Safety evaluation of a barrier cream.

A barrier cream containing propylene glycol, silica, xylene, dioctyl adipate and amyl acetate was applied topically for 3 months in 3 species of animal. Patch tests were carried out in human volunteers up to 72 h. The cream produced slight erythema in rats, guinea pigs and rabbits, but the irritation indices remained within safe limits. Histologically, mild focal thickening and moderate thickening of stratum corneum were observed in rats and guinea pigs, respectively, after 3 months of daily application. Patch testing in human volunteers indicated that the barrier cream is reasonably safe for human use.