EFFECTS OF D-AND-C-YELLOW-NO-11 INGESTION ON F344 N RATS AND B6C3F(1)MICE/

D&C yellow no. 11 (CAS no. 8003-22-3) was administered in the feed at concentrations of 500-50,000 ppm to groups of F344/N rats and B6C3F, m ice of each sex for 13 wk to determine the toxicity. In addition, a pe rinatal study was conducted to determine the effects of feeding diets containing D&C yellow no. I I to female rats during reproduction and t o their offspring. Although the estimated intake (g/kg) of D&C yellow no. 11 of mice was more than twice that of rats, the results were gene rally similar for both rats and mice. In both species, D&C yellow no. 11 caused no mortality, but it did reduce body weight gain slightly in both sexes of rats exposed to 17,000 and 50,000 ppm. Absolute and rel ative liver weights were significantly increased in all groups of rats and mice administered D&C yellow no. 11 in the feed. There was minima l to mild degeneration of the periportal hepatocytes in rats at doses of 1700 ppm and higher and in mice at 5000 ppm and above. A dose-relat ed yellow-brown pigment was observed in hepatocytes, Kupffer cells, an d biliary epithelium of the liver of both sexes of both species and in the renal tubule epithelium in both sexes oi rats. In male rats, all treated groups had increased number and size of hyaline droplets in th e renal tubule epithelium of the cortex and outer medulla. To determin e if these renal and hepatic lesions were reversible, male rats were a dministered 5000 ppm dietary D&C yellow no. 11 for 70 d and then exami ned at 3, 14, and 28 d alter the chemical was removed from the diet. P igment persisted in the kidney and liver for as long as 28 d following removal of D&C yellow no. 11 from the diet, but hepatocellular degene ration and cytoplasmic alteration in the kidney completely resolved by d 3 and 14, respectively. In the perinatal toxicity study, body weigh t gain in rat dams given diets containing as much as 50,000 ppm D&C ye llow no. 11 for 4 wk before mating to untreated males was similar to t hat oi controls at the time of mating but was lower at parturition and weaning. However, fertility gestation length, litter size, and pup bi rth weights were unaffected by treatment. At weaning there was a signi ficant dose-related decrease in pup body weights from the 5000, 17,000 and 50,000 ppm groups. At 8 wk of age, pups fed the same dosed-feed c oncentrations as the dams had depressed body weights in the 17,000 and 50,000 ppm treated groups. Microscopic lesions in the liver and kidne y of the pups in all dose groups were similar to those described in th e 13-wk study. The results of these studies indicate that compound-rel ated effects occurred at all dietary concentrations of D&C yellow no. 11. Liver weights were increased in dosed rats and mice, minimal to mi ld hepatocellular degeneration was seen in rats receiving dietary conc entrations of 1700 ppm and above and in mice 5000 ppm and above, and t here was an increase in the number and size of hyaline droplets in all dosed groups of male rats. Similar compound-related effects were also seen in all dosed rats in the perinatal toxicity study. With the exce ption of pigment accumulation, the treatment-related kidney and liver lesions in male rats were reversible by 14 d after chemical was withdr awn from the diet.