Sodium Cocoyl Isethionate is used as a surfactant-cleansing agent in cosmetic formulations. Sodium Cocoyl Isethionate is slightly to practically nontoxic, with an oral LD50 of ≥ 4.33 g/kg for rats. Dermal application of 1.0–36.0% w/w aqueous Sodium Cocoyl Isethionate to rats for 28 days did not produce any significant toxic effects.
The ocular irritation produced by Sodium Cocoyl Isethionate was concentration dependent, ranging from a mild reaction at a test concentration of 2.5% to a primary ocular irritant at test concentrations of 49%. Sodium Cocoyl Isethionate is neither a sensitizer nor phototoxic compound.
Sodium Cocoyl Isethionate was nonmutagenic in an in vitro chromosomal aberration assay and did not produce a positive response in an S. typhimurium reverse mutation assay.
Based on the concentration of test cited in this report, it is concluded that Sodium Cocoyl Isethionate is safe for use in cosmetic formulations at 50% in rinse-off products and at 17% in leave-on products.
References
1.
Ames, BN., Mc Cann, J., and Yamasaki, E. (1975). Methods for detecting carcinogens and mutagens with the Salmonella/mammalian microsome mutagenicity test. Mutat. Res.31:347–64.
2.
BIO/Dynamics, INC. (1985a). Submission of unpublished data by CTFA. Acute oral toxicity study in rats of a gel cleanser containing 15% Sodium Cocoyl Isethionate. (9 pp.)*
3.
BIO/Dynamics, INC. (1985b). Submission of unpublished data by CTFA. Eye irritation study in rabbits (FHSA) of a gel cleanser containing 15% Sodium Cocoyl Isethionate. (10 pp.)*
4.
BIO/Dynamics, INC. (1985c). Submission of unpublished data by CTFA. Eye irritation study in rabbits (low volume procedure) of a gel cleanser containing 15% Sodium Cocoyl Isethionate. (15 pp.)*
5.
BIO/Dynamics, INC. (1987). Submission of unpublished data by CTFA. Phototoxicity and primary skin irritation study in rabbits of a syndet bar containing 47.5% Sodium Cocoyl Isethionate. (21 pp.)*
6.
Buehler, EV. (1965). Delayed contact hypersensitivity in the guinea pig. Arch. Dermatol.91:171–5.
7.
CODE OF FEDERAL REGULATIONS (CFR). (January 1, 1985). Title 16, part 1500.3(c). Consumer Product Safety Commission, Federal Hazardous Substances Act Regulations, Definitions, pp. 325–42.
8.
CONCORDIA RESEARCH Laboratories, INC. (1987). Submission of unpublished data by CTFA. Human repeat insult patch test ofa syndet soap containing 47.5% Sodium Cocoyl Isethionate. (16 pp.)*
9.
CONSUMER PRODUCT TESTING Company, INC. (1982). Submission of unpublished data by CTFA. Primary ocular irritation in rabbits of a 2.5% aqueous solution of Sodium Cocoyl Isethionate. (11 pp.)*
10.
CONSUMER PRODUCT TESTING Company, INC. (1984). Submission of unpublished data by CTFA. Primary dermal irritation in rabbits of a 5% solution of Sodium Cocoyl Isethionate. (11 pp.)*
11.
Cosmetic, Toiletry, AND FRAGRANCE ASSOCIATION (CTFA). (1983). Submission of unpublished data from CTFA. Rabbit eye irritation test. (1 p.)*
12.
CTFA. (1984a). Submission of unpublished data from CTFA. Repeat application patch test. (23 pp.)*
13.
CTFA. (1984b). Submission of unpublished data from CTFA. Fourteen-day irritation study of a gel cleanser containing 15% Sodium Cocoyl Isethionate. (2 pp.)*
14.
CTFA. (1985a). Submission of unpublished data by CTFA. (Received 4/15/92). Modified soap chamber test using an 8% aqueous solution of Sodium Cocoyl Isethionate. (23 pp.)*
15.
