In Depth: Review of New Data on BPA Reproductive Effects

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March 6, 2018 - Hans Plugge

Bisphenol A (BPA, CAS RN 80-05-7) is once again in the news. Following the recent tightening of regulations related to BPA in food contact materials in the European Union, a U.S. government research agency brings new data which shows much less reproductive toxicity impact than previously suspected.

In February 2018, the U.S. National Toxicology Program (NTP) released a draft study report on a Chronic Extended-Dose-Range study of BPA in rats. The actual study was primarily conducted by the U.S. Food and Drug Administration (FDA) National Center for Toxicological Research. The study included both a continuous dose design (dosed from gestation throughout year 1-2) as well as a stop-dose study (exposure gestation through postnatal day 21). The study covered a very wide dose range (2.5 to 25000 BPA ug/kg bw/day, noted as “BPA”), which is much wider than usual and definitely more extensive than other/previous studies.

The results can be described as negative to equivocal (more details below). However, results cannot be interpreted as a final determination, as the draft report is only meant for peer review. Additional studies are underway as part of the CLARITY-BPA project.

Summary of Findings

A variety of effects on organs were observed; many of these were present at interim sacrifice but not at terminal sacrifice, or vice versa. Random non-dose related positive or negative responses are just that: random. In short, a 95% certainty leaves room for 5% false positives (an acknowledged oversimplification for a huge collection of statistical equations/theories).

We are thus left with few consistent reprotoxic effects, none of which are very dramatic. Neoplastic lesions incidence data require more detailed study before confirming the initial conclusion of little to no effect at terminal sacrifice. 

More information

For more information, including an in-depth summary of the details of the 249 page report, please log in to 3E Monitor to read the full in-depth analysis. Free trials of 3E Monitor are available from the Verisk 3E website.

Detailed analysis will be required to provide data interpretation and feedback to NTP regarding the quality and draft conclusions, which Verisk 3E’s team of regulatory toxicologists can provide (contact hplugge@Verisk3E.com). The comment deadline is 12 April 2018.








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