1: Final Report on the Safety Assessment of Sodium Lauryl Sulfoacetate

Abstract

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

References

Hawley, G.G. (ed.). (1971). The Condensed Chemical Dictionary, 8th ed. New York: Van Nostrand Reinhold, Co.

Estrin, N.F. , Haynes, C.R. , and Whelan, J.M. (eds.). (1982). CTFA Compendium of Cosmetic Ingredient Composition; Cosmetic Ingredient Descriptions. Washington, DC: CTFA.

Balsam, M.S. and Sagarin, E. (eds). (1972). Cosmetics and Technology. New York: Wiley Interscience.

FOOD AND DRUG ADMINISTRATION (FDA). (December 22, 1981). Computer printout of voluntary submission of cosmetic ingredient data.

CODE OF FEDERAL REGULATIONS (CFR). (1979). Title 21, Part 720.4, Washington, DC.

ROSSOFF. I.S . (1974). Handbook of Veterinary Drugs. New York: Springer Publishing Company.

Elder, R.L. (ed.). (1983). Final report on the safety assessment of sodium lauryl sulfate and ammonium lauryl sulfate. J. Am. Coll. Toxicol. 2 (7), 127-81.

Blakemore, W.M. , Rule, J.E. , and Bowman, M.C . (1979). Trace analysis of two detergents in blood from guinea pigs after immersion in aqueous baths. Toxicol. Lett. (AMST) 3(3), 127–36.

Cosmetic, Toiletry, and FRAGRANCE ASSOCIATION (CTFA). (September 5, 1978). Submission of data by CTFA. Unpublished acute oral, dermal, ocular, and mucous membrane testing of a bath product containing 50 percent Sodium Lauryl Sulfoacetate (2-18-1).*

10.

Epstein, S. , Throndson, A.H. , Dock, W. and Tainter, M.L . (1939). Possible deleterious effects of using soap substitutes in dentifrices. J. Am. Dent. Assoc. 26, 1461.

11.

CTFA. (1983). Submission of data by CTFA. Unpublished rabbit eye irritation study for a milk bath containing 45 percent Sodium Lauryl Sulfoacetate.*

12.

HAZELTON RALTECH. (1983). Submission of data by CTFA. Unpublished rabbit primary dermal irritation study on undiluted Sodium Lauryl Sulfoacetate.*

13.

CTFA (March 23-May 1, 1979). Submission of data by CTFA. Unpublished guinea pig sensitization study on a 10 percent aqueous dilution of a cream shampoo containing 3 percent Sodium Lauryl Sulfoacetate (2-18-7).*

14.

CTFA. (April 4-5. 1978). Submission of data by CTFA. Unpublished guinea pig phototoxicity study on acne wash containing 1 percent Sodium Lauryl Sulfoacetate (2-18-8).*

15.

CTFA. (March 23-24, 1979). Submission of data by CTFA. Unpublished guinea pig phototoxicity study on a cream shampoo containing 3 percent Sodium Lauryl Sulfoacetate (2-18-6).*

16.

CTFA. (October 2-3, 1980). Submission of data by CTFA. Guinea pig phototoxicity test (2-18-10).*

17.

T.P.S. INC. (October 20, 1978). Submission of data by CTFA. Unpublished subacute dermal toxicity studies in swine on an acne wash containing 1 percent Sodium Lauryl Sulfoacetate (2-18-9).*

18.

TOXICOL LABORATORIES LIMITED. (August 1985). Submission of unpublished data by CTFA. Twenty-eight day oral range finding study in the rat. Report Reference No. SUS/1/C. Test Material: 910-74. Test Sponsor: Stepan Company.*

19.

TOXICOL LABORATORIES LIMITED. (March 1986). Submission of unpublished data by CTFA. Ninety-day oral toxicity study in the rat. Report Reference No SUS/2/C. Test Material: 910-74 Test Sponsor: Stepan Company.*

20.

LITTON Bionetics, INC. (September 1978). Submission of data by CTFA. Unpublished mutagenicity evaluation of a cleansing bar containing 23 percent Sodium Lauryl Sulfoacetate (2-18-3).*

21.

LITTON Bionetics, INC. (August 15, 1978). Submission of data by CTFA. Unpublished mutagenicity evaluation of a shampoo containing 3 percent Sodium Lauryl Sulfoacetate (2-18-5).*

22.

LITTON Bionetics, INC. (September 1978). Submission of data by CTFA. Unpublished mutagenicity evaluation of a cleansing bar containing 19 percent Sodium Lauryl Sulfoacetate (2-18-4).*

23.

CTFA. (1983). Submission of data by CTFA. Unpublished human patch-single insult test on a milk bath containing 15 percent Sodium Lauryl Sulfoacetate.*

24.

HILL TOP RESEARCH INC. (October 19, 1983). Submission of unpublished data by CTFA. Primary Irritation Study No. 441. Test Sample 441.01.*

25.

Jordan, W.P . (1980). 24-, 48-, and 48/48 hour patch tests. Contact Dermatitis 6, 151–2.

26.

Jordan, W.P. and King, S.E . (1977). Delayed hypersensitivity in females The development of allergic contact dermatitis in females during the comparison of two predictive patch tests. Contact Dermatitis 3, 19–23.

27.

HILL TOP RESEARCH INC. (December 2, 1983). Submission of unpublished data by CTFA. Repeated insult patch test. Project No. 75. Test Sample 431.01.*

28.

CTFA. (January 21, 1982). Submission of data by CTFA. Unpublished prophetic patch and in-use testing of a bath product containing 50 percent Sodium Lauryl Sulfoacetate (2-18-2).*