CTFA. (1985b). Submission of unpublished data from CTFA. Irritation/sensitization potential of a gel cleanser containing 15% Sodium Cocoyl Isethionate using the Jordan-King modification of the Draize-Shelanski procedure. (8 pp.)*
16.
CTFA. (1986a). Submission of unpublished data by CTFA. (Received 4/15/92). Modified soap chamber test using an 8% aqueous solution of Sodium Cocoyl Isethionate. (24 pp.)*
17.
CTFA. (1986b). Submission of unpublished data by CTFA. (Received 4/15/92). Modified soap chamber test using an 8% aqueous solution of Sodium Cocoyl Isethionate. (13 pp.)*
18.
CTFA. (1988a). Submission of unpublished data by CTFA. (Received 4/15/92). Modified soap chamber test using an 8% aqueous solution of Sodium Cocoyl Isethionate. (17 pp.)*
19.
CTFA. (1988b). Submission of unpublished data by CTFA. (Received 4/15/92). Modified soap chamber test using an 8% aqueous solution of Sodium Cocoyl Isethionate. (27 pp.)*
20.
CTFA. (1989). Submission of unpublished data from CTFA. Three-day irritation study of a gel cleanser containing 15% Sodium Cocoyl Isethionate. (16 pp.)*
21.
CTFA. (1990a). Submission of unpublished data from CTFA. Physical properties of and general data concerning Sodium Cocoyl Isethionate. (8 pp.)*
22.
CTFA. (1990b). Submission of unpublished data by CTFA. (Received 4/15/92). Modified soap chamber test using an 8% aqueous solution of Sodium Cocoyl Isethionate. (26 pp.)*
23.
CTFA. (1990c). Submission of unpublished data from CTFA. Summary of human studies on Sodium Cocoyl Isethionate. (2 pp.)*
24.
CTFA. (1991). Submission of unpublished data by CTFA. UV absorption data on Sodium Cocoyl Isethionate and executive summaries of two mutagenicity studies. (6 pp.)*
25.
Draize, J.H. (1959). The Appraisal of Chemicals in Foods, Drugs, and Cosmetics. Austin, TX: Association of Food and Drug Officials of the United States, p. 51.
26.
Draize, JH. (1975). Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics–Dermal Toxicity.Association of Food and Drug Officials of the U.S. pp. 46–59.
27.
Draize, JH., Woodard, G., and Calvery, HO. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther.82: 377–90.
28.
ESSEX TESTING Clinic, INC. (1989). Submission of unpublished data by CTFA. Clinical safety evaluation using a repeated insult patch test of a skin cleanser containing 17% Sodium Cocoyl Isethionate. (15 pp.)*
29.
Estrin, N.F., Crosley, PA., and Haynes, C.R. (eds.). (1982a). CTFA Cosmetic Ingredient Dictionary.Washington, D.C.: Ctfa, p. 281.
30.
Estrin, N.F., Haynes, CR., and Whelan, J.M. (eds.). (1982b). CTFA Compendium of Cosmetic Ingredient Composition–Specifications/Spectra.Washington, D.C.: CTFA.
31.
FEDERAL REGISTER. (January 28, 1992). Modification in Voluntary Filing of Cosmetic Product Ingredient and Cosmetic Raw Composition Statements. Final rule.57(18):3128–30.
32.
FOOD AND DRUG ADMINISTRATION (FDA). (1984). Cosmetic product formulation data. FDA computer printout.
33.
FDA. (1992). Cosmetic product formulation data. FDA computer printout.
34.
Frosch, PJ. and Kligman, AM. (1979). The soap chamber test. A new method for assessing the irritancy of soaps. J. Am. Acad. Dermatol.1:35–41.
35.
HAZLETON LABORATORIES America, INC. (1986a). Submission of unpublished data by CTFA. Acute oral toxicity in rats of a syndet bar containing 47.5% Sodium Cocoyl Isethionate. (14 pp.)*
36.
