1: Final Report on the Safety Assessment of Tragacanth Gum

Abstract

Tragacanth Gum is a complex polysaccharide composed of D-galacturonic acid, D-galactose, D-xylose, and L-arabinose. It is used in cosmetics at concentrations up to 10%. In acute toxicity studies, Tragacanth Gum was practically nontoxic when administered orally to mice, rats, hamsters, and rabbits. In subchronic studies, a diet containing 2% Tragacanth Gum produced a significant reduction in growth in chickens. However, no significant reductions in average body weights were noted in quail, rats, or insect larvae. In a chronic study, six baboons receiving Tragacanth Gum had no significant adverse effects. Cosmetic products containing up to 1.5% Tragacanth Gum were slightly to mildly irritating when applied topically to rabbits and nonirritating to mildly irritating to rabbit eyes. No significant toxic or teratogenic effects were produced by oral administration of Tragacanth Gum to pregnant mice. Tragacanth Gum was essentially nonmutagenic in a variety of mutagenic assays. Tragacanth Gum has been used as the solvent control in a carcinogenicity study. The number and type of tumors were not different from those seen in the untreated control mice. Cosmetic products containing up to 1.5% Tragacanth Gum were essentially nonirritating and nonsensitizing when evaluated in humans. Tragacanth Gum at a concentration of 10% did not induce a contact dermal phototoxic response when tested in humans. It is concluded that Tragacanth Gum is safe as a cosmetic ingredient in the present practices of use and concentration.