• 생약학회지
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• 제33권1호통권128호
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• pp.5-12
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• 2002

This study was performed to evaluate hepatoprotective effect of Daewhang-whangryunhaedok-Tang(DWT) on liver injured rats induced by $CCl_4$ and the acute oral toxicity of it in mice. The activities of serum transaminase(ALT/AST), alkaline phosphatase(ALP) and lactic dehydrogenase (LDH), the levels of serum total cholesterol(TC) and triglyceride(TG), change of liver enlargement, and inhibitory activities of lipid peroxidation, catalase and glutathione-S-transferase(GST) in liver microsome were determined in hepatotoxic rats induced by $CCl_4$ DWT DWT was significantly reduced the serum ALT, AST, ALP, LDH, TC and TG levels. And, the increase of lipid peroxidation, decrease of catalase and GST activities in the liver microsome of $CCl_4$-intoxicated rat were significantly improved by the treatment of DWT. Male and female mice were administered maximum dosages of 5,000 mg/kg b.w. of DWT. After single oral administration of DWT to mice, we observed them daily for 2 weeks. DWT did not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of mice. Based on these results, it is concluded that DWT may have the hepatoprotective effect on $CCl_4$ induced hepatotoxicity in rats. Also, DWT may have no side effect and its $LD_{50}$ value may be over 5,000 mg/kg b.w. in mice.

• 농업과학연구
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• 제45권2호
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• pp.248-257
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• 2018

Overexpression of AtCYP78A7, a gene encoding a cytochrome P450 protein, has been reported to improve tolerance to drought stress in genetically modified (GM) rice (Oryza sativa L.). The aim of this study was to evaluate the potential allergenicity and acute oral toxicity of the AtCYP78A7 protein expressed in GM rice. Bioinformatics analysis of the amino acid sequence of AtCYP78A7 did not identify any similarities with any known allergens or toxins. It showed that no known allergen had more than a 35% amino acid sequence homology with the AtCYP78A7 protein over an 80 amino acid window or more than 8 consecutive identical amino acids. The gene encoding the AtCYP78A7 protein was cloned in the pGEX-4T-1 vector and expressed in E. coli. Then, the AtCYP78A7 protein was purified and analyzed for acute oral toxicity. The AtCYP78A7 protein was fed at a dose of 2,000 mg/kg body weight in mice, and the changes in mortalities, clinical findings, and body weight were monitored for 14 days after the dosing. Necropsy was carried out on day 14. The protein did not cause any adverse effects when it was orally administered to mice at 2000 mg/kg body weight. These results indicate that the AtCYP78A7 protein expressed in GM rice would not be a potential allergen or toxin.

• Toxicological Research
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• 제28권4호
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• pp.263-268
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• 2012

The aim of this study was to investigate the acute oral toxicity of fermented Scutellariae Radix (JKTMHGu-100) in rats and dogs. JKTM-HGu-100 was orally administered at a dose of 2,000 mg/kg in Sprague-Dawley rats. An escalating single-dose oral toxicity test in beagle dogs was performed at doses of 500, 1000, and 2000 mg/kg with 4-day intervals. Clinical signs, changes in body weight, mortality, and necropsy findings were examined for 2 weeks following oral administration. No toxicological changes related to the test substance nor mortality was observed after administration of a single oral dose of JKTM-HGu-100 in rats or dogs. Therefore, the approximate lethal dose (LD) for oral administration of JKTMHGu-100 in rats was considered to be over 2,000 mg/kg, and the maximum tolerance doses (MTDs) in rats and dogs were also estimated to be over 2,000 mg/kg. These results indicate that JKTM-HGu-100 shows no toxicity in rodents or non-rodents at doses of 2,000 mg/kg or less.

