• Herbal Formula Science
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• v.17 no.2
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• pp.65-72
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• 2009

Objectives : Yukmijihwang-tang (YJT) is known as a tonifying formula for reinforcement of yin deficiency conditions. The present study was carried out to investigate the potential acute toxicity of YJT in ICR male and female mice. Methods : We investigated the acute toxicity about boiling water-extracted YJT. The test article was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000 mg/kg body weight. Mortalities, clinical findings, autopsy and body weight changes were monitored daily for the 14 days following the administration according to the Regulation of Korean Food and Drug Administration. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. Single oral administration of YJT with different dosages, no animals died of the test drug. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of YJT for ICR mice was more than 5000 mg/kg on oral route. Conclusions : These results suggest that no toxic dose level of YJT in mice is considered to be more than 5000 mg/kg. Consequently, it was concluded that YJT have no effect on acute toxicity and side effect in ICR mice.

• Biomolecules & Therapeutics
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• v.2 no.3
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• pp.256-259
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• 1994

This study was performed to evaluate the acute toxicity of DA-3030(granulocyte-colony stimulating factor, G-CSF) in mice and rats via intragastrical and intravenous routes. DA-3030(G-CSF) in the acute toxicity study did not induce any toxic signs in the mice and rats in mortalities, clinical findings, body weights and gross findings. It is suggested that LD$_{50}$ values in mice and rats would be >13, 800 $\mu\textrm{g}$/kg in the oral route and >6, 900 $\mu\textrm{g}$/kg in the intravenous route.e.

• Toxicological Research
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• v.21 no.3
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• pp.255-261
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• 2005

Gami-Samhwang-San, a herbal prescription for obesity treatment, is composed of seven crude herbs such as Rehmanniae Radix Preparata, Ephedrae Herba, Scutellariae Radix, Acori Gramineri Rhizoma, Polygalae Radix, Typhae Pollen, Armeniacae Semen, Menthae Herba. In this study, marker substances in n-butanol fraction (SH-21-B) from Gami-Samhwang-San were analyzed by high performance liquid chromatography (HPLC) and acute toxicity of standardized SH-21-B was evaluated by good laboratory practices (GLP) guideline of Korea Food and Drug Administration. Therefore we confirmed that there were baicalin of 15.92%, amygdalin of 6.57% and ephedrine of 2.49% in SH-21-B. SH-21-B was administered in rats at dose of 0 mg/kg, 2,000 mg/kg, and 5,000mg/kg. Clinical signs of both sexes of rats were observed daily for 14 days after single oral administration. Two female rats one administered at 2,000 mg/kg and the other administered at 5,000 mg/kg, died, but no dead animal was observed among male rats. Therefore $LD_{50}$ in the female rat is observed to be 8,710 mg/kg, and MLD (Minimun Lethal Dose) of the male rat is observed to be more than 5,000 mg/kg.

• The Journal of Korean Medicine
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• v.44 no.3
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• pp.29-38
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• 2023

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

• The Korea Journal of Herbology
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• v.33 no.4
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• pp.53-58
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• 2018

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications. Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 mg/kg to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety). Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 mg/kg and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• 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.

• The Journal of Internal Korean Medicine
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• v.32 no.3
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• pp.334-344
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• 2011

Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

• Biomolecules & Therapeutics
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• v.2 no.3
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• pp.213-222
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• 1994

The acute tonicity of DWP305 (Ursodeoxycholic acid : Silymarin : Fursulthiamine : Riboflavin tetrabutyrate=1: 1 : 0.1 : 0.05) was evaluated in both sexes of Sprague-Dawley rats, 6weeks old by the oral route of administration. DWP305 was not considered to induce any toxic effect on the rats in mortalities, clinical findings, body weights and gross findings. It is suggested that LD$_{50}$ value in rats would be above 5 g/kg in the oral administration. Subacute toxicity of DWP305 was examined in Sprague-Dawley rats. Four groups of rats were administered orally at doses of 0, 0.32, 0.8, and 2.0 g/kg/day of DWP305 for one month. Any significant toxic clinical symptom was not observed in the treated rats during the experimental period. Macroscopic examination on the organs of tested animals showed no abnormal findings. On autopsy, no significant changes were found in organs examined. Maximum tolerated dose of DWP305 for the rat was estimated to be above 2 g/kg in this study.y.

• Herbal Formula Science
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• v.30 no.4
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• pp.281-291
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• 2022

Objectives : In this study, acute oral toxicity test of pomace Schisandra chinensis extracts was conducted in order to up-cycling to a high value-added industry using by-products discarded in the production process of Schisandra chinensis products and active ingredients such as dibenzocyclooctadiene lignans in Schisandra chinensis. Methods : Pomace Schisandra chinensis extracts were orally administered to SD-rats(female, n=3) without a control group according to the 'OECD guidelines'. After, mortality and clinical signs were observed, and the deceased animals were subjected to an autopsy. In addition, acute oral toxicity test was sequentially performed in step I (300 mg/kg), step II(300 mg/kg), step III(2,000 mg/kg), and step IV(2,000 mg/kg) according to the mortality. Results : There were no abnormalities caused by pomace Schisandra chinensis extracts in step I and step II. However, one animal each died in step III and step IV. In addition, clinical signs(salivation, decrease in food intake, prone position, decrease of locomotor activity, loss of locomotor activity, convulsion, hypothermia, lacrimation, staining around mouth, soiled perineal region, reddish urine, chromaturia, decrease of fecal volume, lying on side, blackish stool, no stool, compound-colored stool, refusal to feed, excitement, hypersensitivity, rigidity, dorsal position, etc.) were observed. But, no clinical signs were observed from 5th day, and experiment animals recovered completely. Conclusions : As a result of this study, pomace Schisandra chinensis extracts may exhibit acute toxicity at concentrations of 2,000 to 5,000 mg/kg, and the GHS classification was designated as 'Category 5'.

• Toxicological Research
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• v.21 no.1
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• pp.51-55
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• 2005

To investigate the acute toxicity of adventitious roots extract derived from wild ginseng, it was orally administered to beagle dogs with a single dose. In acute toxicity test, three groups (9 beagle dogs of male) were administered with different dosages of adventitious roots extract (prepared by Biopia Corp.) 500 mg/kg (G2), 1,000 mg/kg (G3), 2,000 mg/kg (G4) and one group (G1, 2 beagle dogs of male) were received by only capsule without the extract according to the Regulation on Korea Food and Drug Administration (1999. 12. 22). There were vomitus for a time and mucous stool at the day, and anorexia and mucous stool at the first day in the group of 2,000 mg/kg administration. There were mucous stool in one and anorexia for a while in two beagle dogs at the first day in the 1,000 mg/kg administration. But no death or abnormal clinical sign was observed through the study period. Therefore, the adventitious roots extract derived from wild ginseng is considered not to have the acute toxicity in the beagle dogs. These results suggest that LD/sub 50/ value of the test substance was considered to be more than 2,000 mg/kg in the beagle dogs.