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  • H3C

    CH3

    CH3

    ent Report

    European Union R

    isk Assessm

    tert-butyl methyl ether

    3rd Priority List Volume: 19

    European C

    hemicals B

    ureau C

    AEC

    : S:1634-04-4216-653-1

    Institute for Health and Consumer Protection

    European Chemicals Bureau Existing Substances

    European Union Risk Assessment ReportEINECS No: 216-653-1rtert-butyl methyl etheO

    CH3

    EUROPEAN COMMISSION

    JOINT RESEARCH CENTRE

    EUR 20417 EN PL-3 19 CAS No: 1634-04-4

  • European Union Risk Assessment Report

    TERT-BUTYL METHYL ETHER

    CAS No: 1634-04-4

    EINECS No: 216-653-1

    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

    European Communities, 2002 Reproduction is authorised provided the source is acknowledged.

    Printed in Italy

  • TERT-BUTYL METHYL ETHER

    CAS No: 1634-04-4

    EINECS No: 216-653-1

    RISK ASSESSMENT

    Final Report, 2002

    Finland

    The rapporteur for the risk assessment report on MTBE is the Finnish Environment Institute, in co-operation with the National Product Control Agency for Welfare and Health.

    The scientific work on this report has been prepared by the Finnish Environment Institute, the National Product Control Agency for Welfare and Health and the Finnish Institute of Occupational Health.

    Contact point:

    Chemicals Division Finnish Environment Institute P.O.Box 140 FIN - 00251 Helsinki Finland

  • Date of Last Literature Search : 2001 Review of report by MS Technical Experts finalised: 2001 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: 1634-04-4 EINECS Number: 216-653-1 IUPAC Name: Propane, 2-methoxy-2-methyl

    Environment

    Results of risk characterisation for the aquatic environment

    Conclusion (i) There is a need for further information and/or testing.

    This conclusion is reached because there is a need for better information to adequately characterise the risks to the aquatic ecosystem regarding the emission of the substance to surface water.

    The information and test requirements are: a tiered testing approach for investigation of avoidance behaviour in fish and if necessary in other wildlife animals related to water contaminated with the substance.

    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.

    This conclusion applies to production, production/formulation, formulation and processing sites; to transport, storage and delivery except for intermittent release to surface water from terminal site storage tank bottom waters; to road traffic (runoff) and to boating (exhaust).

    Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

    This conclusion applies to intermittent release to surface water from terminal site storage tank bottom waters.

    Results of risk characterisation for microorganisms in wastewater treatment plants

    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.

    This conclusion applies to production, production/formulation, formulation and processing sites.

    Results of risk characterisation for the atmospheric compartment

    Conclusion (ii) There is at present no need for further information or testing or risk reduction measures beyond those which are being applied already.

    Results of risk characterisation for soil

    Conclusion (ii) There is at present no need for further information or testing or risk reduction measures beyond those which are being applied already.

    This conclusion applies to production, formulation, processing and runoff infiltrated.

    VII

  • Results of risk characterisation for groundwater

    Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account

    This conclusion applies to overall quality of groundwater. The risks are mainly related to leaking underground storage tanks and spillage from overfilling of the storage tanks.

    Human health

    Human health (toxicity)

    Workers

    Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

    This conclusion applies for maintenance and automotive repair scenarios, due to the long-term local effects to skin.

    Consumers

    Conclusion (ii) There is at present no need for further information or testing or 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 or testing or risk reduction measures beyond those which are being applied already.

    Combined exposure

    Conclusion (ii) There is at present no need for further information or testing or risk reduction measures beyond those which are being applied already.

    Human health (risks from physico-chemical properties)

    Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account

    This conclusion is reached for humans exposed via the environment due to concerns for the potability of drinking water in respect of taste and odour as a consequence of exposure arising from leaking underground storage tanks and spillage from overfilling of the storage tanks.

    VIII

  • CONTENTS

    1 GENERAL SUBSTANCE INFORMATION................................................................................................ 9

    1.1 IDENTIFICATION OF THE SUBSTANCE........................................................................................ 9

    1.2 PURITY/IMPURITIES, ADDITIVES .........................................................