Development of new endocrine disruption-relevant test methods has been the subject of intensive research efforts for the past several decades, prompted in part by mandates in the 1996 Food Quality Protection Act (FQPA). While scientific understanding and test methods have advanced, questions remain on whether current scientific methods are capable of adequately addressing the complexities of the endocrine system for regulatory health and ecological risk assessments. The specific objective of this article is to perform a comprehensive, detailed evaluation of the adequacy of current test methods to inform regulatory risk assessments of whether a substance has the potential to perturb endocrine-related pathways resulting in human adverse effects. To that end,  approximately 42 existing test guidelines (TGs) were considered in the evaluation of coverage for endocrine-related adverse effects. In addition to evaluations of whether test methods are adequate to capture endocrine-related effects, considerations of further enhancements to current test methods, along with the need to develop novel test methods to address existing test method gaps are described. From this specific evaluation, up to 35 test methods are capable of informing whether a chemical substance perturbs known endocrine related biological pathways. Based on these findings, it can be concluded that current validated test methods are adequate to discern substances that may perturb the endocrine system, resulting in an adverse health effect. Together, these test methods predominantly form the core data requirements of a typical food-use pesticide registration submission. It is recognized, however, that the current state of science is rapidly advancing and there is a need to update current test methods to include added enhancements to ensure continued coverage and public health and environmental protection.

译文

在过去的几十年中,新的内分泌干扰物相关测试方法的开发一直是深入研究的主题,这在一定程度上是由1996年《食品质量保护法》(FQPA)的授权推动的。尽管科学的理解和测试方法已经取得了进步,但目前的科学方法是否能够充分解决内分泌系统的复杂性,以进行监管健康和生态风险评估仍存在疑问。本文的具体目标是对当前测试方法的适当性进行全面,详细的评估,以为某种物质是否具有干扰内分泌相关途径而导致人为不良影响的潜在风险提供监管风险评估。为此,在评估内分泌相关不良反应的覆盖范围时,考虑了大约42种现有的测试指南(TG)。除了评估测试方法是否足以捕获与内分泌相关的作用外,还描述了对当前测试方法进一步增强的考虑,以及开发新型测试方法以解决现有测试方法空白的需求。通过这种特定的评估,多达35种测试方法能够告知化学物质是否干扰了与内分泌有关的生物学途径。基于这些发现,可以得出结论,当前经过验证的测试方法足以识别可能扰乱内分泌系统,对健康产生不利影响的物质。这些测试方法共同构成了典型的食品用农药注册提交文件的核心数据要求。但是,已经认识到,当前的科学状态正在迅速发展,需要更新当前的测试方法以包括更多的增强功能,以确保持续的覆盖范围以及公共卫生和环境保护。

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