Final Report on the Safety Assessment of Triacetin

International Journal of Toxicology

Volumn 22, Issue SUPPL. 2, 2003, Pages 1-10

  Andersen, F Alan ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETIC ACID; BIOCIDE; COSMETIC; FLAVORING AGENT; FRAGRANCE; GLYCEROL; GLYCEROL DERIVATIVE; IRRITANT AGENT; PLASTICIZER; TRIACETIN; ACETYLSALICYLIC ACID; BUTYLOCTYL SALICYLATE; CALCIUM SALICYLATE; CAPRYLOYL SALICYLATE; CYSTEAMINE DERIVATIVE; ETHYLHEXYL SALICYLATE; HEXYLDODECYL SALICYLATE; HYDROCORTISONE; ISOCETYL SALICYLATE; ISODECYL SALICYLATE; KERATOLYTIC AGENT; MACROGOL; MAGNESIUM SALICYLATE; MYRISTYL SALICYLATE; PHOTOSENSITIZING AGENT; POTASSIUM SALICYLATE; PRESERVATIVE; RETINOL; SALICYLATE SODIUM; SALICYLIC ACID; SALICYLIC ACID DERIVATIVE; SALICYLIC ACID METHYL ESTER; SUNSCREEN; TRIDECYL SALICYLATE; UNCLASSIFIED DRUG;

ALOPECIA; ANIMAL EXPERIMENT; CELL GROWTH; CELL HYPERPLASIA; CELL PROLIFERATION; CONFERENCE PAPER; DESQUAMATION; ERYTHEMA; EXPOSURE; EYE IRRITATION; FEMALE; FOOD AND DRUG ADMINISTRATION; GUINEA PIG; MALE; METABOLISM; MOUSE; NONHUMAN; RABBIT; RAT; REPRODUCTIVE TOXICITY; SAFETY; SENSITIZATION; SKIN EDEMA; SKIN IRRITATION; TOXICITY TESTING; TUMOR GROWTH; ATOPY; BLOOD LEVEL; BONE LESION; CONCENTRATION (PARAMETERS); DENATURATION; DISEASE ASSOCIATION; DOG; EXPERT SYSTEM; GENOTOXICITY; HYDROLYSIS; INTESTINE ABSORPTION; LIVER TOXICITY; LYMPH NODE; MALIGNANT TRANSFORMATION; NEPHROTOXICITY; PH; PHOTOTOXICITY; REPRODUCTION; REVIEW; RISK; RISK ASSESSMENT; SKIN PENETRATION; TERATOGENESIS; ULTRAVIOLET RADIATION; WEIGHT;

ANIMALS; ANTI-INFECTIVE AGENTS, LOCAL; CONSUMER PRODUCT SAFETY; COSMETICS; HUMANS; TOXICITY TESTS; TRIACETIN; ADMINISTRATION, INHALATION; ADMINISTRATION, ORAL; ADMINISTRATION, TOPICAL; MUTAGENS; SALICYLATES; SKIN ABSORPTION; SPECIES SPECIFICITY;

ANIMALIA; CAVIA; CAVIA PORCELLUS; ORYCTOLAGUS CUNICULUS; SUS SCROFA; CANIS FAMILIARIS;

EID: 1642515826     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/10915810305082     Document Type: Conference Paper

References (54)

