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Data integration, analysis, and interpretation of eight academic CLARITY-BPA studies.
Reproductive Toxicology ( IF 3.3 ) Pub Date : 2020-07-16 , DOI: 10.1016/j.reprotox.2020.05.014
Jerrold J Heindel 1 , Scott Belcher 2 , Jodi A Flaws 3 , Gail S Prins 4 , Shuk-Mei Ho 5 , Jiude Mao 6 , Heather B Patisaul 2 , William Ricke 7 , Cheryl S Rosenfeld 6 , Ana M Soto 8 , Frederick S Vom Saal 9 , R Thomas Zoeller 10
Affiliation  

“Consortium Linking Academic and Regulatory Insights on BPA Toxicity” (CLARITY-BPA) was a comprehensive “industry-standard” Good Laboratory Practice (GLP)-compliant 2-year chronic exposure study of bisphenol A (BPA) toxicity that was supplemented by hypothesis-driven independent investigator-initiated studies. The investigator-initiated studies were focused on integrating disease-associated, molecular, and physiological endpoints previously found by academic scientists into an industry standard guideline-compliant toxicity study. Thus, the goal of this collaboration was to provide a more comprehensive dataset upon which to base safety standards and to determine whether industry-standard tests are as sensitive and predictive as molecular and disease-associated endpoints. The goal of this report is to integrate the findings from the investigator-initiated studies into a comprehensive overview of the observed impacts of BPA across the multiple organs and systems analyzed. For each organ system, we provide the rationale for the study, an overview of methodology, and summarize major findings. We then compare the results of the CLARITY-BPA studies across organ systems with the results of previous peer-reviewed studies from independent labs. Finally, we discuss potential influences that contributed to differences between studies. Developmental exposure to BPA can lead to adverse effects in multiple organs systems, including the brain, prostate gland, urinary tract, ovary, mammary gland, and heart. As published previously, many effects were at the lowest dose tested, 2.5μg/kg /day, and many of the responses were non-monotonic. Because the low dose of BPA affected endpoints in the same animals across organs evaluated in different labs, we conclude that these are biologically – and toxicologically – relevant.



中文翻译:


八项学术 CLARITY-BPA 研究的数据整合、分析和解释。



“将 BPA 毒性的学术和监管见解联系起来的联盟”(CLARITY-BPA) 是一项符合“行业标准”良好实验室规范 (GLP) 的双酚 A (BPA) 毒性的综合性为期 2 年的慢性暴露研究,并辅以假设- 驱动的独立研究者发起的研究。研究者发起的研究重点是将学术科学家之前发现的疾病相关、分子和生理终点整合到符合行业标准指南的毒性研究中。因此,此次合作的目标是提供更全面的数据集,以此作为安全标准的基础,并确定行业标准测试是否与分子和疾病相关终点一样敏感和具有预测性。本报告的目标是将研究者发起的研究结果整合到所分析的多个器官和系统中观察到的 BPA 影响的全面概述中。对于每个器官系统,我们提供了研究的基本原理、方法概述并总结了主要发现。然后,我们将跨器官系统的 CLARITY-BPA 研究结果与独立实验室之前经过同行评审的研究结果进行比较。最后,我们讨论了导致研究之间差异的潜在影响。发育过程中接触 BPA 会导致多个器官系统产生不良影响,包括大脑、前列腺、泌尿道、卵巢、乳腺和心脏。正如之前发表的,许多效应是在最低剂量(2.5μg/kg/天)下测试的,并且许多响应是非单调的。 由于低剂量的 BPA 会影响同一动物在不同实验室评估的器官的终点,因此我们得出结论,这些在生物学和毒理学上是相关的。

更新日期:2020-07-16
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