• The Journal of Internal Korean Medicine
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• v.30 no.4
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• pp.780-787
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• 2009

Purpose : This study was carried out to investigate the acute toxicity and safety of fermented Ssanghwa-tang extract. Methods : To evaluate their acute toxicity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 20 male and 20 female ICR mice. After a single administration, we observed survival rates. general toxicity. changes of body weight, and autopsy. Results : Compared with the control group, we could not find any toxic alteration in any of the treated groups (1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ of Ssanghwa-tang and fermented Ssanghwa-tang extracts might be over 5000 mg/kg and it is very safe for ICR mice.

• Toxicological Research
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• v.16 no.1
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• pp.83-87
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• 2000

This study was carriet out to evaluate the acute intravenous toxicity and antigenicity of Guamerin, newly developed by Mogam Biotechnology Research Institute (MBRI). In acute intravenous toxicity test, ICR mice were administered intravenously with single dose of 1,000mg/kg, and body weights and clinical signs were observed for 14 days. No dead animal, clinical signs, body weight change and abnormal autopsy findings were found in control and Gumerin treated group. Therefore, the 50% lethoal dose (LD50) of Guamerin for ICR mice was more than 1,000mg/kg on intravenous route for male and female. And the antigenic potential of Guamerin was examined by active systemic anaphylaxis(ASA) and passive cutaneous anaphylaxis(PCA) tests. In the ASA test, low and high doses (10 and 100ug/animal, respectiwely) of Guamerin were administed subcutaneously to guinea pigs for 9 times 3 weeks. All experimental groups showed negative responses whereas the positive control group given ovalbumin plus Freunds complete adjuvant (FCA) showed severe anaphylactic responses. PCA test using rats with mice anti-serum against Guamerin, low and high doses(10 and 100 ug/animal, respectively) of Guamerin were administered to mice for 9 times in 3 weeks. The anti-serum against Guamerin was administed intradermally at the back of rats, however, any positive responses were not detected in the experimental groups. These results strongly indicate that Guamerin does not induce IgE production and is not a PCA reaction inducer under these experimental conditions.

• Korean Journal of Oriental Medicine
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• v.15 no.3
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• pp.93-98
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• 2009

In this research, the acute toxicity of fermented Yukmijihwangtang extract was examined using male and female ICR mice, To evaluate the acute toxity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of fermented Yukmijihwangtang extract were orally administered to male and female ICR mice. After single administration, we observed survival rates, general toxicity, changes of body weight for the 14 days and autopsy at 1 day following the administration according to the Regulation of Korean Food and Drug Administration. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). $LD_{50}$ of fermented Yukmijihwangtang extract might be over 5000 mg/kg and it is very safe to ICR mice.

• Journal of Sasang Constitutional Medicine
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• v.22 no.1
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• pp.59-65
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• 2010

1. Objectives: The aim of this study is data analysis for acute toxicity and safety of Cheongsimyeonja-tang. 2. Methods: We investigated the acute toxicity for water-extracted Cheongsimyeonja-tang. Fifty five male and female mice were observed for 14 days after one day oral administration of Cheongsimyeonja-tang at the respective doses of 0 (control group), 2560, 3200, 4000 and 5000 mg/kg. 3. Results: We observed survival rates, general toxicity, change of body weight and autopsy. In animals administered with Cheongsimyeonja-tang, there were nither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical sign and autopsy. 4. Conclusion: The data confirmed that Cheongsimyeonja-tang is free from the toxicity and safety problems in treated groups. Compared with the control group, we could not find any toxic alteration in all treated groups(2560, 3200, 4000 and 5000 mg/kg). Lethal Dose 50 (LD50) value for mice was more than 5000 mg/kg per oral for both male and females. It suggest that Cheongsimyeonja-tang in mice is considered to be safe.

• Herbal Formula Science
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• v.19 no.2
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• pp.73-82
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• 2011

Objectives : This study aims to investigate the acute oral toxicity and safety of Samsoeum (Shensuyin) extracts and fermented Samsoeum extracts. Methods : For that objective, we used ICR mice. ICR mice were administerd orally with dosage of 1250mg/kg, 2500mg/kg and 5000mg/kg of Samsoeum extracts and fermented Samsoeum extracts. Results : We daily examined number of deaths, clinical signs, body weights and gross findings for 2 weeks. 1. The results of acute oral toxicity using ICR mice showed that LD50 of value over 5000 mg/kg. 2. Samsoeum extracts and fermented Samsoeum extracts not affect on bodyweight gross findings of ICR mice. 3. The results of Serum chemistry analysis and Complete Blood Count(CBC) through the autopsy were showed normal range values. Conclusions : Samsoeum extracts and fermented Samsoeum extracts did not show any toxic effects in ICR mice. And oral LD50 value was over 5000mg/kg in ICR mice and it is very safe for ICR mice.

