Amended final report of the safety assessment of t-Butyl alcohol as used in cosmetics

International Journal of Toxicology

Volumn 24, Issue SUPPL. 2, 2005, Pages 1-20

  Andersen, F Alan ^a  

^a Cosmetic Ingredient Review ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC; DEODORANT AGENT; DISINFECTANT AGENT; FRAGRANCE; FUNGICIDE; INSECTICIDE; SHAMPOO; SOAP; TERT BUTYL ALCOHOL;

ACUTE TOXICITY; ANIMAL EXPERIMENT; ANIMAL MODEL; CHEMICAL CARCINOGENESIS; CHEMICAL INDUSTRY; CHEMICAL STRUCTURE; CHRONIC TOXICITY; CONTROLLED STUDY; COSMETIC INDUSTRY; CYTOTOXICITY; EYE IRRITATION; FEMALE; GENOTOXICITY; HUMAN; LD 50; MALE; MOUSE; NEPHROTOXICITY; NONHUMAN; OCCUPATIONAL HEALTH; OCCUPATIONAL SAFETY; RAT; REPRODUCTIVE TOXICITY; REVIEW; SAFETY; SENSITIZATION; SKIN IRRITATION; THYROID DISEASE; THYROID FOLLICULAR CARCINOMA; THYROID HYPERPLASIA; TISSUE DISTRIBUTION; TOXICITY TESTING;

ADMINISTRATION, INHALATION; ADMINISTRATION, ORAL; ANIMALS; CARCINOGENICITY TESTS; CHEMISTRY, PHYSICAL; COSMETICS; DRUG CONTAMINATION; FEMALE; GROWTH; HUMANS; IRRITANTS; MUTAGENICITY TESTS; OCCUPATIONAL EXPOSURE; PREGNANCY; RATS; SKIN TESTS; TERATOGENS; TERT-BUTYL ALCOHOL;

ANIMALIA; MAMMALIA; ORYCTOLAGUS CUNICULUS;

EID: 22344452645     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/10915810590953833     Document Type: Review

References (111)

1. Abbondandolo, A., S. Bonatti, C. Corsi, G. Corti, R. Fiorio, C. Leporini, A. Mazzaccaro, and R. Nieri. 1980. The use of organic solvents in mutagenicity testing. Mutat. Res. 79:141-150.
2. Abel, E. L., and P. J. Bilitzke. 1992. Effects of prenatal exposure to methanol and t-butanol in Long Evans rats. Am. J. Obstet. Gynecol. 166:433.
3. Achyara, S., K. Mehta, S. Rodriguez, S. Pereira, S. Krishnan, and C. V. Rao. 1995. Administration of subtoxic doses of t-butyl alcohol and trichloroacetic acid to male Wistar rats to study the interactive toxicity. Toxicol. Lett. (Shannon) 80:97-104.
4. Achyara, S., K. Mehta, S. Rodriguez, S. Pereira, S. Krishnan, and C. V. Rao. 1997. A histopathological study of liver and kidney in male Wistar rats treated with subtoxic doses of t-butyl alcohol and trichloroacetic acid. Exp. Toxic. Patholol. 49:369-373.
5. American Conference of Governmental Industrial Hygienists (ACGIH). 2000. 2000 TLVs and BEIs. Cincinnati, OH:ACGIH.
6. Ames, B. N., J. McCann, and M. Yamasaki. 1975. Methods for detecting carcinogens with the Salmonella/mammalian-microsome mutagenicity test. Mutat. Res. 31:347-364.
7. Amoco Corporation. 1994. Subchronic test of t-butanol in B6C3F1 mice and Fischer 344 rats in drinking water with cover letter dated 032394. NTIS Report No. OTS0556795. Springfield, VA: NTIS.
8. Anderson, R. A., Jr, J. M. Reddy, C. Joyce, B. R. Willis, H. Van der Ven, and L. J. D. Zaneveld. 1982. Inhibition of mouse sperm capacitation by ethanol. Biol. Reprod. 27:833-840.
