3: Final Report on the Safety Assessment of Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine

Abstract

Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are used as water-soluble emulsifiers and neutralizers in cosmetic products at concentrations up to 1%. In animal studies these ingredients were slightly toxic to practically nontoxic to rats and guinea pigs via acute oral administration. Triisopropanolamine was relatively nontoxic to rats in the two subchronic oral studies. These ingredients were moderate skin irritants for rabbits. All four ingredients, when tested at 100% concentrations, were severe ocular irritants in rabbits. Products containing small amounts (-1%) of Diisopropanolamine or Triisopropanolamine were not ocular irritants in rabbits. The Triisopropanolamine salt was not mutagenic in Aspergillus nidulans. Diisopropanolamine and Isopropanolamine at concentrations of 2% did not induce allergic contact dermatitis or photoallergic dermatitis in humans. Clinical studies on cosmetic products containing no more than 1% Diisopropanolamine or 1.1% Triisopropanolamine were minimal skin irritant and contact sensitizers. It is concluded that Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are safe as cosmetic ingredients in the present practices of use and concentration. The Isopropanolamines should not be used in products containing N-nitrosating agents.