Gardenia blue is not carcinogenic in the rasH2 mouse

Introduction Gardenia blue is currently being considered as a naturally derived food colorant for use in the global marketplace. Methods To assess its carcinogenic potential, 100 female and male CByB6F1-Tg (HRAS)2Jic (rasH2) mice were allocated to four dose groups exposed gardenia diet 26 weeks at levels of 0.0% (control), 0.5%, 2.5%, or 5.0% (corresponding 0.0, 664.8, 3341.0, 6623.2 mg/kg/day 1182.7, 5561.1, 10,440.3 mice, respectively). An additional group 10 males females was administered intraperitoneal N-methyl-N-nitrosourea (MNU) positive control. Clinical observations, body organ weights, clinical chemistry, hematology, hormone analyses performed addition urinalysis histopathology. Results The control elicited expected responses specific rasH2 mice. There sporadic background non-dose-related findings pathology parameters anatomic common absence any induced dose-related changes. Discussion Under these study conditions, no-observed-adverse-effect level 5% (6623.2 mice). Conclusions Based on this high dietary negative carcinogenicity mouse test system.