Final Report on the Safety Assessment of Cetearyl Octanoate

Abstract

Cetearyl Octanoate is the esterification product of 2-ethylhexanoic acid and cetearyl alcohol. The acute oral LD50 for Cetearyl Octanoate is estimated from studies with rats to be greater than 8.0 ml/kg. The ingredient produced no significant acute, subchronic or dermal skin or eye irritation when tested in rabbits. The ingredient produced no evidence of skin sensitization in the guinea pig. Similar studies with product formulations containing Cetearyl Octanoate confirmed these results, as well as indicated the ingredient was not phototoxic. In clinical studies, four of 100 subjects showed slight to moderate irritation with undiluted Cetearyl Octanoate. Product formulations containing between 0.2% and 30% Cetearyl Octanoate were tested on a total of 644 subjects with no signs of skin sensitization, photocontact allergenicity, or phototoxicity. From the available information, it is concluded that Cetearyl Octanoate is safe as a cosmetic ingredient in the present practices of use.