9 Final Report on the Safety Assessment of Toluenesulfonamide/Formaldehyde Resin

Abstract

Toluenesulfonamide/Formaldehyde Resin (TSFR) is used in such cosmetic products as fingernail polishes and enamels at concentrations up to 10%. TSFR was practically nontoxic to rats when given orally as a 70% solution in acetone and when applied to the skin of rabbits as a 40% suspension in corn oil. TSFR in the form of a finely ground powder was nonirritating to rabbit skin and slightly irritating to the rabbit eye. The undiluted material was nonirritating to rabbit skin, slightly irritating to the rabbit eye, and practically nontoxic to rabbits by dermal application. No significant treatment-related effects were observed in a subchronic oral study in dogs. TSFR was negative in the Ames test for mutagenicity. In clinical studies, 10% TSFR in dimethyl phthalate was nonirritating and nonsensitizing to the skin. Nail products containing up to 12% TSFR were nonsensitizing, nonphotosensitizing, and essentially nonirritating to the human skin. Reports of nail polish dermatitis of allergic origin have been attributed to TSFR and other liquid thermoplastic resins. It is concluded that Toluenesulfonamide/Formaldehyde Resin (TSFR) and Toluenesulfonamide/Formaldehyde Resin-80% (TSFR-80) are safe as cosmetic ingredients in the present practices of use and concentration.