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KMID : 0379519990150030379
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한국독성학회지
1999 Volume.15 No. 3 p.379 ~ p.387
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Four-week Repeated Oral Dose Toxicity of DA-7101, A Novel Combined Antibiotic (Cefatrizine/Clavulanic Acid), in Rats
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Kim Dong-Hwan
Cho Hyeon
Kang Kyung-Koo
Ahn Byoung-Ok
Kim Won-Bae
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Abstract
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Toxic effects of a new combination antibiotic of cefatrizine/clavulanic acid (CFT/CVA, DA-7101) were investigated in Sprague-Dawley rats by repeated oral administration. Four groups of 10 male and 10 female rats were treated with DA-7101 at a dose of 0 (control), 75, 300, or 1,200 mg/kg/day for 4 weeks. All rats survived until the end of the study. Results of the study showed that the target organ of subacute exposure to DA-7101 is intestine especially cecum. The rats treated with 300 and 1,200 mg/kg of DA-7101 showed inflated abdomen and excreted soft stool throughout the study. At necropsy, most of them showed enlarged large intestine, especially cecum, filled with soft stool. In serum ion analysis, sodium and potassium values were decreased in 1,200 mg/kg group, while chloride value was increased in 300 and 1,200 mg/kg groups of female rats. Urine pH was decreased in 1,200 mg/kg groups, in both males and females, and 300 mg/kg group of males. Except these changes, there were no histological, hematological, or biochemical abnormalities attributed to DA-7101. Based on these results, the no-observed-adverse-effect-level of DA-7101 was estimated to be 75 mg/kg in male and female rats under the present test condition.
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KEYWORD
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D-7101, Cefatrizine, Clavulantic acid, Rat
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