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European Union Risk Assessment Report EU RISK ASSESSMENT - PRIMARY ALKYL AMINES TITLE European Union Risk Assessment Report AMINES, TALLOW ALKYL CAS No: 61790-33-8 EINECS No: 263-125-1 (Z)-OCTADEC-9-ENYLAMINE CAS No: 112-90-3 EINECS No: 204-015-5 OCTADECYLAMINE CAS No: 124-30-1 EINECS No: 204-695-3 AMINES, HYDROGENATED TALLOW ALKYL CAS No: 61788-45-2 EINECS No: 262-976-6 AMINES, COCO ALKYL CAS No: 61788-46-3 EINECS No: 262-977-1 RISK ASSESSMENT RAPPORTEUR GERMANY R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT - PRIMARY ALKYL AMINES TITLE 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 R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT - PRIMARY ALKYL AMINES TITLE AMINES, TALLOW ALKYL CAS No: 61790-33-8 EINECS No: 263-125-1 (Z)-OCTADEC-9-ENYLAMINE CAS No: 112-90-3 EINECS No: 204-015-5 OCTADECYLAMINE CAS No: 124-30-1 EINECS No: 204-695-3 AMINES, HYDROGENATED TALLOW ALKYL CAS No: 61788-45-2 EINECS No: 262-976-6 AMINES, COCO ALKYL CAS No: 61788-46-3 EINECS No: 262-977-1 RISK ASSESSMENT October 2008 Germany Rapporteur for the risk assessment of the primary alkyl amines is Germany 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] RAPPORTEUR GERMANY R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT - PRIMARY ALKYL AMINES TITLE Date of Last Literature Search : [insert year] Review of report by MS Technical Experts finalised: [insert month and year] Final report: [year] RAPPORTEUR GERMANY R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT – PRIMARY ALKYL AMINES FOREWORD Foreword This Draft Risk assessment Report is 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. This Draft Risk Assessment Report is currently under discussion in the Competent Group of Member State experts with the aim of reaching consensus. During the course of these discussions, the scientific interpretation of the underlying scientific information may change, more information may be included and even the conclusions reached in this draft may change. The Competent Group of Member State experts seek as wide a distribution of these drafts as possible, in order to assure as complete and accurate an information basis as possible. The information contained in this Draft Risk Assessment Report does not, therefore, necessarily provide a sufficient basis for decision making regarding the hazards, exposures or the risks associated with the priority substance. This Draft Risk Assessment Report is the responsibility of the Member State rapporteur. In order to avoid possible misinterpretations or misuse of the findings in this draft, anyone wishing to cite or quote this report is advised to contact the Member State rapporteur beforehand. Contact Details of the Rapporteur(s) 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 V R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT – PRIMARY ALKYL AMINES OVERALL RESULTS OF THE RISK ASSESSMENT 0 OVERALL RESULTS OF THE RISK ASSESSMENT 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. Conclusion (ii) applies to • Releases into surface waters during production of primary alkyl amines. • Releases into surface waters during formulation of fertilizers, processing to aminoethoxylates, amides, sulphosuccinamates and other downstream products. • Releases into surface water using primary alkyl amines as floatation agent. • Releases into agricultural soils during application of sewage sludge onto agricultural soil due to production, formulation of fertilizers, and use as floatation agent. • Releases into agricultural soils during the use as anticaking agent in fertilizers. • Releases into the atmosphere during all life-cycle steps. • Possible PBT/vPvB properties of the substance. Human health Human health (toxicity) Workers Conclusion (i) There is a need for further information and/or testing. Available data on the skin sensitisation potential of the primary alkyl amines are not sufficiently conclusive. Due to the limited hazard information, the occupational risk of skin sensitisation following dermal exposure to the primary alkyl amines cannot be sufficiently assessed. Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. The primary alkyl amines are classified and labelled as skin irritants or corrosives. Skin irritation and corrosive lesions need to be avoided by adequate skin-related risk management measures. In addition, further risk management measures have to be implemented because of concern for repeated dose toxicity (systemic effects) following dust exposure and dermal contact to the solid and skin irritating primary alkyl amines (octadecyl amine and hydrogenated tallow alkyl amine). Based on the actual dermal exposure assessment, there is concern for fertility impairment as well. RAPPORTEUR GERMANY VII R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT – PRIMARY ALKYL AMINES OVERALL RESULTS OF THE RISK ASSESSMENT To prevent chronic systemic health effects while handling primary alkyl amines, occupational exposure by inhalation is proposed to be controlled down to a level of 0.15 mg/m³ (8-hour time-weighted average). The corresponding health-based reference level for controlling repeated dermal exposure is calculated to be 0.04 mg/kg/day. Consumers Conclusion (i) There is a need for further information and/or testing. Conclusion (i) applies to potential skin sensitisation reactions of primary alkyl amines from the use of metal care products. For the assessment of the possible skin sensitisation potential of the primary alkyl amines the performance of a Local Lymph Node Assay (LLNA) is proposed with an appropriate substance of the category. Test results are needed to perform a firm calculation for consumers. Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account. Conclusion (iii) applies to the dermal route for local and systemic repeated exposure and fertility through uptake of primary alkyl amines from the use of metal care products. Humans exposed via the environment Conclusion (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. Conclusion (ii) applies to all other toxicological endpoints and scenarios. Human health (physico-chemical properties) 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 VIII R070_410_412_429_430_0811_ENV_HH.DOC EU RISK ASSESSMENT – PRIMARY ALKYL AMINES CONTENTS CONTENTS 1 GENERAL SUBSTANCE INFORMATION ............................................................................................. 13 1.1 IDENTIFICATION OF THE SUBSTANCE.....................................................................................
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