Final Report on the Safety Assessment of Decyl and Isodecyl Oleates

Author:

Abstract

Decyl Oleate and Isodecyl Oleate are esters of oleic acid. Decyl Oleate is used in cosmetic products at concentrations ranging from ≤0.1 to > 50%. Isodecyl Oleate is used at concentrations of > 0.1-25%. Animal studies have shown both Decyl Oleate and Isodecyl Oleate to possess low acute oral toxicities in rats with LD50s of > 40 ml/kg. Single application dermal and eye studies with rabbits have shown these materials at 100% concentrations produce little or no irritation. Daily applications of 15% or 100% concentrations for 60 days to the skin of rabbits produced a moderate degree of irritation with both Decyl and Isodecyl Oleate. Neither of the ingredients was found to be a sensitizer when tested in guinea pigs at concentrations of 15%. Repeated insult patch tests containing 1-5% Decyl Oleate showed no signs of sensitization. Testing with formulations containing 5.5% Decyl Oleate produced a low number of reactions in 402 human subjects in the Schwartz-Peck Prophetic Patch Test and 204 subjects with undiluted Isodecyl Oleate on nine subjects showed a total irritation score of 1.0 out of a maximum of 756. It is concluded that, because of both the chemical similarity of these compounds and the similarity of the available animal and human data, Decyl and Isodecyl Oleates warrant a conclusion of safe in the concentrations of present practices and use in cosmetics.

Publisher

SAGE Publications

Subject

Toxicology

Reference21 articles.

1. Reactions of fatty materials with oxygen. XX. Recent developments in the autoxidation of methyl oleate and other monounsaturated fatty materials

2. White, A., Handler, P., and Smith, E.(1973). Principles of Biochemistry, 5th ed. New York: McGraw-Hill Book Co. p. 65.

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