Final Report on the Safety Assessment of TEA Stearate

Abstract

TEA Stearate is the triethanolamine salt of stearic acid used as a surfactant-cleansing agent and a surfactant-emulsifying agent in a wide variety of cosmetic formulations. Published data on TEA Stearate as an individual ingredient were not available, but data on its two components, TEA and stearic acid, were previously reviewed and considered adequate to evaluate the safety of TEA Stearate. Information from the earlier reports was summarized in this report and updated with more recent data on TEA. These data were consistent with the conclusion that TEA is safe for use in rinse-off cosmetic formulations, that its concentration should not exceed 5% in leave-on formulations, and that in no case should it be used in products containing N-nitrosating agents. Stearic Acid was found safe as used. Because the TEA salt of stearic acid is not expected to exhibit any toxic effects not seen with the separate moities, these conclusions, including the concentration limit for TEA, are considered applicable to TEA Stearate, once adjusted for the appropriate molecular weights. Therefore, it is concluded that TEA Stearate is safe as used in cosmetic formulations designed for discontinuous, brief use followed by thorough rinsing; that it is safe in concentrations not to exceed 15% in formulations intended for prolonged contact with the skin; and that it should not be used in products under conditions resulting in N-nitrosation reactions.