• Toxicological Research
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• 제35권2호
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• pp.181-190
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• 2019

Lentinus squarrosulus (Mont.) is an edible wild mushroom with tough fruiting body that belongs to the family Polyporaceae. It is used in ethnomedicine for the treatment of ulcer, anaemia, cough and fever. Recent studies have demonstrated its anticancer, anti-diabetic and antioxidant properties. However, little or no information is available regarding the bioactive components and toxicological study of wild dried L. squarrosulus. Therefore, this study investigated the bioactive components of aqueous extract of boiled wild dried L. squarrosulus and its toxicological effects in rats. The extract of L. squarrosulus was subjected to GC-MS analysis. The acute toxicity test was performed by oral administration of a single dose of up to 5,000 mg/kg extract of L. squarrosulus. In subacute study, the rats were orally administered extract of L. squarrosulus at the doses of 500, 1,000 and 1,500 mg/kg body weight daily for 14 days. The haematological, lipid profile, liver and kidney function parameters were determined and the histopathology of the liver and kidney were examined. The GC-MS analysis revealed the presence of bioactive compounds; 1-tetradecene, fumaric acid, monochloride, 6-ethyloct-3-yl ester, 9-eicosene, phytol, octahydropyrrolo[1,2-a]pyrazine and 3-trifluoroacetoxypentadecane. In acute toxicity study, neither death nor toxicity sign was recorded. In the sub-acute toxicity study, significant differences (p < 0.05) were observed on creatinine, aspartate aminotransferase, alanine aminotransferase, total cholesterol, triglycerides and high-density lipoprotein cholesterol. Whilst no significant differences (p > 0.05) were observed on packed cell volume, heamoglobin, red blood cell, white blood cell and alkaline phosphatase, in all the tested doses. No histopathological alterations were recorded. Our findings revealed that aqueous extract of L. squarrosulus may have antimicrobial, antinocieptive and antioxidant properties based on the result of GC-MS analysis. Results of the toxicity test showed no deleterious effect at the tested doses, suggesting that L. squarrosulus is safe for consumption at the tested doses.

• 한방안이비인후피부과학회지
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• 제23권1호
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• pp.111-117
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• 2010

Objectives : This study was conducted to evaluate the acute toxicity and safety of Bangpungtongsung-san (Fangfengtongsheng-san) in Sprague-Dawley rat though the current regulatory guideline. Methods : The preliminary study showed that the single oral administration of Bangpungtongsung-san (Fangfengtongsheng-san) did not induce any toxic effect at a dose level of 2000 mg/kg. Based on the results, 2000 mg/kg was selected as the limited dose. In this study, 10 rats of each sex were randomly assigned to two groups of 5 rats each and were administrated singly by gavage at dose levels of 0 and 2000 mg/kg. Mortalities, clinical signs, and body weight changes were monitored for the 15-day period following administration. At the end of observation period, all animals were sacrificed and complete gross postmortem examinations were performed. Results : Throughout the study period, no treatment-related deaths were observed. There were no adverse effects on clinical signs, body weight, and gross findings at all treatment groups. Conclusions : These results showed that the single oral adminstration of Bangpungtongsung-san (Fangfengtongsheng-san) did not cause any toxic effect at the dose levels of 2000 mg/kg in rats. In conclusion, the $LD_{50}$ of Bangpungtongsung-san (Fangfengtongsheng-san) was considered to be over 2000 mg/kg body for both sexes.

• 생명과학회지
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• 제24권10호
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• pp.1132-1136
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• 2014

울금(Curcuma longa L., turmeric)은 생강과(Zingiberaceae)에 속하는 다년생 초본 식물로 전통적으로 한약재, 향신료 및 식용으로 사용되어 왔다. 강력한 항산화 작용, 울금 에탄올 추출물의 항산화 활성, 항돌연변이성, 항염증, 항암성 및 항균성 효과 등이 보고되고 있다. 그러나 울금에 대한 생리활성 연구는 이미 많이 이루어져 있는 반면 울금에 대한 독성평가는 이루어지지 않았다. 본 연구는 울금 에탄올 추출물에 대한 안정성을 확보하기 위하여 단회경구투여 독성시험을 BALB/c 마우스를 이용하여 실시하였다. 울금 에탄올 추출물은 0, 20, 200, 2,000 mg/kg 농도로 경구 투여하였으며, 14일간 관찰 후 희생시켰다. 울금 에탄올 추출물 투여 후 운동성, 비정상적 임상증상, 부검 소견상, 체중의 유의적인 변화는 관찰되지 않았다. 혈액 생화학적 측정과 다양한 장기의 무게에서도 유의적인 변화를 관찰할 수 없었다. 이들 결과로 미루어볼 때 울금 에탄올 추출물의 단회 투여에 따른 치사량은 2,000 mg/kg 이상을 상회할 것으로 추정되며 급성독성에 어떠한 유해성이 없다는 것을 의미한다.

