The steareth group is a series of compounds prepared by reacting stearyl alcohol with ethylene oxide to form polyoxyethylene stearyl ethers. Steareths are waxy solids used primarily as emulsifiers in cosmetics at concentrations of up to 25%.
Steareth-2 and-10 were nontoxic to rats in acute oral toxicity studies. In subchronic testing, steareth-20 was nontoxic to rabbits when administered dermally at concentrations of 4%. Steareth-2 and-10, at concentrations of up to 60% in water, were at most mildly irritating to rabbit eyes and only mild irritants when tested in cosmetic formulations at concentrations of up to 60%.
Structurally similar polyoxyethylene alkyl ethers were neither mutagenic nor tumor promoters.
Steareth-2,-10, and-20 in water were neither primary irritants nor sensitizers to human skin. Steareth-20 was not phototoxic.
On the basis of the available data it is concluded that steareths-2,-4,-6,-7,-10,-11,-13,-15, and-20 are safe as cosmetic ingredients in the present practices of use and concentration.
2. Chemline. (1985). Online database. National Library of Medicine. U.S. Dept. of Health and Human Services.
3.
3. CAS ONLINE. (1985). Online database. Chemical Abstracts Service. Columbus, OH.
4.
4. Treon, J. (1965). Physiologic properties of selected non-ionic surfactants. Soap Perfum. Cosmet.38, 47–54.
5.
5. Estrin, N.F., Haynes, C.R., and Whelan, J.M. (1982). Cosmetic Ingredient Specifications/Spectra. CTFA Compendium of Cosmetic Ingredient Composition. Steareth-2; Steareth-10; Steareth-20. Washington, D.C.: Cosmetic, Toiletry and Fragrance Assoc.
6.
6. Hawley, G.G. (1971). The Condensed Chemical Dictionary, 8th ed.New York: Van Nostrand Reinhold, p. 127.
7.
7. Windholz, M. (1983). The Merck Index, 10th ed.Rahway, NJ: Merck and Co., p. 1094.
8.
8. Kudoh, M. (1984). Separation of alcohol ethoxylates by high-performance liquid chromatography. J. Chromatogr.291, 327–30.
9.
9. Favretto, L., Stancher, B., and Tunis, F. (1981). Preconcentration and rapid spectrophotometric determination of polyoxyethylene nonionic surfactants in waters as potassium picrate-active substances. Int. J. Environ. Anal. Chem.10(1), 23–33.
10.
10. Stolzenberg, G.E. (1982). Analysis of ethoxylated nonionic surfactants. In: Touchstone, J.C. (ed.). Advances in Thin Layer Chromatography (Proc. Bienn. Symp.), 2nd Meeting Date 1980. New York: Wiley, pp. 503–16.
11.
11. Davis, H.M. (1977). In: Senzel, A.J. (ed.). Newburger's Manual of Cosmetic Analysis, 2nd ed.Washington, D.C.: Assoc. of Official Analytical Chemists, pp. 32, 49.
12.
12. Bonadeo, I., and Bottini Massa, E. (1974). Determination of the hydrophilic-lipophilic balance of polyoxyethylene ethers of fatty alcohols by gas chromatography. Riv. Ital. Essenze Profumi Piante Off. Aromi Saponi Cosmet. Aerosol56(12), 707–11.
13.
13. Horie, K., Tanaka, S., and Akabori, T. (1976). Determination of emulsion stability by spectral absorption. Part 1. Relationship between surfactant type, concentration and stability index. J. Soc. Cosmet. Chem. Japan10(1–2), 28–33.
14.
14. Horie, K., Tanaka, S., and Akabori, T. (1978). Determination of emulsion stability by spectral absorption. I. Relationship between surfactant type, concentration and stability index. Cosmet. Toiletries93(5), 53–4, 56–8, 60, 62.
15.
15. Roehl, E.L. (1980). Effect of perfumes and surface active substances on the viscosity of surfactant-containing cosmetics. Seifen Oele Fette Wachse106(2), 45–9.
16.
16. Griffin, W.C. (1974). Emulsification. In: Balsam, M.S., and Sagarin, E. (eds.). Cosmetic—Science and Technology, 2nd ed., Vol. 3. New York: John Wiley and Sons, Chap. 44, pp. 573, 581, 588, 596.
17.
17. ALLURED PUBLISHING CO. (1973). McCutcheon's Detergents and Emulsifier. North American edition. Ridgewood, N.J., p. 27.
18.
18. Sanders, P.A. (1969). Molecular interactions in aerosol emulsion systems. III. Pearlescent structures. J. Soc. Cosmet. Chem.20(9), 577–93.
19.
19. Walters, K.A., Florence, A.T., and Dugard, P.H. (1982). Nonionic surfactants and the membrane transport of barbiturates in goldfish. Int. J. Pharm.10(2), 153–63.
20.
20. Rinzler, A. (1977). Cosmetics—What the Ads Don't Tell You. New York: Thomas Y. Growell Co., p. 188.
21.
21. Saunal, H., Alvarado, D., Passet, J., and Delonca, H. (1984). Stabilization of emulsions: Effect of hydrophilic colloids. Int. J. Cosmet. Sci.6(4), 177–86.
22.
22. FOOD AND DRUG ADMINISTRATION (FDA). (1986). Cosmetic product formulation data: Ingredients used in each product category. FDA computer printout. Washington, D.C.
23.
23. CODE OF FEDERAL REGULATIONS. (1982, revised as of April 1, 1984). Title 21 Part 720.4. Information requested about cosmetic products.
24.
