FINAL REPORT ON THE SAFETY ASSESSMENT OF POLYACRYLAMIDE

Polyacrylamide is a polymer of controllable molecular weight formed from the polymerization of acrylamide monomers. Average concentrations of the monomer were reported as less than 0.01 % by several manufacturers. Polyacrylamide is used as a foam builder and stabilizer in shampoo products and as a vehicle in sunscreen preparations. An acute oral toxicity study of Polyacrylamide in rats reported that a single maximum oral dose of 4.0 g/kg body weight was tolerated. In a subchronic oral toxicity study in both rats and dogs, animals were given a maximum dose of 464 mg/kg body weight, with no signs of toxicity in any animals. Two separate studies in rats reported no absorption when the compound was administered by gavage. In a 2-year chronic oral toxicity study, rats fed between 500 and 10,000 ppm in their diet had no significant adverse effects. Similar results were obtained in dogs. A 2-year feeding study in rats fed up to 5.0% Polyacrylamide reported no significant adverse effects. Cutaneous tolerance tests performed to evaluate the irritation of Polyacrylamide indicated that the compound was relatively well tolerated. Undiluted Polyacrylamide applied to the conjunctival sac of the rabbit caused a very slight response. No compound-related lesions were noted in a three-generation reproductive study in which rats were fed either 500 or 2000 ppm Polyacrylamide. On the basis of data presented in this report, it is concluded that Polyacrylamide, with less than 0.01% acrylamide monomer content, is safe as a cosmetic ingredient as currently used.