产前发育毒性研究(OECD TG 414)

Tg
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引用次数: 5

摘要

795. 经合组织产前发育毒性研究是一项尖端试验,旨在提供有关产前暴露于化学物质对怀孕试验动物和发育中的生物体的影响的一般信息。这可能包括评估母体影响以及死亡、结构异常或胎儿生长改变。这项研究的主要目的是提供与发育有关的不良影响的数据。该指引的当前版本于2001年1月通过。该测试指南(TG)的早期版本的暴露期较短,终点较少。该研究的目的不是检测内分泌活性物质(EASs),但有一些与评估可能的内分泌干扰相关的终点,目前正在更新以包括更多。经过可行性研究(OECD, 2015年),该检测于2018年7月更新,包括一些内分泌相关终点,因为暴露期涵盖了发育过程中的一些敏感期(产前期)。应该注意的是,如果在2018年之前进行检测,则不太可能包括这些额外的终点。
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Prenatal Developmental Toxicity Study (OECD TG 414)
795. The OECD Prenatal Developmental Toxicity Study is an apical assay designed to provide general information concerning the effects of prenatal exposure to a chemical on the pregnant test animal and on the developing organism. This may include assessment of maternal effects as well as death, structural abnormalities or altered growth in the foetus. The primary purpose of this study is to provide data on adverse effects related to development. The current version of the guideline was adopted in January 2001. Previous versions of this test guideline (TG) had a less extensive exposure period and fewer endpoints. The study was not designed to detect endocrine active substances (EASs), but has some endpoints relevant for the assessment of possible endocrine disruption and is currently being updated to include more. Following a feasibility study (OECD, 2015), this assay was updated in July 2018 to include some endocrine-relevant endpoints as the exposure periods cover some of the sensitive periods during development (prenatal period). It should be noted that if an assay was conducted before 2018, it is unlikely to include these extra endpoints.
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