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Toxicol Res. 2019 Apr;35(2):131-136. doi: 10.5487/TR.2019.35.2.131. Epub 2019 Apr 15.

Risk Assessment of Ethylhexyl Dimethyl PABA in Cosmetics.

Author information

1
Department of Bio Health Science, College of Natural Science, Changwon National University, Changwon, Korea.
2
College of Pharmacy, Dankook University, Cheonan, Korea.
3
BK21Plus Team, College of Pharmacy, The Catholic University of Korea, Bucheon, Korea.
4
College of Pharmacy, Sungkyunkwan University, Suwon, Korea.

Abstract

Ethylhexyl dimethyl para-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl dimethyl PABA is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5-2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that ethylhexyl dimethyl PABA is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that ethylhexyl dimethyl PABA inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of ethylhexyl dimethyl PABA following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of ethylhexyl dimethyl PABA in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% ethylhexyl dimethyl PABA, which is the maximum level allowed by the relevant domestic authorities.

KEYWORDS:

Cosmetics; Ethylhexyl dimethyl PABA; Risk assessment; Sunscreen; Toxicity

Conflict of interest statement

CONFLICT OF INTEREST The authors of this article hereby declare that there are no conflicts of interest.

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