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首页> 外文期刊>Environmental toxicology and chemistry >Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)
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Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)

机译：鱼胚急性毒性（FET）测试（OECD 236）在化学品注册，评估，授权和限制（REACH）法规环境中的适用性

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In 2013 the Organisation for Economic Co-operation and Development (OECD) test guideline (236) for fish embryo acute toxicity (FET) was adopted. It determines the acute toxicity of chemicals to embryonic fish. Previous studies show a good correlation of FET with the standard acute fish toxicity (AFT) test; however, the potential of the FET test to predict AFT, which is required by the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation (EC 1907/2006) and the Classification, Labelling and Packaging (CLP) Regulation (EC 1272/2008), has not yet been fully clarified. In 2015 the European Chemicals Agency (ECHA) requested that a consultant perform a scientific analysis of the applicability of FET to predict AFT. The purpose was to compare the toxicity of substances to fish embryos and to adult fish, and to investigate whether certain factors (e.g., physicochemical properties, modes of action, or chemical structures) could be used to define the applicability boundaries of the FET test. Given the limited data availability, the analysis focused on organic substances. The present critical review summarizes the main findings and discusses regulatory application of the FET test under REACH. Given some limitations (e.g., neurotoxic mode of action) and/or remaining uncertainties (e.g., deviation of some narcotic substances), it has been found that the FET test alone is currently not sufficient to meet the essential information on AFT as required by the REACH regulation. However, the test may be used within weight-of-evidence approaches together with other independent, relevant, and reliable sources of information. The present review also discusses further research needs that may overcome the remaining uncertainties and help to increase acceptance of FET as a replacement for AFT in the future. For example, an increase in the availability of data generated according to OECD test guideline 236 may provide evidence of a higher predictive power of the test. Environ Toxicol Chem 2018;37:657-670. (c) 2017 SETAC
机译：2013年，采用了经济合作与发展组织（OECD）关于鱼胚急性毒性（FET）的测试指南（236）。它决定了化学品对胚胎鱼的急性毒性。先前的研究表明FET与标准急性鱼毒性（AFT）测试具有良好的相关性；但是，FET测试可能预测AFT，这是化学品注册，评估，授权和限制（REACH）法规（EC 1907/2006）和《分类，标签和包装（CLP）法规》（EC）所要求的1272/2008），尚未完全阐明。 2015年，欧洲化学品管理局（ECHA）要求顾问对FET预测AFT的适用性进行科学分析。目的是比较物质对鱼胚和成鱼的毒性，并调查是否可以使用某些因素（例如，理化性质，作用方式或化学结构）来定义FET测试的适用范围。鉴于有限的数据可用性，分析重点放在有机物质上。本重要评论总结了主要发现，并讨论了REACH下FET测试的监管应用。给定某些限制（例如，神经毒性作用方式）和/或剩余的不确定性（例如，某些麻醉物质的偏差），目前发现仅FET测试不足以满足AFT要求的有关AFT的基本信息。 REACH法规。但是，该测试可以与其他独立，相关且可靠的信息源一起用于证据权重方法中。本文还讨论了进一步的研究需求，这些需求可能会克服仍然存在的不确定性，并有助于在将来增加FET作为AFT替代品的接受度。例如，根据OECD测试指南236生成的数据的可用性的增加可以提供更高的测试预测能力的证据。 Environ Toxicol Chem 2018; 37：657-670。 （c）2017年SETAC

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