• Herbal Formula Science
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• v.19 no.1
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• pp.233-241
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• 2011

Objectives : This study was carried out to investigate the acute toxicity and safety of Ssanghwa-tang extract fermented with Paecilomyces japonica. Methods : To evaluate the acute toxity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 35 male and 35 female ICR mice. After single administration, we observed number of death, general toxicity, changes of body weight, and autopsy. Results : Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ of Ssanghwa-tang and fermented Ssanghwa-tang extracts might be over 5000 mg/kg and it is very safe to ICR mice.

• Journal of Pharmacopuncture
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• v.5 no.2
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• pp.6-24
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• 2002

This experiment was carried out to study on the safety assessment of Bos tures$^{\circ}{\S}Ursus thibetanus^{\circ}{\S}$Moschus extract solution(BUM) for Herbal-acupuncture. SD rats and ICR mice were used for acute toxicity test. the results were summerized as follows; 1. In rats and mice, LD50 value could not be measured. 2. There were no abnormal finding in acute toxicity test treated BUM for Herbal-acupuncture

• Journal of Pharmacopuncture
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• v.6 no.2
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• pp.7-27
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• 2003

Objective : The purpose of this study was to investigate acute and subacute toxicity and sarcoma-180 anti-cancer effects of herbal acupuncture with cultivated wild ginseng (distilled) in mice and rats. Method : Balb/c mice were injected intravenous with cultivated wild ginseng herbal acupuncture for $LD_{50}$ and acute toxicity test. Sprague-Dawley rats were injected intravenous with cultivated wild ginseng herbal acupuncture for subacute toxicity test. The cultivated wild ginseng herbal-acupuncture was injected at the tail vein of mice. Results : 1. In acute $LD_{50}$ toxicity test, there was no mortality thus unable to attain the value. 2. Examining the toxic response in the acute toxicity test, there was no sign of toxication. 3. In acute toxic test, running biochemical serum test couldn't yield any differences between the control and experiment groups. 4. In subacute toxicity test, there was no sign of toxication in the experimental groups and didn't show any changes in weight compared to the normal group. 5. In subacute toxicity test, biochemical serum test showed significant increase of Total albumin, Albumin, and Glucose in the experimental group I compared with the control group. Significant decrease of GOT, ALP, GPT, and Triglyceride were shown. In experiment group II, only Glucose showed significant increase compared with the control group. 6. Measuring survival rate for anti-cancer effects of Sarcoma-180 cancer cell line, all the experimental groups showed significant increase in survival rate. 7. Measuring NK cell activity rate, no significant difference was shown throughout the groups. 8. Measuring Interleukin-2 productivity rate, all the experimental groups didn't show significant difference. 9. For manifestation of cytokine mRNA, significant decrease of interleukin-10 was witnessed in the experimental group compared to the control group. Conclusion : According to the results, we can conclude cultivated wild ginseng herbal acupuncture caused negligible toxicity, and had anti-tumor effects in mice.

• Journal of Korean Medicine for Obesity Research
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• v.9 no.2
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• pp.11-19
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• 2009

Objectives In this study, we investigated the acute toxicity and safety about fermented Bangpungtongsung-san(Fangfengtongsheng-san) extract. Methods To evaluate the acute toxity and safety, fermented Bangpungtongsung-san (Fangfengtongsheng-san) at the respective doses of 0(control group), 1250, 2500 and 5000 mg/kg were orally treated to 20 male and 20 female mice. After single administration, we observed survival rates, general toxicity, changes of body weight and autopsy. Results Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions $LD_{50}$ of fermented Bangpungtongsung-san(Fangfengtongsheng-san) extract might be over 5000 mg/kg and it is very safe to ICR mice.

• Toxicological Research
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• v.16 no.1
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• pp.67-71
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• 2000

It has been demonstrated that the injection of naked DNA expressing vascular endothelial growth factor 165(VEGFl165) to the affected area can provide significant therapeutic effects on peripherol artery occlusive diseases. Success with this type of gene therapy highly depends on the quality of the vector delivering the therapeutic gene, especially in terms of the level and duration of gene expression in the localized area. We have recently developed a vector expressing VEGF165(pCK-VEGF) for the treatment of peripheral artery occulsive diseases and demonstrated high level expression of VEGF165 in mouse skeletal muscle. This study was designed to assess the acute toxicity of intramuscularly injected pCK-VEGF in BALB/c mice and Sprague-Dawely rats. There was no evidence of any changes in clinical signs, body weights, or gross pathological signs. We estimate LD50 values of pCK-VEGF higher than 50mg/kg in mice and 20 mg/kg in rats by intramuscular injection.