Risk assessment of ethyl hexyl salicylate as a UV filter

Ethyl hexyl salicylate (EHS) is a salicylate derivative commonly used as a UV filter in cosmetic products at concentrations up to 5%. This study reviews the toxicological profile of EHS, including acute and repeated dose toxicity, skin and eye irritation, skin sensitization, reproductive and developmental toxicity, genotoxicity, phototoxicity, and dermal absorption, in order to assess its safety for cosmetic use. Acute toxicity studies demonstrated low toxicity, with oral and dermal LD₅₀ values exceeding 2 g/kg in rats and 5 g/kg in rabbits, respectively. In a 13-week repeated oral toxicity study in rats, no treatment-related adverse effects were observed at doses up to 250 mg/kg/day, establishing a no-observed-adverse-effect level (NOAEL) of ≥ 250 mg/kg/day. EHS was non-irritating to human skin and rabbit eyes and did not induce skin sensitization in guinea pigs. In reproductive and developmental toxicity studies in rats, no maternal toxicity was observed up to 250 mg/kg/day; however, reduced pregnancy index and increased post-implantation loss were observed at doses of 80 mg/kg/day or higher. Consequently, the maternal NOAEL was determined to be 250 mg/kg/day and the developmental NOAEL to be 25 mg/kg/day. Genotoxicity assessments, including in vitro and in vivo assays, consistently yielded negative results, indicating no genotoxic concern. No phototoxic effects were observed in humans exposed to 15% EHS. An in vitro human skin absorption study estimated dermal absorption at 0.5%. Based on this value, the systemic exposure dose for adults using cosmetics containing 5% EHS was calculated to be 0.0708 mg/kg/day, resulting in a margin of safety of 353 when compared with the developmental NOAEL of 25 mg/kg/day. These findings indicate that EHS poses a low risk to human health when used as a cosmetic UV filter within the current regulatory limits.