Risk Assessment of Predicted Serum Concentrations of Bisphenol A in Children and Adults Following Treatment with Dental Composite Restoratives, Dental Sealants, or Orthodontic Adhesives using Physiologically Based Pharmacokinetic Modeling.

Risk Assessment of Predicted Serum Concentrations of Bisphenol A in Children and Adults Following Treatment with Dental Composite Restoratives, Dental Sealants, or Orthodontic Adhesives using Physiologically Based Pharmacokinetic Modeling. Regul Toxicol Pharmacol. 2020 Dec 07;:104839 Authors: Bagley BD, Smith JN, Teeguarden JG Abstract Bisphenol A (BPA) is a chemical used to manufacture bisphenol A glycidyl methacrylate (BisGMA). BisGMA has been used for decades in dental composite restoratives, sealants, and adhesives. Based on published studies, exposure to low concentrations of BPA are possible from dental and orthodontic devices. The serum BPA concentrations arising from such devices and oral doses were predicted using a PBPK model in children and adult females based on 1) published extraction data for cured and uncured 3M ESPE Filtek Supreme Ultra Flowable, 3M ESPE Filtek Bulk Fill Restorative, and 3M ESPE Clinpro Sealant and 2) published 20% ethanol/water and water rinsate data following orthodontic application with 3M ESPE Transbond MIP Primer and 3M ESPE Transbond XT Adhesive. Predicted oral exposure to BPA arising from these dental and orthodontic devices is low (median <10 ng/treatment) and predicted serum BPA concentrations were also low (<10-4 nM). Even the maximum predicted exposure in this study (533.2 ng/treatment) yields a margin of exposure of 7.5 relative to the EFSA t-TDI (4 μg/kg-day) and is only 2.8% of th...
Source: Regulatory Toxicology and Pharmacology : RTP - Category: Toxicology Authors: Tags: Regul Toxicol Pharmacol Source Type: research