Subchronic and developmental toxicity studies in rats with Ac-Di-Sol croscarmellose sodium

International Journal of Toxicology

Volumn 22, Issue 3, 2003, Pages 149-157

  Freeman, Christine ^a   Weiner, Myra L ^b   Kotkoskie, Lois A ^e   Borzelleca, Joseph ^c   Butt, Mark ^d  

^a SANOFI   (France)

^b FMC CORPORATION   (United States)

^c VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d CHARLES RIVER LABORATORIES   (United States)

^e Box 8 ^*

Author keywords

Ac Di Sol Croscarmellose Sodium; Developmental Toxicity; Excipient; Pharmaceutical Disintegrant; Sodium Carboxymethylcellulose; Subchronic Toxicity

Indexed keywords

CROSCARMELLOSE SODIUM; SWEETENING AGENT;

ACUTE TOXICITY; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CHRONIC TOXICITY; CONTROLLED STUDY; CROSS LINKING; DEVELOPMENTAL BIOLOGY; DIET SUPPLEMENTATION; EMBRYOTOXICITY; FETOTOXICITY; MINERALIZATION; NONHUMAN; RAT; SKIN SENSITIZATION; TOXICITY TESTING; TOXICOKINETICS; URINARY EXCRETION; WEIGHT GAIN;

ABNORMALITIES, DRUG-INDUCED; ADMINISTRATION, ORAL; ANIMALS; BODY WEIGHT; CALCINOSIS; CARBOXYMETHYLCELLULOSE; DIET; DOSE-RESPONSE RELATIONSHIP, DRUG; EMBRYONIC AND FETAL DEVELOPMENT; EXCIPIENTS; FEMALE; KIDNEY MEDULLA; MALE; MATERNAL EXPOSURE; NO-OBSERVED-ADVERSE-EFFECT LEVEL; PREGNANCY; RATS; RATS, SPRAGUE-DAWLEY;

ANIMALIA;

EID: 0043269874     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/10915810305108     Document Type: Article

References (15)

1. Bar, A., B. Van Ommen, and M. Timonen. 1995. Metabolic disposition in rats of regular and enzymatically depolymerized sodium Carboxymethylcellulose. Food Chem. Toxicol. 33:901-907.
2. Bar, A., H. P. Til, and M. Timonen. 1995. Subchronic oral toxicity study with regular and enzymatically depolymerized sodium carboxymethylcellulose in rats. Food Chem. Toxicol. 33:909-917.
3. European Communities. 1987. Subchronic oral toxicity test, 90-day repeated oral dose using rodent species. In Official Journal of the European Communities, no. L133/8-11, November 18, 1987 (87/302/EEC).
4. FMC Corporation. 1997a. Ninety-day feeding study in rats with Ac-Di-Sol SD-711 and modified cellulose gum. FMC study I95-2054. Princeton, NJ: FMC Corp.
5. FMC Corporation. 1997b. Dietary teratology study in rats with Ac-Di-Sol SD-711 and modified cellulose gum. FMC study I96-2090. Princeton, NJ: FMC Corp.
6. Joint FAO/WHO Expert Committee on Food Additives (JECFA). 1990. Toxicological evaluation of some food additives and contaminants. WHO Food Additives Series 26:81-123.
7. Kotkoskie, L. A., and C. Freeman. 1998. Subchronic toxicity study in rats with two food ingredients: Ac-Di-Sol and accelerate. Toxcoicol. Lett. 95 (Suppl. 1):158-159.
8. Montgomery C. A., and J. L. Seely. 1990. Kidney. In Pathology of the Fischer Rat, ed. G. A. Boorman, S. L. Eurtis, M. R. Elwell, C. A. Montgomery, and W. F. Mackenzie, 134. San Diego, CA: Academic Press.
9. Organization for Economic Cooperation and Development (OECD). 1998a. OECD principles on good laboratory practice (as revised in 1997). Series on principles of good laboratory practice and compliance monitoring - number 1. OECD ENV/MC/CHEM (98)17. Paris, France: Environment Directorate. Organization for Economic Co-operation and Development.
10. Organization for Economic Cooperation and Development (OECD). 1998b. OECD guidelines for the testing of chemicals. Paris, France: OECD Publishers.
11. Scientific Committee for Food, European Commission. 1998. Opinion on use Of cross-linked sodium carboxymethyl cellulose in solid dietary supplements. DG XXXIV SCF Opinion.
12. U.S. Environmental Protection Agency (U.S. EPA). 1989. Toxic Substances Control Act (TSCA), Good laboratory practice standards; final rule. 40 CFR Part 792. Washington, DC: U.S. EPA.
13. U.S. Food and Drug Administration (U.S. FDA) Bureau of Foods. 1982. Toxicological principles for the safety assessment of direct food additives and color additives used in food. NTIS PB83-170696. Washington, DC: U.S. Dept. Commerce.
14. U.S. United States Food and Drug Administration (U.S. FDA). 1987. Good laboratory practice regulations; final rule. 21 CFR Part 58. Washington, DC: U.S. FDA.
15. Weiner, M., L. A. Kotkoskie, C. Freeman, K. J. Batt, and M. J. Fletcher. 1992. Acute toxicity evaluation of Ac-Di-Sol and Avicel PH, Avicel RC and CL: pharmaceutical excipients. Toxicol Lett (Suppl): 243.