• 동국한의학연구소논문집
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• 제11권
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• pp.66-73
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• 2008

Objectives: The study was designed to evaluate the single dose toxicity of modified Bo-yang-Hwan-o-Tang (mBHT) in Sprague-Dawley (SD) rats. Methods: The mBHT was once administrated orally to both sexes of rats at dose 2,000 mg/kg body weight which are the recommended maximum limit dose for acute toxicity. We recorded clinical signs of toxicity, body weight, gross and histological changes in target organs for all rats. Results: Neither significant changes of body weight not death was observed during the observation period in mBHT-administrated rats. Neither significant toxic signs not histopathological changes were shown during the observation period. There were not observed significant gross abnormality between the control and mBHT-administrated rats. Conclusions: These results indicated that the toxicity of mBHT is greater than 2,000 mg/kg body weight in SD rats.

• Toxicological Research
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• 제6권1호
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• pp.41-49
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• 1990

Aconiti Tuber is the root of Aconitum sp (Ranunclaceae) which has been considered as one of the most important medicinal plant having cordiotonic, diuretic and analgesic effect. On the other hand, it has been known that Aconiti Tuber contained toxic agent, aconitine alkaloids so that only processed Aconiti Tubers have been used as herbal drug traditionally. For the safety evaluation of processed Aconiti Tuber, quantitative determination of aconitine and acute, subacute toxicity test were performed on 5 commercial processed Aconiti Tubers. Arapid and precise method using HPLC has been developed for the separation and determination of aconitine. Samples were extracted with hydrochloric acid (pH3) and hot water decoction. In case of d-HCL extracts, the contents of aconitine were from 0.08 mg/g to trace. But in case of hot water decoction extracts, the contents of aconitine were not detected. For the investigation of Aconiti Tuber toxicity in rats, hot water decoction samples and methanol extracts were tested. 1) Acute toxicity test Hot water decoction sample and methanol extracts from Aconiti Tuber did not show any toxic effects in rats by an oral administration. $LD_50values of 2 extracts were above 10.0 g/kg. 2) Subacute toxicity study In the repeated administration study, hot water decoction samples were given orally to Sprague-Dawlay rats for 2 week at daily doses of 5.0 g/kg. The results are as follows; No toxic manifestation, body weight changes and lethality were observed during wxperimental period. There were no significant changes in serum enzyme activities such as GOT, GPT, LDH, ALP between treated and control groups. However CPK values were decreased in the Subuja-treated group. (P<0.01). In addition, no gross and microscopic changes were noted in Aconiti Tuber-treated groups.

• 대한본초학회지
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• 제33권1호
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• pp.71-76
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• 2018

Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.

• 생약학회지
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• 제45권2호
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• pp.181-185
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• 2014

This study was carried out to investigate the acute toxicity of the bark of Diospyros kaki (Ebenaceae) in mice. The aqueous extract of the bark of Diospyros kaki (AEDK) was administered orally at a doses of 5 mg/kg, 50 mg/kg, 300 mg/kg and 2,000 mg/kg. In this study, number of deaths, clinical signs, body weights and pathological examinations were investigated after administration of AEDK. There were neither dead animals nor significant changes of body weights during the experimental period. In addition, no differences were found between control and AEDK treated groups in clinical signs, organ weights and gross pathological findings. AEDK did not show any toxic effect in mice.