Investigation of the Genotoxicity of Substances Migrating From Polycarbonate Replacement Baby Bottles to Identify Chemicals of High Concern - Poster @ ILSI Europe 2016: Poster S1-39-B

Introduction: Due to the worldwide concern that bisphenol A might act as an endocrine disruptor, alternative materials for polycarbonate (PC) have been introduced on the European market. However, PC-replacement products might also release substances of which the toxicological profile – including their genotoxic effects - has not yet been characterized. Because a thorough characterization of the genotoxic profile of all these substances is impossible in the short term, a strategy was developed in order to prioritize those substances for which additional data are urgently needed.

Materials and Methods: Forty-eight substances for which migration from baby bottles has been reported in literature were included in the study. The developed strategy consisted of a decision tree using hazard information related to genotoxicity. The relevant information was obtained from the database of the European Chemicals Agency (ECHA), in silico prediction tools (ToxTree and Derek NexusTM) and the in vitro Vitotox® test for detecting DNA damage.

Results: By applying the decision tree, substances could be classified into different groups, each characterized by a different probability to induce genotoxic effects. Although none of the investigated substances could be unequivocally identified as genotoxic, the presence of genotoxic effects could neither be excluded for any of them. Consequently, more genotoxicity data are needed for all substances. Most of the substances show a low (15) or medium (19) priority with regard to the need for additional genotoxicological information. For 13 of the substances, the necessity for more genotoxicity data is high, and for one substance, i.e. 2,4,6-trimethylbenzaldehyde, it is even very high.

Conclusion: All substances require more data to investigate the genotoxic potential. However, the type and the urge for these data differs among the substances. Although the developed strategy is not suited, nor intended, to replace the data required in a regulatory context, the current study illustrates that it can help to assign priority to substances migrating from food contact materials such as PC-replacement baby bottles.