Applicability of the fish embryo acute toxicity (FET) test (OECD 236) in the regulatory context of Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)

被引：112

作者：

Sobanska, Marta ^{[1
]}

Scholz, Stefan ^{[2
]}

Nyman, Anna-Maija ^{[1
]}

Cesnaitis, Romanas ^{[1
]}

Alonso, Simon Gutierrez ^{[1
]}

Kluever, Nils ^{[3
]}

Kuehne, Ralph ^{[4
]}

Tyle, Henrik ^{[5
]}

de Knecht, Joop ^{[6
]}

Dang, Zhichao ^{[6
]}

Lundbergh, Ivar ^{[7
]}

Carlon, Claudio ^{[1
]}

De Coen, Wim ^{[1
]}

机构：

[1] European Chem Agcy, Helsinki, Finland

[2] UFZ Helmholtz Ctr Environm Res, Dept Bioanalyt Ecotoxicol, Leipzig, Germany

[3] UFZ Helmholtz Ctr Environm Res, Dept Cell Toxicol, Leipzig, Germany

[4] UFZ Helmholtz Ctr Environm Res, Dept Ecol Chem, Leipzig, Germany

[5] Danish Environm Protect Agcy, Copenhagen, Denmark

[6] Natl Inst Publ Hlth & Environm RIVM, Ctr Safety Subst & Prod, Bilthoven, Netherlands

[7] Swedish Chem Agcy KEMI, Sundbyberg, Sweden

来源：

ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY | 2018年 / 37卷 / 03期

关键词：

Hazard; risk assessment; Predictive toxicology; Aquatic toxicology; Registration; Evaluation; Authorisation and Restriction of Chemicals; REACH regulation; Fish embryo toxicity; Alternative methods; ZEBRAFISH DANIO-RERIO; AQUATIC TOXICITY; RISK-ASSESSMENT; ENVIRONMENTAL-POLLUTANTS; PREDICTION; TOXICOKINETICS; HAZARD; ACETYLCHOLINESTERASE; IDENTIFICATION; SUBSTANCES;

D O I：

10.1002/etc.4055

中图分类号：

X [环境科学、安全科学];

学科分类号：

08 ; 0830 ;

摘要：

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

引用

页码：657 / 670

页数：14

共 58 条

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