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        Difructose Dianhydrides(DFA IV)의 랫드를 이용한 단회 및 4주간 반복 경구투여 독성시험

        이창우(Chang-Woo Lee),이명렬(Myong-Lyoll Lee),김환묵(Hwan-Mook Kim),윤원기(Won-Kee Yoon),김승환(Seung-Hwan Kim),손화영(Hwa-Young Son),김형진(Hyoung-Chin Kim) 한국독성학회 2004 Toxicological Research Vol.20 No.3

        This study was to investigate single and repeated-dose toxicities of DFA IV, a new<br/> candidate of nutraceutical which has preventive effect on anemia and osteoporosis. In single-dose<br/> oral toxicity study, the test article were administered once by gavage to rats at dose level of 0, 2,000<br/> and 5,000 mg/kg. No dead animal, abnormal sign and abnormal necropsy finding was found in control<br/> and treated groups. Thus the approximate lethal dose of DFA IV was considered to be higher<br/> than 5,000 mg/kg in rats. In four week repeated dose oral toxicity study, the test article was administered<br/> once daily by gavage to rats at dose levels of 0, 500, 1,000 and 2,000 mg/kg. No abnormality<br/> was observed in mortality, clinical findings, body weight changes, food and water consumptions,<br/> opthalmoscopic findings, hematological findings, necropsy findings, organ weights and histopathological<br/> findings. In urinalysis, specific gravity was increased in 2,000 mg/kg groups of male rats. In serum<br/> biochemical analysis, creatine phosphokinase was increased in all treatment groups of male rats.<br/> These increases in urine specific gravity and serum creatine phosphokinase activity were not accompanied<br/> with related signs such as histopathological changes or clinical findings. In conclusion, four<br/> week repeated oral dose of DFA IV to rats did not cause apparent toxicological change at the dose of<br/> 500, 1,000 or 2000 mg/kg body weight. Thus it is suggested that no-observed-adverse-effect level<br/> (NOAEL) of DFA IV in rats would be 2,000 mg/kg/day body weight.

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