any change of technology at these sites or any new site will lead to different exposure calculations and thus will have to be evaluate on a case by case basis. Conclusions to the risk assessment for the aquatic compartment Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account Conclusion (iii) is applied to the use of chloroform as a solvent. As the PEC estimation is based on monitoring data and the improvement of the PNEC might not be sufficient to decrease the ratio, it is necessary to limit the risk from now on for this application. 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 Conclusion (ii) is applied to all levels of the life cycle of chloroform: production, all uses (except its use as a solvent) and unintended releases of chloroform due to losses as a by-product during chemical manufacturing. Conclusions to the risk assessment for the sediment compartment Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account Conclusion (iii) is applied to the use of chloroform as a solvent. As additional toxicity testings on sediment organisms requested under article 10(2) do not permit to decrease the PEC/PNECratio below 1, it is necessary to limit the risk from now on for this application. 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 Conclusion (ii) is applied to all levels of the life cycle of chloroform: production, all uses (except its use as a solvent) and unintended releases of chloroform due to losses as a by-product during chemical manufacturing. Conclusions to the risk assessment for the sewage compartment Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account Conclusion (iii) is applied to production sites A, C, E and J, to all uses and unintended releases. Given that toxicity testings on micro-organisms requested under article 10(2) were not valid, the exposure assessment could not be refined and risks still remain. It is therefore necessary to limit the risk from now on. EU RISK ASSESSMENT – C HLOROFORM CAS 67-66-3 COVER Conclusions to the risk assessment for the atmosphere compartment 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 Conclusions to the risk assessment for the terrestrial compartment 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 It should be noticed that the assessment considers that sludge from chloroform and HCFC production sites are not applied on agricultural soils. Conclusions to the risk assessment for non-compartment specific effects relevant to the food chain 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 RAPPORTEUR F RANCE V ESR R EPORT DRAFT OF JUNE 2007 EU RISK ASSESSMENT – C HLOROFORM CAS 67-66-3 CONTENTS CONTENTS 0. OVERALL RESULTS OF THE RISK ASSESSMENT ................................ IV 1. GENERAL SUBSTANCE INFORMATION .....................................................6 1.1. IDENTIFICATION OF THE SUBSTANCE.....................................................................6 1.2. PURITY/IMPURITIES, ADDITIVES ...............................................................................6 1.3. PHYSICO-CHEMICAL PROPERTIES ...........................................................................7 1.3.1. Melting point.................................................................................................................7 1.3.2. Boiling point..................................................................................................................7 1.3.3. Relative density.............................................................................................................7 1.3.4. Vapour pressure ............................................................................................................7 1.3.5. Surface tension..............................................................................................................7 1.3.6. Water solubility.............................................................................................................8 1.3.7. Henry’s law constant.....................................................................................................8 1.3.8. Partition coefficient octanol water................................................................................8
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