6 Final Report on the Safety Assessment of Glyceryl Oleate

Open Access
Publisher Website
Google Scholar
Abstract
Glyceryl Oleate, the glyceryl 1-monoester of oleic acid, is used in cosmetic products as an emulsifier at concentrations up to 5%. Oral administration of a single 13 ml/kg dose of a sunscreen formulation containing 5% Glyceryl Oleate to rats produced no signs of toxicity and no lethality. A single exposure of undiluted Glyceryl Oleate in animal dermal irritation studies produced only minimal irritation. Daily applicatoins of 25.0% corn oil solution of a formulation containing Glyceryl Oleate for 20 days produced severe dermal irritation in rabbits. In a 4-week dermal toxicity/phototoxicity study, product formulations containing up to 5% Glyceryl Oleate produced slight reversible dermal irritation. Subchronic and chronic toxicity data from studies with animals and humans that were used in the safety assessment of glycerides, glycerol, oleic acid, and sodium oleate are presented. Minimal to moderate eye irritation was produced by undiluted Glyceryl Oleate in rabbits. Glyceryl Oleate administration was associated with development of a small number of brain tumors in a two-generation study in mice. Digestive tract tumors were found in mide fed 200 mg/mouse per day Glyceryl Oleate for four-seven generations. The results of these studies were considered equivocal. Doses of 1.5 and 6.0 mg/mouse per day of Glyceryl Oleate in saline increased the survival period of mice with implanted Ehrlich ascites tumors; the higher dose inhibited tumor growth. Formulations containing 5% Glyceryl Oleate were nonirritating in a human cumulative occlusive patch test and in repeat insult patch testing at 15%. Glyceryl Oleate in formulations is not phototoxic. It is concluded that Glyceryl Oleate is safe as a cosmetic ingredient in the present practices of use and concentration.