• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.8-15
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• 2016

Objectives: To provide information on the safety of GST (Gami-Sasangja-tang), we carried out a single oral dose-increasing toxicity test of GST in beagle dogs.Materials and Methods: Six beagle dogs (three males and three females) were randomly assigned to two groups (experimental group: n=4, control group: n=2). The experimental group (two males, two females) was given oral doses of GST in increasing order (1,250, 2,500, and 5,000 mg/kg) at three-day intervals. After administration, the participants’ mortality, clinical signs, and body weight changes were monitored for two weeks. After two weeks, all dogs were sacrificed for autopsy.Results: Temporary vomiting was observed according to increasing dosage (n=1, 250 mg/kg; n=4, 2,500 and 5,000 mg/kg). Transient diarrhea was observed on the second and third dosing day (n=1, 2,500 mg/kg; n=2, 5,000 mg/kg). Temporary salivation was noted on the third dosing day (n=3, 5,000 mg/kg). Compound-colored stool was observed in all dogs fed the GST on all dosing days and also on the following days. We found no mortality and no abnormalities in the clinical signs, body weight, and gross findings in any of the dogs tested.Conclusions: The maximum tolerated dose was over 5,000 mg/kg for both male and female dogs.

• The Journal of Internal Korean Medicine
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• v.35 no.3
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• pp.223-243
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• 2014

Objectives: To provide information on the safety of GST (GamiSasangja-tang; CnidiiFructus, Sophora Root, Angelica Gigas Root, Clematidis Radix, Stemonae Radix, Spirodelae Herba), we carried out a 13-week repeated oral dose toxicity and a 4-week recovery test of GST in Sprague-Dawley rats. Methods: Female and male rats were treated with GST at oral doses of 1,250, 2,500, and 5000 mg/kg. The GST was administered for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers were monitored during the study period. The rats were then monitored for 4 extra weeks to determine recovery time after the study period. Results: We found no mortality or abnormalities among clinical signs, body weight, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights or histological markers in any of the rats tested. Conclusions: The no-observed adverse effects level (NOAEL) is considered as over 5000 mg/kg for male and female rats.