1. Anstadt, G. W. 1976. Letter dated September 13 from Dr. Anstadt, Eastman Kodak Co., to D. R. Mathieu, Flavor and Extract Manufacturer's Association, regarding information on the toxicity of Triacetin. Data submitted by FDA in response to an FOI request.
2. Bailey, J. W., R. L. Barker, and M. D. Karlstad. 1992. Total parenteral nutrition with short- and long-chain triglycerides: Triacetin improves nitrogen balance in rats. J. Nutr. 122:1823-1829.
3. Bailey, J. W., M. W. Haymond, and J. M. Miles. 1991. Triacetin: A potential parenteral nutrient. J. Parenter. Enteral. Nutr. 15:32-36.
4. Bailey, J. W., H. Heath III, and J. M. Miles. 1989. Calcium, magnesium, and phosphorus metabolism in dogs given intravenous triacetin. Am. J. Clin. Nutr. 49:385-388.
5. Bailey, J. W., J. M. Miles, and M. W. Haymond. 1993. Effect of parenteral administration of short-chain triglycerides on leucine metabolism. Am. J. Clin. Nutr. 58:912-916.
6. Bleiberg, B., T. R. Beers, M. Persson, and J. M. Miles. 1993. Metabolism of triacetin-derived acetate in dogs. Am. J. Clin. Nutr. 58:908-911.
7. Blumenthal, H. 1964. Letter dated April 10 from Dr. Blumenthal to E. V. Burton that includes a summary of an oral subchronic toxicity test on Triacetin. Data submitted by FDA in response to an FOI request.
8. Budavari, S., ed. 1989. The Merck index. An encyclopedia of chemicals, drugs, and biologicals, 11th ed., 1510. Rahway, NJ: Merck & Co.
9. ChemID. 1998. Online database. Bethesda, MD: National Library of Medicine.
10. Conquet, Ph., G. Durand, J. Laillier, and B. Plazonnet. 1977. Evaluation of ocular irritation in the rabbit: Objective versus subjective assessment. Toxicol. Appl. Pharmacol. 39:129-139.
11. 2
12. Draize, J. H., G. Woodard, and H. O. Calvery. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82:377-390.
13. Efremova, G. I. 1962. The mutagenic effect of vanillin and of some of its derivatives. Dokl. Biol. Sci. 146:1034-1036.
14. 2
15. European Commission. 2003. Cosmetics Directive 76/768/EEC, as amended. http://pharmacos.eudra.org/F3/home.html
16. Federation of American Societies for Experimental Biology. 1975. Evaluation of the health aspects of glycerin and glycerides as food ingredients. National Technical Information Service report no. # PB254536.
17. 2
18. FDA. 1983. Certain glycerides; affirmation of GRAS status. Final rule. Fed. Register 54:7401-7404.
19. FDA. 1998. Frequency of use of cosmetic ingredients. FDA database. Washington, DC: FDA.
20. 2
21. Gast, J. H. 1963. Some toxicity studies with triacetin. Abstract 1243. Fed. Proc. Fed. Am. Soc. Exp. Biol. 22:368.
22. Gennaro, A. R. 1990. Remington's pharmaceutical sciences, 18th ed., 1237. Easton, PA: Mack Publishing Co.
23. Grant, J., ed. 1972. Hackh's chemical dictionary, 4th ed., 688. New York, NY: McGraw-Hill Book Co.
24. Graves, G. R., T. F. Baskett, J. H. Gray, and E. R. Luther. 1985. The effect of vaginal administration of various doses of prostaglandin E2 on cervical ripening and induction of labor. Am. J. Obstet. Gynecol. 151:178-181.
25. Lawrence, W. H., M. Malik, and J. Autian, 1974. Development of a toxicity evaluation program for dental materials and products. II. Screening for systemic toxicity. J. Biomed. Mater. Res. 8:11-34.
26. Lewis, R. J., Sr. 1993a. Hazardous chemicals desk reference, 3rd ed., 1256-1257. New York: Van Nostrand Reinhold.
27. Lewis, R. J., Sr. 1993b. Hawley's condensed chemical dictionary, 12th ed., 1165. New York: Van Nostrand Reinhold Co.
28. Li, R. C., P. T. P. Sah, and H. H. Anderson. 1941. Acute toxicity of monoacetin, diacetin, and triacetin. Proc. Scod. Exp. Biol. Med. 46:26-28.
29. Lide, D. R., ed. 1993. CRC handbook of chemistry and physics, 74th ed., 3-499. Boca Raton, FL: CRC Press, Inc.
