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Evaluation of the Toxicity of Bisphenol A (BPA) in Male and Female Sprague-Dawley Rats Exposed Orally from Gestation Day 6 through Postnatal Day 90 - Subchronic II

Investigators
Delclos, Kenneth
Institutions
DHHS/FDA - National Center for Toxicological Research
Objective
The goal of this subchronic study is to characterize the dose-response for orally administered BPA in the NCTR Sprague-Dawley (CD) rat to address the question of adverse effects in rodents near levels of exposure potentially attainable in humans. A broad dose-range will be covered, but the focus will be on doses less than 5 mg/kg body weight/day. Animals will be exposed throughout development. Pups will be directly dosed through the lactation period rather than relying on exposure through the dam's milk, and environmental conditions (background phytoestrogens, background BPA) will be strictly controlled and monitored. Since the effects of BPA that have been described in the literature largely involve perturbation of estrogen signaling, the potent orally active estrogen ethinyl estradiol (EE2) will be included as a reference to demonstrate the estrogen responsiveness of the animal model under these exposure conditions. Although there will be a focus on reproductive endpoints, endpoints related to the reported effects of BPA on other organ systems, including the development of obesity and cardiovascular disease, will be evaluated. The results will also be used to set doses for a chronic toxicity study.
More information
Responsible Division: Biochemical Toxicology
Collaborating Division(s): Associate Director of Scientific Coordination
Collaborating FDA Center(s): CFSAN
Funding Source
Nat'l. Center For Toxicological Research
Project number
E0217601
Categories
Sanitation and Quality Standards