Final report of the safety assessment of Kojic acid as used in cosmetics

Int J Toxicol. 2010 Nov-Dec;29(6 Suppl):244S-73. doi: 10.1177/1091581810385956.

Abstract

Kojic acid functions as an antioxidant in cosmetic products. Kojic acid was not a toxicant in acute, chronic, reproductive, and genotoxicity studies. While some animal data suggested tumor promotion and weak carcinogenicity, kojic acid is slowly absorbed into the circulation from human skin and likely would not reach the threshold at which these effects were seen. The available human sensitization data supported the safety of kojic acid at a use concentration of 2% in leave-on cosmetics. Kojic acid depigmented black guinea pig skin at a concentration of 4%, but this effect was not seen at 1%. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the 2 end points of concern, dermal sensitization and skin lightening, would not be seen at use concentrations below 1%; therefore, this ingredient is safe for use in cosmetic products up to that level.

Publication types

  • Case Reports
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • Antioxidants
  • Carcinogenicity Tests
  • Consumer Product Safety*
  • Cosmetics / chemistry
  • Cosmetics / toxicity*
  • Dose-Response Relationship, Drug
  • Humans
  • Irritants
  • Mutagenicity Tests
  • Pyrones / chemistry
  • Pyrones / toxicity*
  • Skin*
  • Toxicity Tests, Acute
  • Toxicity Tests, Chronic
  • United States
  • United States Food and Drug Administration

Substances

  • Antioxidants
  • Cosmetics
  • Irritants
  • Pyrones
  • kojic acid