R064_0805_env_hh 28.05.2008 European Union Risk Assessment Report 4-METHYL-M-PHENYLENEDIAMINE (TOLUENE-2,4-DIAMINE) RISK ASSESSMENT CAS-No.: 95-80-7 EINECS-No.: 202-453-1 28.05.2008 FINAL APPROVED VERSION 1 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 Information on the rapporteur Contact point: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Anmeldestelle Chemikaliengesetz Friedrich-Henkel-Weg 1-25 44149 Dortmund e-mail: [email protected] This document is the last version of the Comprehensive Risk Assessment Report Toluene- 2,4-diamine, a substance chosen from the EU 1st Priority List in 1994. 2 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 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 3 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 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 95-80-7 R064_0805_env_hh 28.05.2008 CONTENTS 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT 7 1 GENERAL SUBSTANCE INFORMATION 10 2 GENERAL INFORMATION ON EXPOSURE 21 2.1 Production 21 2.2 Processing and use 21 3 ENVIRONMENT 23 3.1 Environmental exposure 23 3.1.1 General discussion 23 3.1.2 Aquatic compartment (incl. Sediment) 31 3.1.3 Atmosphere 37 3.1.4 Terrestrial compartment 38 3.1.5 Non compartment specific exposure relevant to the food chain 38 3.1.6 Regional Exposure 38 3.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 40 3.2.1 Aquatic compartment 40 3.2.2 Atmosphere 50 3.2.3 Terrestrial compartment 50 3.2.4 Non compartment specific effects relevant to the food chain 51 3.3 Risk characterisation 52 5 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 3.3.1 Aquatic compartment 52 3.3.2 Atmosphere 56 3.3.3 Terrestrial compartment 57 3.3.4 Non compartment specific effects relevant to the food chain 57 4 HUMAN HEALTH 58 4.1 HUMAN HEALTH (TOXICITY) 58 4.1.1 Exposure assessment 58 4.1.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 73 4.1.3 Risk characterisation 149 4.2 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES) 181 4.2.1 Exposure assessment 181 4.2.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 182 4.2.3 Risk characterisation 182 4.3 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES) 182 4.3.1 Exposure assessment 182 4.3.2 Effects assessment: Hazard identification and Dose (concentration) - response (effect) assessment 183 4.3.3 Risk characterisation 183 5 CONCLUSIONS / RESULTS 184 6 REFERENCES 186 6.1 Calculation for 2,6-TDA 229 6 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 0 OVERALL CONCLUSIONS/RESULTS OF THE RISK ASSESSMENT CAS No. 95-80-7 EINECS No. 202-453-1 IUPAC Name Toluene-2,4-diamine Overall results of the risk assessment: ( X ) 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 7 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 Summary of conclusions: Environment Conclusion (i) There is need for further information and/or testing This conclusion applies to the site dye1 that processes 2,4-TDA to dyes. PEC/PNEC ratios for wastewater treatment plant, surface water and sediment are above 1 for the scenario “processing of 2,4-TDA to dyes” at site dye1. As this scenario is fully based on default values, improvement of the exposure data basis is possible. Information on TDA emission from the production of dyes at this site should be provided. 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 the aquatic compartment and for wastewater treatment plants for all other sites and the environmental compartments atmosphere and soil and secondary poisoning. Human Health Workers Conclusion (i) (on hold) There is need for further information and/or testing There is a need for better information to adequately characterise the risks regarding the mutagenicity (germ cell mutagenicity) and developmental toxicity because the current database does not adequately cover these endpoints. The collection of additional information should, however, not delay the implementation of appropriate control measures needed to address the concern related to other endpoints (conclusion (i) on hold). Conclusion (iii) There is a need for specific measures to limit the risks There is concern for mutagenicity (somatic cell mutagenicity) and carcinogenicity as a consequence of dermal and inhalation exposure arising from all investigated occupational exposure scenarios. Extensive technical and organisational reduction measures have already led to very low levels of exposure. Carcinogenicity risk assessment was conducted with a quantitative approach. Additionally a risk evaluation for this endpoint was done by calculating with different levels of risk acceptance. The specific conclusions for the different occupational exposure scenarios critically depend on the chosen level of risk acceptance. This comparison may be helpful for risk managers in order to evaluate the necessity and priority of further risk reduction measures beyond those that has already been successfully implemented. There is concern for skin sensitisation as a consequence of dermal exposure arising from all investigated occupational exposure scenarios. Risks of skin sensitisation are considered to be small. However, because the corresponding risk cannot be quantified or excluded, a general concern for skin sensitisation is expressed. 8 CAS No 95-80-7 R064_0805_env_hh 28.05.2008 Consumer 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. Since a consumer exposure seems not to exist, a health risk of consumers is not expected. Man exposed indirectly via the environment Conclusion (i) (on hold) There is need for further information and/or testing There is a need for better information to adequately characterise the risks regarding the mutagenicity (germ cell mutagenicity) and developmental toxicity because the current database does not adequately cover these endpoints.