Dimethyl Sulfate Final Version
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N port 3 N te N COMMISSIO OCH ha 838 E p INT RESEARCH CENTRE EINECS No: 201-058-1 EUR 19 EUROPEA JO S O O l sul y CO dimeth 3 H CAS No: 77-78-1 European Union Risk Assessment Re Protection 12 : Substances Priority List nd European Institute for Health and Consumer 2 Bureau Chemicals Existing Volume European Chemicals Bureau European Union Risk Assessment Report CAS: 77-78-1 EC: 201-058-1 dimethyl sulphate 12 PL-2 European Union Risk Assessment Report DIMETHYL SULPHATE CAS No: 77-78-1 EINECS No: 201-058-1 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 ISBN 92-894-1274-7 © European Communities, 2002 Reproduction is authorised provided the source is acknowledged. Printed in Italy DIMETHYL SULPHATE CAS No: 77-78-1 EINECS No: 201-058-1 RISK ASSESSMENT Final report, 2002 The Netherlands Rapporteur for the risk evaluation of dimethyl sulphate is the Ministry of Housing, Spatial Planning and the Environment (VROM) in consultation with the Ministry of Social Affairs and Employment (SZW) and the Ministry of Public Health, Welfare and Sport (VWS). 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 Netherlands Organisation for Applied Scientific Research (TNO) and the National Institute of Public Health and the Environment (RIVM), by order of the rapporteur. Contact point: Chemical Substances Bureau P.O. Box 1 3720 BA Bilthoven The Netherlands Date of Last Literature Search : 1994 Review of report by MS Technical Experts finalised: September 1998 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 No. 77-78-1 EINECS No. 201-058-1 IUPAC name dimethyl sulphate Environment ( ) i) There is need for further information and/or testing (X) ii) There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied ( ) iii) There is a need for limiting the risks: risk reduction measures which are already being applied shall be taken into account Human health (toxicity) Workers ( ) i) There is need for further information and/or testing. ( ) ii) There is at present no need for further information and/or testing or for risk. reduction measures beyond those which are being applied. (X) 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 reached because of: - concerns for risks for respiratory tract irritation, mutagenicity, and carcinogenicity as a consequence of inhalation exposure arising from production, processing and use of the substance; - concerns for the pregnant population for additional adverse health effects as a consequence of repeated inhalation exposure arising from the use of the substance as an intermediate. It is noted that the toxicological database of DMS has gaps with respect to systemic toxicity after repeated exposure, and with respect to effects on reproduction. Furthermore, the carcinogenicity study of Schlögel has serious limitations. However, it is noted that the carcinogenic activity of DMS, i.e., the cancer incidence per mg/m3 under occupational conditions of exposure, points to very low acceptable exposure levels with regard to the carcinogenic effects, which implies a considerable reduction of the current occupational exposure limits. It is expected that compliance to these low exposure levels will prevent effects other than carcinogenic effects to occur. Consumers ( ) i) There is need for further information and/or testing. ( ) ii) There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. (X) iii) There is a need for limiting the risks: risk reduction measures which are already being applied shall be taken into account. VII Conclusion (iii) is reached because of: - the risk assessment shows that risks cannot be excluded at any exposure as the substance is identified as a non-threshold carcinogen. However, the risks covered by this risk assessment are not of a magnitude, that immediate action is deemed necessary. Risk reduction measures already being applied are considered sufficient to impose pressure in reducing and controlling exposure to the substance. Indirect exposure via the environment (industrial emissions) ( ) i) There is need for further information and/or testing. ( ) ii) There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied. (X) 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 reached because of: - the risk assessment shows that risks cannot be excluded at any exposure as the substance is identified as a non-threshold carcinogen. However, the risks covered by this risk assessment are not of a magnitude, that immediate action is deemed necessary. Risk reduction measures already being applied are considered sufficient to impose pressure in reducing and controlling exposure to the substance. In addition to the conclusions according to Council Reg. 793/93/EEC given above, the RAR came to the conclusion concerning emissions from unintentional sources as follows: Indirect exposure via the environment (unintentional sources) (X) i) There is need for further information and/or testing ( ) ii) There is at present no need for further information and/or testing or for risk reduction measures beyond those which are being applied ( ) iii) There is a need for limiting the risks: risk reduction measures which are already being applied shall be taken into account Conclusion (i) is reached because: - more information is needed about actual atmospheric concentrations of DMS from unintentional sources. Such data are important to make an up-to-date exposure assessment for this compound, being with a genotoxic carcinogen. Human health (physico-chemical properties) Given the physico-chemical data, DMS is considered not to form a risk