European Union Risk Assessment Report
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European Union Risk Assessment Report BENZENE CAS No: 71-43-2 EINECS No: 200-753-7 RISK ASSESSMENT GENERAL NOTE This report contains different documents: - Environment and Human Health Report (pages 393) Appendix 1 (pages 4) Appendix 2 (pages 68) Appendix 3 (pages 3) Appendix 4 (pages 13) Appendix 5 (pages 3) Appendix 6 (pages 2) RISK ASSESSMENT Benzene CAS-No.: 71-43-2 EINECS-No.: 200-753-7 Final version of 2008 FINAL APPROVED VERSION R063_0707_env_hh 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) fax: +49(231)9071-679 e-mail: [email protected] The first draft of the Comprehensive Risk Assessment Report of Benzene, a substance chosen from the EU 1st priority list in 1994 was discussed preliminarily at the Technical Meeting III / 2000 (19.-22. September 2000). The Environment Section of the Risk Assessment Report was discussed “in-depth” at the Technical Meeting in June 2001 and as “2nd in-depth” at the Technical Meeting in March 2002. Furthermore, the Environment Section was distributed for the final written procedure in May 2002. The Human Health Section of the Risk Assessment Report was discussed “in-depth” at the Technical Meeting in September 2001, as “2nd in-depth” at the Technical Meeting in June 2002 and as “last visit” at the Technical Meeting in September 2002. Furthermore, the Human Health Section was distributed for the final written procedure in March 2003. After the OECD discussion at SIAM 21 the Human Health Section of the RAR Benzene was distributed for a 2nd final written procedure in December 2006 followed by a second OECD consultation in written procedure in July 2007. This document is the final version of the Risk Assessment Report of Benzene which is submitted for publication. 2 CAS-No. 71-43-2 R063_0707_env_hh CONTENTS 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT 5 1 GENERAL SUBSTANCE INFORMATION 9 2 GENERAL INFORMATION ON EXPOSURE 12 3 ENVIRONMENT 18 3.1 ENVIRONMENTAL EXPOSURE 20 3.1.1 General discussion 20 3.1.2 Aquatic compartment 64 3.1.3 Atmosphere 73 3.1.4 Terrestrial compartment 83 3.1.5 Non compartment specific exposure relevant to the food chain 87 3.2 EFFECTS ASSESSMENT: HAZARD IDENTIFICATION AND DOSE (CONCENTRATION) - RESPONSE (EFFECT) ASSESSMENT 90 3.2.1 Aquatic compartment 92 3.2.2 Atmosphere 103 3.2.3 Terrestrial compartment 106 3.2.4 Non compartment specific effects relevant to the food chain 106 3.3 RISK CHARACTERISATION 108 3.3.1 Aquatic compartment 108 3.3.2 Atmosphere 113 3.3.3 Terrestrial compartment 116 3.3.4 Non compartment specific effects relevant to the food chain 117 3 CAS-No. 71-43-2 R063_0707_env_hh 4 HUMAN HEALTH 119 4.1 HUMAN HEALTH (TOXICITY) 119 4.1.1 Exposure assessment 119 4.1.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 164 4.1.3 Risk characterisation 258 4.2 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES) 346 4.2.1 Exposure assessment 346 4.2.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 346 4.2.3 Risk characterisation 346 5 CONCLUSIONS / RESULTS 348 6 REFERENCES 353 4 CAS-No. 71-43-2 R063_0707_env_hh 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT CAS No. 71-43-2 EINECS No. 200-753-7 IUPAC Name Benzene 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 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 microorganisms in industrial Waste-water treatment plants 5 CAS-No. 71-43-2 R063_0707_env_hh Clocaleff/PNECmicroorganism ratios are > 1 for 23 out of 48 production and/or processing sites of the substance. For all these sites the Clocaleff is based on default values. It is not expected to obtain site-specific exposure data with reasonable efforts and time expenditure. In addition, it is not likely that the performance of a test with industrial activated sludge will result in a Clocaleff/PNECmicroorganism ratio < 1 for all sites due to the partly very high benzene concentrations in wwtp effluents (up to 102 mg/l). • to the local Aquatic ecosystems For two production and processing sites of the substance, the PEClocal/PNECaqua ratio is > 1. It has to be noted that the PEC calculations for these sites are partly based on default values. • to the Atmosphere Concerns arise as isolated benzene contributes to the formation of ozone and other harmful substances i.e. smog formation. In the context of the consideration of which risk reduction measures that would the most appropriate, it is recommended that under the relevant air quality Directives a specific in-depth evaluation be performed. Such an evaluation should focus on the contribution of isolated as well as non-isolated benzene to the complex issue of ozone and smog formation and the resulting impact on air quality. 