Identifying the potential endocrine disruptor hazard of environmental chemicals is a regulatory mandate for many countries. However, due to the adaptive nature of the endocrine system, absence of a single method capable of identifying endocrine disruption, and the latency between exposure to endocrine disrupting chemical during sensitive life stages and the manifestation of adverse responses, satisfying the regulatory requirement needed to identify a chemical as an endocrine disruptor is a challenge. There are now a variety of validated regulatory tests that can be used in combination to provide evidence that a chemical affects the oestrogen, androgen, thyroid, and steroidogenic pathways of vertebrates, but most rely (at least to some extent) on animal testing and require considerable cost and time to produce the necessary data. Emerging research methods are able to evaluate other endocrine pathways, incorporate more sensitive endpoints, and combine multiple alternative methods to predict in vivo outcomes. Some research approaches may also bridge gaps that have been identified in current endocrine regulatory testing. For the near term, considering new endpoints in a regulatory context may require adding them to existing test methods in order to establish relationships between the traditional and the innovative. From the outset, endocrine testing has always required integration of multiple methods that provide data on different levels of biological organisation, thus, the area of endocrine disruption is particularly adaptable to adverse outcome pathway (AOP) frameworks and integrated test methods built around AOPs. Herein, we provide a review of the status of endocrine disruptors in the OECD context, examples where innovation from research is needed to improve or bridge gaps in endocrine testing, and suggestions for regulators and researchers to facilitate uptake of innovate methods for endocrine disruptor regulatory testing. The increase in several human complex human disorders that include an endocrine component and the alarming decrease in wildlife biodiversity are commanding directives to include the best, most informative, innovative approaches to accelerate the rate and throughput of chemical evaluation for endocrine disruption.

中文翻译：

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经合组织对内分泌干扰物进行监管评估的方法和注意事项。

对于许多国家/地区而言，识别环境化学物质的潜在内分泌干扰物危害是一项法规要求。然而，由于内分泌系统的适应性，缺乏能够识别内分泌干扰的单一方法，以及在敏感的生命阶段接触内分泌干扰化学物质与不良反应的表现之间的等待时间，满足了识别所需的监管要求作为内分泌干扰物的化学物质是一个挑战。现在有多种经过验证的监管测试可以组合使用，以提供证据表明化学物质会影响脊椎动物的雌激素，雄激素，甲状腺和类固醇生成途径，但大多数依赖（至少在某种程度上）动物试验并需要产生必要数据所需的大量成本和时间。新兴的研究方法能够评估其他内分泌途径，纳入更敏感的终点，并结合多种替代方法来预测体内结果。一些研究方法还可以弥合当前内分泌法规测试中已经发现的差距。在短期内，在监管环境中考虑新的端点可能需要将它们添加到现有的测试方法中，以便在传统和创新之间建立联系。从一开始，内分泌测试一直要求整合多种方法，以提供有关不同生物组织水平的数据，因此，内分泌干扰区域特别适合不良结果途径（AOP）框架和围绕AOP构建的综合测试方法。在此处，我们对OECD背景下内分泌干扰物的状况进行了综述，需要通过研究创新来改善或弥合内分泌测试方面的差距的示例，并为监管机构和研究人员提供建议，以促进采用创新方法进行内分泌干扰物监管测试。包括内分泌成分在内的几种人类综合性人类疾病的增加以及野生生物多样性的惊人减少是指令的指令，其中应包括最佳，最有用的创新方法，以加快用于内分泌干扰的化学评估的速度和通量。并为监管机构和研究人员提供建议，以促进采用创新方法进行内分泌干扰物监管测试。包括内分泌成分在内的几种人类综合性人类疾病的增加以及野生生物多样性的惊人减少是指令的指令，其中应包括最佳，最有用的创新方法，以加快用于内分泌干扰的化学评估的速度和通量。并为监管机构和研究人员提供建议，以促进采用创新方法进行内分泌干扰物监管测试。包括内分泌成分在内的几种人类综合性人类疾病的增加以及野生生物多样性的惊人减少是指令的指令，其中应包括最佳，最有用的创新方法，以加快用于内分泌干扰的化学评估的速度和通量。