A 90-day repeated-dose oral toxicity study on Chelidonium majus extract in Fischer 344/N rats
2009
Kim, D.H., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Zhang, H.S., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Kim, K.H., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Kang, S.C., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Kim, H.S., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Gil, K.H., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Kong, K.H., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Ahn, T.H., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Bae, J.S., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Go, H.K., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Kim, K.H., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Park, C.K., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Lee, H.K., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Song, S.W., Preclinical Research Center, ChemOn, Yongin, Republic of Korea | Han, Z.Z., Preclinical Research Center, ChemOn, Yongin, Republic of Korea
This study was performed to evaluate repeated-dose oral toxicities of Chelidonium majus extract in Fischer 344/N rats. Chelidonium majus extract was administered orally to rats at dose levels of 0, 25, 74, 222, 666 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Chelidonium majus extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, There were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Chelidonium majus extract. These results suggest that the oral no observed adverse-effect level of the test item, Chelidonium majus extract, in rats is higher than 2.000 mg/kg/day in both genders. The target organs were not established.
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