N port N N N COMMISSIO 839 E INT RESEARCH CENTRE EINECS No: 200-835-2 C EUR 19 EUROPEA JO acetonitrile C 3 H CAS No: 75-05-8 European Union Risk Assessment Re Protection 18 : Substances Priority List st European Institute for Health and Consumer 1 Bureau Chemicals Existing Volume European Chemicals Bureau European Union Risk Assessment Report CAS: 75-05-8 EC: 200-835-2 nitrile 18 aceto PL-1 European Union Risk Assessment Report ACETONITRILE CAS No: 75-05-8 EINECS No: 200-835-2 RISK ASSESSMENT LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa Server (http://europa.eu.int). Cataloguing data can be found at the end of this publication Luxembourg: Office for Official Publications of the European Communities, 2002 ISBN 92-894-1275-5 © European Communities, 2002 Reproduction is authorised provided the source is acknowledged. Printed in Italy ACETONITRILE CAS No: 75-05-8 EINECS No: 200-835-2 RISK ASSESSMENT Final Report, 2002 Spain Rapporteur for the risk evaluation report on acetonitrile is the Spanish Health Ministry. Competent Authority: Francisco Vargas Marcos Subdirección General de Sanidad Ambiental. Ministerio de Sanidad y Consumo Paseo del Prado 18-20 28014 Madrid (España) Contact person: Covadonga Caballo Diéguez Subdirección General de Sanidad Ambiental Ministerio de Sanidad y Consumo Paseo del Prado 18-20 28014 Madrid (España) Working Group: Jose Luis Tadeo Lluch Jose Vicente Tarazona Lafarga Ministerio de Agricultura, Pesca y Alimentación. INIA Carretera de La Coruña Km 7 28040 Madrid (España) Ester Martin de Dios Instituto Nacional de Seguridad e Higiene en el Trabajo Calle Torrelaguna, 73 28027 Madrid (España) Date of Last Literature Search: 1998 Review of report by MS Technical Experts finalised: 1999 Final report: 2002 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 0 OVERALL RESULTS OF THE RISK ASSESSMENT CAS Number: 75-05-8 EINECS Number: 200-835-2 IUPAC Name: acetonitrile Environment Conclusion (ii) There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already. Conclusion (ii) applies to atmosphere. 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) applies to the aquatic, terrestrial ecosystems and microorganisms in the sewage treatment plant as a consequence of exposure rising from the use in the pharmaceutical industry. Human health Human health (toxicity) Workers Conclusion (ii) There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already. Conclusion (ii) applies to acute toxicity, irritation/corrosivity, sensitisation, mutagenicity, carcinogenicity and reproductive toxicity for all occupational scenarios. 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) applies to general systemic toxicity as a consequence of dermal exposure arising from use as a solvent and as an intermediate. Consumers Conclusion (ii) There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already. Humans exposed via the environment Conclusion (ii) There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already. VII Human health (risks from physico-chemical properties) Conclusion (ii) There is at present no need for further information and/or testing and no need for risk reduction measures beyond those that are being applied already. Unintentional sources The risk assessment has identified other sources of exposure of the substance to humans and to the environment, in particular, the substance is produced during biomass burning and is present in automobile exhaust, which do not result from the life-cycle of the substance produced in or imported into the European Community. The assessment of the risks arising from these exposures are not part of the this risk assessment. The comprehensive Risk Assessment Reports as forwarded to the Commission by the Member State Rapporteur however provides information about these risks. VIII CONTENTS 1 GENERAL SUBSTANCE INFORMATION................................................................................................ 5 1.1 IDENTIFICATION OF THE SUBSTANCE ....................................................................................... 5 1.2 PURITY/IMPURITIES, ADDITIVES.................................................................................................. 5 1.3 PHYSICO-CHEMICAL PROPERTIES .............................................................................................. 5 1.3.1 Physical state at normal temperature and pressure (ntp) ............................................................... 5 1.3.2 Melting point ................................................................................................................................. 5 1.3.3 Boiling point.................................................................................................................................. 5 1.3.4 Relative density ............................................................................................................................. 6 1.3.5 Vapour pressure............................................................................................................................. 6 1.3.6 Water solubility ............................................................................................................................. 6 1.3.7 Partition coefficient (log n-octanol/water)..................................................................................... 6 1.3.8 Flash point ..................................................................................................................................... 6 1.3.9 Autoflammability........................................................................................................................... 6 1.3.10 Flammability.................................................................................................................................