Final report on the safety assessment of sodium cetearyl sulfate and related alkyl sulfates as used in cosmetics

International Journal of Toxicology

Volumn 29, Issue 3_suppl, 2010, Pages 115S-132S

  Fiume, Monice ^a   Bergfeld, Wilma F ^a   Belsito, Donald V ^a   Klaassen, Curtis D ^a   Marks, James G ^a   Shank, Ronald C ^a   Slaga, Thomas J ^a   Snyder, Paul W ^a   Andersen, F Alan ^a  

^a Cosmetic Ingredient Review ^*  (United States)

Author keywords

cosmetics; safety; sodium cetearyl sulfate

Indexed keywords

ALKYL SULFATE; BLEACHING AGENT; COSMETIC; DODECYLSULFATE AMMONIUM; DYE; FATTY ACID; FOOD ADDITIVE; HEXADECANOL; MYRISTYL ALCOHOL; OCTADECANOL; OLEYL ALCOHOL; SHAMPOO; SODIM OLEYL SULFATE; SODIUM CETEARYL SULFATE; SODIUM CETYL SULFATE; SODIUM DECYL SULFATE; SODIUM ETHYLHEXYL SULFATE; SODIUM MYRISTYL SULFATE; SODIUM SULFATE; TETRADECYL SULFATE SODIUM; UNCLASSIFIED DRUG; ALKYLSULFATES; CETYL SULFATE; FATTY ALCOHOL; STEARIC ACID DERIVATIVE; SULFATE;

ABSORPTION; ARTICLE; CARCINOGENICITY; CHEMICAL STRUCTURE; CLINICAL ASSESSMENT; CYTOTOXICITY; DEVELOPMENTAL TOXICITY; DYSPNEA; EXCRETION; EYE IRRITATION; GAS CHROMATOGRAPHY; GENOTOXICITY; HUMAN; HYDRATION; IN VITRO STUDY; IN VIVO STUDY; INFRARED SPECTROSCOPY; METABOLISM; NONHUMAN; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PERSONAL HYGIENE; PHYSICAL CHEMISTRY; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; SKIN CARE; SKIN IRRITATION; SKIN SENSITIZATION; SKIN TOXICITY; SULFATION; SUNTAN; THIN LAYER CHROMATOGRAPHY; ULTRAVIOLET SPECTROSCOPY; ANIMAL; EXPERIMENTAL ANIMAL; REVIEW; SAFETY; TOXICITY TESTING;

ANIMALS; ANIMALS, LABORATORY; CONSUMER PRODUCT SAFETY; COSMETICS; FATTY ALCOHOLS; HUMANS; RISK ASSESSMENT; STEARATES; SULFURIC ACID ESTERS; TOXICITY TESTS;

EID: 77955879969     PISSN: 10915818     EISSN: 1092874X     Source Type: Journal    
DOI: 10.1177/1091581810364665     Document Type: Article

References (56)

