Dioctyl Sodium Sulfosuccinate is an anionic surfactant used in a wide variety of cosmetic formulations. In September 1994, the Cosmetic Ingredient Review (CIR) Expert Panel evaluated the ingredient to be safe up to 0.42% in cosmetic formulations. Since that time, CIR received a petition to re-open the safety assessment based on new clinical data. This amendment is a compilation of data contained in the original plus the data received in the petition; the latter appear at the end of this document. Studies conducted in the 1940's indicate that the oral LD50 in rats can be as low as 1.9 g/kg. Short-term subchronic and chronic animal studies of the same vintage found little toxicity at levels around 1% of the LD50 level. Inhalation studies likewise had few findings. Dioctyl Sodium Sulfosuccinate was minimally irritating to intact animal skin, but moderate to severely irritating to abraded skin. A concentration of 25% was a severe ocular irritant, but 10% produced little or no irritation. Mutagenesis tests were negative. A repeated insult patch test (RIPT) in 110 individuals produced no sensitization at a concentration of 5%. Erythema was noted during induction in a number of subjects at concentrations ≤5%. The CIR Expert Panel recognized that surfactants such as Dioctyl Sodium Sulfosuccinate would likely produce irritation under the conditions of a RIPT. The Panel cautioned that as the ingredient is a cumulative irritant, care should be taken to avoid irritancy in formulations intended for prolonged contact with the skin. The Panel concluded that Dioctyl Sodium Sulfosuccinate is safe for use in cosmetics.
