2 Final Report on the Safety Assessment of Propyl Gallate

Abstract

Propyl Gallate acid is used as an antioxidant in cosmetic products at concentrations normally less than 0.1 percent. Propyl Gallate is absorbed when ingested, methylated, conjugated, and excreted in the urine. Acute animal toxicity studies indicate that Propyl Gallate is slightly toxic when ingested and practically nontoxic when applied to the skin. Numerous chronic oral toxicity studies indicate that Propyl Gallate at concentrations up to 5 percent is practically nontoxic to rats, mice, dogs, and guinea pigs. Propyl Gallate is nonirritating to human skin at concentrations up to 10 percent; however, it is sensitizing at this and higher concentrations. Propyl Gallate was nonphototoxic. It is concluded that Propyl Gallate is safe as a cosmetic ingredient at concentrations not exceeding 1 percent.