Laboraroty Animal Research

Korean Association for Laboratory Animal Science (한국실험동물학회)
권호 표지

A 90-day Repeated-Dosed Toxicity Study of Euphorbiae kansui radix Extract in Fischer 344/N Rats

Han, Zhong-Ze;Zhang, Hu-Song;Gil, Ki-Hyun;Lee, Joo-Young;Kong, Kwang-Han;Han, Myoung-Kyu;Yang, Hyun-Ju;Kim, Hak-Soo;Kim, Do-Hyung;Ahn, Tae-Hwan;Bae, Jin-Sook;Ko, Hyun-Kyu;Lee, Jung-Woon;Kim, Moon-Soon;Song, Si-Whan;Kim, Kap-Ho;Lee, Hyun-Kul;Park, Chan-Koo

  • Published : 20081200
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Abstract

This study was performed to evaluate repeated-dose toxicities of Euphorbiae kansui radix extract in F344/N rats. Euphorbiae kansui radix extract was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 ㎎/㎏/day. Each group consisted of 10 rats of each gender. The Euphorbiae Kansui, Radix 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 dose-related changes in mortality, clinical signs, body weights, ophthalmoscopy, urine analysis, hematological findings, estrus cycle and sperm examination of all animals treated with Euphorbiae kansui radix extract. There were increases of liver weights in 2,000 ㎎/㎏/day groups of males and in 333, 1,000 and 2,000 ㎎/㎏/day groups of females. There were decreases of alkaline phosphatase levels in 1,000 and 2,000 ㎎/㎏/day groups of both sexes. These results suggest that the oral no-observed-adverse-effect level (NOAEL) of the test item, Euphorbiae kansui radix extract, in rats is 2,000 ㎎/㎏/day in both genders; no-observed-effect level (NOEL) is 1,000 ㎎/㎏/day in male and 111 ㎎/㎏/day in female. The target organs were thought to be liver and thymus.

Keywords

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