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薬理と治療
Abstract
To assess the safety of burdock sprout extract(GSE), single and repeated dose toxicity studies by oral administration were performed. Male and female 6-week-old Crl: CD(SD)rats were administered orally with single dose of 2000 mg/kg of GSE. During 14 days after the single administration, neither mortality nor abnormal symptom was observed in any animals administered with GSE. Subsequent 91/day repeated dose toxicity study, maximum dose was set at 2000 mg╱kg which is the same dose as used in the single dose toxicity study, and dose levels of 1000 and 500 mg╱kg for middle and low dose were set with a proportionality factor of 2. Male and female 6-week-old Crl: CD(SD)rats were administered orally by gavage for 91 days. During the treatment period, the treatment caused no deaths, and no toxicological effect related to the treatment was observed for the general condition, body weight, food consumption, water consumption, urinalysis and ophthalmology. At necropsy, incidence of dilatation of the cecum was increased in the male and female 2000 mg╱kg. As to the post-mortem examination, no alteration in hematology, clinical chemistry, organ weights or histopathological examination was observed. Dilatation of the cecum was not considered adverse effect since the dilatation was considered to be caused by dextrin which was included in GSE. In conclusion, the no observed adverse effect level(NOAEL)of GSE for male and female was judged to be 2000 mg╱kg under the experimental conditions here reported.
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