4: Final Report on the Safety Assessment of Sorbic Acid and Potassium Sorbate

Abstract

Sorbic acid is a straight-chain monocarboxylic acid used in cosmetic formulations as a preservative at concentrations up to 1.0%. Sorbic acid and potassium sorbate were practically nontoxic to rats and mice in acute oral toxicity studies. In subchronic studies no significant adverse effects were observed in rats, mice, or dogs when 10% sorbic acid was included in the diet. Sorbic acid and potassium sorbate at concentrations up to 10% were practically nonirritating to the rabbit eye. Both ingredients at concentrations up to 10% were at most only slightly irritating. Sorbic acid and potassium sorbate have been tested for mutagenic effects using the Ames test, genetic recombination tests, reversion assays, rec assays, tests for chromosomal aberrations, sister chromatid exchanges, and gene mutations. Results have been both positive and negative. Potassium sorbate at 0.1% in the diet or 0.3% in drinking water of rats for up to 100 weeks produced no neoplasms. In other chronic studies, no carcinogenic effect was demonstrated by sorbic acid in rats or mice fed diets containing up to 10% sorbic acid. No teratogenic effects have been observed in pregnant mice and rats administered potassium sorbate. In three repeat insult patch tests, sorbic acid had overall sensitization rates of 0, 0.33, and 0.8%. All of the subjects sensitized were inducted with 20% sorbic acid and challenged with 5% sorbic acid. Formulations containing up to 0.5% sorbic acid and or potassium sorbate were not significant primary or cumulative irritants and not sensitizers at this test concentration. A formulation containing 0.01% sorbic acid was not a photosensitizer. On the basis of the available data, it is concluded that sorbic acid and potassium sorbate are safe as cosmetic ingredients in the present practices of use and concentration.