Final Safety Assessment for PCA and Sodium PCA

Abstract

PCA is the cosmetic ingredient term used for the cyclic organic compound known commonly as pyroglutamic acid. Sodium PCA is the sodium salt of PCA. Both are used as hair and skin conditioning agents. These ingredients are recommended to be used in a concentration range of 0.2-4%. One optical isomer of PCA (the L form) is a naturally occurring component of mammalian tissue. PCA applied to the skin is absorbed to a limited extent. Absorption is in addition to PCA already present in the skin. In short-term and subchronic studies in several animal species, findings were unremarkable except for neurotoxicity in mice when injected interstriatally. No such findings were seen in similar studies using rats or with oral administration using mice. In animal studies, Sodium PCA was nonirritating to the eye and skin at concentrations up to 50%. No evidence of phototoxicity, sensitization, or comedogenicity was found. These ingredients were not genotoxic. In a range of clinical tests, PCA and Sodium PCA were found to be nonirritating and nonsensitizing (with and without UV exposure). Based on the low actual skin penetration of dermally applied PCA and in recognition of the endogenous levels found in the skin, it was considered that reproductive and developmental toxicity data were not critical to completion of the safety assessment. Based on the available data, it was concluded that PCA and Sodium PCA are safe as presently used in cosmetic formulations. These ingredients, however, should not be used in cosmetic products containing nitrosating agents.