5: Final Report on the Safety Assessment of 2-Methylresorcinol and Resorcinol

Abstract

2-Methylresorcinol and Resorcinol are most frequently used in cosmetic hair dye formulations at concentrations between 1 and 5%. The results of cutaneous and oral feeding studies have indicated that both 2-Methylresorcinol and resorcinol are readily absorbed by rodents and are rapidly eliminated. Acute oral toxicity studies indicate that 2-Methylresorcinol is moderately toxic and Resorcinol is slightly to moderately toxic. Subchronic feeding and dermal studies of bothingredients produced no significant effects. A chronic dermal study was uneventful. Significant skin effects were observed in mice, but not in rabbits, following dermal application of Resorcinol at 5%. A 10% Resorcinol solution was not irritating to guinea pigs. A 2.5% 2-Methylresorcinol solution was classified as a primary irritant in rabbits, but 10% 2-Methylresorcinol was not irritating to guinea pigs. 2-Methylresorcinol was not an ocular irritant at 2.5%, but irritation was produced at 5% concentration in unwashed rabbit eyes. Neither 2-Methylresorcinol at 5% nor Resorcinol at 3% produced sensitization in guinea pigs. 2-Methylresorcinol was not photoallergenic to guinea pigs but was a sensitizer at 10%. Resorcinol was not photoallergenic to guinea pigs but was a sensitizer at 10%. Resorcinol and 2-Methylresorcinol were nonmutagenic in microbial and tissue culture assays for mutagenicity. Topically applied hair dyes containing 2-Methylresorcinol and Resorcinol were negative for carcinogenicity. Resorcinol showed no cocarcinogenic potential when tested on mice and rats. 2-Methylresorcinol at 3% concentration produced no evidence of irritation or sensitization in human subjects. Resorcinol was a mild skin irritant and rare sensitizer in clinical testing, but not when tested on nonclinical groups. On the basis of the available animal and clinical data, it is concluded that 2-Methylresorcinol and Resorcinol are safe as cosmeticingredients in the present practices of use and concentrations.