9. Arco Chemical Company. 1992. Initial submission: Letter submitting preliminary results from subchronic toxicity studies of tertiary butyl alcohol in rats and mice dated 101492 and attachments. NTIS Report No. OTS0538283. Springfield, VA: NTIS.
10. Arco Chemical Company. 1994a. Toxicologist's report on metabolism and pharmacokinetics studies of radiolabeled TBA 534 tertiary butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572366. Springfield, VA: NTIS.
11. Arco Chemical Company. 1994b. Acute oral toxicity (LD50) study in rats with t-butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572351. Springfield, VA: NTIS.
12. Arco Chemical Company. 1994c. Acute oral toxicity (LD50) study in rats with arconol with cover letter dated 03/24/94. NTIS Report No. OTS0572358. Springfield, VA: NTIS.
13. Arco Chemical Company. 1994d. Primary dermal irritation test in rabbits with t-butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572354. Springfield, VA: NTIS.
14. Arco Chemical Company. 1994e. Primary dermal irritation test in rabbits using arconol with cover letter dated 03/24/94. NTIS Report No. OTS0572361. Springfield, VA: NTIS.
15. Arco Chemical Company. 1994f. Acute dermal toxicity (LD50) study in rabbits with t-butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572352. Springfield, VA: NTIS.
16. Arco Chemical Company. 1994g. Acute dermal toxicity (LD50) study in rabbits with arconol with cover letter dated 03/24/94. NTIS Report No. OTS0572359. Springfield, VA: NTIS.
17. 50 acute inhalation toxicity evaluation in rats using t-butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572353. Springfield, VA: NTIS.
18. Arco Chemical Company. 1994i. LC50 acute inhalation toxicity evaluation in rats with arconol with cover letter dated 03/24/94. NTIS Report No. OTS0572360. Springfield, VA: NTIS.
19. Arco Chemical Company. 1994j. Eye irritation study in rabbits using t-butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572355. Springfield, VA: NTIS.
20. Arco Chemical Company. 1994k. Eye irritation study in rabbits using arconol with cover letter dated 03/24/94. NTIS Report No. OTS0572362. Springfield, VA: NTIS.
21. Arco Chemical Company. 19941. An in vitro evaluation of t-butyl alcohol-Arconol batch # A209411 to produce sister chromatid exchanges in Chinese hamster ovary cells with cover letter dated 03/24/94. NTIS Report No. OTS0572364. Springfield, VA: NTIS.
22. Arco Chemical Company. 1994m. An in vitro evaluation of t-butyl alcohol 99.9% to produce sister chromatid exchanges in Chinese hamster ovary cells with cover letter dated 03/24/94. NTIS Report No. OTS0572357. Springfield, VA: NTIS.
23. Arco Chemical Company. 1994n. Evaluation of test article t-butyl alcohol 99.9% (MRI #635) & arconol (MRI#636) for mutagenic potential employing the L5178Y tk +/- mutagenesis assay with cover letter dated 03/24/94. NTIS Report No. OTS0572365. Springfield, VA: NTIS.
24. Arco Chemical Company. 1994o. Salmonella/mammalian-microsome preincubation mutagenicity assay with t-butyl alcohol with cover letter dated 03/24/94. NTIS Report No. OTS0572356. Springfield, VA: NTIS.
25. Arco Chemical Company, 1994p. Salmonella/mammalian-microsome preincubation mutagenicity assay using arconol with cover letter dated 03/24/94. NTIS Report No. OTS0572363. Springfield, VA: NTIS.
26. Baker, R. C., and R. E. Kramer. 1999. Cytotoxicity of short-chain alcohols. Annu. Rev. Pharmacol. Toxicol. 39:127-150.
27. Baker, R. C., S. M. Sorensen, and R. A. Deitrich, 1982. The in vivo metabolism of tertiary butanol by adult rats. Alcohol. Clin. Exp. Res. 6:247-251.
28. BASF Corporation. 1994. Letter from BASF Corp. to USEPA regarding submission of health and safety data subject to 8D reporting with attachments, dated 05/05/94 (Sanitized). NTIS Report No. OTS0572606. Springfield, VA: NTIS.
29. Beauge, F., M. Clement, J. Nordmann, and R. Nordmann. 1981. Liver lipid disposal following t-butanol administration to rats. Chem. Biol. Interact. 38:45-51.
