Final Report on the Safety Assessment of Diisopropylamine

Abstract

Diisopropylamine is a strongly alkaline, aliphatic amine used to adjust the p H of cosmetic formulations. In 1993, it was reported to be used in only one formulation. In acute and short-term inhalation studies, toxic effects were observed in the respiratory system and eyes of rats and guinea pigs. Dermal application of diluted and undiluted Diisopropylamine in rats and guinea pigs showed irritation but not sensitization. This ingredient is considered an ocular irritant. Mixed results were obtained in evaluating the mutagenicity of this ingredient by the Ames test, but there were negative results in the rat hepato-cyte primary culture/DNA repair assay. Occupational exposure to Diisopropylamine vapor (5–10 min, two or three times per day, mean concentration 0.1–0.2 mg/l) was associated with dimness of vision, nausea, and headaches. Because the skin irritation results were interpreted as attributable to the alkaline p H of this ingredient, and it is recognized that it is likely neutralized in cosmetic formulations, the irritation potential in actual use was not a concern. In the presence of N-nitrosating agents, Diisopropylamine has the potential to form nitrosamines. Based on the data presented in this report, it is concluded that Diisopropylamine is safe as a cosmetic ingredient in the present practices of use, except it should not be used in products containing N-nitrosating agents.