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European Union Risk Assessment Report N-Cyclohexylbenzothiazol-2-Sulphenamide

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European Union Risk Assessment Report N-Cyclohexylbenzothiazol-2-Sulphenamide EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 European Union Risk Assessment Report N-Cyclohexylbenzothiazol-2-sulphenamide CAS No: 95-33-0 EINECS No: 202-411-2 RISK ASSESSMENT FINAL APPROVED VERSION RAPPORTEUR GERMANY I R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 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 RAPPORTEUR GERMANY II R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 N-Cyclohexylbenzothiazol-2-sulphenamide CAS No: 95-33-0 EINECS No: 202-411-2 RISK ASSESSMENT May 2008 Germany FINAL APPROVED VERSION Rapporteur for the risk assessment of N-Cyclohexylbenzothiazol-2-sulphenamide is Germany. Contact point: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Anmeldestelle Chemikaliengesetz Friedrich-Henkel-Weg 1-25 44149 Dortmund e-mail: [email protected] RAPPORTEUR GERMANY III R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 RAPPORTEUR GERMANY IV R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 Date of Last Literature Search : 2005 Review of report by MS Technical Experts finalised: [insert month and year] Final report: 2008 RAPPORTEUR GERMANY V R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 FOREWORD 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] RAPPORTEUR GERMANY VII R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 FOREWORD 0. OVERALL RESULTS OF THE RISK ASSESSMENT CAS Number: 95-33-0 EINECS Number: 202-411-2 IUPAC Name: N-Cyclohexylbenzothiazol-2-sulphenamide Environment Conclusion (i) There is a need for further information and/or testing. Several tire recycling activities have been shown to cause exposure of the environment by benzothiazole derivatives. This exposure could not be quantified on the basis of available information. While tire recycling is increasing, exposure of aquatic and terrestrial environment from these activities should be investigated. These activities are especially tire shredding and uses of tire crumb in ground materials. A number of benzothiazole derivatives were measured in road runoff, in receiving waters and in road border soil. The substances originate from tire abrasion. The measured data indicate that there may be risk in these receiving environments. The available data are, however, too few and no final conclusions should be based on them. Therefore measured data from water bodies receiving road runoff and soils in the vicinity of roads should be produced. Landfills are according to the available few studies from leachate a source of benzothiazole derivative releases to aquatic environment. A major source of these substances are expected to be landfilled general rubber products and already deposited tires. Possible risks cannot be excluded due to the scarce and variable data. Measured data are needed to draw conclusions for landfills in general. In most of the scenarios chronic ecotoxicity data on MeSBT, MeBT, BT and BTon might be able to refine the risk ratios. However, such tests should be considered only after the above required information is made available. 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 concerns CBS emissions from the three CBS production sites to the aquatic environment as a source of CBS and waste water treatment plants of the sites. The conclusion also covers the secondary poisoning route of CBS with present exposure levels. In addition, the combined exposure of CBS and its breakdown products in the aquatic environment and waste water treatment plants does not cause risks at any producer site. In rubber industry, no releases of vulcanisation agents to the surface waters occur. Consequently, no risks for aquatic environment are expected. This conclusion covers also the exposure of soil for the CBS production and rubber industry (emissions to air). Human health RAPPORTEUR GERMANY VIII R035_HH_ENV_0805.DOC EU RISK ASSESSMENT - N-Cyclohexylbenzothiazol-2-sulphenamide CAS 95-33-0 FOREWORD 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. Two occupational exposure scenarios have been identified: (1) production of CBS in the large-scale chemical industry and (2) the use of CBS as vulcanisation accelerator in the rubber industry. For CBS, systemic toxicity by repeated inhalation and skin sensitisation are the most relevant toxicological endpoints. For respiratory tract irritation a conclusion i (on hold) was drawn. With respect to systemic effects there is concern for repeated dose toxicity by inhalation for scenario 1 (production of CBS). A critical exposure level of 2 mg/m3 is proposed as reference for establishing an occupational exposure limit. It is assumed that adherence to this reference level will effectively minimise the risk for respiratory tract irritation as well. For skin sensitisation, dermal contact results in concern for both scenarios; however, because of relevant control measures, the risk of allergic skin reactions during production of CBS (scenario 1) is considered relatively low. Consumers 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. Humans exposed via the environment 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. RAPPORTEUR GERMANY IX R035_HH_ENV_0805.DOC
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