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- W2076465611 abstract "Chemical substances with potential reproductive and/or endocrinedisrupting effects may be harmful for human or animal health. Consequently,the new EU legislation (i.e. for plant protection products,biocides and chemicals under REACH) names as cut-off criteria thatsuch substances shall only be approved if they are not consideredto have reproductive effects or endocrine disrupting propertiesthat may cause adverse effects in humans, unless the exposure ofhumans under realistic proposed conditions of use is negligible.However, the new legislation fails to provide specific scientific criteriafor the assessment and decision on substances with endocrinedisrupting properties, but only mentions hazard-based interim criteria.While for reproductive effects specific criteria were developedover a period of 12 years within the United Nations structure,resulting in the Globally Harmonised System of Classification andLabelling of Chemicals (GHS), there is an urgent need to harmonisescientific criteria for the assessment of substances with a potentialto modulate the endocrine system. For the interpretation ofendocrine effects detected in studies required for regulatory purposesa conceptual framework for a tiered decision process issuggested which includes the analysis of adversity of effects onthe endocrine system, toxicological relevance of effects as well asthe analysis of mechanistic data to establish a mode of action inanimals, and the evaluation of relevance of such effects to humans.Concerning the criteria for decision making on endocrine disruptingproperties, two options are proposed as the last step of thetiered approach, which may be regarded as alternatives, based onrisk or hazard assessment, respectively.An overview on the proposed assessment and decision criteriafor the interpretation of reproductive and endocrine effectsdetected in studies required for regulatory purposes under the newEU legislation will be presented." @default.
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- W2076465611 date "2010-07-01" @default.
- W2076465611 modified "2023-10-14" @default.
- W2076465611 title "SY10-5: Criteria for the interpretation of reproductive and endocrine effects detected in regulatory guideline studies" @default.
- W2076465611 doi "https://doi.org/10.1016/j.toxlet.2010.03.069" @default.
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