• The Korea Journal of Herbology
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• v.27 no.3
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• pp.101-106
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• 2012

Objectives : To evaluate the toxicity of KOB03, polyherbal medicine for the treatment of allergic rhinitis, we performed the dose-range finding test of KOB03 by oral supplementation for 4 weeks in Sprague-Dawley rats. Methods : The water extract of KOB03 consisting of five different herbs was supplied from GLP company. KOB03 was supplemented by gavage at 0, 500, 2,500 and 5,000 mg/kg/day for 4-week consecutive days. We recorded the clinical signs of toxicity, body weight, organ weights, hematology, gross and histological changes in target organs of rats, and clinical chemistry analysis. Results : KOB03 at all doses was shown no mortality or abnormal clinical signs in rats during at the observation period. Furthermore, there was no difference in body weight and food-take consumption, organ weight, gross pathological findings, and urine analysis among the groups of rats treated with different doses of KOB03. The hematological analysis and clinical blood chemistry data were revealed no toxic effects from KOB03-supplemented rats. Conclusions : The results suggest that KOB03 is a wide margin of safety on dose-range toxicity in rats. The no observable adverse effect level (NOAEL) of the test, KOB03 in rats is no less than 5,000 mg/kg/day.

• The Korea Journal of Herbology
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• v.28 no.1
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• pp.15-21
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• 2013

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) mg/kg/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 mg/kg/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 mg/kg/day for male rats under these study conditions.