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,与内分泌干扰相关的新测试方法的开发一直是深入研究的主题,部分原因是《1996食品质量保护法》 (FQPA) 的授权。尽管科学理解和测试方法已经发展,但当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充分性进行全面,详细的评估,以告知监管风险评估一种物质是否有可能干扰内分泌相关途径,从而导致人类不良影响。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个现有的测试指南 (TGs)。除了评估测试方法是否足以捕获与内分泌相关的影响外,还描述了对当前测试方法的进一步增强的考虑,以及开发新颖的测试方法以解决现有测试方法差距的需求。通过此特定评估,多达35种测试方法能够告知化学物质是否干扰已知的内分泌相关生物学途径。根据这些发现,可以得出结论,当前经过验证的测试方法足以识别可能干扰内分泌系统,从而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农药注册提交的核心数据要求。然而,人们认识到,当前的科学状况正在迅速发展,有必要更新当前的测试方法,以包括额外的增强功能,以确保持续覆盖以及公共卫生和环境保护。

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