Final report on the safety assessment of Stearyl Heptanoate

Abstract

The ester Stearyl Heptanoate, a waxy solid that is insoluble in water, is used as a skin conditioning agent-occlusive in a wide variety of cosmetic formulations at varying concentrations (e.g., up to 25% in lip balms, up to 5% in ointments). Studies report a high oral LD50 >5 g/kg, for rats. Animal data indicate potential for mild skin irritation, but none for sensitization. Undiluted Stearyl Heptanoate did produce some ocular irritation in rabbits, but a 1.5% solution produced no effects. Mutagenesis assays (Ames and micronucleus test) were negative. Clinical data showed no evidence of irritation or sensitization or comedogenicity. Although animal and clinical sensitization studies were done at a low concentration compared with expected use concentrations, the data suggest that it would not be a sensitizer even at higher concentrations. Data on ocular irritation show only mild reactions to undiluted Stearyl Heptanoate, suggesting that expected use concentrations should not produce significant ocular irritation. On the basis of the available animal and clinical data, it is concluded that Stearyl Heptanoate is safe for use as a cosmetic ingredient in the present practice of use.