4 Final Report on the Safety Assessment of Isopropyl Linoleate

Abstract

Isopropyl Linoleate is the ester of isopropyl alcohol and linoleic acid. In cosmetics, it is used as a skin conditioning agent and emollient at concentrations ranging from 0.1 % to 10.0%.

In an acute oral toxicity study, none of the albino rabbits that received doses of 10.0% Isopropyl Linoleate in corn oil died. Isopropyl Linoleate (undiluted and 10.0% suspension) were classified as slight ocular irritants. Undiluted Isopropyl Linoleate was classified as a slight skin irritant. The report concludes that the safety of use of Isopropyl Linoleate has not been documented and substantiated, and that it is not possible to conclude that the ingredient is safe for use in cosmetic products. The report details the type of safety test data that is needed to substantiate the safety of use of Isopropyl Linoleate in cosmetic products.

References

1. Estrin, N.F. , Haynes, C.R. , and Whelan, J.M. (1982). Cosmetic Ingredient Descriptions. CTFA Compendium of Cosmetic Ingredient Composition. Washington, DC: Cosmetic, Toiletry and Fragrance Association, Inc.

2. Estrin, N.F. , Haynes, C.R. , and Whelan, J.M. (1982). Cosmetic Ingredient Specifications. CTFA Compendium of Cosmetic Ingredient Composition. Washington, DC: The Cosmetic, Toiletry and Fragrance Association, Inc.

3. Estrin, N.F. , Crosley, P.A. , and Haynes, C.R. (1982). Cosmetic Ingredient Dictionary. Washington, DC: The Cosmetic, Toiletry, and Fragrance Association, Inc., p. 138.

4. VAN DYK CO., INC. (1990). Submission of unpublished data by CTFA. UV spectral analysis on isopropyl linoleate.1

5. Guillot, J.P. , Giauffret, J.Y. , Martini, M.C. , Gonnet, J.F. , and Soule, G. (1981). Raw materials used in cosmetology. Informations Chimie 213, 239–49.

6. Nikitakis, J.M. (Editor). (1988). CFTA Cosmetic Ingredient Handbook, First Edition. Washington, DC: The Cosmetic, Toiletry and Fragrance Association, Inc., p. 237.

7. FOOD AND DRUG ADMINISTRATION (FDA). (1988). Cosmetic product formulation data on isopropyl linoleate. FDA computer printout.

8. CODE OF FEDERAL REGULATIONS (CFR) . (Revised as of April 1, 1984). Title 21 Part 720.4. Voluntary filing of cosmetic product ingredient and cosmetic raw material composition statement. Information requested about cosmetic products. Washington, DC: Government Printing Office.

9. NIKKOL CHEMICALS CO., LTD. (1989). Cross Reference Index: An Index Cross-referencing the English Names of Cosmetic Ingredients in Japan with CTFA Adopted Names. Tokyo, Japan: Nikkol Chemicals Co., Ltd.

10.

10. Dupuis, J. (1989). The European Economic Community (EEC) Cosmetics Directive. Updated Version—incorporating all amendments up to March 15, 1989.

11.

11. BIO-TOXICOLOGY LABORATORIES, INC. (1975). Submission of unpublished data by CTFA. Eye irritation, primary irritation, and acute oral LD50 toxicity studies on isopropyl linoleate.1

12.

12. Draize, J.H. (1959). Scale for scoring ocular lesions. In: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics. Austin, TX: The Association of Food and Drug Officials of the United States, p. 51.

13.

13. Guillot, J.P., Giauffret, J.Y., Martini, M.C., Gonnet, J.F., and Soule, G. (1980). Safety evaluation of cosmetic raw materials: results obtained with 160 samples from various origin. pp. 105–108, 109, 110, and 123.