2: Final Report on the Safety Assessment of Retinyl Palmitate and Retinol

Abstract

Retinol is the naturally occurring form of vitamin A; Retinyl Palmitate is the ester of Retinol and Palmitic Acid. In acute oral studies, Retinol was slightly toxic to mice, and Retinyl Palmitate was practically nontoxic in mice and rats. Large single doses can be lethal. It is recognized that Retinol is essential for reproduction; however, high intake of Retinol has produced adverse effects on several reproductive functions. Vitamin A was nonmutagenic in several in vitro tests. There is no evidence that vitamin A is carcinogenic. However, the vitamin has both enhanced and inhibited responses to viral or chemical carcinogens. Cosmetic products containing 0.1-1% Retinyl Palmitate were, at most, slightly irritating and nonsensitizing when tested on a total of 607 subjects. Results of cumulative irritation tests of two products containing 0.1% Retinyl Palmitate indicated that the products were nonirritating and non-sensitizing. On the basis of the available animal and clinical data presented in this report, it is concluded that Retinyl Palmitate and Retinol are safe as cosmetic ingredients in the present practices of use and concentration.