• 대한한방내과학회지
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• 제37권1호
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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.

• 동의생리병리학회지
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• 제26권2호
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• pp.189-198
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• 2012

Our former study indicated efficacy of apoptotic cell death on animal study by using Egg white combined Chalcanthite (EC). Clinically, bamboo salt is using because of safety. Hence we investigated a toxicity study for determining safety by adding bamboo salt in former materiel. We had two studies: toxicity of EC and of Bamboo salt with egg white combined Chalcanthite (BC). Both were studied in 1-week single and 5-week repeated oral dose toxicity tests on male Imprinting Control Region mice. In EC, doses used in 1 week single oral dose toxicity tests were 0, 0.05, 0.5, 5 and 50 mg/kg/day and 0, 0.01, 0.05, 0.25 and 0.5 mg/kg/day. In BC, doses used by 0, 0.08, 8.3, 83.3 and 166.6 mg/kg/day in single oral dose toxicity and 0, 4.2, 8.3, 41.7 and 83.3 mg/kg/day in repeated oral dose toxicity tests. Their blood and urine were assayed and organ morphology were examined. Mann-Whitney U test and ANOVA tests were used by analysing methods. First, significant increased left renal weight in all groups of EC and BC. Second, increased ALT score was found in EC-S2 and increased relative liver weight was found in EC-S3. In addition, increased relative weight and urine bilirubin and urobilinogen were found in EC-R2 and EC-R3. There was no significant toxic change in BC. The Mixture of EC had a possibility of hepatotoxicity in the short and long term. Processed BC appears to be safe and non-toxic in these studies and a no-observed adverse effect level (NOAEL) was established at 83.3 mg/kg/day in mice. Relatively, The BC were safer than The EC.

• 대한약침학회지
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• 제18권3호
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• pp.63-67
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• 2015

Objectives: This study was performed to analyze the single-dose oral toxicity of the super key (processed sulfur). Methods: All experiments were conducted at Medvill, an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate the oral toxicity of super key. We administered it orally to Sprague-Dawley (SD) rats. The SD rats were divided into four groups of five male and five female animals per group: group 1 being the control group and groups 2, 3, and 4 being the experimental groups. Doses of super key 500 mg/kg, 1,000 mg/kg and 2,000 mg/kg were administered to the experimental groups, and a dose of normal saline solution, 10 mL/kg, was administered to the control group. We examined the survival rates, weights, clinical signs, gross findings and necropsy findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. (Approval number: A01-14018). Results: No deaths or abnormalities occurred in any of the four groups. Although slight decreases in the weights of some female rats were noted, no significant changes in weights or differences in the gross findings between the control group and the experimental groups were observed. To check for abnormalities in organs, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs. Conclusion: The results of this research showed that administration of 500 - 2,000 mg/kg of super key did not cause any changes in the weights or in the results of necropsy examinations. Neither did it result in any mortalities. The above findings suggest that treatment with super key is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

• 한방안이비인후피부과학회지
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• 제14권2호
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• pp.118-124
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• 2001

The single dose toxicity of Injinhotang, a herbal drug for treatment of hepatic injuries. was evaluated in Sprague-Dawley rats. Injinhotang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125 mg/kg for oral route. After single administration, clinical signs were observed every day for 14 days and body weights were measured 5 times including initial measurement on day 0 (the days of administration). When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. In addition, the histopathological profiles of these major organs were also conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea. In addition, no abnormal necropsy findings, changes of body weight and histopathological profiles were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Injinhotang is over 2000 mg/kg in oral administration in both sexes of rats.

• Toxicological Research
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• 제35권3호
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• pp.225-232
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• 2019

Thymus vulgaris L. is widely used as an ingredient in cooking and in herbal medicine. However, there is little information about its toxicity. The present study was performed to evaluate the acute and repeated 28-day oral dose toxicity of thyme essential oil in rats. For the acute toxicity test, two groups of three rats were used. The rats received a single dose of essential oil: 300 or 2,000 mg/kg of body weight (bw). The rats were observed individually during the first four hours, and then daily until day 14. For the toxicity test with repeated doses, four groups of 10 rats were used. Doses of 100, 250, and 500 mg/kg/day were tested for 28 days. At the end of the experiment, blood was collected and the animals were sacrificed. Histopathological examination showed that in the lungs of rats given the 2,000 mg/kg bw dose, polymorph nuclear infiltrates, hemosiderin macrophages, and interstitial space thickening were present. In the repeated dose study, all rats survived the 28-day treatment period and apparently showed no signs of toxicity. The hematological and biochemical parameters were not altered. The histopathological study of the organs showed severe changes in the lung, with the dose of 500 mg/kg/day; in the other organs, no alterations were observed or the changes were slight. The body weight was only altered in male rats given the 500 mg/kg dose. The relative weight of the organs did not show any significant changes. Our studies revealed that the essential oil of Thymus vulgaris has moderate oral toxicity according to the results of the acute test, whereas the results of the 28-day oral toxicity test suggest that the no-observed-adverse effect level (NOAEL) is greater than 250 mg/kg/day.