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 This conclusion applies to Atmosphere (direct effects of benzene on plants) Terrestrial compartment Non compartment specific effects relevant to the food chain (secondary poisoning) Human Health The conclusion of the assessment of the risks to Workers 6 CAS-No. 71-43-2 R063_0707_env_hh is that there is a need for specific measures to limit the risks. Conclusion (iii) This conclusion is reached because of: — concerns for mutagenicity and carcinogenicity as a consequence of dermal and inhalation exposure arising from all worker scenarios, — concerns for acute toxicity as a consequence of inhalation exposure during production of perfumes (use of benzene) and cleaning of crude benzene and gasoline tanks, — concerns for repeated dose toxicity and developmental toxicity as a consequence of inhalation exposure during production of perfumes (use of benzene), cleaning of crude benzene and gasoline tanks, recovery of benzene in coking plants, distribution of gasoline (without vapour recovery) foundries (without local exhaust ventialtion) and production, further processing and refinery, — concerns for fertility as a consequence of inhalation exposure during production of perfumes (use of benzene), cleaning of crude benzene and gasoline tanks and recovery of benzene in coking plants. Benzene is easily absorbed after inhalation and skin contact. Internal body burdens after demal exposure are generally low because of rapid evaporation of benzene and only prolonged exposure might pose a risk. For prolonged dermal exposure and inhalation exposure at levels below 1 ppm (3,2 mg/m3) the only concerns are for mutagenicity and carcinogenicity. Occupational exposure scenarios 5, 6 and 7 refering to benzene in gasoline are included only for illustrative purposes and are not a formal part of the present risk assessment. According to Council Regulation 793/93 risk reduction measures concerning benzene in gasoline should await a special risk assessment of gasoline. The conclusion of the assessment of the risks to Consumers is that there is a need for specific measures to limit the risks. Conclusion (iii) This conclusion is reached because of: — concerns due to mutagenic and carcinogenic effects by inhalation exposure from use of contaminated paints and from car interior accessories. For exposure to benzene arising from exposures to gasoline at filling stations no formal risk characterisation has been performed since benzene exposures arising from handling gasoline are not formally a part of this risk assessment. Any conclusions regarding risk reduction measures for gasoline have to wait for the risk assessment of gasoline. The conclusion of the assessment of the risks to Humans exposed via the environment 7 CAS-No. 71-43-2 R063_0707_env_hh is that there is a need for specific measures to limit the risks. Conclusion (iii) This conclusion is reached because of: — concerns due to repeated dose toxicity, mutagenicity and carcinogenicity. The predominant indirect exposure of humans via the environment occurs via the air. Due to the genotoxic and carcinogenic effects of benzene no safe level of exposure can be recommended. For exposure to benzene from traffic no formal risk characterisation has been performed since benzene exposures arising from gasoline are not formally a part of this risk assessment. 8 CAS-No. 71-43-2 R063_0707_env_hh 1 GENERAL SUBSTANCE INFORMATION Identification of the substance CAS No.: 71-43-2 EINECS No.: 200-753-7 IUPAC Name: Benzene Synonyma: Cyclohexatriene; Benzol Empirical formula: C6H6 Structural formula: Molecular weight: 78.11 g/mol Purity/impurities, additives Purity: > 99.9 % Impurities: 0.04 % non-aromatics 0.015 % toluene 0.02 % methylcyclohexane + toluene 9 CAS-No. 71-43-2 R063_0707_env_hh Physico-chemical properties Benzene is a clear colourless liquid. Data on the physical and chemical properties are given in the following table: Table 1.1 Physico-chemical properties of benzene Melting point 5.5 °C Römpp, 1995 Boiling point 80.1 °C at 1013 hPa Römpp, 1995 Relative density 0.879 at 20 °C Römpp, 1995 Surface tension 28.9 mN/m Weast et al, 1988 (substance as such) Vapour pressure 99.7 hPa at 20 °C Folkins, 1985 Partition coefficient log Pow 2.13 (HPLC method) Sangster, 1989 Water solubility 1.8 g/l at 25 °C Freier, 1976 Flash point - 11 °C (DIN 51755) Chemsafe, 1995 Auto flammability 555 °C (DIN 51794) Chemsafe, 1995 Flammability highly flammable 1) Chemsafe, 1995 Explosive properties not explosive 2) Chemsafe, 1995 Oxidising properties no oxidising properties 2) Chemsafe, 1995 1) A.12 not conducted because of structural reasons 2) no test conducted because of structural reasons 10 CAS-No.