Final Report on the Safety Assessment of Hydrogenated Cottonseed Oil, Cottonseed (Gossypium) Oil, Cottonseed Acid, Cottonseed Glyceride, and Hydrogenated Cottonseed Glyceride

Abstract

Hydrogenated Cottonseed Oil, Cottonseed (Gossypium) Oil, Cottonseed Acid, Cottonseed Glyceride, and Hydrogenated Cottonseed Glyceride are cosmetic ingredients derived from Cottonseed Oil and used as skin-conditioning agents and surfactants. Non-oils known to be toxic that may be found in cottonseed oils include gossypol, aflatoxin, and cyclopropenoid fatty acids (CPFA). Toxic heavy metal and/or polychlorinated biphenyl (PCB) or other pesticide contamination is also possible. Cottonseed Oil was nontoxic in acute oral toxicity studies in rats. In a short-term study, rabbits that had been fed 2% Cottonseed Oil for 7 weeks had significantly lower blood chemistry parameters (compared to wheat bran controls) and significantly more stored hepatic vitamin A (compared to rabbits fed other fats). Cottonseed Oil controls used as vehicles in two parenteral studies produced negative results. Hydrogenated Cottonseed Oil tested in formulation did not produce dermal or ocular irritation in rabbits. An oral-dose reproductive study tested up to 30% Cottonseed Oil (with 1% CPFAs) and reported no adverse effects on sexual maturity and reproductive performance of the F0 generation; changes were noted in the F1 generation but reproductive capacity was not altered. Parenteral-dose reproductive studies reported no adverse effects. Cottonseed Oil was not mutagenic. Cottonseed Oil did not induce aberrant crypt foci when given orally to mice, but in other studies, it increased the incidence of spontaneous mammary tumors in rats and mice. Mice fed 20% Hydrogenated Cottonseed Oil during induction and promotion of photocarcinogenesis had significantly lower tumor incidence compared to mice fed 20 % sunflower oil. Hydrogenated Cottonseed Oil in formulation (up to 21 %) was neither an irritant nor sensitizer in clinical studies. Limited clinical data indicated that Cottonseed Oil does not contain allergic protein. Based on the available data, it was concluded that these ingredients may be used safely in cosmetic formulations if established limits on gossypol, heavy metals, and pesticide concentrations are not exceeded.