title: A 13-week subchronic toxicity study of paprika color in F344 rats.
abstract: The fruit of the paprika (Capsicum annuum) has been widely used in various countries as a spice and food-coloring additive. As a part of the safety assessment of paprika color (Paprika oleoresin), a 13-week subchronic toxicity study was performed in F344 rats. To establish a no-observed-adverse-effect level (NOAEL) for application in subsequent long-term studies, rats were fed powder diet containing paprika color at dose levels of 0 (basal diet), 0.62, 1.25, 2.5 and 5% (maximum) for 13 weeks. During the experiment, there were no remarkable changes in general appearance and no deaths occurred in any experimental group. Although serum total cholesterol was dose-dependently increased in both sexes, no related histopathological changes were observed in the liver. Slight inflammatory cell infiltration in the myocardium and vacuolation of hepatocytes were noted in both control and paprika color-treated animals, but there were no clear differences between groups. In conclusion, paprika color even at 5% in the diet (0.67 g/rat/day or 2948.4 mg/kg bw/day for male rats and 0.43 g/rat/day or 3197.4 mg/kg bw/day for female rats) did not cause remarkable adverse effects in F344 rats. Thus, the NOAEL and the maximum dose level for carcinogenicity testing of paprika color were concluded to be 5% in the diet.
authors.affiliation: Division of Pathology, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, 158-8501 Tokyo, Japan.
authors.forename: Keita
authors.initials: K
authors.lastname: Kanki
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Nishikawa
authors.forename: Fumio
authors.initials: F
authors.lastname: Furukawa
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Kitamura
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Imazawa
authors.forename: Takashi
authors.initials: T
authors.lastname: Umemura
authors.forename: Masao
authors.initials: M
authors.lastname: Hirose
mesh_terms: D000818:Animals; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D002212:Capsicum / Q000633:toxicity*; D015197:Carcinogenicity Tests; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D005505:Food Coloring Agents / Q000633:toxicity*; D006128:Growth / Q000187:drug effects; D008297:Male; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D011916:Rats, Inbred F344
chemical_list: D005505:Food Coloring Agents