30. Bleyman, M. A., and R. G. Thurman. 1980. The swift increase in alcohol metabolism: Comparative studies with other alcohols. Curr. Alcohol. 7:115-121.
31. Borghoff, S. J., J. S. Prescott, D. B. Janszen, B. A. Wong, and J. I. Everitt. 2001. α2μ-globulin nephropathy, renal cell proliferation, and dosimetry of inhaled tert-butyl alcohol in male and female F-344 rats. Toxicol. Sci. 61:176-186.
32. Candura, S. M., W. Balduini, and L. G. Costa. 1991. Interaction of short chain aliphatic alcohols with muscarinic receptor-stimulated phosphoinoisitide metabolism in cerebral cortex from neonatal and adult rats. Neurotoxicology 12:23-32.
33. Cederbaum, A. I., and G. Cohen. 1980. Oxidative demethylation of t-Butyl alcohol by rat liver microsomes. Biochem. Biophys. Res. Commun. 97:730-736.
34. Cederbaum, A. I., A. Qureshi, and G. Cohen. 1983. Production of formaldehyde and acetone by hydroxyl radical generating systems during the metabolism of tertiary butyl alcohol. Biochem. Pharmacol. 32:3517-3524.
35. Cirvello, J. D., A. Radovsky, J. E. Heath, D. R. Farnell, and C. Lindamood III. 1995. Toxicity and carcinogenicity of t-butyl alcohol in rats and mice following chronic exposure in drinking water. Toxicol. Ind. Health 11:151-164.
36. Clark, J. 1953. The mutagenic action of various chemicals on Micrococcus aureus. Proc. Okla. Acad. Sci. 34:114-118.
37. 2
38. Cosmetic Ingredient Review (CIR). 1989. Final report on the safety assessment of t-butyl alcohol. Journal of the American College of Toxicology 8:627-641.
39. 2
40. 2
41. Damrau, F., and A. H. Goldberg. 1971. Adsorption of whiskey congeners by activated charcoal: Chemical and clinical studies related to hangover. Southwest Med. 5:179-182.
42. Daniel, M. A., and M. A. Evans. 1982. Quantitative comparison of maternal ethanol and maternal tertiary butanol diet on postnatal development. J. Pharmacol. Exp. Ther. 222:294-300.
43. Derache, R. 1970. Toxicology, pharmacology and metabolism of higher alcohols. In Alcohols and derivatives. Vol. II, International encyclopedia of pharmacology and therapeutics, Sec. 20, edi J. Tremolieres, 507-522. London: Pergamon Press.
44. Dickey, F. H., G. H. Cleland, and C. Lotz. 1949. Role of organic peroxides in the induction of mutations. Proc. Natl. Acad. Sci. U. S. A. 35:581-586.
45. Dow Chemical Company. 1994. Report on animal toxicity experiments with ethyl alcohol, tertiary butyl alcohol, and Stoddard's solvent with cover letter dated 03/28/94 (sanitized). NTIS Report No. OTS0572373.
46. Edwards, E. K., Jr., and E. K. Edwards. 1982. Allergic reaction to tertiary butyl alcohol in a sunscreen. Cutis 29:476-478.
47. Eiceman, G. A., and F. W. Karasek. 1981. Identification of residual organic compounds in food packages. J. Chromatogr. 210:93-104.
48. Elf Atochem North American Incorporated. 1994a. Repeated dose test of t-butanol (C55367) in B6C3F1 mice and Fischer 344 rats with cover letter dated 031594. NTIS Report No. OTS0556768.
49. Elf Atochem North American Incorporated. 1994b. Subchronic test of t-butanol (C55367) in B6C3F1 mice and Fischer 344 rats in drinking water with cover letter dated 031594. NTIS Report No. OTS0556767.
50. Faulkner, T. P., J. D. Wiechart, D. M. Harman, and A. S. Hussain. 1989. The effects of prenatal tertiary butanol administration in CBA/J and C57BL/6J mice. Life Sci. 45:1989-1995.
