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

Food Chem Toxicol. 2019 Oct:132:110728. doi: 10.1016/j.fct.2019.110728. Epub 2019 Jul 28.


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.

Keywords: Bisphenol A; Chronic toxicity; Safety assessment; Sprague-Dawley.

MeSH terms

  • Animals
  • Benzhydryl Compounds / toxicity*
  • Dose-Response Relationship, Drug
  • Endocrine Disruptors / toxicity*
  • Ethinyl Estradiol / administration & dosage
  • Female
  • Genitalia, Female / drug effects
  • Male
  • Maternal Exposure
  • Phenols / toxicity*
  • Pregnancy
  • Rats
  • Rats, Sprague-Dawley


  • Benzhydryl Compounds
  • Endocrine Disruptors
  • Phenols
  • Ethinyl Estradiol
  • bisphenol A