Food and Drug Administration proposed testing guidelines for developmental toxicity studies

Regulatory Toxicology and Pharmacology

Volumn 30, Issue 1, 1999, Pages 39-44

  Collins, Thomas F X ^a   Sprando, Robert L ^a   Shackelford, Mary E ^a   Hansen, Deborah K ^b   Welsh, John J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FOOD ADDITIVE; FOOD DYE;

ENVIRONMENTAL EXPOSURE; FETUS DEVELOPMENT; FOOD AND DRUG ADMINISTRATION; FOOD INDUSTRY; PRACTICE GUIDELINE; PRENATAL EXPOSURE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; TOXICITY TESTING;

EID: 0032847252     PISSN: 02732300     EISSN: None     Source Type: Journal    
DOI: 10.1006/rtph.1999.1307     Document Type: Article

References (10)

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2. Collins T. F. X., Sprando R. L., Hansen D. L., Shackelford M. E., Welsh J. J. Testing guidelines for evaluation of reproductive and developmental toxicity of food additives in females. Int. J. Toxicol. 17:1998;299-325.
3. Guidelines for the Care and Use of Laboratory Animals. 1996;National Academy Press, Washington.
4. Salewski (Koeln) V. E. Faerbermethode zum makroskopischen nachweis von implantations stellen am uterus der ratte. Naunyn-Schmeidebergs Arch. Pharmakol. Exp. Pathol. 247:1964;367.
5. Staples R. E. Detection of visceral alterations in mammalian fetuses. Teratology. 9:1977;A37-A38.
6. U.S. Food and Drug Administration (FDA), 1978, Good laboratory practice regulations for nonclinical laboratory studies, U.S. Code of Federal Regulations, Title 21, Part 8.
7. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food. 1982;U.S. Food and Drug AdministrationBureau of Foods, Washington.
8. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, Redbook II (Draft). 1993;U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition, Washington.
9. Wilson J. G. Methods for administering agents and detecting malformations in experimental animals. Wilson J. G., Warkany J. Teratology Principles and Techniques. 1965;262-277 Univ. of Chicago Press, Chicago.
10. Yasuda M., Yuki T. Color Atlas of Fetal Skeleton of the Mouse, Rat, and Rabbit. 1996;Ace Art Co. Osaka.