Final Report on the Safety Assessment of Pyrogallol

Abstract

Pyrogallol, a benzenetriol, is used in oxidative hair dyes at concentrations ranging from ≤0.1 to 5.0%. The oral LD50's in rats ranged from 800 to 1270 mg/kg. Pyrogallol was not an ocular irritant when tested at a concentration of 1%. It was slightly irritating and induced sensitization reaction in the skin of guinea pigs. Sensitization reactions were noted in 3 of 25 patients patch tested with Pyrogallol. Significant teratogenic effects were not observed in the offspring of female rats dosed with Pyrogallol. No treatment-related effects were observed in a multigeneration reproductive toxicity study in which rats received dermal applications of a hair dye containing 0.4% Pyrogallol. Pyrogallol was mutagenic in almost all systems tested. However, in two carcinogenicity studies, the number of neoplasms in mice dermally treated with 50% Pyrogallol in acetone was not significantly different from that of controls. Similar results were reported in a carcinogenicity study in which a hair dye containing 0.49% Pyrogallol and H2O2 in aqueous solution was applied to the skins of mice. On the basis of the available animal and clinical data presented in this report, it is concluded that Pyrogallol is safe as a cosmetic ingredient in the present practices of use and concentration.