Beekhuijzen Manon, van Otterdijk Francois, Wieland Willemien, van Tuyl Miranda, Rijcken Robert Pels, Peter Birgit, Emmen Harry
WIL Research Europe B.V., 's-Hertogenbosch, The Netherlands.
WIL Research Europe B.V., 's-Hertogenbosch, The Netherlands.
Reprod Toxicol. 2016 Sep;64:64-71. doi: 10.1016/j.reprotox.2016.04.002. Epub 2016 Apr 7.
In 1998, the OECD initiated a high-priority project aimed at revising existing test guidelines and developing new test guidelines for screening of potential endocrine disruptors. In 2011, OECD 443 was adopted, and in 2015 OECD 421 and OECD 422 were updated with endocrine disruptor relevant endpoints. A feasibility study for the enhancement of OECD 414 with endocrine disruptor relevant endpoints is currently ongoing. The addition of these endpoints is considered crucial for gaining more information on endocrine disruptor potency of tested chemicals, however it should be noted that these additions have a major impact on the study designs and give rise to several practical challenges. The aim of this review is to discuss important aspects of these challenging study designs and to share our knowledge on their implementation in our laboratory. Together, this review can be used as guidance for other laboratories, study monitors and registration officers.
1998年，经济合作与发展组织（OECD）启动了一个高度优先的项目，旨在修订现有的测试指南，并制定用于筛查潜在内分泌干扰物的新测试指南。2011年，OECD 443被采用，2015年，OECD 421和OECD 422更新了与内分泌干扰物相关的终点指标。目前正在进行一项关于用与内分泌干扰物相关的终点指标强化OECD 414的可行性研究。添加这些终点指标被认为对于获取有关受试化学品内分泌干扰物效力的更多信息至关重要，然而应该注意的是，这些添加对研究设计有重大影响，并带来了几个实际挑战。本综述的目的是讨论这些具有挑战性的研究设计的重要方面，并分享我们在实验室中实施这些设计的知识。总之，本综述可作为其他实验室、研究监测人员和注册官员的指南。