51. Food and Drug Administration (FDA). 1986. Cosmetic product formulation and frequency of use data. FDA database. Washington, DC: FDA.
52. FDA. 1998. Frequency of use of cosmetic ingredients. FDA database. Washington, DC: FDA.
53. Fregert, S., O. Groth, N. Hjorth, G. Magnusson, H. Rorsman, and P. Ovrum. 1969. Alcohol dermatitis. Acta. Derm. Venereol. 49:493-497.
54. Fregert, S., R. Hokanson, H. Rorsman, N. Tryding, and P. Ovrum. 1963. Dermatitis from alcohols. J. Allergy 34:404-408.
55. Gaillard, D., and R. Derache. 1965. Effect of acute intoxication, by various alcohols, on hepatic lipid fractions in female rats. C. R. Hebd. Seances Acad. Sci. 261:3880-3883.
56. Gaillard, D., and R. Derache. 1966. Effect of some aliphatic alcohols on the mobilization of various lipid fractions in the rat. Food Cosmet. Toxicol. 4:515-520.
57. Gordon, D. S., and E. J. Calabrese. 1992. The in vitro effect of acetaldehyde and tert-butanol on 1-napthol-induced oxidant stress in human and sheep erythrocytes. J. Environ. Sci. Health A 27:301-316.
58. Grant, K. A., and H. H. Samson. 1982. Ethanol and tertiary butanol induced microcephaly in the neonatal rat: comparison of brain growth parameters. Neurobehav. Toxicol. Teratol. 4:315-321.
59. Green, B. D., and J. I. Steinfeld. 1977. Monitoring complex trace-gas mixtures by long-path laser adsorption spectrometry. Proc. Soc. Photo-Opt. Instrum. Eng. 99:32-38.
60. Greenberg, L. A., and D. Lester. 1954. Handbook of Cosmetic Materials. New York: Interscience Publishers.
61. Groth, G., and K. J. Freundt. 1994. Inhaled tert-butyl acetate and its metabolite tert-butyl alcohol accumulate in the blood during exposure. Hum. Exp. Toxicol. 13:478-480.
62. Harris, R. A., and F. Schroeder. 1981. Effects of ethanol and related drugs on the physical and functional properties of brain membranes. Curr. Alcohol. 8:461-68.
63. Hawley, G. G., ed. 1971. The condensed chemical dictionary, 8th ed. New York: Van Nostrand Reinhold.
64. Hiller, J. M., L. M. Angel, and E. J. Simon. 1984. Characterization of the selective inhibition of the delta subclass of opioid binding sites by alcohols. Mol. Pharmacol. 25:249-55.
65. Hoshino, H., G. Chihara, and F. Fukuoka. 1970. Detection of potential weak carcinogens and procarcinogens. II. Carcinogenicity of tertiary butyl hydroperoxide. Gann 61:121-124.
66. Hunt, W. A., E. Majchrowicz, and T. K. Dalton. 1979. Alterations in high-affinity choline uptake in brain after acute and chronic ethanol treatment. J. Pharmacol. Exp. Ther. 210:259-263.
67. Jacobs, G., M. Martens, and G. Mosselmans. 1987. Proposal of limit concentrations for skin irritation with the context of new EEC directive on the classification and labeling of preparations. Regul. Toxicol. Pharmacol. 7:370-378.
68. Kamil, I. A., J. N. Smith, and R. T. Williams. 1953. Studies in detoxification. 46. The metabolism of aliphatic alcohols. The glucuronic conjugation of acyclic aliphatic alcohols. Biochem. J. 53:129-136.
69. Kirk-Othmer 1992a. Encyclopedia of chemical technology, 4th ed., Butyl Alcohols entry. Volume 4. New York: John Wiley and Sons.
70. Kirk-Othmer 1992b. Encyclopedia of chemical technology, 4th ed., Butylenes entry, Volume 4. New York: John Wiley and Sons.
71. Kool, H. J., C. F. Van Kreijl, and B. C. J. Zoeteman. 1982. Toxicology assessment of organic compounds in drinking water. Crit. Rev. Environ. Control. 12:307-57.
72. Kulyk, W. M., and L. M. Hoffman. 1996. Ethanol exposure stimulates cartilage differentiation by embryonic limb mesenchyme cells. Exp. Cell Res. 223:290-300.
