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KMID : 0861020130280010015
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Korea Journal of Herbology
2013 Volume.28 No. 1 p.15 ~ p.21
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Thirteen-week repeated-dose oral toxicity study of KOB03, a polyherbal medicine for allergic rhinitis, in rats
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Kang Seok-Yong
Park Yeong-Chul
Park Yong-Kee
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Abstract
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Objectives : To evaluate the safety of KOB, a polyherbal medicine for allergic rhinitis, we conducted a
subchronic toxicology study.
Methods : Dried extract of KOB(Lot. No. 11003, yield : 41.1%) was prepared from GLP company (Hanpoong
Pharm & Food Co., Ltd). KOB was repeatedly administrated orally of male SD rats at daily dose levels of 500
(G2), 1250 (G3) and 5000 (G4) ㎎/㎏/day for 13 weeks. We recorded the clinical signs of toxicity, body weight,
food intake/consumption, optometry, urine analysis, organ weights, hematology, and conducted serum
biochemical analysis, necropsy, gross and histological changes in target organs of Sprague-Dawley rats, and
clinical chemistry analysis.
Results : Neither death nor any toxicological signs were obserbed in KOB at all doses of 500, 1250 and 5000
㎎/㎏/day during the administration period for thirteen-week. Furthermore, there was no difference in body
weight and food-take consumption, optometry, necropsy, organ weight, gross pathological findings, and urine
analysis among the groups of rats treated with different doses of KOB, during at the observation period for
thirteen-week. The hematological analysis and clinical blood chemistry data were revealed no toxic effects from
repeated-dose administration of KOB in rats during the observation period.
Conclusions : Based on these results, the no observable adverse effect level (NOAEL) of KOB was considered to
be 5000 ㎎/㎏/day for male rats under these study conditions.
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KEYWORD
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KOB, polyherbal medicine, safety, thirteen-week repeated-dose oral toxicity
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