Developmental toxicity study of Aquacoat® ECD ethylcellulose aqueous dispersion administered orally to rats

Food and Chemical Toxicology

Volumn 38, Issue 1, 2000, Pages 71-74

  Freeman, C ^a  

^a FMC CORPORATION   (United States)

Author keywords

Aqueous coating; Ethylcellulose; Excipient; Pharmaceutical coating; Teratogenicity

Indexed keywords

ETHYL CELLULOSE;

ANIMAL EXPERIMENT; ANIMAL MODEL; AQUEOUS SOLUTION; ARTICLE; CONTROLLED STUDY; DIET SUPPLEMENTATION; DISPERSION; EMBRYO DEVELOPMENT; EMBRYOTOXICITY; FETUS DEVELOPMENT; GESTATIONAL AGE; NONHUMAN; RAT; SEX RATIO; TERATOGENICITY; TOXICITY TESTING;

ANIMALIA;

EID: 0033983013     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0278-6915(99)00116-7     Document Type: Article

References (7)

1. Dempster A. P., Selwyn M. R., Patel C. M., Roth A. J. Statistical and computational aspects of mixed model analysis. Applied Statistics. 33:1984;203-214.
2. FDA (1982) Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. US Food and Drug Administration. Bureau of Foods. US Department of Commerce, NTIS PB83-170696.
3. ® ECD ethylcellulose aqueous dispersion in the rat. Food and Chemical Toxicology. 36:1998;705-709.
4. Nishimura M., Iizuka M., Iwaki S., Kast A. Reparability of drug-induced "wavy ribs" in rat offspring. Arzneimittelforschung. 32:1982;1518-1522.
5. OECD (1981) Section 414. Teratogenicity. In OECD Guideline for Testing of Chemicals, pp. 1-6. Organisation for Economic Cooperation and Development, Paris.
6. 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.
7. Sterz H., Sponer G., Neubert P., Hebold G. A postulated mechanism of (-sympathomimetic induction of rib and limb anomalies in rat fetuses. Teratology. 31:1985;401-412.