73. LaFleur, M. V., and H. Loman. 1982. Influence of anoxic sensitizers on the radiation damage in biologically active DNA in aqueous solution. Int. J. Radiat. Biol. 41:295-302.
74. Lennox, J. L., and C. A. Waldren. 1981. Measurement of the mutagenic action of alcohols in mammalian cells. Clin. Res. 29:36A.
75. Lewis, R. J., ed. 2000. Dangerous Properties of Industrial Materials, 10th ed., vol. 2, 611-612. New York: John Wiley and Sons.
76. Lindamood, C. III; D. R. Farnell, H. D. Giles, J. D. Prejean, J. J. Collins, K. Takahashi, and R. R. Maronpot. 1992. Subchronic toxicity studies of t-butyl alcohol in rats and mice. Fundam. Appl. Toxicol. 19:91-100.
77. Lyon, R. C., J. A. McComb, J. Schreurs, and D. B. Goldstein. 1981. A relationship between alcohol intoxication and the disordering of brain membranes by a series of short-chain alcohols. J. Pharmacol. Exp. Ther. 218:669-675.
78. Mackison, F. W., R. S. Stricoff, and L. J. Partridge, Jr. 1978. NIOSH/OSHA Pocket Guide to Chemical Hazards. National Institute for Occupational Safety and Health [NIOSH] and Occupational Safety and Health Administration [OSHA]. DHEW (NIOSH) Publication No. 78-210.
79. McComb, J. A., and D. B. Goldstein. 1979. Quantitative comparison of physical dependence on tertiary butanol and ethanol in mice: Correlation with lipid solubility. J. Pharmacol. Exp. Ther. 208:113-117.
80. McGregor, D. B., A. Brown, P. Cattanach, I. Edwards, D. McBride, and W. J. Caspary. 1988. Responses of the L5178Y tk+/tk-mouse lymphoma cell forward mutation assay II: 18 Coded chemicals. Environ. Mol. Mutagen. 11:91-118.
81. Muhtadi, F. J., M. M. A. Hassan, and M. M. Tawakkol. 1982. PMR assay of betalactam antibiotics. I. Assay of cephalosporins. Spectrosc. Lett. 15:373-381.
82. Munch, J. C. 1972. Aliphatic alcohols and alkyl esters: Narcotic and lethal potencies to tadpoles and to rabbits. Ind. Med. Surg. 41:31-33.
83. Munch, J. C., and E. W. Schwarze. 1925. Narcotic and toxic potency of aliphatic alcohols upon rabbits. J. Lab. Clin. Med. 10:985-996.
84. National Toxicology Program (NTP). January, 1982. NTP Technical Bulletin. Issue No. 6. Research Triangle Park, NC.
85. 1 mice (Drinking water studies). Research Triangle Park, NC.
86. 1 mice. Research Triangle Park, NC.
87. Nelson, B. K., W. S. Brightwell, A. Khan, J. R. Burg, and P. T. Goad. 1989. Lack of selective developmental toxicity of three butanol isomers administered by inhalation to rats. Fundam. Appl. Toxicol. 12:469-479.
88. Nihlén, A., A. Lof, and G. Johanson. 1995. Liquid/air partition coefficients of methyl and ethyl t-butyl ethers, t-amyl methyl ether, and t-butyl alcohol. J. Expos. Anal. Environ. Epidemiol. 5:573-582.
89. Poet, T. S., J. L. Valentine, and S. J. Borghoff. 1997. Pharmacokinetics of tertiary butyl alcohol in male and female Fischer 344 rats. Toxicol. Lett. 92:179-186.
90. Renkonen, K. O., and H. Teir. 1957. Studies on the local reactions of the skin to chemical compounds. Ann. Med. Exp. Biol. Fenn. 35:67.
91. Reuvers, A. P., C. L. Greenstock, J. Borsa, and J. D. Chapman. 1973. Mechanism of chemical radioprotection by dimethyl sulfoxide. Int. J. Radiat. Biol. 24:533-536.
