In a scientific study published online on January 21, 2016 in the peer-reviewed journal Food and Chemical Toxicology, Birgit Mertens and colleagues from the Scientific Institute of Public Health, Belgium report on the development and application of a decision tree to identify potentially genotoxic substances. 48 chemicals previously found to migrate from polycarbonate (PC)-replacement baby bottles were assessed. All 48 chemicals selected for evaluation are considered non-intentionally added substances (NIAS) as they are not listed in the Annex I of commission regulation (EU) No 10/2011 (EU positive list for plastics).
In response to widespread concerns about the health effects of bisphenol A (BPA; CAS 80-05-7), various BPA-free PC-alternative products have been introduced on the market (FPF reported). However, the toxicity of their migrants remains largely unknown. Hence, prioritization strategies are urgently needed to identify the chemicals of high concern that should be tested in the first place.
Information sources used by the authors included genotoxicity data from ECHA REACH dossiers (available for 22 out of 48 evaluated chemicals), as well as in silico predictions of genotoxic potential by two rule-based systems ToxTree and Derek NexusTM and testing data from in vitro assay for DNA damage (Vitotox®), carried out for all evaluated chemicals. Based on these sources, unequivocal conclusions on the genotoxic potential or the absence of such could not be made for any of the 48 assessed substances, including those registered under REACH, as the authors concluded that more data are required to investigate the genotoxic potential of all these migrating chemicals. However, since the relative need for such data differs widely, four subgroups with low, medium, high and very high need for additional genotoxicity data could be formed, containing 15, 19, 13 and one compound, respectively.
Mertens, B., et al. (2016). “Investigation of the genotoxicity of substances migrating from polycarbonate replacement baby bottles to identify chemicals of high concern.” Food and Chemical Toxicology 89:126-137.