3 Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate

Abstract

The Sorbitan esters, including Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate, are used in cosmetic products as emulsifiers and stabilizers at concentrations normally under 5 percent. Toxicity was reported in subchronic and chronic studies at concentrations above that normally used in cosmetics. They are generally mild skin irritants but nonsensitizers in animals. They have the potential to induce cutaneous irritation in humans but not sensitization to normal skin. Carcinogenic studies using Sorbitan Stearate and Laurate were negative. At concentrations of 10 percent or greater, Sorbitan Laurate is a tumor promoter in mouse skin. It is concluded that the latter is not relevant to the use of the Sorbitan esters at low concentrations in cosmetics and that the Sorbitan esters reviewed in the report are safe as cosmetic ingredients under present conditions of concentration and use.