Cosmetic-grade Shellac is a mixture of hydroxyaliphatic and alicyclic acids and their polyesters. It is used in cosmetic formulations at concentrations up to 25%.
Shellac had an LD50 of greater than 5 g/kg in rats. Results of acute animal toxicity studies using cosmetic formulations containing up to 6% Shellac indicated no adverse effects upon oral (rats), dermal (rabbits), ocular (rabbits), and respiratory tract (rabbits) exposure. Chronic inhalation of a Shellac hair spray formulation by rabbits produced no observable toxicity. No treatment-related toxic or pathologic effects were observed when concentrations of Shellac up to 10,000 ppm were fed to rats in a subchronic study.
Ames' mutagenicity assays, with and without metabolic activation, were negative.
Clinical assessment of safety of cosmetic formulations containing up to 6% Shellac indicated no measurable irritation and absence of sensitization and photosensitization.
It is concluded that cosmetic-grade Shellac is safe for use in cosmetic formulations at concentrations up to 6%, the maximum concentration tested.
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