24. PROCTER AND GAMBLE, CO. (1977). In: Alcohol Ethoxylates. Human Safety and Environmental Aspects of Major Surfactants. A Report to the Soap and Detergent Association. Cambridge, MA: Arthur D. Little, Inc.
25.
25. Steber, J., and Wierich, P. (1983). The environmental fate of detergent range fatty alcohol ethoxylates—biodegradation studies with a carbon-14-labeled model surfactant. Tenside Deterg.20(4), 183–7.
26.
26. Steber, J., and Wierich, P. (March 1985). Metabolites and biodegradation pathways of fatty alcohol ethoxylates in microbial biocenoses of sewage treatment plants. Appl. Environ. Microbiol.49(3), 530–7.
27.
27. Bergueiro, J.R., Bao, M., Casares, J.J., and Sancho De La Jordana, P. (1979). Biological degradation of dispersants of Brij and Myrj series. Kinetic aspects. An. Quim.75(1), 74–81.
28.
28. Litchfield, J.T., Jr., and Wilcoxon, F. (June 1947). A simplified method of evaluating dose-effect experiments. J. Pharmacol. Exp. Ther.96, 99–112.
29.
29. CTFA. (Jan. 1974). Industry submission of unpublished data. Toxicity report on steareth-2. (3–13–27). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
30.
30. CTFA. (Nov. 20, 1975). Industry submission of unpublished data. Acute toxicity studies on steareth-2. (3–13–5). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
31.
31. CTFA. (Dec. 19, 1985). Industry submission of unpublished data. Toxicity studies on steareth-2 and steareth-10. Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
32.
32. CTFA. (May 1976). Industry submission of unpublished data. Toxicity studies on steareth-20. (3–13–26). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
33.
33. CTFA. (Nov. 20, 1975). Industry submission of unpublished data. Acute toxicity studies on steareth-20. (3–13–6). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
34.
34. CTFA. (Aug. 24, 1979). Industry submission of unpublished data. Toxicity studies on a body lotion. (3–13–11). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
35.
35. CTFA. (Aug. 18, 1978). Industry submission of unpublished data. Toxicity studies on a roll-on antiperspirant. (3–13–33). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
36.
36. CTFA. (March 4, 1984). Industry submission of unpublished data. Toxicity studies on a mousse (conditioner). (3–13–30). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
37.
37. CTFA. (June 28, 1984). Industry submission of unpublished data. Toxicity studies on a mousse (conditioner). (3–13–32). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
38.
38. CTFA. (May 15, 1984). Industry submission of unpublished data. Toxicity studies on a mousse conditioner. (3–13–29). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
39.
39. CTFA. (March 14, 1983). Industry submission of unpublished data. Toxicity studies on a mousse conditioner. (3–13–31). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
40.
40. CTFA. (March 31, 1980). Industry submission of unpublished data. Toxicity studies ona moisturizer. (3–13–19). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
41.
41. Draize, J.H. (1959). Dermal toxicity. In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of U.S. Baltimore, MD: The Editorial Committee Pub., pp. 48–59.
42.
42. Kay, J.H., and Calandra, J.C. (1962). Interpretation of eye irritation tests. J. Soc. Cosmet. Chem.13, 281–9.
43.
43. CTFA. (July 5, 1982). Industry submission of unpublished data. Comparative rabbit eye irritation study. (3–13–13). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
44.
44. CTFA. (Sept. 5, 1979). Industry submission of unpublished data. Acute dermal and ocular irritation study. (3–13–21). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
45.
45. CTFA. (March 3, 1980). Industry submission of unpublished data. Dermal irritation study of a solid antiperspirant. (3–3–79). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
46.
46. CTFA. (March 3, 1980). Industry submission of unpublished data. Dermal irritation study of a solid antiperspirant. (3–3–80). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
47.
47. CTFA. (June 1981). Industry submission of unpublished data. Subchronic (three month) dermal toxicity study in rabbits. (3–13–22). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
48.
48. CTFA. (Oct. 1983). Industry submission of unpublished data. Three month subchronic toxicity study of a formulation administered dermally to New Zealand white rabbits. (3–13–14). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
49.
49. Yamamoto, H. (1977). Carcinogenic and cocarcinogenic test of detergents (alkyl-sulfonic-natrium, polyoxy-ethylene-alkyl ether and potassium soap) on the skin of mouse (abstract). J. Nara. Med. Assoc.28, 307–27.
50.
50. CTFA. (Sept. 9, 1984). Industry submission of unpublished data. Soap chamber test. (3–13–28). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
51.
51. CTFA. (Sept. 1979). Industry submission of unpublished data. Repeat insult patch test. (3–13–23). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
52.
52. CTFA. (April 1983). Industry submission of unpublished data. Repeat insult patch test. (3–13–16). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
53.
53. CTFA. (Feb. 1983). Industry submission of unpublished data. Repeat insult patch test. (3–13–20). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
54.
54. CTFA. (June 15, 1982). Industry submission of unpublished data. Human skin cumulative irritation test. (2–13–15). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
55.
55. CTFA. (June 20, 1983). Industry submission of unpublished data. Photoallergy and repeat insult patch test. (3–13–17). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
56.
56. CTFA. (Nov. 28, 1977). Industry submission of unpublished data. Phototoxicity test. (3–13–12). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
57.
57. CTFA. (June 30, 1983). Industry submission of unpublished data. Phototoxicity test. (3–13–18). Available for review: Director, Cosmetic Ingredient Review, 1110 Vermont Ave., N.W., Suite 810, Washington, D.C. 20005.
58.
58. Kligman, A.M. and Frosch, P.J. (1979). The soap chamber test. A new method for assessing the irritancy of soaps. J. Am. Acad. Dermatol.1, 35–41.
