RISK ASSESSMENT Vinyl acetate CAS-No.: 108-05-4 EINECS-No.: 203-545-4 19.08.2008 FINAL APPROVED VERSION R059_0805_env_hh 19.08.2008 Information on the rapporteur Contact point: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA) Anmeldestelle Chemikalien / Zulassungsstelle Biozide (Federal Institute for Occupational Safety and Health Division for Chemicals and Biocides Regulation) Friedrich-Henkel-Weg 1-25 44149 Dortmund (Germany) fax: +49(231)9071-2679 e-mail: [email protected] The first draft of the Comprehensive Risk Assessment Report of Vinyl acetate, a substance chosen from the EU 1st Priority List in 1994, was discussed preliminary (written procedure) at the TM II / 2001 (June 2001). The Environmental part was discussed in depth at the TM III/2002 (August 2002) and further in depth at the TC NES IV 04 (December 2004). It was distributed for the last visit written procedure in May 2005 and for the final written approval in May 2006. The Human Health part was discussed first in depth at the TM I/2002 (March 2002), second in depth at the TM IV/2002 (December 2002), last visit at the TM II/2003 (June 2003), 2nd last visit (effects assessment only) at TC NES I/2007 and 2nd last visit (Risk characterisation) at TC NES II/2007. It was distributed for the final written procedure in December 2007 and for a further written approval in May 2008. 2 CAS No.: 108-05-4 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, [ECB: year] ISBN [ECB: insert number here] © European Communities, [ECB: insert year here] Reproduction is authorised provided the source is acknowledged. Printed in Italy R059_0805_env_hh 19.08.2008 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 Health and Environmental Risks (SCHER) 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 and confirmed in the Johannesburg Declaration on Sustainable Development at the World Summit on Sustainable Development, held in Johannesburg, South Africa in 2002. 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] 4 CAS No.: 108-05-4 R059_0805_env_hh 19.08.2008 Contents 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT 8 1 GENERAL SUBSTANCE INFORMATION 12 2 GENERAL INFORMATION ON EXPOSURE 16 2.1 Exposure sources 16 2.1.1 Production 17 2.1.2 Processing 18 2.2 Uses 21 3 ENVIRONMENT 24 3.1 Environmental exposure 24 3.1.1 General discussion 24 3.1.2 Exposure Assessment for the Aquatic Compartment 35 3.1.3 Exposure Assessment for the Atmosphere 43 3.1.4 Exposure assessment for the terrestrial compartment 46 3.1.5 Non compartment specific exposure relevant to the food chain 48 3.1.6 Regional concentrations 48 3.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 50 3.2.1 Effects assessment for the aquatic compartment (including sediment) 50 3.2.2 Effects assessment for the terrestrial compartment 58 5 CAS No.: 108-05-4 R059_0805_env_hh 19.08.2008 3.2.3 Effects assessment for the atmosphere 59 3.2.4 Non compartment specific effects relevant to the food chain 60 3.3 Risk characterisation 61 3.3.1 Aquatic compartment (incl. sediment) 61 3.3.2 Atmosphere 65 3.3.3 Terrestrial compartment 66 3.3.4 Non compartment specific effects relevant to the food chain 67 3.3.5 Marine Assessment including PBT Assessment 67 4 HUMAN HEALTH 69 4.1 HUMAN HEALTH (TOXICITY) 69 4.1.1 Exposure assessment 69 4.1.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 90 4.1.3 Risk characterisation 198 Mutagenicity 226 Carcinogenicity 227 4.2 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES) 228 4.2.1 Exposure assessment 228 4.2.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 228 4.2.3 Risk characterisation 228 5 CONCLUSIONS / RESULTS 230 6 REFERENCES 233 6 CAS No.: 108-05-4 R059_0805_env_hh 19.08.2008 7 ABBREVIATIONS 252 7 CAS No.: 108-05-4 R059_0805_env_hh 19.08.2008 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT CAS No. 108-05-4 EINECS No. 203-545-4 IUPAC Name Vinyl acetate Overall results of the risk assessment: ( ) i) There is need for further information and/or testing (x) ii) There is at present no need for further information and/or testing and for risk reduction measures beyond those which are being applied already (x) iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account Summary of conclusions: Environment As a follow up to conclusion (i), which was drawn in the first draft of the Environment Section of the Comprehensive Risk Assessment Report of Vinyl acetate (August 2002), further acute and long-term toxicity tests were performed for the aquatic compartment and more data on a number of production and processing sites were obtained, leading to the following revised risk characterisation. conclusion iii): Terrestrial compartment A risk to the local terrestrial compartment can be identified for the life cycle stage of vinyl acetate processing. This conclusion applies to the generic processing scenario for the local main source. The unknown processing sites account for a missing tonnage of 325,000 t/a (or 41 % of the total production volume of 800,000 t/a), compared to a verified processing tonnage of 475,000 t/a. 8 CAS No.: 108-05-4 R059_0805_env_hh 19.08.2008 The risk characterisations for selected (worst case) production and processing sites with site specific data indicate no actual risk to the terrestrial compartment. However, the highest PEC/PNEC ratio calculated with site specific data (0.86) is not very far from the PEC/PNEC ratio calculated for the generic processing scenario (2.33), and there was also a risk at one of the production sites (which has been eliminated during the time of the preparation of this RAR). Consequently, it is not completely implausible that unknown processing sites pose a risk to the terrestrial environment. The risk characterisation for the terrestrial compartment could still be revised by requesting further testing (i.e. OECD 207 Earthworm acute toxicity test and OECD 208 Terrestrial plants growth test). However, a further data improvement by means of testing is not considered a reasonable next step by the rapporteur for the following reasons. Further information on the toxicity of vinyl acetate to terrestrial organisms allows for a re- evaluation of the potential risk that emanates from the unknown processing sites, but delays risk reduction measures in case that a risk still remains with the new data.