Final Report on the Safety Assessment of Polyquaternium-7

Abstract

The quaternary ammonium compound Polyquaternium-7 is used as an antistatic agent, film former, and hair fixative in a wide variety of cosmetics. This ingredient is formed by the polymerization of acrylamide with dimethyl dialylammonium chloride; residual acrylamide monomer can be found at levels as high as 10 ppm. An 8% aqueous solution of Polyquaternium-7 is typically supplied and this solution may be used in cosmetic formulations at a concentration as high as 5%. Most uses are at lower concentrations. Rats were fed up to 50,000 ppm of an 8% aqueous solution for 30 days; a decrease in organ weight was noted in the higher exposure groups. Dermal exposure of rats to 2.25 ml/kg per day for 14 weeks was nonirritating to both intact and abraded skin. Dermal exposure of rabbits to an 8% solution produced no irritation, and ocular exposure showed mild irritation that cleared after 24 h. Polyquaternium-7 was not mutagenic in an Ames test. Repeated insult patch test data suggest that 8% Polyquaternium-7 is at best a mild cumulative irritant, but not a sensitizer. Clinical tests with an 8% solution indicated that Polyquaternium-7 is not a photosensitizer. Given its structure, this material is considered not likely to be significantly absorbed in the skin and therefore is unlikely to produce general toxicity, developmental toxicity, or mutagenic/carcinogenic effects under use conditions. The presence of unreacted acrylamide monomer is considered sufficiently low so as to have no toxicologic significance. Based on the available data, it is concluded that Polyquaternium-7 is safe for use in cosmetic formulations.