• 대한수의학회지
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• 제47권4호
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• pp.379-387
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• 2007

This study was conducted to investigate the pathogenicity of Paenibacillus (R) polymyxa JB 115 and single oral dose toxicity of culture broth containing (${\beta}$-glucan (CBG-JB 115) produced from P. polymyxa JB 115 in Sprague-Dawely rats of both sexes for 14 days. After oral administration of P. polymyxa JB 115 into rats, we could not find any abnormal clinical signs and variation in the body weight and temperature as compared with control group. We also investigated the acute toxicity of CBG-JB 115. As the results, there were no clinical signs and variance in the body weight and temperature related with CBG-JB 115 in comparison with the control group. From the this experiment, we could not find out any significant pathogenicity and toxicity induced by P. polymyxa JB 115 or by CBG-JB 115. Results of this study demonstrated that consumption of P. polymyxa JB 115 and its culture broth containing (${\beta}$-glucan was not associated with any obvious signs of toxicity in Sprague-Dawely rats even following consumption of large quantities.

• 생약학회지
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• 제40권3호
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• pp.251-256
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• 2009

Cordyceps bassiana is a parasitic fungus and used as a Chinese traditional medicine. It has been called as DongChungHaCho(summer-plant, winter-worm) in China. Acute oral toxicity was examined in male and female ICR mice. Butanol fraction from Cordyceps bassiana(BuCb) was administered orally at a dose of 2,500 mg/kg, 5,000 mg/kg, 10,000 mg/kg. No death and abnormal clinical signs were observed throughout the administration period. The acute toxicity test on mouse did not show any oversign in net body weight gain, food and water consumptions, organ weights, gross pathological findings by different doses of BuCb. Also, biochemical examination revealed no evidence of specific toxicity. These findings show that BuCb has wide margin of safety on acute toxicity with single exposure.

• 대한한방부인과학회지
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• 제23권4호
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• pp.47-56
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• 2010

Purpose: This study was performed to evaluate the single dose oral toxicity of Gwibi-tang extract in ICR mice. Methods: 0(control group), 1250, 2500 and 5000 mg/kg of Gwibi-tang extracts were orally administered to 20 male and 20 female ICR mice. After single oral administration of Gwibi-tang extract to ICR mice, we observed number of the death, clinical signs, changes of body weights for 14 days. After 14 day of Gwibitang extract administration, all mice were sacrificed and major organs were observed. Results: Compared with the control group, we could not find any toxic signs in the mortalities, clinical signs, body weight changes, necropsy findings and hematological values in all treated groups(1250, 2500 and 5000 mg/kg). Conclusions: $LD_{50}$ value of Gwibi-tang extracts may be over 5000 mg/kg and it may have no side toxic effect to ICR mice.

• 대한본초학회지
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• 제37권3호
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• pp.21-27
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• 2022

Objectives : Single oral dose toxicity test of Lythri Herba water extracts (LHWE) in Sprague-Dawley (SD) rat was performed to determine approximate lethal dose (ALD) of LHWE. Methods : This test was progressed according to OECD Guidelines for the Testing of Chemicals : acute oral toxicity. After adaptation of 7 days, SD rats were divided into 2 groups : vehicle control and 5000 mg/kg LHWE-treated group. Each group consisted of 5 female rats and 5 male rats. Vehicle or 5000 mg/kg LHWE was orally administrated once a day. Survival rates, general toxicity, and changes of body weight were investigated for 14 days after administration. On the last day of examination, the weight of all animals was measured and an autopsy was performed. All internal organ abnormalities were checked macroscopically and their findings were recorded. Results : In both groups, dead animals were not observed. During 14 days of administration, abnormal clinical signs were not detected. There was also no significant difference in weight gains between each group. Autopsy analysis showed that one case of the LHWE-treated female group had retention of clear fluid in the uterus; however, it was not considered to be affected by LHWE administration. Moreover, abnormal findings were not discovered in the control male group and the LHWE-treated male group. Conclusions : These results suggest that the ALD of LHWE exceed 5000 mg/kg and single oral administration of LHWE below 5000 mg/kg is nontoxic.

• 생명과학회지
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• 제26권2호
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• pp.204-211
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• 2016

본 실험에서는 유산균발효 독활의 마우스 단회 경구 투여 독성 자료를 얻기 위해 식품의약품안전청 고시 제 2013-121 “의약품 등의 독성시험 기준”에 의거하여, 설치류 투여 한계 용량인 2,000 mg/kg을 최고 투여군을 설정하고 공비 2로 1,000 및 500 mg/kg 투여군을 중간 및 저용량 투여군으로 설정하여 실험을 실시하였으며, 그 결과는 독활 열수 추출물 2,000 mg/kg 암수 투여군 및 암수 매체 대조군과 비교 평가 하였다. 본 실험의 결과, 설치류 투여한계 용량인 2,000 mg/kg 투여군까지, 유산균발효 독활 열수 추출물 투여와 관련된 사망례, 임상증상, 체중, 장기중량, 육안부검 및 조직병리학적 소견이 인정되지 않았다. 따라서 유산균발효 독활 열수 추출물의 마우스에 대한 단회 경구 투여 반수 치사량 및 개략적 치사량은 암수 각각 2,000 mg/kg이상으로 산출되었으며, 특정 임상증상 및 표적 장기 역시 없는 것으로 판단되어, 유산균발효 독활은 매우 안전한 물질로 판단된다. 또한 독활 열수 추출물 2,000 mg/kg 투여와 관련된 사망례, 임상 증상, 체중, 장기중량, 육안 및 조직병리학적 변화 역시 인정되지 않았다. 이러한 결과는 독활의 활용도를 증대시키는 기초 자료가 될 것으로 사료된다.