Toxicological risk assessment of bisphenol a released from dialyzers under simulated-use and exaggerated extraction conditions

Bisphenol A (BPA) belongs to a group of chemicals used in the production of polycarbonate, polysulfone, and polyethersulfone which are used, among other applications, in the manufacture of dialyzers. While exposure to BPA is widespread in the general population, dialysis patients represent a populat...

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Bibliographic Details
Published in:	Regulatory toxicology and pharmacology Vol. 118; p. 104787
Main Authors:	Badding, Melissa A., Vargas, Jessica R., Fortney, Julian, Cheng, Qiuqiong J., Ho, Chih-Hu
Format:	Journal Article
Language:	English
Published:	Elsevier Inc 01-12-2020
Subjects:	Bisphenol A BPA Dialyzer Extractables Hemodialysis Leachables Risk assessment Extractables Bisphenol A Dialyzer BPA Hemodialysis Risk assessment Leachables
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Summary:	Bisphenol A (BPA) belongs to a group of chemicals used in the production of polycarbonate, polysulfone, and polyethersulfone which are used, among other applications, in the manufacture of dialyzers. While exposure to BPA is widespread in the general population, dialysis patients represent a population with potentially chronic parenteral BPA exposures. To assess the potential risk of BPA exposure to dialysis patients through dialyzer use, exposure estimates were calculated based on BPA levels measured by ultra-high performance liquid chromatography-quadrupole time-of-flight mass spectrometry following extractions from dialyzers manufactured by Fresenius Medical Care. Extraction conditions included both simulated-use leaching and exaggerated extractions to evaluate possible leachable and extractable BPA, respectively, from the devices. The mean BPA concentrations were 3.6 and 108.9 ppb from simulated-use and exaggerated extractions, respectively, from polycarbonate-containing dialyzers. No BPA was detected from polypropylene-containing dialyzers. Margins of Safety (MOS) were calculated to evaluate the level of risk to patients from estimated BPA exposure from the dialyzers, and the resulting MOS were 229 and 45 for simulated-use and exaggerated extractions, respectively. The findings suggest that there is an acceptable level of toxicological risk to dialysis patients exposed to BPA from use of the dialyzers tested in the current study. •Simulated-use and exaggerated extractions conducted on dialyzers for BPA analysis.•BPA was measured in extracts of polycarbonate-containing dialyzers.•Toxicological risk assessment conducted on measured BPA for hemodialysis exposure.•Even under exaggerated conditions, acceptable level of risk was determined.
ISSN:	0273-2300 1096-0295
DOI:	10.1016/j.yrtph.2020.104787