title: A subchronic toxicity study of shea nut color in Wistar rats.
abstract: Shea nut color, obtained from nuts of the shea tree (Butyrospermum parkii), is used as a food-coloring agent. Flavonoid pigments are considered to be the responsible constituents. As there have been no reports of toxicological evaluation, a 13-week subchronic toxicity study was performed in Wistar Hannover rats at dose levels of 0 (control), 0.07, 0.31, 1.25 and 5% in powdered basal diet. The average of daily shea nut color intake was 51.3, 226.1, 986.8 and 3775.5 mg/kg/day for males and 56.4, 272.9, 1166.7 and 4387.7 mg/kg/day for females, respectively. During the administration period, daily observation of clinical signs and weekly measurement of body weights and food consumption were performed. After the end of the treatment, hematology, serum biochemistry, organ weight and histopathological examinations were conducted. No significant toxicological changes were observed in any parameters in this study. Hence, the no adverse effect dose of shea nut color was estimated to be greater than 5.0% for both sexes (3775.5 mg/kg/day for males and 4387.7 mg/kg/day for females).
authors.affiliation: Division of Pathology, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Kitamura
authors.forename: A
authors.initials: A
authors.lastname: Nishikawa
authors.forename: F
authors.initials: F
authors.lastname: Furukawa
authors.forename: H
authors.initials: H
authors.lastname: Nakamura
authors.forename: K
authors.initials: K
authors.lastname: Okazaki
authors.forename: T
authors.initials: T
authors.lastname: Umemura
authors.forename: T
authors.initials: T
authors.lastname: Imazawa
authors.forename: M
authors.initials: M
authors.lastname: Hirose
mesh_terms: D000818:Animals; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D004032:Diet; 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; D010936:Plant Extracts / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar
chemical_list: D005505:Food Coloring Agents; D010936:Plant Extracts