HAZLETON LABORATORIES America, INC. (1986b). Submission of unpublished data by CTFA. FHSA–Eye irritation in rabbits of a syndet bar containing 47.5% Sodium Cocoyl Isethionate. (21 pp.)*
37.
HILL TOP Research, INC. (1985). Submission of unpublished data by CTFA. Report of a human skin test of cumulative irritation for Sodium Cocoyl Isethionate. (17 pp.)*
38.
HILL TOP Research, INC. (1986). Submission of unpublished data by CTFA. Delayed contact hypersensitivity study in guinea pigs of a syndet bar containing 47.5% Sodium Cocoyl Isethionate. (19 pp.)*
39.
Hodge, H.C. and Sterner, J.H. (1949). Tabulation of toxicity classes. Am. Ind. Hyg. A. Q.10:93–6.
40.
Hoffmann, DK. (1990). Personal communication. (1 p.)*
41.
Hunting, AL.L. (1983). Encyclopedia of Shampoo Ingredients.Cranford, NJ: Micelle Press, Inc. p. 357.
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 Derm.3:19–23.
44.
Kay, JH., and Calandra, JC. (1962). Interpretation of eye irritation tests. J. Soc. Cosmet. Chem.13:281–9.
45.
Lanman, BM. (1968). Human skin test of cumulative irritation procedure described by Dr. Lanman at the Joint Conference on Cosmetic Sciences, April 21-23, 1968, Washington, D.C.
46.
LEVER RESEARCH. (1988). Submission of unpublished data by CTFA. Rabbit eye irritation test (RET). (2 pp.)*
47.
Maron, DM. and Ames, BN. (1983). Revised methods for the Salmonella mutagenicity test. Mutat. Res.113, 173–215.
48.
Marzulli, FN. and Maibach, HI. (1974). Experimental contact sensitization in man. Food and Cosmet. Toxicol.12, 219–227.
49.
MICROBIOLOGICAL Associates, INC. (1991a). Submission of unpublished data by CTFA. In vitro chromosomal aberration assay on LB-7818-1 (Sodium Cocoyl Isethionate) in Chinese hamster ovary (CHO) cells. Study No. LB-7818. (65 pp.)*
50.
MICROBIOLOGICAL Associates, INC. (1991b). Submission of unpublished data by CTFA. Salmonella typhimurium preincubation reverse mutation assay with confirmation on LB-7819-1 (Sodium Cocoyl Isethionate). Study No. LB-7819. (88 pp.)*
Phillips, L., Steinberg, M., Maibach, H., and Akers, W. (1972). A modification of the human skin test of cumulative irritation procedure described by Lanman 0968). Toxicol. Appl. Pharmacol.21:369–82.
53.
PRODUCT SAFETY LABS. (1984a). Submission of unpublished data by CTFA. Draize primary eye irritation in rabbits of a 5% solution of Sodium Cocoyl Isethionate. (5 pp.)*
54.
PRODUCT SAFETY LABS. (1984b). Submission of unpublished data by CTFA. Primary skin irritation in rabbits of a 5% solution of Sodium Cocoyl Isethionate. (3 pp.)*
55.
Ritz, HL. and Buehler, EV. (1980). In: Current Concepts in Cutaneous Toxicity, V.A. Drill and T. Lazar (eds.). Academic Press: New York, pp. 25–40.
56.
Schoenberg, T. (1985). Formulating mild foaming bath products. Cosmet. Toiletries100:53–8. (Secondary reference in Hill Top Research, Inc., 1986.)
57.
SPRINGBORN INSTITUTE FOR Bioresearch, INC. (1985). Submission of unpublished data by CTFA. Delayed contact hypersensitivity (Buehler method–modified) of a gel cleanser containing 15% Sodium Cocoyl Isethionate. (13 pp.)*
58.
UNILEVER RESEARCH U.S., INC. (1991). Submission of unpublished data by CTFA. Twenty-eight day dermal application study on Sodium Cocoyl Isethionate. (37 pp.)*