1. Elder RL Final report on the safety assessment of sodium cetearyl sulfate. J Am Coll Toxicol. 1992; 11 (1): 145-155.
2. Elder RL Final report on the safety assessment of sodium lauryl sulfate and ammonium lauryl sulfate. J Am Coll Toxicol. 1983; 2 (7): 127-181.
3. Andersen FA Annual review of cosmetic ingredient safety assessments-2002/2003. Int J Toxicol. 2005; 24 (S2): 89-98.
4. Elder RL Final report on the safety assessment of cetearyl alcohol, cetyl alcohol, isostearyl alcohol, myristyl alcohol, and behenyl alcohol. J Am Coll Toxicol. 1988; 7 (3): 359-413.
5. Cosmetic Ingredient Review. Final amended safety assessment on the cetearyl alcohol group; 2005.
6. Elder RL Final report on the safety assessment of stearyl alcohol, oleyl alcohol, and octyl dodecanol. J Am Coll Toxicol. 1985; 4 (5): 1-29.
7. Andersen FA Annual review of cosmetic ingredient safety assessments-2004/2005. Int J Toxicol. 2006; 25 (S2): 73-78.
8. Cosmetic Ingredient Review. Final amended safety assessment on the Cocos Nucifera (Coconut) Oil group; 2008.
9. Gottschalck TE, Bailey JE International Cosmetic Ingredient Dictionary and Handbook. 12 ed. Washington, DC: CTFA; 2008.
10. Estrin NF, Haynes CR, Whelan JW Cosmetic Ingredient Descriptions. CTFA Compedium of Cosmetic Ingredient Composition. Washington, DC: CTFA; 1982.
11. Product Safety Labs. Initial submission: modified eye irritation study in rabbits using sodium 2-ethylhexyl sulfate with cover letter; 1980.
12. National Toxicology Program. NTP Technical report on the carcinogenesis bioassay of sodium 2-ethylhexyl sulfate in F344/N rats & B6C3F1 mice (Feed Study). (Draft) NTP #82-63; 1982.
13. National Toxicology Program. Carcinogenesis studies of sodium 2-ethylhexyl sulfate (CAS No 126-92-1) in F344/N rats and B6C3F1 mice (feed study). (Draft) OTS0522508 NTP-82-63; 1982.
14. Valencia R., Mason JM, Woodruff RC, Zimmering S. Chemical mutagenesis testing in Drosophilia. III. Results of 48 coded compounds tested for the National Toxicology Program. Environ Mutagen. 1985; 7 (3): 325-348.
15. Nikko Chemicals Co, Ltd. Manufacturing process Nikkol SMS (sodium myristyl sulfate). Unpublished data submitted by the Council, 2008.
16. Nikko Chemicals Co, Ltd. Specification Nikkol SMS (sodium myristyl sulfate). Unpublished data submitted by the Council, 2008.
17. Product Safety Labs. Initial submission: modified eye irritation study in rabbits using sodium tridecyl sulfate with cover letter; 1980.
18. Gale LE, Scott PM A pharmacological study of a homolgous series of sodium alkyl sulfates. J Am Pharm Assoc Am Pharm Assoc (Baltim). 1953; 42 (5): 283-287.
19. Hunting ALL Encyclopedia of Shampoo Ingredients. Cranford, NJ: Micelle Press; 1983.
20. Zimmerman RE, Nevin RS, Allen DJ, Jones CD, Goettel ME, Burck PJ Antifertility effects of tetradecyl sodium sulphate in rabbits. J Reprod Fert. 1983; 68 (2): 257-263.
21. Food and Drug Administration. Frequency of Use of Cosmetic Ingredients. FDA Database. Washington, DC: FDA; 2008.
22. Personal Care Products Council. Data from industry survey of use concentrations. Unpublished data submitted by the Council, 2007.
23. Europa. Cosmetic use in European Union. 2008. http://ec.europa.eu/enterprise/cosmetics/cosing/
24. Food and Drug Administration. The list of ''indirect'' additives used in food contact substances; 2008. http://www.cfsan.fda.gov/∼dms/opa-indt.html. Accessed December 9, 2007.
25. National Institute for Environmental Health Sciences. Draft internal memorandum on comparative chronic toxicities and carcinogenic potentials of four 2-ethylhexyl-containing compounds in rats and mice; 1983.
26. Smyth HF Jr, Seaton J., Fischer L. Some pharmacological properties of the ''Tergitol'' penetrants. J Ind Hyg Toxicol. 1941; 23 (10): 478-483.
27. Knaak JB, Kozbelt SJ, Sullivan LJ Metabolism of 2-ethylhexyl sulfate by the rat and rabbit. Toxicol Appl Pharmacol. 1966; 8 (3): 369-379.
28. Prottey C., Ferguson T. Factors which determine the skin irritation potential of soaps and detergents. J Soc Cosmet Chem. 1975; 26: 29-46.
29. Consumer Product Testing Co, Inc. Acute oral toxicity, ocular irritation, and skin irritation studies on sodium cetearyl sulfate (full strength). Unpublished data submitted by the Cosmetic, Toiletry, and Fragrance Association (CTFA); 1976.
