8 Final Report on the Safety Assessment of Polyquaternium-11

Abstract

Polyquaternium-11 is a quaternized copolymer of vinylpyrrolidone and di-methylamine ethylmethacrylate, and is used at concentrations up to 50% in a variety of hair care preparations. The acute oral LD50 in test animals of high molecular weight Polyqua-ternium-11 is estimated to be greater than 12.8 g/kg; the LD50 for the low molecular weight polymer is calculated to be 6.2 g/kg. At concentrations of up to 50% in water, the raw ingredient produced no signs of skin or eye irritation. There was no evidence of dermal toxicity in subchronic tests nor in a maximization test for sensitization. In clinical studies, 1 of 19 subjects showed slight skin irritation after a 24-hour single insult skin patch with 9.5% Polyquaternium-11 in water. Repeated insult patch tests at concentrations up to 50% produced no instances of skin sensitization and only isolated instances of transient skin irritation. Clinical photoreactivity studies on both low and high molecular weight polymers showed no evidence of phototoxicity or photoallergenicity. From the available information, it is concluded that Polyquaternium-11 is safe as a cosmetic ingredient in the present practices of use.