• Toxicological Research
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• 제19권3호
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• pp.211-215
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• 2003

This study was carried out to investigate the acute oral toxicity of a crude extract derived from fruiting body of Phellinus gilvus (PGE) using male and female SD rats. Groups consisted of five male and female rats were treated with a single dose of the test substance intragastrically at 0, 500, 1,000, 2,000, and 5,000 mg/kgaj, respectively. Clinical signs, body weight change, and food and water consumption change were observed for 14 days after administration. No mortality or abnormal clinical signs in animals were shown during the observation period at the dose used in this study. Also there was no difference in net body weight gain, water and food consumption or gross pathological findings at terminal sacrifice among the groups of rat treated with different doses of the test substance. The results suggested that acute oral toxicity of PGE in rats is very low at the conditions employed in this study and $LD_{50}$ of PGE was estimated to be over 5,000 mg/$\textrm{m}{\ell}$ in both sexes of rats.

• Biomolecules & Therapeutics
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• 제4권1호
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• pp.32-35
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• 1996

SKI306X is a herbal extract prepared from three herbs Clematis mandshurica, Trichosanthes kirilowii and Prunella vulgaris. It showed strong antiinflammatory actions on carrageenan-induced edema, acetic acid-induced pain, adjuvant-induced arthritis, and oxygen radical-generated reactions. In this study, the acute toxicity of SKI306X was evaluated in rats by a single oral administration. Thirty male and thirty female rats were divided into 6 groups according to the dose levels, respectively. After oral administration of SKI306X with several doses (5.0 g/kg, 3.3 g/kg, 2.2 g/kg, 1.5 g/kg, 1.0 g/kg), mortality, clinical signs, body weight, and gross findings in organs were examined. No toxic effect was shown in terms of mortality, clinical signs, body weight changes and gross findings. It is suggested the LD$_{50}$ of SKI306X would be more than 5.0 g/kg in rats.s.

• Toxicological Research
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• 제21권3호
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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.

• Biomolecules & Therapeutics
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• 제2권3호
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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.

• 한국한의학연구원논문집
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• 제9권2호
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• pp.131-148
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• 2003

This study was performed to evaluate the acute oral toxicity of an oriental medical prescription for obesity treatment, SH21-B, in Sprague-Dawley rats and Beagle dogs. SH21-B was administered in rats at does of 0mg/kg, 2,000mg/kg, and 5,000mg/kg. And also SH21-B was administered in Beagle dogs at does of 150mg/kg, 300mg/kg, and 600mg/kg. The rats and dogs of both sexes were observed daily for 14 days after single oral administration. Two female rats, one administered at 2,000mg/kg and the other administered at 5,000mg/kg, died, but no dead animal was observed among male rats. Therefore LD50 in the female rat is observed to be 8,710mg/kg, and MLD(Minimum Lethal Dose) of the male rat is observed to be more than 5,000mg/kg. Among dogs, no dead animal was observed up to 600mg/kg and MLD is observed to be more than 600mg/kg.

• 한방안이비인후피부과학회지
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• 제27권1호
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• pp.68-78
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• 2014

Objectives : This study was carried out to evaluate the acute oral toxicity of Dictamnus dasycarpus Turcz in Sprague-Dawley(SD) rats. Methods : Male and female rats were administered orally with Dictamnus dasycarpus Turcz water extract of 1,000 mg/kg(low dosage group), 2,000 mg/kg(middle dosage group) and 4,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 7 days. After 7 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology. But we found out subtle changes in body weight and individual organ weight of the female group. In addition specific changes were observed in serum biochemical value of female group. Conclusions : These results suggest that water soluble extract of Dictamnus dasycarpus Turcz has not acute oral toxicity and oral $LD_{50}$ value was over 4,000 mg/kg in SD rats. Also Dictamnus dasycarpus Turcz is expected to be sensitive with respect to the female.

• 대한한의학회지
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• 제44권3호
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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.

• 대한한의학방제학회지
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• 제17권2호
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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.

• 대한한의학방제학회지
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• 제21권1호
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• pp.111-118
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• 2013

Objectives : Traditional medicine Oryeong-san (ORS) has been prescribed for a long time to treat light fever, thirst, dysuria, and accompanying edema. However, the acute toxicity and safety were not reported. In this study, we evaluated the potent acute toxicity and safety of ORS. Methods : ICR mice were used to evaluate acute toxicity and safety by oral administration of 0, 500, 1,000, 2,000mg/kg of ORS. Mortality, body weight, and clinical symptoms were observed, and organ weight and blood biochemical parameters were analyzed after necropsy. Results : We found no mortality and no toxic or abnormal clinical symptoms by administration of ORS. Comparing with control group, no significant alterations in organ weight and blood biochemical parameters were observed. Conclusions : ORS recognized as safe and non-toxic medicinal material, and median lethal dose considered to be over 2,000 mg/kg in both male and female ICR mice.

• 대한한의학회지
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• 제28권2호통권70호
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• pp.200-204
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• 2007

Objectives : The purpose of this study was to investigate acute toxicity of orally-treated Sagunja-tang(Sijunzi-tang) in ICR mice. Methods : In this study, we investigated the acute toxicity of water-extracted Sagunja-tang(Sijunzi-tang). Twenty-five mice completed 14 days of oral Sagunja-tang(Sijunzi-tang) at respective doses of 0 (control group), 2560, 3200, 4000 and 5000 mg/kg. Results : We observed survival rates, clinical signs of male ICR mice with acute toxicity, change of body weight and autopsy. Conclusions : Compared with the control group, we could not find any toxic alteration in anytreated groups (2560, 3200, 4000 and 5000mg/kg). LD50 of Sagunja-tang(Sijunzi-tang) was over 5000 mg/kg and it is very safe for ICR mice.