European Union Risk Assessment Report

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European Union Risk Assessment Report CN N EINECS No: 203-466-5 857 E lonitrile CH y EUR 20 acr C 2 H CAS No: 107-13-1 European Union Risk Assessment Report Protection 32 : Substances Priority List st European Institute for Health and Consumer 1 Bureau Chemicals Existing Volume European Chemicals Bureau European Union Risk Assessment Report CAS: 107-13-1 EC: 203-466-5 acrylonitrile 32 PL-1 European Union Risk Assessment Report ACRYLONITRILE CAS No: 107-13-1 EINECS No: 203-466-5 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). © European Communities, 2004 Reproduction is authorised provided the source is acknowledged. ACRYLONITRILE CAS No: 107-13-1 EINECS No: 203-466-5 RISK ASSESSMENT Final Report, 2004 The risk assessment of acrylonitrile has been prepared by Ireland on behalf of the European Union. The scientific work contained in the report has been prepared by the Hazardous Substances Assessment Unit of the Health and Safety Authority. Contact: Hazardous Substances Assessment Unit Health and Safety Authority, 10, Hogan Place, Dublin 2 Mrs Roisin McEneany, Dr Majella Cummins Tel: 353-1-6147000 Fax: 353-1-6147017 E-mail: [email protected] Date of Last Literature Search: 1999 Review of report by MS Technical Experts finalised: 2000 Final report: 2004 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.: 107-13-1 EINECS-No.: 203-466-5 IUPAC name: 2-propenenitrile Synonyms acrylonitrile Environment 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 of: • concerns for effects on the local aquatic sphere as a consequence of exposure arising from production of acrylic fibres at a particular site. 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: • the aquatic compartment including sediment and microorganisms, for production of acrylonitrile and further processing to fibres and other plastics, with the exception of processing to acrylic fibres at one site only. It also applies to the terrestrial compartment, secondary poisoning and to the atmospheric compartment, the major compartment of distribution of acrylonitrile, for production of acrylonitrile and further processing to fibres and other plastics. Summary of results Acrylonitrile monomer released to the environment as a consequence of production or further processing will distribute primarily to the atmosphere and to the aqueous environment. Redistribution to other environmental compartments is anticipated to be negligible. There is rapid photodegradation of acrylonitrile, while in the aquatic environment acrylonitrile, while not readily biodegradable based on available information, appears to degrade rapidly in wastewater treatment plants following acclimation, and also degrades in surface water. Up to 99% biodegradation has been reported in simulation tests. Since acrylonitrile is toxic to aquatic organisms and is not readily biodegradable, release into the aquatic environment could present some risk to aquatic species in the vicinity of plants producing or further processing acrylonitrile. However, the data for virtually all sites involved in production and processing of acrylonitrile in Europe in 1995/96, numbering 43 in all, most of which have industrial WWTPs, indicate PEC:PNEC ratios of less than 1 for surface water, using a PNEC of 17 µg/l. PEC:PNEC ratios for sediment for these sites are similarly below 1, indicative overall of low concern for the aquatic environment. It should be noted, however, that this conclusion applies only at a particular point in time to 42 out of the total of 43 European sites existing at that time and which provided aquatic release data relating to the period 1994- 1996, and cannot be extrapolated generally for the aquatic environment. The specific risk reduction measures (e.g. wastewater treatment) or particular characteristics of the assessed sites (e.g. high dilution factors due to effluent emissions into very large rivers or estuaries) cannot be VII extrapolated to sites not covered by this risk assessment, for example new sites starting up after the data for this assessment were gathered, or sites located outside the European Union. In this risk assessment it was established that one site, located in a coastal position, had a PEC:PNEC ratio of 3.1, and the levels of acrylonitrile in effluent were comparatively high compared with other sites, at 35 mg/l. It is concluded that there are concerns for possible effects on the local aquatic environmental sphere as a consequence of exposure arising from production of acrylic fibres at this site. In relation to risk assessment for microorganisms in wastewater treatment plants, PEC:PNEC ratios were in general below 1, indicative of little risk for microorganisms in WWTP. All 43 production and further processing companies provided data on atmospheric emissions. These showed that emissions were generally low, being reduced by scrubbing of gaseous and volatile wastes before discharge to the atmosphere. Predicted atmospheric concentrations (PEClocalair) of acrylonitrile in the vicinity of acrylonitrile production facilities and facilities involved in further processing of acrylonitrile into acrylonitrile-containing polymers and other monomers were between 0.001 and 0.240 mg/m3. Results of monitoring have indicated average concentrations of below 1 µg/m3 at the perimeter of acrylonitrile plants. There is a paucity of data about the effects of these low levels of acrylonitrile on species exposed via the atmospheric environment, although results of the mammalian toxicology reported in Section 4 would indicate a low level of concern. Derivation of PEC:PNEC ratios for the atmospheric environment provided values of below 1.0 for all sites. Acrylonitrile is also rapidly photodegraded. In addition, information regarding a catastrophic event which happened outside the EU and during which the contents of a large storage tank containing acrylonitrile were released very rapidly, showed damage to vegetation observed within a 100 m zone of the spill. No damage to vegetation was observed greater than 100 m from the spill where acrylonitrile concentrations of up to 20 ppm were measured, a concentration far greater than the expected fence-line value. Risk characterisation for the terrestrial compartment has excluded the possibility of sludge application to land, given information from industry that little industrial sludge from acrylonitrile production and processing facilities is spread on land in Europe. The majority of companies providing information on this aspect indicated that contaminated sludge is incinerated together with other wastes.
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