92. Rhone-Poulenc Inc. 1992. Primary dermal irritation in rabbits and primary ocular irritation in rabbits with hair spray formula 8758-47-2 with cover letter dated 102692. NTIS Report No. OTS0571816.
93. Roots, R., and S. Okada. 1972. Protection of DNA molecules of cultured mammalian cells from radiation-induced single-strand scissions by various alcohols and sulfhydryl compounds. Int. J. Radiat. Biol. 21:329-42.
94. Schaffarzick, R. W., and B. J. Brown. 1952. Anticonvulsant activity and toxicity of methylparafynol (dormison) and some other alcohols. Science 116:663.
95. Takahashi, K., C. Lindamood III, and R. R. Maronpot. 1993. Retrospective study of possible α-2μ-globulin nephropathy and associated cell proliferation in male Fischer 344 rats dosed with t-butyl alcohol. Environ. Health Perspect. 101:281-286.
96. Thomas, M., A. L. A. Boura, and R. Vijayakumar. 1980. Prostaglandin release by aliphatic alcohols from the rat isolated lung. Clin. Exp. Pharmacol. Physiol. 7:373-381.
97. Thore, A., and H. Baltscheffsky. 1965. Inhibitory effects of lower aliphatic alcohols on electron transport phosphorylation systems. II. Secondary, tertiary, and di-alcohols. Acta Chem. Scand. 19:1600-1606.
98. Thurman, R. G., K. Winn, and B. Urquhart. 1980. Rat brain cyclic AMP levels and withdrawal behavior following treatment with tert-butanol. Adv. Exp. Med. Biol. 126:271-281.
99. United States Pharmacopeia (USP) Committee of Revision. 1979. The United States Pharmacopeia, 20th revision. Easton, PA: Mack Printing Company.
100. Videla, L. A., V. Fernandez, A. De Marinis, N. Fernandez, and A. Valenzuela. 1982. Liver lipoperoxidative pressure and glutalhione status following acetaldehyde and aliphatic alcohols pretreatments in the rat. Biochem. Biophys. Res. Commun. 104:965-970.
101. Von Oettingen, W. F. 1943. The aliphatic alcohols, their toxicity and potential dangers in relation to their chemical constitution and their fate in metabolism. U.S. Public Health Service Public Health Bulletin No. 281. Washington, DC: US Government Printing Office.
102. Wakabayashi, T., K. Adachi, and J. Popinigis. 1991. Effects of alkyl alcohols and related chemicals on rat liver structure and function I. Induction of two distinct types of megamitochondria. Acta Pathol. Jpn. 41:405-413.
103. Waldren, C. 1982. Detection of chromosome deletions and nondisjunction produced by environmental agents in cultured somatic mammalian cells. Mutat. Res. 97:234.
104. Weast, R. C., ed. 1982. CRC handbook of chemistry and physics, 5th ed. Boca Raton, FL: CRC Press.
105. Wenninger, J. A., R. C. Canterbery, and G. N. McEwen, Jr. eds. 2000. International cosmetic ingredient dictionary and handbook, 8th ed; Vol. 1-3. Washington, DC: CTFA.
106. Williams, T. M., and S. J. Borghoff. 2001. Characterization of tert-butyl alcohol binding to α-2μ-globulin in F-344 rats. Toxicol. Sci. 62:228-235.
107. Wimer, W. W., J. A. Russell, and H. L. Kaplan. 1983. Alcohols toxicology. Park Ridge, NJ: Noyes Data Corporation.
108. Windholz, M. (Editor). 1983. The Merck index, 10th ed. Rahway, NJ: Merck and Co.
109. Yamaguchi, T. 1980. Activation with catalase of mutagenicity of hydroperoxides of some fatty acids and hydrocarbons. Agric. Biol. Chem. 44:1989-1991.
110. Zamarakhina, L. E. 1973. Determination of tertiary butyl alcohol in the air of industrial rooms. Gig. Sanit. 38:72-73.
111. Zeiger, E., B. Anderson, S. Haworth, T. Lawlor, K. Mortelmans, and W. Speck. 1987. Salmonella mutagenicity tests III. Results from the testing of 255 chemicals. Environ. Mutagen. 9:1-110.