Final Report on the Safety Assessment of Quaternium-18, Quaternium-18 Hectorite, and Quaternium-18 Bentonite

Abstract

Quaternium-18 is a mixture of quaternary ammonium chloride salts. Quaternium-18 Hectorite and Bentonite are the reaction products of Quaternium-18 with clays. These compounds are poorly absorbed through the skin. Acute oral and percutaneous toxicity tests in animals indicate that they exhibit little or no systemic toxic effects. Subchronic oral and dermal toxicity tests on Quaternium-18 and Quaternium-18 Bentonite present no evidence of systemic toxicity. These compounds are only slightly irritating to the animal skin, and are not sensitizing agents. In ocular irritation studies all three compounds have been shown to be at most mild irritants. Quaternium-18 has been found to be practically nonirritating and nonsen-sitizing to human skin. Quaternium-18 Hectorite is classified as a nonirritating, and nonsensitizing agent. It does not present adverse phototoxic or photo-allergenic effects. Quaternium-18 Bentonite is not an irritating or sensitizing agent to the human skin and does not induce ocular irritation in humans. On the basis of the available information, it is concluded that Quaternium-18, Quaternium-18 Hectorite, and Quaternium-18 Bentonite are safe as cosmetic ingredients in the present practices of use and concentration.