Parabens and bisphenol A and its structural analogues in over-the-counter medicines from China

Abstract

Pharmaceuticals, such as over-the-counter (OTC) medicines, may be an important source of human exposure to several endocrine disruptors, though unnoticed to date. In the present study, we investigated the presence of six parabens and nine bisphenol A (BPA) and its analogues in OTC medicines manufactured in China. Parabens and bisphenols were present in more than 90% of the samples. The total measured concentrations of parabens and bisphenols were in the range of non-detectable (ND) to 213 ng/g and ND to 415 ng/g, respectively. Regarding parabens, methyl paraben (MeP) was the predominant analog, accounting for 43 ± 36% of the total amount, followed by ethyl paraben (EtP) (39 ± 35%), and others (< 10%). Bisphenol F and BPA were the predominant bisphenols, accounting for 24 ± 28% and 22 ± 26% of the total amount, respectively. The median values of estimated daily intakes (EDIs) of parabens and bisphenols were the highest for infants (2.96 and 3.14 ng/kg_bw/day, respectively) and the lowest for adults (0.69 and 0.25 ng/kg_bw/day, respectively); moreover, the EDIs of parabens and bisphenols were higher in Chinese patent medicines than in western pediatric medicines. The hazard quotient (HQ) for sum of MeP and EtP (∑(MeP + EtP)) and BPA in three age groups were within the safe zone (HQ < 0.0004). Monte Carlo simulation was applied to predict the human exposure risk of parabens and bisphenols. The predicted ranges of EDIs of parabens and bisphenols were much wider, and the extreme predicted values were observed in all four age groups, which were higher than the acceptable daily intake. The extreme predicted values of ∑(MeP + EtP) and BPA were indicative of carcinogenic risk in toddlers. These results implied potential risks for the Chinese people existed. Considering the huge export of Chinese traditional medicines and western medicines worldwide, and easy access to OTC medicines for the general population, the presence of parabens, bisphenols, and other environmental contaminants in medicines still need to be monitored.

Keywords: Bisphenols; EDIs; Monte Carlo Simulation; Over-the-counter medicines; Parabens.