Risk assessment of unintentional phthalates contaminants in cosmetics

Abstract

A risk assessment was performed for three types of phthalates, benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), and di(2-ethylhexyl)phthalate (DEHP) unintentionally contaminated in cosmetics. A total of 100 products of 8 types of cosmetics were analyzed employing gas chromatography-mass spectrometry (GC-MS). By applying the maximum detected values of phthalates based on the worst exposure cases, their systemic exposure dosage (SED) was calculated. Accordingly, DEHP was identified as the main unintentional phthalates contaminants (0.10-600.00 ppm) in the cosmetics, with an SED of 3.37 × 10^-9-3.75 × 10^-4 mg/kg/day. In the non-cancer risk assessment, a margin of safety (MOS ≥ 100, safe) of 1.28 × 10⁴-1.42 × 10⁹ was estimated. In the cancer risk assessment, the lifetime cancer risk (LCR ≤ 10^-5, safe) was determined to be 8.81 × 10^-12-9.79 × 10^-7. Based on the results of both risk assessments, the levels of unintentional phthalates contaminants in cosmetics were deemed safe. Some phthalates are widely used as plasticizers and are essential for daily life; however, various toxicities, including endocrine disruption, have been reported. Therefore, even under these "worst case" assumptions, an adequate margin of safety is shown such that this might be a low priority for further work although exposure to unintentional phthalates contaminants through cosmetics should be considered as part of cumulative exposure.

Keywords: Benzyl butyl phthalate (BBP); Cosmetics; Di(2-ethylhexyl)phthalate (DEHP); Dibutyl phthalate (DBP); Risk assessment; Unintentional phthalates contaminants.