European Union Risk Assessment Report 2-ETHOXYETHANOL CAS No: 110-80-5 EINECS No: 203-804-1 RISK ASSESSMENT GENERAL NOTE This document contains different reports: - Environment Version December 2007 (pages 43 – conclusions resumed on the last one) - Human Health Version October 2008 (pages 125 - conclusions resumed on the last one) - Environment and Human Health Appendices A1, A2, A3, A4, A5 A6 (pages 53) RISK ASSESSMENT 2-Ethoxyethanol CAS-No.: 110-80-5 EINECS-No.: 203-804-1 Draft of 14.12.2007 1 CAS No 110-80-5 Information on the rapporteur Contact point: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Anmeldestelle Chemikaliengesetz (BAuA) (Federal Institute for Occupational Safety and Health Notification Unit) Friedrich-Henkel-Weg 1-25 44149 Dortmund Germany 2 CAS No 110-80-5 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), now renamed Scientific Committee on Health and Environmental Risks (SCHER) which gives its opinion to the European Commission on the quality of the risk assessment. This Draft Risk Assessment Report has undergone a discussion in the Competent Group of Member State experts with the aim of reaching consensus by interpreting the underlying scientific information, or including more data, but this work has not yet been totally finalised. 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 under 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. 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] 3 CAS No 110-80-5 CONTENTS OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT 6 1 GENERAL SUBSTANCE INFORMATION 8 2 GENERAL INFORMATION ON EXPOSURE 11 2.1 Production/ Import 11 2.2 Processing / application (categories of use, amounts) 11 3 ENVIRONMENT 13 3.1 Environmental exposure 13 3.1.1 General discussion 13 3.1.2 Aquatic compartment (incl. sediment) 18 3.1.3 Atmosphere 20 3.1.4 Terrestrial compartment 22 3.1.5 Non compartment specific exposure relevant to the food chain (secondary poisoning) 22 3.1.6 Other non industrial emissions 22 3.1.7 Regional exposure consideration 22 3.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 25 3.2.1 Aquatic compartment (incl. sediment) 25 3.2.2 Atmosphere 28 3.2.3 Terrestrial compartment 28 3.3 Risk characterisation 30 4 CAS No 110-80-5 3.3.1 Aquatic compartment (incl. sediment) 30 3.3.2 Atmosphere 31 3.3.3 Terrestrial compartment 32 3.3.4 Non compartment specific effects relevant to the food chain (secondary poisoning) 33 4 HUMAN HEALTH 34 4.1 HUMAN HEALTH (TOXICITY) 34 4.1.1 Exposure assessment 34 4.1.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 36 4.1.3 Risk characterisation 37 4.2 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES) 38 4.2.3 Risk characterisation 38 5 CONCLUSIONS / RESULTS 39 Environment 39 Human Health 39 6 REFERENCES 40 5 CAS No 110-80-5 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT CAS No. 110-80-5 EINECS No. 203-804-1 IUPAC Name 2-Ethoxyethanol 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 () 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 ii) Based on the available data, 2-ethoxyethanol represents no risk to the environment resulting from production, processing, formulation and use. 6 CAS No 110-80-5 Human Health Workers Consumers Man indirectly exposed via the environment 7 CAS No 110-80-5 1 GENERAL SUBSTANCE INFORMATION Identification of the substance CAS-No.: 110-80-5 EINECS-No.: 203-804-1 IUPAC Name 2-ethoxyethanol Synonyms: ethylglycol 2-ethoxyethanol ethylene glycol mono ethyl ether Molecular weight: 90.1 g/mol Empirical formula: C4H10O2 Structural formula: HO O CH 3 Purity/impurities, additives Purity: > 99 % w/w Impurity: < 0.005 % w/w acetic acid < 0.2 % w/w water Additives: < 0.012 % w/w 2,6-di-tert-butyl-p-cresol 2-aminoethanol function: inhibition of peroxide formation 8 CAS No 110-80-5 Table 1: Physico-chemical properties Physical state colourless liquid at 20 °C Melting point < - 80 °C Ullmann, 1978 Boiling point 132 - 137 °C at 1013hPa Ullmann, 1978 Relative density 0.930 at 20 °C Ullmann, 1978 Vapour pressure 5.3 hPa at 20 °C Kirk-Othmer, 1980 Surface tension 69.5 mN/m at 25 °C 1) Union Carbide, 1998 Water solubility miscible in each ratio at 20 °C Kirk-Othmer, 1980 Partition coefficient log Pow –0.54 to –0.10 2) Dearden & Bresnen, 1988 Flash point 40 °C (closed cup) Chemsafe, 1996 Flammability flammable 3) Chemsafe, 1996 Ignition temperature 235 °C Chemsafe, 1996 Explosive properties not explosive 4) Chemsafe, 1996 Oxidising properties no oxidising properties 5) Chemsafe, 1996 Henry’s law constant 0.048 Pa m³ mol-1 Howard, Meylan; SRC 1993 1) Ring method 2) In the following risk assessment report a log Pow of – 0.43 is used 3) Test A.10 not conducted (substance is a liquid) Test A.12 and A.13 not conducted because of structural reasons 4) No test conducted because of structural reasons 5) No test conducted because of structural reasons 9 CAS No 110-80-5
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