The European Chemical Agency and European Food Safety Authority recommend that gross pathology findings, from avian reproduction studies, be used to support assessment of potential endocrine disrupting properties of active pesticidal and biocidal substances. In open literature, little information is available on the utility of gross pathology data for informing endocrine evaluations. Here the gross pathology data from historical control groups of 51 northern bobwhite and 51 mallard reproduction tests is analyzed to evaluate the utility of such information. Incidence of gross morphology findings in untreated birds may aid the interpretation of some gross abnormalities, potentially indicative of an endocrine interaction (e.g. reproductive condition). Statistical analysis of the historical control data indicates that gross pathology is not likely to be useful for detecting endocrine effects as abnormalities with relatively high increases in prevalence (more than 20-30%, depending on prevalence in controls) are reliably interpreted as a treatment response. Gross pathology changes are only indicative and not diagnostic of endocrine interactions making it difficult to distinguish gross pathology abnormalities, due to endocrine-mediated effects, from systemic toxicity. This work demonstrates the utility of using historical control analyses to establish the value and properties of selected endpoints for regulatory applications.

中文翻译：

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禽肉眼病理学在识别内分泌干扰物方面的价值。

欧洲化学局和欧洲食品安全局建议将禽类繁殖研究中的总体病理结果用于评估活性杀虫和杀生物活性物质的潜在内分泌干扰特性。在公开的文献中，关于总病理数据用于内分泌评估的实用性的信息很少。在这里，对来自51个北部bobwhite和51个野鸭繁殖试验的历史对照组的总体病理数据进行了分析，以评估此类信息的实用性。未经处理的禽类的总体形态发现的发生率可能有助于解释某些总体异常，可能表明内分泌相互作用（例如生殖状况）。对历史对照数据的统计分析表明，总的病理学不太可能用于检测内分泌作用，因为具有较高患病率增加（超过20-30％，取决于对照患病率）的异常可靠地解释为治疗反应。大体病理改变仅是指示性的，而不能诊断内分泌相互作用，因此很难将由于内分泌介导的作用而导致的大体病理异常与全身毒性相区别。这项工作演示了使用历史控制分析为监管应用程序确定选定端点的价值和属性的实用性。取决于对照组的患病率）被可靠地解释为治疗反应。大体病理改变仅是指示性的，而不能诊断内分泌相互作用，因此很难将由于内分泌介导的作用而引起的大体病理异常与全身毒性相区别。这项工作演示了使用历史控制分析为监管应用建立选定端点的价值和属性的实用性。取决于对照组的患病率）被可靠地解释为治疗反应。大体病理改变仅是指示性的，而不能诊断内分泌相互作用，因此很难将由于内分泌介导的作用而引起的大体病理异常与全身毒性相区别。这项工作演示了使用历史控制分析为监管应用建立选定端点的价值和属性的实用性。