Risk assessment of endocrine active chemicals: Identifying chemicals of regulatory concern |
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Authors: | Remi Bars Ivana Fegert Melanie Gross Dick Lewis Lennart Weltje Arnd Weyers James R Wheeler Malyka Galay-Burgos |
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Institution: | 1. Bayer CropScience, 355 rue Dostoïevski, F-06903 Sophia Antipolis, France;2. BASF SE, Carl-Bosch-Strasse 38, D-67056 Ludwigshafen, Germany;3. WCA Environment Limited, Brunel House, Volunteer Way, Faringdon SN7 7YR, United Kingdom;4. Syngenta Product Safety, Jealott’s Hill International Research Centre, Bracknell, Berkshire RG42 6EY, United Kingdom;5. BASF SE, Crop Protection – Ecotoxicology, Speyerer Strasse 2, D-67117 Limburgerhof, Germany;6. Bayer CropScience, Building 6620, Environmental Safety – Ecotoxicology, D-40789 Monheim, Germany;g ECETOC, 4 Avenue E. Van Nieuwenhuyse, B-1160 Brussels, Belgium |
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Abstract: | The European regulation on plant protection products (1107/2009) (EC, 2009a), the revisions to the biocides Directive (COM2009]267) (EC, 2009b), and the regulation concerning chemicals (Regulation (EC) No. 1907/2006 ‘REACH’) (EC.2006) only support the marketing and use of chemical products on the basis that they do not induce endocrine disruption in humans or wildlife species. In the absence of agreed guidance on how to identify and evaluate endocrine activity and disruption within these pieces of legislation a European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) task force was formed to provide scientific criteria that may be used within the context of these three legislative documents. The resulting ECETOC technical report (ECETOC, 2009a) and the associated workshop (ECETOC, 2009b) presented a science-based concept on how to identify endocrine activity and disrupting properties of chemicals for both human health and the environment. The synthesis of the technical report and the workshop report was published by the ECETOC task force (Bars et al., 2011a and Bars et al., 2011b). Specific scientific criteria for the determination of endocrine activity and disrupting properties that integrate information from both regulatory (eco)toxicity studies and mechanistic/screening studies were proposed. These criteria combined the nature of the adverse effects detected in studies which give concern for endocrine toxicity with an understanding of the mode of action of toxicity so that adverse effects can be explained scientifically. A key element in the data evaluation is the consideration of all available information in a weight-of-evidence approach. However, to be able to discriminate chemicals with endocrine properties of low concern from those of higher concern (for regulatory purposes), the task force recognised that the concept needed further refinement. Following a discussion of the key factors at a second workshop of invited regulatory, academic and industry scientists (ECETOC, 2011), the task force developed further guidance, which is presented in this paper. For human health assessments these factors include the relevance to humans of the endocrine mechanism of toxicity, the specificity of the endocrine effects with respect to other potential toxic effects, the potency of the chemical to induce endocrine toxicity and consideration of exposure levels. For ecotoxicological assessments the key considerations include specificity and potency, but also extend to the consideration of population relevance and negligible exposure. It is intended that these complement and reinforce the approach originally described and previously published in this journal (Bars et al., 2011a and Bars et al., 2011b). |
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Keywords: | ACR acute-to-chronic ratio BfR Bundesinstitut fü r Risikobewertung (German regulatory body) CLP Classification Labelling and Packaging CRD Chemicals Regulation Directorate (UK regulatory body) ECETOC European Centre for Ecotoxicology and Toxicology of Chemicals ED endocrine disruptor IPCS International Programme on Chemical Safety LOAEL Lowest Observed Adverse Effect Level MoA mode of action MoE margin of exposure NOAEL No Observed Adverse Effect Level NOEC No Observed Effect Concentration REACH Registration Evaluation Authorisation and Restriction of Chemicals STOT-RE Specific Target Organ Toxicity-Repeated Exposure TDI Tolerable Daily Intake WHO World Health Organisation |
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