A 4-week Repeated dose Oral Toxicity Study of Mecasin in Sprague-Dawley Rats to Determine the Appropriate Doses for a 13-week, Repeated Toxicity Test
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Objectives: In this study, we investigated the 4-weekrepeated-dose oral toxicity of gami-jakyak gamcho bujadecoction (Mecasin) to develop safe treatments. Methods: In order to investigate the 4-week oral toxicityof Mecasin, we administered Mecasin orally to rats. Sprague-Dawley (SD) rats were divided into four groupsof five male and five female animals per group: group 1being the control group and groups 2, 3, and 4 being theexperimental groups. Doses of Mecasin of 500, 1,000,and 2,000 mg/kg of body weight were administered tothe experimental groups, and a dose of normal salinesolution of 10 mL/kg was administered to the controlgroup. We examined the survival rate, weight, clinicalsigns, and gross findings for four weeks. This study wasconducted under the approval of the Institutional AnimalEthics Committee. Results: No deaths occurred in any of the four groups. No significant changes in weights or food consumptionbetween the control group and the experimentalgroups were observed. Serum biochemistry revealedthat some groups showed significant decrease in inorganicphosphorus (IP) (P < 0.05). During necropsyon the rats, one abnormal macroscopic feature, a slightloss of fur, was observed in the mid dosage (1,000 mg/kg) male group. No abnormalities were observed inany other rats. In histopathological findings, the tubularbasophilia and cast of the kidney and extramedullaryhematopoiesis of the spleen were found. However,those changes were minimal and had occurred naturallyor sporadically. No other organ abnormalitieswere observed. Conclusion: During this 4-week, repeated, oral toxicitytest of Mecasin in SD rats, no toxicity changes dueto Mecasin were observed in any of the male or the femalerats in the high dosage group. Thus, we suggestthat the doses in a 13-week, repeated test should be 0,500, 1,000, and 2,000 mg/kg respectively.
Abstract
Objectives: In this study, we investigated the 4-weekrepeated-dose oral toxicity of gami-jakyak gamcho bujadecoction (Mecasin) to develop safe treatments. Methods: In order to investigate the 4-week oral toxicityof Mecasin, we administered Mecasin orally to rats. Sprague-Dawley (SD) rats were divided into four groupsof five male and five female animals per group: group 1being the control group and groups 2, 3, and 4 being theexperimental groups. Doses of Mecasin of 500, 1,000,and 2,000 mg/kg of body weight were administered tothe experimental groups, and a dose of normal salinesolution of 10 mL/kg was administered to the controlgroup. We examined the survival rate, weight, clinicalsigns, and gross findings for four weeks. This study wasconducted under the approval of the Institutional AnimalEthics Committee. Results: No deaths occurred in any of the four groups. No significant changes in weights or food consumptionbetween the control group and the experimentalgroups were observed. Serum biochemistry revealedthat some groups showed significant decrease in inorganicphosphorus (IP) (P < 0.05). During necropsyon the rats, one abnormal macroscopic feature, a slightloss of fur, was observed in the mid dosage (1,000 mg/kg) male group. No abnormalities were observed inany other rats. In histopathological findings, the tubularbasophilia and cast of the kidney and extramedullaryhematopoiesis of the spleen were found. However,those changes were minimal and had occurred naturallyor sporadically. No other organ abnormalitieswere observed. Conclusion: During this 4-week, repeated, oral toxicitytest of Mecasin in SD rats, no toxicity changes dueto Mecasin were observed in any of the male or the femalerats in the high dosage group. Thus, we suggestthat the doses in a 13-week, repeated test should be 0,500, 1,000, and 2,000 mg/kg respectively.
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