A 90-day oral toxicity study of purple corn color, a natural food colorant, in F344 rats.
A subchronic oral toxicity study of purple corn color (PCC), a natural food colorant, was performed with groups of 10 male and 10 female F344 rats fed the agent at dietary levels of 0%, 0.5%, 1.5% and 5.0% for 90 days. No mortalities occurred during the treatment period. No treatment-related changes in the body weight, food and water consumption, ophthalmology, hematology, organ weight data and histopathology were observed. Regarding general conditions and gross pathology, staining of fur and black feces were noted in rats of the 1.5% and 5.0% diet groups. Moreover, brown urine and black material in the stomach, small and large intestine were evident in rats receiving 5.0%. These changes were considered due to the anthocyanin content. On clinical chemistry analysis, total cholesterol, phospholipid and triglyceride were significantly lowered in both sexes of the 5.0% group, but these were not considered to be toxicologically significant. Thus, the No-observed-adverse-effect-level (NOAEL) was judged to be 5.0% in diet for both sexes (male: 3542 mg/kg/day, female: 3849 mg/kg/day) for PCC under the present experimental conditions.
Nabae
Kyoko
K
DIMS Institute of Medical Science, Inc., 64 Goura, Nishiazai, Azai-cho, Ichinomiya 491-0113, Japan.
Hayashi
Shim-Mo
SM
Kawabe
Mayumi
M
Ichihara
Toshio
T
Hagiwara
Akihiro
A
Tamano
Seiko
S
Tsushima
Yoko
Y
Uchida
Koji
K
Koda
Takatoshi
T
Nakamura
Mikio
M
Ogawa
Kumiko
K
Shirai
Tomoyuki
T
D000818:Animals; D000872:Anthocyanins / Q000378:metabolism / Q000633:toxicity*; D004032:Diet; D004305:Dose-Response Relationship, Drug; D005260:Female; D005505:Food Coloring Agents / Q000378:metabolism / Q000633:toxicity*; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D011916:Rats, Inbred F344; D012449:Safety
D000872:Anthocyanins; D005505:Food Coloring Agents