化合物详情

A 2025 publication by authors in the U.S. and U.K. reviewed the toxicity and human exposure data for ensulizole as currently used in over-the-counter sunscreen formulations. The information included results from in vitro, animal toxicity, and human studies. The authors concluded that ensulizole does not pose risks to human health when used in sunscreen products at concentrations up to 4% (permitted maximum usage level in the U.S., Canada, and Australia), and that it is a Category I (generally recognized as safe and effective) UV filter under the U.S. FDA 1999 final monograph while being under current review by the FDA under over-the-counter (OTC) reform legislation.

A 2025 review by authors in the U.S. and U.K. noted that postmarketing clinical safety studies reported only occasional local skin effects and no association with systemic toxicity.

A 2025 reviw by authors in the U.S. and U.K. noted that local skin irritation with no systemic effects was noted in a rabbit 3-month repeated-dose dermal toxicity study; however, ensulizole is not classifiable as an irritant, They also noted that ensulizole is non-(photo)sensitizing, non-phototoxic, and has low toxicity in acute (oral, dermal, and intraperitoneal) and subchronic repeated-dose studies in mammalian species. Further, the authors noted that ensulizole is considered non-genotoxic based on negative in vitro studies, and that carcinogenicity is not expected based on a) the negative genotoxicity data, b) empirical evidence from repeated-dose toxicity and developmental toxicity studies, and c) the absence of effects on the androgen, estrogen, thyroid, immune, developmental, or r...