Risk Assessment of Ethylhexyl Dimethyl PABA in Cosmetics
Toxicol. Res. 2019;35:131−136
Published online April 15, 2019;  https://doi.org/10.5487/TR.2019.35.2.131
© 2019 Korean Society of Toxicology.

Chi Rim Sung1, Kyu-Bong Kim2, Joo Young Lee3, Byung-Mu Lee4 and Seung Jun Kwack1

1Department of Bio Health Science, College of Natural Science, Changwon National University, Changwon, Korea
2College of Pharmacy, Dankook University, Cheonan, Korea
3BK21Plus Team, College of Pharmacy, The Catholic University of Korea, Bucheon, Korea
4College of Pharmacy, Sungkyunkwan University, Suwon, Korea
Seung Jun Kwack, Department of Bio Health Science, College of Natural Science, Changwon National University, 20 Changwondachak-ro, Uichang-gu, Changwon, Gyeongnam 51140, Korea
E-mail: sjnkwack@changwon.ac.kr
Received: February 21, 2019; Revised: March 8, 2019; Accepted: March 10, 2019
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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 : Ethylhexyl dimethyl PABA, Cosmetics, Sunscreen, Risk assessment, Toxicity


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