TERATOLOGICAL EVALUATION OF FD AND C RED NO 2-A COLLABORATIVE GOVERNMENT-INDUSTRY STUDY .4. NCTRS STUDY

Data is presented from the National Center for Toxicological Research''s evaluation of Food Drug and Cosmetics [FD&C] Red Dye Number [No.] 2 teratogenicity in rats [part of a collaborative government-industry study]. The NCTR study was a double one in that the common protocol was duplicated in both Charles River [CD] and Osborne-Mendel [OM] rats. In OM rats the numbers of implants, resorptions and viable fetuses per litter were not significantly affected by any of the treatment regimens, but the average fetal weights of females and males were statistically significantly less in 1 experimental group than in 2 control groups. In CD rats the average fetal weight and average number of implants per litter were not significantly affected by any of the treatment schedules, but the average percent of resorptions per litter was statistically significantly higher in 1 experimental group than in 2 control groups. In all rats, there were no statistically significant differences between control and experimental groups for external, soft-tissue and skeletal abnormalities. Amaranth metabolism is discussed.