30. Food and Drug Research Laboratories, Inc. Acute oral toxicity, ocular irritation, and skin irritation studies on 10.0% aqueous sodium cetearyl sulfate. Unpublished data submitted by CTFA; 1976.
31. Henkel and CIE GMBH Dusseldorf. Studies on the acute toxicity of sodium cetearyl sulfate. Unpublished data submitted by CTFA; 1972.
32. Leberco Laboratories. Acute oral toxicity study on sodium cetearyl sulfate. Unpublished data submitted by CTFA; 1975.
33. Potokar MS Acute, subacute, and chronic toxicity data on anionic. Surfactant Sci Ser. 1992; 43: 81-116.
34. Smyth HF Jr, Carpenter CP, Weil CS, King JM Experimental toxicity of sodium 2-ethylhexyl sulfate. Toxicol Appl Pharmacol. 1970; 17 (1): 53-59.
35. Burck PJ, Zimmerman RE An intravaginal contraceptive device for the delivery of an acrosin and hyaluronidase inhibitor. Fertil Steril. 1984; 41 (2): 314-318.
36. Hall GC Pulmonary toxicity of wetting agents dispensed as aerosols. AMA Am J Dis Child. 1950; 80 (3): 408-412.
37. Daweke H. The irritant effect of aliphatic alcohol sulfates on the conjunctiva of the rabbit eye [in German]. Arch Klin Exp Derm. 1959; 209: 520-524.
38. Iimori M., Ogata T., Kudo K. Eye-irritation test of surface active agents by experimental animal. Yukagaku. 1972; 21 (6): 344-347.
39. Kästner W. Local tolerance (animal tests): mucous membranes and skin. Surfactant Sci Ser. 1992; 43: 127-290.
40. Leopold IH Local toxic effect of detergents on ocular structure. Arch Ophthal. 1945; 34: 99-102.
41. Muir CK, Flower C., van Abbé NJ A novel approach to the search for in vitro alternativse to in vivo eye irritancy testing. Toxicol Lett. 1983; 18 (1-2): 1-5.
42. Muir CK A simple method to assess surfactant-induced bovine corneal opacity in vitro: preliminary findings. Toxicol Lett. 1984; 22 (2): 199-203.
43. Scaife KH An in vitro cytotoxicity test to predict the ocular irritation potential of detergents and detergent products. Food Chem Toxicol. 1985; 23 (2): 253-258.
44. Stern M., Klausner M., Alvarado R., Renskers K., Dickens M. Evaluation of the EpiOcular tissue model as an alternative to the Draize eye irritation test. Toxicol In Vitro. 1998; 12: 455-461.
45. Product Safety Labs. Initial submission: DOT skin corrosion study in rabbits with sodium tridecyl sulfate with cover letter; 1980.
46. Wilhelm KP, Samblebe M., Siegers CP Quantitative in vitro assessment of N-alkyl sulphate-induced cytotoxicity in human keratinocytes (HaCaT). Comparison with in vitro human irritation tests. Br J Dermatol. 2009; 130 (1): 18-23.
47. Henkel. Experimental test on allergy inducing properties of sodium cetearyl sulfate. Unpublished data submitted by CTFA; 1978.
48. Loveday KS, Anderson BE, Resnick MA, Zeiger E. Chromosome aberration and sister chromatid exchange tests in Chinese hamster ovary cells in vitro V. Results with 46 chemicals. Environ Mol Mutagen. 1990; 16 (4): 272-303.
49. McGregor DB, Brown AG, Howgate S., McBride D. Responses of the L5178Y mouse lymphoma cell forward mutation assay. V: 27 Coded Chemicals. Environ Mol Mutagen. 1991; 17 (3): 169-219.
50. Schulz KH, Rose G. Studies on the stimulative effects of fatty acids & alkylsulfates of defined chain length on human skin. Arch Klin Exp Derm. 1957; 205 (3): 254-260.
51. Wilhelm KP Effect of surfactants on skin hydration. Curr Prob Dermatol. 1995; 22: 72-79.
52. TKL Research, Inc. Human repeat insult patch test with challenge of a face care product containing 0.4% sodium cetearyl sulfate. Unpublished data submitted by the Council, 2007.
53. Institute d'Expertise Clinique. In-use test under dermatological control of a facial product containing a 0.4% sodium cetearyl sulfate. Unpublished data submitted by the Council, 2007.
54. Emery BE, Edwards LD The pharmacology of soaps III. The irritant action of sodium alkyl sulfates on human skin. J Am Pharm Assoc Sci Edn. 1940; 29: 254-255.
55. Wilhelm KP Effect of surfactants on skin hydration. Curr Prob Dermatol. 1995; 22: 72-79.
56. Fronek H., Fronek A., Saltzberg G. Allergic reactions to sotradecol. J Dermatol Surg Oncol. 1989; 15 (6): 684.