Korean Journal of Veterinary Research 2009;49(1):23-34.
A 90-day repeated-dose oral toxicity study on Chelidonium majus extract in Fischer 344/N rats
Do-Hyung Kim, Hu-Song Zhang, Kwang-Ho Kim, Sang-Chul Kang, Hak-Soo Kim, Ki-Hyun Gil, Kwang-Han Kong, Tae-Hwan Ahn, Jin-Sook Bae, Hyeon-Kyu Go, Kap-Ho Kim, Chan-Koo Park, Hyun-Kul Lee, Si-Whan Song, Zhong-Ze Han
Preclinical Research Center, ChemOn
백굴채(Chelidonium majus) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험
김도형, 장호송, 김광호, 강상철, 김학수, 길기현, 공광한, 안태환, 배진숙, 고현규, 김갑호, 박찬구, 이현걸, 송시환, 한충택
켐온 전임상 연구센터
Abstract
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.
Key Words: Chelidonium majus, F344/N rats, repeated dose toxicity test


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