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证据权重方法在化学品内分泌干扰特性鉴定中的应用:综述及对欧盟法规应用的建议。

Weight of evidence approaches for the identification of endocrine disrupting properties of chemicals: Review and recommendations for EU regulatory application.

机构信息

wca, Brunel House, Volunteer Way, Faringdon, SN7 7YR, UK.

Dow AgroSciences, 3b, Milton Park, Abingdon, Oxfordshire, OX14 4RN, UK.

出版信息

Regul Toxicol Pharmacol. 2017 Dec;91:20-28. doi: 10.1016/j.yrtph.2017.10.004. Epub 2017 Oct 4.

Abstract

A Weight-of-evidence (WoE) evaluation should be applied in assessing all the available data for the identification of endocrine disrupting (ED) properties of chemicals. The European Commission draft acts specifying criteria under the biocidal products and plant protection products regulations require that WoE is implemented for the assessment of such products. However, only some general considerations and principles of how a WoE should be conducted are provided. This paper reviews WoE approaches to distil key recommendations specifically for the evaluation of potential ED properties of chemicals. In a manner, which is consistent with existing, published WoE frameworks, the WoE evaluation of ED properties can be divided into four phases: 1) Definition of causal questions and data gathering and selection, 2) Review of individual studies, 3) Data integration and evaluation, and 4) Drawing conclusions based on inferences. Recommendations are made on how to conduct each phase robustly and transparently to help guide the WoE evaluation of potential endocrine disrupting properties of chemicals within a European regulatory context.

摘要

应对所有可用数据进行证据权重(WoE)评估,以识别化学品的内分泌干扰(ED)特性。欧洲委员会关于生物杀灭剂产品和植物保护产品法规规定标准的法令草案要求对这些产品进行 WoE 评估。然而,仅提供了一些关于如何进行 WoE 的一般性考虑因素和原则。本文回顾了 WoE 方法,以提炼出专门用于评估化学品潜在 ED 特性的关键建议。按照与现有已发表 WoE 框架一致的方式,可以将 ED 特性的 WoE 评估分为四个阶段:1)确定因果问题和数据收集与选择,2)审查个别研究,3)数据整合与评估,以及 4)根据推断得出结论。就如何稳健和透明地进行每个阶段提出了建议,以帮助指导在欧洲监管背景下对化学品潜在内分泌干扰特性进行 WoE 评估。

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