A kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrates no evidence of a health risk from developmental toxicity

Abstract

Salicylic acid (SA) has a long history of safe use as ingredient in topical cosmetic products. In 2016, the Committee for Risk Assessment of the European Chemicals Agency proposed to classify SA as a Category 2 reproductive toxicant based on adverse developmental effects in animal toxicity studies. This hazard-based classification (based on mg/kg doses) requires a reassessment of the safety of the current SA concentrations in cosmetic consumer products. Herein, a safety reassessment was performed in which margins of safety were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with ASA (rapidly converts to SA in plasma), human SA plasma levels from oral exposure to ASA and human dermal exposure to SA-containing cosmetic products. In addition, a literature review was performed, which shows that there are no adverse developmental effects despite extensive human clinical oral use of ASA up to the maximum recommended therapeutic doses. The plasma exposure-based safety assessment for SA combined with an absence of any clinical health risk with oral ASA use in the literature supports that there is an acceptable margin of safety for the consumer exposure to SA as authorized in the current EU cosmetic regulation.