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European Union Risk Assessment Report European Chemicals Bureau Institute for Health and Consumer Protection European Union Risk Assessment Report European Chemicals Bureau CAS No: 79-11-8 EINECS No: 201-178-4 Existing Substances monochloroacetic acid (MCAA) European monochloroacetic acid Union Risk Assessment Report Report Assessment Risk Union H O Cl C C ( MCAA OH ) H CAS: EC: 201-178-4 79-11-8 3rd Priority List Volume: 52 PL-3 EUR 21403 EN 52 European Union Risk Assessment Report MONOCHLOROACETIC ACID (MCAA) CAS-No.: 79-11-8 EINECS-No.: 201-178-4 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, 2005 © European Communities, 2005 Reproduction is authorised provided the source is acknowledged. Printed in Italy MONOCHLOROACETIC ACID (MCAA) CAS No: 79-11-8 EINECS No: 201-178-4 RISK ASSESSMENT Final Report, 2005 The Netherlands Rapporteur for the risk evaluation of monochloroacetic acid 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 Organization for Applied Scientific Research (TNO) and the National Institute of Public Health and 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: 2000 Review of report by MS Technical Experts finalised: 2002 Final report: 2005 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, 05/04/1993 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: 79-11-8 EINECS No: 201-178-4 IUPAC Name: Monochloroacetic acid Environment Conclusion (i) There is need for further information and/or testing. This conclusion (unintentional sources) is reached because substantial MCAA levels are measured in various environmental compartments, wet deposition, surface water and soil. These regional/continental background concentrations exceed the corresponding PNEC in some cases, especially in soil. Further research is needed to investigate, quantitatively, the origin of these MCAA levels (natural versus anthropogenic). 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 because the local PECs in surface water exceed the PNEC for MCAA production/processing site I-B1 and site I-C. In case of site I-B1 the conclusion is based on monitoring data. For site I-C the PEC/PNEC is >1 for the STP as well. For both sites industry has indicated that the efficiency of the local WWTP will be improved, but up to now no data are available to verify this statement. Human Health Human health (toxicity) Workers Warning: It is noted that molten/liquid MCAA is very dangerous for dermal exposure. Following accidental dermal exposure to molten/liquid MCAA, fatal and non-fatal cases of severe acute systemic intoxication have been reported. Conclusion (i) There is need for further information and/or testing. This conclusion is ‘on hold’ (waiting for the Risk Reduction Strategy) is reached because a developmental toxicity study should be performed. 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 because: • acute toxic effects after short-term dermal exposure cannot be excluded for Scenario 4 ‘Use of paint removers’; • acute toxic effects after short-term inhalation exposure cannot be excluded for all scenarios except the sub-scenarios 'Production of MCAA: production and cleaning and maintenance’ and the scenario ‘Use of MCAA: use of solids’; • the occurrence of dermal and eye irritation cannot be excluded in Scenario 4 ‘Use of paint removers’(without the use of PPE); VII • the occurrence of respiratory (sensory) irritation cannot be excluded in the sub-scenarios ‘Production of MCAA: transfer of molten MCAA and transfer of 80% MCAA’ and the scenario ‘Use of paint removers’; • systemic effects after repeated dermal exposure cannot be excluded for Scenario 4 ‘Use of paint removers’; • systemic effects after repeated inhalation exposure cannot be excluded for the sub-scenarios ‘Production of MCAA: transfer of molten MCAA and transfer of 80% MCAA’ and for the scenario ‘Use of paint removers’. It might be possible that in some industrial premises these worker protection measures are already applied. However, it should be realised that PPE has already been taken into account for the estimation of the exposure levels. In relation to all other potential adverse effects and the worker population, it is concluded that based on the available information at present no further information/testing on the substance is needed. Consumers Conclusion (i) There is need for further information and/or testing. This conclusion ‘on hold’ (waiting for the Risk Reduction Strategy) is reached because a developmental toxicity study should be performed. Humans exposed via the environment Conclusion (i) There is need for further information and/or testing. This conclusion ‘on hold’ (waiting for the Risk Reduction Strategy) is reached because a developmental toxicity study should be performed. 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 because: • for local production scenario I-C a possible risk for repeated dose toxicity after oral exposure may be observed. The main exposure for man at this site is via drinking water (see also conclusion environment). • for one of the processing sites (off-site) II with a high emission to air a possible risk for repeated dose toxicity after oral exposure may be observed. The main exposure for man at this site is via eating leaf crops. The concentration in the leaf crops is caused by deposition of MCAA from air. VIII CONTENTS 1 GENERAL SUBSTANCE INFORMATION.........................................................................................
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