30. Lipschitz, W. L., S. D. Upham, C. N. Hotchkiss, and G. H. Carlson. 1942. The parenteral use of organic esters. J. Pharmacol. Exp. Ther. 76:189-193.
31. Litton Bionetics, Inc. 1976. Mutagenic evaluation of compound FDA 75-40. 000102-76-1, Triacetin, (Kressco). Report dated March 31. National Technical Information Service report no. PB257871.
32. Lynch, J. W., and J. W. Bailey. 1995. Dietary intake of the short-chain triglyceride triacetin vs. long-chain triglycerides decreases adipocyte diameter and fat deposition in rats. J. Nutr. 125:1267-1273.
33. Lynch, J. W., J. M. Miles, J. W. Bailey. 1994. Effects of the short-chain triglyceride triacetin on intestinal mucosa and metabolic substrates in rats. J. Parenter. Enteral. Nutr. 18:208-213.
34. Ministry of Health, Labor and Welfare (MHLW). 2001. Unofficial translation of MHLW Ordinance No. 331, including attached Tables. Ministry of Health, Labor and Welfare, Pharmaceutical and Medical Safety Bureau, Inspection and Guidance Division, 2-2, 1-chome, Kasumigaseki, Chiyoda-ku, Tokyo 100-8045, Japan.
35. National Academy of Sciences (NAS). 1996. Food chemicals codex, 4th ed., 424-425. Washington, DC: National Academy Press.
36. 2 gel for preinduction cervical softening. Prostaglandins 30:305-311.
37. Ogawa, T., R. Fujii, K. Tanaka, et al. 1988. A method for determination of triacetin in foods by gas chromatography. J. Food Hyg. Soc. Jpn. 29:180-184.
38. Ogawa, T., N. Moriwaki, R. Fujii, et al. 1992. Triacetin as food additive in gummy candy and other foodstuffs on the market. Kitasato Arch. Exp. Med. 65:33-44.
39. Oguchi, M., N. Shikama, S. Sasaki, et al. 1998. Mucosa-adhesive water-soluble polymer film for treatment of acute radiation-induced oral mucositis. Int. J. Radiat. Oncol. Biol. Phys. 40:1033-1037.
40. Opdyke, D. L. J. 1978. Fragrane raw materials monographs: Triacetin. Food Cosmet. Toxicol. 16:879-882.
41. Pepe, R. C., J. A. Wenninger, and G. N. McEwen, Jr. eds. 2002. International cosmetic ingredient dictionary and handbook, 9th ed. Washington, DC: CTFA.
42. Robertson, C., J. C. Goodman, R. G. Grossman, M. Claypool, and A. White. 1992. Dietary nonprotein calories and cerebral infarction size in rats. Stroke 23:564-568.
43. Sax, N. I. 1979. Dangerous properties of industrial materials, 5th ed., 706. New York: Van Nostrand Reinhold Co.
44. Shapira, J., A. D. Mandel, P. D. Quattrone, and N. L. Bell. 1969. Current research on regenerative systems. Life Sci. Space Res. 7:123-129.
45. Shapira, J., L. S. Vann, and A. Furst. 1975. Glycerol, propylene glycol and triacetin as dietary starch substitutes: Some effects on rats. Proc. West Pharmac. Soc. 18:339-343.
46. Stoughton, R. B. 1970. Bioassay of antimicrobials. A method for measuring penetration of agents into human skin. Arch. Dermatol. 101:160-166.
47. Tarr, B. D., T. G. Sambandan, and S. H. Yalkowsky. 1987. A new parenteral emulsion for the administration of taxol. Pharm. Res. 4:162-165.
48. Uematsu, Y., Y. Sadamasu, K. Hirata, et al. 1997. Determination of carrier solvents in flavor preparations by GC and GC/MS. J. Food Hyg. Soc. Jpn. 38:452-459.
49. 2
50. 2
51. United States Pharmacopeial Convention, Inc. (USP). 1995. The United States Pharmacopeia, vol. 23, and The National Formulary, vol. 18, 206. Taunton, MA: Rand McNally.
52. von Oettingen, W. F. 1960. The aliphatic acids and their esters: Toxicity and potential dangers. A. M. A. Arch. Ind. Health 21:28-65.
53. Wretlind, A. 1957. The toxicity of low-molecular-weight triglycerides. Acta Physiol. Scand. 40:338-343.
54. Yalkowsky, S. H., and T. J. Roseman. 1979. Stability of E-type prostaglandins in triacetin. J. Pharm. Sci. 68:114-115.