Risk Assessment of Drometrizole, a Cosmetic Ingredient used as an Ultraviolet Light Absorber
Toxicological Research 2019;35:119−129
Published online April 30, 2019;  https://doi.org/10.5487/TR.2019.35.2.119
© 2019 Korean Society of Toxicology.

Jae Kwon Lee1, Kyu-Bong Kim2, Jung Dae Lee3, Chan Young Shin4, Seung Jun Kwack5, Byung-Mu Lee3, and Joo Young Lee1

1BK21Plus Team, College of Pharmacy, The Catholic University of Korea, Bucheon, Korea, 2College of Pharmacy, Dankook University, Cheonan, Korea, 3College of Pharmacy, Sungkyunkwan University, Suwon, Korea, 4Department of Neuroscience, School of Medicine, Konkuk University, Seoul, Korea, 5Department of Bio Health Science, Changwon National University, Changwon, Korea
Joo Young Lee, College of Pharmacy, The Catholic University of Korea, Bucheon 14662, Korea, E-mail: joolee@catholic.ac.kr
Received: February 20, 2019; Revised: March 7, 2019; Accepted: March 8, 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

As the use of cosmetics has greatly increased in a daily life, safety issues with cosmetic ingredients have drawn an attention. Drometrizole [2-(2′-hydroxy-5′-methylphenyl)benzotriazole] is categorized as a sunscreen ingredient and is used in cosmetics and non-cosmetics as a UV light absorber. No significant toxicity has been observed in acute oral, inhalation, or dermal toxicity studies. In a 13-week oral toxicity study in beagle dogs, No observed adverse effect level (NOAEL) was determined as 31.75 mg/kg bw/day in males and 34.6 mg/kg bw/day in females, based on increased serum alanine aminotransferase activity. Although drometrizole was negative for skin sensitization in two Magnusson-Kligman maximization tests in guinea pigs, there were two case reports of consumers presenting with allergic contact dermatitis. Drometrizole showed no teratogenicity in reproductive and developmental toxicity studies in which rats and mice were treated for 6 to 15 days of the gestation period. Ames tests showed that drometrizole was not mutagenic. A long-term carcinogenicity study using mice and rats showed no significant carcinogenic effect. A nail product containing 0.03% drometrizole was nonirritating, non-sensitizing and non-photosensitizing in a test with 147 human subjects. For risk assessment, the NOAEL chosen was 31.75 mg/kg bw/day in a 13-week oral toxicity study. Systemic exposure dosages were 0.27228 mg/kg bw/day and 1.90598 mg/kg bw/day for 1% and 7% drometrizole in cosmetics, respectively. Risk characterization studies demonstrated that when cosmetic products contain 1.0% of drometrizole, the margin of safety was greater than 100. Based on the risk assessment data, the MFDS revised the regulatory concentration of drometrizole from 7% to 1% in 2015. Under current regulation, drometrizole is considered to be safe for use in cosmetics. If new toxicological data are obtained in the future, the risk assessment should be carried out to update the appropriate guidelines.

Keywords : Risk, Safety, Drometrizole, Cosmetics, Toxicity, Skin


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