• 대한본초학회지
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• 제28권2호
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• pp.61-65
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• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• 한국한의학연구원논문집
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• 제15권1호
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• pp.79-83
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• 2009

In this study, we investigated the single dose toxicity and safety about water-extracted Galgeuntang. To evaluate single dose toxicity, 20 male and 20 female ICR mice were observed survival rates, general toxicity, changes of body weight for 14 days after single oral administration of 0 (control group), 1250, 2500 and 5000mg/kg Galgeuntang. And after 14 day, We observed autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). LD50 of Galgeuntang might be over 5000mg/kg and it is very safe to ICR mice.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1996년도 춘계학술대회
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• pp.251-251
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• 1996

-Acute oral and subcutaneous toxicity of Aloewhite(30% aloesine) were carried out in ICR mice. In this study, we daily examined number of deaths, clinical signs, body weights, and pathological examinations for 14 days after single oral and subcutaneous administration of Aloewhite with different dose levels. Aloewhite did not show any remarkable toxic effect in mice. These results suggest that oral and subcutaneous LD$\sub$50/ values in mice were over 6.8g/kg and 10g/kg, respectively.

• Toxicological Research
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• 제31권4호
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• pp.403-414
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• 2015

Lithospermum erythrorhizon has long been used as a traditional oriental medicine. In this study, the acute and 28-day subacute oral dose toxicity studies of hexane extracts of the roots of L. erythrorhizon (LEH) were performed in Sprague-Dawley rats. In the acute toxicity study, LEH was administered once orally to 5 male and 5 female rats at dose levels of 500, 1,000, and 2,000 mg/kg. Mortality, clinical signs, and body weight changes were monitored for 14 days. Salivation, soft stool, soiled perineal region, compound-colored stool, chromaturia and a decrease in body weight were observed in the extract-treated groups, and no deaths occurred during the study. Therefore, the approximate lethal dose (ALD) of LEH in male and female rats was higher than 2,000 mg/kg. In the subacute toxicity study, LEH was administered orally to male and female rats for 28 days at dose levels of 25, 100, and 400 mg/kg/day. There was no LEH-related toxic effect in the body weight, food consumption, ophthalmology, hematology, clinical chemistry and organ weights. Compound-colored (black) stool, chromaturia and increased protein, ketone bodies, bilirubin and occult blood in urine were observed in the male and female rats treated with the test substance. In addition, the necropsy revealed dark red discoloration of the kidneys, and the histopathological examination showed presence of red brown pigment or increased hyaline droplets in the renal tubules of the renal cortex. However, there were no test substance-related toxic effects in the hematology and clinical chemistry, and no morphological changes were observed in the histopathological examination of the kidneys. Therefore, it was determined that there was no significant toxicity because the changes observed were caused by the intrinsic color of the test substance. These results suggest that the no-observed-adverse-effect Level (NOAEL) of LEH is greater than 400 mg/kg/day in both sexes.

• 보존과학회지
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• 제33권4호
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• pp.255-266
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• 2017

국내 문화재 생물피해 방제는 농약에서 유래한 화학적 약제를 사용하여 왔다. 그러나 인체와 환경에 대한 유해성 문제로 인하여 사용이 점차 제한되고 있으며, 새로운 방제약제의 탐색과 안전성 연구에 대한 관심이 지속적으로 증가되고 있다. 개발된 천연 생물방제제의 안전성은 동물실험을 통한 독성평가로 확인하고 있으며, 치사량과 자극성 평가를 위하여 경구독성, 경피독성, 안점막자극 및 피부자극 시험법을 이용하여 안전성을 평가한다. 독성평가를 위해 실험용 쥐와 토끼를 이용하며, 쥐에 대해 단회 경구독성과 경피독성 시험을 실시하고, 토끼에 대해 안점막자극시험 및 피부자극 시험을 시행한다. 본 시험에 이용한 천연 생물방제물질은 목재부후균과 흰개미에 대한 항진균활성 및 살충활성이 조사된 족두리풀 추출물을 적용하였다. 쥐에 대한 단회 경구투여한 결과 $LD_{50}$ 값이 수컷 4,000 mg/kg 이상, 암컷 2,000 mg/kg 이상으로 판정되었으며, 단회 경피 투여한 결과 $LD_{50}$ 값이 암수 모두 10,000 mg/kg 이상으로 판정되었다. 토끼의 눈에 대한 자극시험에서는 무자극성으로 판정되었으며, 피부에 대해서는 약한 자극성이 있는 물질로 판단되었다. 본 연구를 통해 천연 생물방제물질인 족두리풀 추출물의 안전성을 동물실험으로 확인함으로써 화학 물질의 안전성 검증을 위한 기본적인 유해성 평가 방법으로 제시하고자 한다.

• 대한한방내과학회지
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• 제35권3호
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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.

• 동의신경정신과학회지
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• 제23권3호
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• pp.143-160
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• 2012

Objectives : To provide information on the safety of ACM, we carried out a 13-week repeated oral dose toxicity and a 4-week recovery test of ACM in Sprague-Dawley rats. Methods : Female and male rats were treated with ACM with oral doses of 800, 2000, and 5000 mg/kg. The ACM 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. Moreover, the rats were monitored for 4 extra weeks to determine recovery time after the study period. Results : We found no mortality and no abnormalities in clinical signs, body weight, food consumption, ophthalmologic findings, urinalysis, hematological and biochemical parameters, gross findings, organ weights and histological markers in any of the rats tested. Conclusions : The no-observed adverse effects level (NOAEL) was considered as over 5000 mg/kg for male and female rats.

• Toxicological Research
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• 제22권2호
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• pp.117-126
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• 2006

This study was conducted to obtain the acute information of the oral dose toxicity of lyophilized water extract of Picrorrhiza Rhizoma (PR) - dried underground stem of Picrorrhiza kurroa, having various pharmacological effects, in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$), approximate lethal dose and target organs, test article was administered once by oral gavage to male and female ICR mice at 2000, 1000, 500 and 250 mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing with organ weight and histopathology of 12 types of principle organs. As the results, we could not find any mortality, clinical signs, changes in the body weight and gross findings except for hair loss, a significantly (p<0.05) increase of body weight gains in 2000mg/kg of PR extracts-dosing male group and some sporadic gross findings. In addition, no meaningful changes on the organ weight and histopathology of 12 types of principle organs were detected in the present study except for significantly (p<0.05) but dose independent changes on thymus, spleen and popliteal lymph nodes weights, and some sporadic accidental histopathological findings. The results obtained in this study suggest that the PR extract is non-toxic in mice and is therefore likely to be safe for clinical use. The $LD_{50}$ and approximate lethal dose of PR extracts in both female and male mice were considered as over 2000 mg/kg.

• 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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• 제23권5호
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• pp.1145-1153
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• 2009

The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.