Final Report On the Safety Assessment of Sodium Lauraminopropionate and Sodium Lauriminodipropionate

Abstract

Sodium Lauraminopropionate and Sodium Lauriminodipropionate are used in a variety of cosmetic formulations as antistatic agents, hair conditioning agents, and surfactants. Current data on concentrations at which these ingredients appear in cosmetic formulations were unavailable. The oral LD50 for Sodium Lauraminopropionate in albino rats was reported to be 8 g/kg. Evidence from limited studies in rabbits suggests that Sodium Lauraminopropionate and Sodium Lauriminodipropionate are both dermal and ocular irritants. No evidence of sensitization was found in guinea pigs with either ingredient. No data were available on the teratogenic, mutagenic, or carcinogenic potential of these ingredients, nor was there any clinical test data available. Because of the lack of data, the safety of Sodium Lauraminopropionate and Sodium Lauriminodipropionate could not be substantiated. The data needed to make a safety assessment include the method of manufacture, chemical characterization (i.e., data on purity / impurities), chemical and physical properties of Sodium Lauraminopropionate, concentration of use in cosmetic formulations, 28-day dermal toxicity, dermal reproductive and developmental toxicity, any available ocular irritation data (no new studies should be undertaken to provide this data), dermal irritation and sensitization at concentration of use, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded the these ingredients are safe for use in cosmetic products until these safety data have been obtained and evaluated.