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The Role of Perinatal Development on Toxicokinetics of Bisphenol A


<OL> <LI> Determine Bisphenol A (BPA) pharmacokinetics at low-dose (100 ug/kg bw single dose; 100 ug/kg bw/d repeated). </LI>
<LI> Measure free and conjugated forms of BPA separately.</LI>

<LI> Use deuterium-labeled BPA to avoid issues of background contamination. Use LC/MS/MS for sensitivity and selectivity of measurement.</LI>

<LI> Determine complete rat-data set for blood, tissue, and excreta across stages of development (pregnant females, fetuses, neonates).</LI>

<LI> Determine BPA pharmacokinetics from oral and intravenous administration in pregnant, lactating, and nonpregnant female rats; neonatal rats.</LI>

<LI> Determine plasma and urinary-pharmacokinetic data in neonatal and adult nonhuman primates.</LI>

<LI> Use the new pharmacokinetic data in conjunction with literature data from experimental animals and humans to build a physiologically based pharmacokinetic model for BPA with the ultimate goal of predicting target-tissue concentrations of active BPA in humans, including fetuses and children, from food and medical device exposures.</LI>

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Responsible Division: Biochemical Toxicology <BR/>
Collaborating FDA Center(s): CDRH

Doerge, Daniel
DHHS/FDA - National Center for Toxicological Research
Project number