Lifetime toxicity/carcinogenicity studies of FD & C red no. 40 (allura red) in mice.
FD & C Red No. 40 (allura red) was fed to Charles River HaM/ICR (CD-1) (study A) and CD-1 outbred (study B) mice as a dietary admixture in two separate lifetime toxicity/carcinogenicity studies. Each study included an in utero exposure phase during which the colouring was fed at dietary concentrations of 0.0, 0.37, 1.39 or 5.19% throughout the mating, gestation and lactation periods. After random selection, the lifetime exposure phase was initiated using the same dietary concentrations with 50 mice/sex/group in study A and 100 mice/sex/group in study B. Exposure was for 104 wk in study A and 109 wk in study B. No compound-related adverse effects were observed. The no-observable-adverse-effect level in these studies was 5.19%; approximately 7300 and 8300 mg/kg body weight/day for male and female mice, respectively.
Borzelleca
J F
JF
Medical College of Virginia, Department of Pharmacology and Toxicology, Richmond 23298-0613.
Olson
J W
JW
Reno
F E
FE
D000284:Administration, Oral; D000818:Animals; D001391:Azo Compounds / Q000008:administration & dosage / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects; D004032:Diet; D005260:Female; D008297:Male; D008431:Maternal-Fetal Exchange; D051379:Mice; D009374:Neoplasms, Experimental / Q000139:chemically induced*; D011247:Pregnancy
D001391:Azo Compounds; C005915:Allura Red AC Dye