A two-year toxicology study of bisphenol A (BPA) in Sprague-Dawley rats: CLARITY-BPA core study results. (October 2019)

• Record Type: Journal Article
• Authors: Camacho, L.; Lewis, S.M.; Vanlandingham, M.M.; Olson, G.R.; Davis, K.J.; Patton, R.E.; Twaddle, N.C.; Doerge, D.R.; Churchwell, M.I.; Bryant, M.S.; McLellen, F.M.; Woodling, K.A.; Felton, R.P.; Maisha, M.P.; Juliar, B.E.; Gamboa da Costa, G.; Delclos, K.B.
• Is Part Of: Food and chemical toxicology. Volume 132(2019)
• Publication Date: 2019-10
• Subjects: Bisphenol A -- Chronic toxicity -- Sprague-Dawley -- Safety assessment; Toxicology -- Periodicals; Food poisoning -- Periodicals; Food Poisoning -- Periodicals; Toxicology -- Periodicals; Toxicologie -- Périodiques; Intoxications alimentaires -- Périodiques; Food poisoning; Toxicology; Periodicals; Electronic journals; 615.9
• DOI: 10.1016/j.fct.2019.110728
• Languages: English
• ISSNs: 0278-6915

Abstract

Abstract: We report the data from the guideline-compliant two-year toxicology study conducted as part of the Consortium Linking Academic and Regulatory Insights on Bisphenol A Toxicity (CLARITY-BPA). BPA (0, 2.5, 25, 250, 2, 500, and 25, 000 μg/kg body weight (bw)/day) was administered daily by gavage in 0.3% carboxymethylcellulose vehicle to NCTR Sprague-Dawley rats from gestation day 6 through the start of parturition and then directly to pups from the day after birth until postnatal day 21 (stop-dose arm) or continuously until termination at one or two years. The stop-dose arm was included to assess the potential for any BPA effects that were due to developmental exposure. No BPA-related effects were evident in the in-life and non-histopathology data. Neoplastic and nonneoplastic lesions diagnosed in both females and males were common age-associated lesions that were variable across control and BPA-treated groups. The lack of consistent responses within the continuous- and stop-dose arms within and across tissues brought into question the plausible relationship of most of these lesions to BPA treatment. There was a possible relationship between the increased incidences of lesions in the female reproductive tract and the male pituitary and exposure to the 25, 000 μg BPA/kg bw/day dose level. Highlights: A two-year daily gavage study of bisphenol A (BPA) over a broad range (2.5–25, 000 μg/kg bw/day) was conducted in SD rats. Dams dosed from gestation day 6 to parturition and pups directly from PND 1 until weaned or until sacrifice at 1 or 2 years. Ethinyl estradiol (0.05 and 0.5 μg/kg bw/day) was administered until sacrifice to assess response to low doses of estrogen. BPA did not elicit adverse effects in the in-life or terminal endpoints monitored in either sex below 25, 000 μg/kg bw/day. Ethinyl estradiol elicited strong effects in female reproductive tissues at the 0.5 μg/kg bw/day dose level.