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• W2023652812 abstract "BackgroundMyers et al. [Environ Health Perspect 117:309–315 (2009)] argued that Good Laboratory Practices (GLPs) cannot be used as a criterion for selecting data for risk assessment, using bisphenol A (BPA) as a case study. They did not discuss the role(s) of guideline-compliant studies versus basic/exploratory research studies, and they criticized both GLPs and guideline-compliant studies and their roles in formal hazard evaluation and risk assessment. They also specifically criticized our published guideline-compliant dietary studies on BPA in rats and mice and 17β-estradiol (E2) in mice.ObjectivesAs the study director/first author of the criticized E2 and BPA studies, I discuss the uses of basic research versus guideline-compliant studies, how testing guidelines are developed and revised, how new end points are validated, and the role of GLPs. I also provide an overview of the BPA guideline-compliant and exploratory research animal studies and describe BPA pharmacokinetics in rats and humans. I present responses to specific criticisms by Myers et al.Discussion and conclusionsWeight-of-evidence evaluations have consistently concluded that low-level BPA oral exposures do not adversely affect human developmental or reproductive health, and I encourage increased validation efforts for “new” end points for inclusion in guideline studies, as well as performance of robust long-term studies to follow early effects (observed in small exploratory studies) to any adverse consequences." @default.
• W2023652812 created "2016-06-24" @default.
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• W2023652812 date "2009-11-01" @default.
• W2023652812 modified "2023-09-28" @default.
• W2023652812 title "Basic Exploratory Research versus Guideline-Compliant Studies Used for Hazard Evaluation and Risk Assessment: Bisphenol A as a Case Study" @default.
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• W2023652812 doi "https://doi.org/10.1289/ehp.0900893" @default.
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