Subchronic oral toxicity study of aquacoat® ECD ethylcellulose aqueous dispersion in the rat

Food and Chemical Toxicology

Volumn 36, Issue 8, 1998, Pages 705-709

  Kotkoskie, L A ^a   Freeman, C ^a  

^a FMC CORPORATION   (United States)

Author keywords

Aqueous coating; Ethylcellulose; Excipient; Pharmaceutical coating; Subchronic toxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; ETHYL CELLULOSE; EXCIPIENT; GLOBULIN; PROTEIN;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BODY WEIGHT; CHRONIC TOXICITY; CONTROLLED STUDY; DISPERSION; FEMALE; FOOD INTAKE; HISTOPATHOLOGY; MALE; NONHUMAN; ORAL DRUG ADMINISTRATION; ORGAN WEIGHT; RAT;

ADMINISTRATION, ORAL; ALANINE TRANSAMINASE; ANIMALS; ASPARTATE AMINOTRANSFERASES; BODY WEIGHT; CELLULOSE; EATING; EXCIPIENTS; FEMALE; MALE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; ORGAN SIZE; RATS; RATS, SPRAGUE-DAWLEY; SUSPENSIONS;

ANIMALIA;

EID: 0031825825     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0278-6915(98)00038-6     Document Type: Article

References (12)

1. 14C-labeled phytol and phytanic acid by the intestine of the rat studied with thoracic duct cannulation. Biochimica et Biophysica Acta. 137:1967;277-290.
2. Blevins R. D., Taylor D. E. Mutagenicity screening of twenty-five cosmetic ingredients with the Salmonella/microsome test. Journal of Environmental Science and Health. Part A 17:1982;217-239.
3. 14C]cetyl alcohol into palmitic acid in the intestinal mucosa of the rat. Acta Physiologica Scandinavica. 32:1954;374-383.
4. Eibert J. (1966a) Final report on thirteen week subacute feeding of Alfol 6 and Alfol 16 to rats. Scientific Associates Inc. Unpublished report.
5. Eibert J. (1966b) Final report on thirteen week subacute feeding in beagle dogs of Alfol 6 and Alfol 16. Scientific Associates Inc. Unpublished report.
6. Elder R. L. Final report on the safety assessment of sodium lauryl sulfate and ammonium lauryl sulfate. Journal of the American College of Toxicology. 2:1983;127-181.
7. Elder R. L. Final report on the safety assessment of ceatearyl alcohol, cetyl alcohol, isostearyl alcohol, myristyl alcohol, behenyl alcohol. Journal of the American College of Toxicology. 7:1988;359-413.
8. FDA (1982) Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. US FDA, Bureau of Foods US Department of Commerce. NTIS PB83-170696.
9. Toxicological evaluation of certain food additives and contaminants. Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives Series. 26:1990;81-123.
10. OECD (1981) Section 408. Subchronic Oral Toxicity - Rodent, 90-Day Study. In OECD Guideline for Testing of Chemicals, pp. 1-9. Organization for Economic Co-Operation and Development. OECD, Paris.
11. Plaa G. L. and Charbonneau M. (1994) Detection and evaluation of chemically induced liver injury. In Principles and Methods of Toxicology, ed. W. A. Hayes, 3rd edn, pp. 839-870. Raven Press, New York.
12. Steinberg M., Borzelleca J. F., Enters E. K., Kinoshita F. K., Loper A., Mitchell D. B., Tamulinas C. B., Weiner M. L. A new approach to the safety assessment of pharmaceutical excipients. Regulatory Toxicology and Pharmacology. 24:1996;149-154.