• 한방비만학회지
• /
• 제17권2호
• /
• pp.96-100
• /
• 2017

Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.

• 대한한의학방제학회지
• /
• 제10권2호
• /
• pp.73-83
• /
• 2002

The single dose toxicity of Jengjengamiyjintang, a herbal drug for duodenal ulcer was evaluated in male and female Sprague-Dawley (SD) rats. Jengjengamiyjintang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125mg／kg for oral route according to KFDA guidelines for single dose toxicity test (1999-61). In addition, vehicle control group was added in order to compare clinical signs, body weight changes and abnormal necropsy findings. After single administration, clinical signs were observed every twice a day for 14 days and body weights were measured 5 times including initial measurement on day 0. When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea that were restricted to Day 1 of 2000 and 1000mg/kg-dosing groups. Although some accidental findings such as gross and histopathological changes of lung that were demonstrated in some animals of all experimental groups including vehicle control group, no abnormal necropsy findings and changes of body weight were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Jengjengamiyjintang is over 2000mg／kg in oral administration in both sexes of rats and approximated lethal dose was considered over 2000mg/kg.

• 대한한방내과학회지
• /
• 제33권1호
• /
• pp.62-68
• /
• 2012

Objectives : This study aimed to evaluate the single oral dose toxicity of Seonpyejeongcheon-tang (SJT) in male and female Sprague-Dawley rats. Methods : In this single oral toxicity study, rats were orally administrated in a single dose of 0 or 5,000 mg/kg SJT. There were 7 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological findings were observed for 14 days. Organ weight, clinical chemistry and hematology were tested after 14 days. Results : There was no mortality or other clinical signs for 14 days. There were also no significant differences in body weight, organ weights, hematological and serum chemical parameters between the SJT and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of SJT is over 5,000 mg/kg, so this finding can be expected to provide scientific evidence for the safety of SJT.

• Toxicological Research
• /
• 제23권1호
• /
• pp.65-72
• /
• 2007

This study was conducted to obtain information of the oral dose acute toxicity of PGB-2, a novel polyglucosamine polymer produced from Citrobacter sp. BL-4 (a new strain) in male and female mice. Mortality, body weight changes, clinical signs were monitored during 14 days after single oral dose of test article at dose levels of 2000, 1000, 500, 250 and 125 ml/kg. Gross lesions, organ weight and histopathology of principal organs were examined after necropsy. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings except for white foci in the liver. In addition, no PGB-2-treatment related abnormal changes on the organ weight and histopathology of principle organs were detected except for atypical signs of liver. White liver foci were confirmed as focal infiltration of inflammatory cells. The results suggest that the PGB-2 is relatively safe in mice but the possibility of hepatotoxicity could not be excluded. The $LD_{50}$ and approximate LD in mice after single oral dose of PGB-2 were considered over 2000 mg/kg, respectively. In future, the potential hepatotoxicity of PGB-2 should be evaluated through the repeat dose toxicity test prior to develop as a new agent.

• 대한약침학회지
• /
• 제21권2호
• /
• pp.104-111
• /
• 2018

Objective:This study is to evaluate both the single-dose intravenous injection toxicity and the approximate lethal dose of Water-soluble Danggui Pharmacopuncture (WDP) in Sprague-Dawley (SD) rats. Methods: Toxicity experiments were conducted at Good Laboratory Practice (GLP) laboratory in Biotoxtech Co., according to the regulations of GLP. WDP injection of dose 0.125, 0.25, and 0.5 mL/animal were experimental groups and normal saline injection group was control group. WDP and normal saline were injected once to 6- week old 5 male and 5 female SD rats at the tail veins at approximately 2 mL/min. During 14 days after the injection, general symptoms were observed and weight were measured. After the observation period, hematological and blood biochemical examination, macroscopic autopsy, topical resistance test at the injection area were performed. Results: RThe WDP 0.5 mL/animal injection group in 4 cases of male rats and all cases of female rats showed hematuria 30 minutes after the administration. However, after 1 hour, no more abnormal general symptoms were observed. The WDP did not affect weight, hematological and blood biochemical examination, macroscopic autopsy, and topical resistance test at the injection area. Conclusion: WDP single dose intravenous injection results showed that WDP have no toxic effects and a lethal dose of WDP should be over 0.5 mL/animal in male and female rats under the study condition. So WDP may be safe.

• 대한본초학회지
• /
• 제32권4호
• /
• pp.33-38
• /
• 2017

Objectives : Termitomyces albuminosus (Berk.) Heim is one of the famous wild edible mushrooms in the southern part of China. It is known that Termitomyces albuminosus, like Aconitum koreanum used in Korean traditional medicine, contains a kind of cerebroside, termitomycesphin, causing a pharmacologic effect on the neuron system. The pharmacologic effect of Termitomyces albuminosus can be used to possibly replace Aconitum koreanum. However, It needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was conducted to obtain acute information of the toxicity of dried-Termitomyces albuminosus powder and to secure its safety in clinical applications. Methods : In order to calculate approximate lethal dose(ALD), test substance was orally administered to male and female SD-rat at dose levels of 5,000 and 0 (vehicle control) mg/kg (body weight). Based on the result of this toxicity, also the estimation of safety classification was calculated using the HED-based (human equivalent dose) MOS (margin of safety). Results : There were no mortalities, test substances treatment-related clinical signs, no changes in the body or organ weights, and no gross or histopathological findings at 14 days after treatment with test substance. Thus, the approximate lethal dose of dried-Termitomyces albuminosus powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the limit dose, 5000 mg/kg, it was estimated that dried-Termitomyces albuminosus powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• 동의생리병리학회지
• /
• 제27권3호
• /
• pp.299-305
• /
• 2013

This study was to evaluate the single dose toxicity of Arecae Semen (AS) in male and female ICR mice. Aqueous extracts of AS (Yield = 13.15%) were administered as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. We could not find any mortality, clinical signs, and changes in the body and organ weight except for diarrhea. Diarrhea were observed in all three different dosage groups of male mice, and in 2000 mg/kg groups of female mice within 48hrs after administration. In addition, no AS extract related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Although the 50% lethal dose and approximate lethal dose of AS aqueous extracts in female and male mice were detected as over 2,000 mg/kg - the limited highest dosage recommended by KFDA guidelines. It should be carefully used in clinics because AS may be induced severe digestive tract disorders.

• Biomolecules & Therapeutics
• /
• 제11권3호
• /
• pp.200-203
• /
• 2003

The present study was carried out to investigate the potential acute toxicity of bamboo leaf water extract by a single oral dose in Sprague-Dawley rats. Twenty male and female rats aged 5 weeks were randomly assigned to four groups of 5 rats each and were administered singly by gavage at dose levels of 0, 1250, 2500, or 5000 mg/kg body weight. Mortalities, clinical findings, and body weight changes were monitored for the l4-day period following the administration. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. Throughout the study period, no treatment-related deaths were observed. There were no adverse effects on clinical signs, body weight, and gross finding at any dose tested. The results showed that the single oral administration of bamboo leaf water extract did not induce any toxic effect at a dose level of below 5000 mg/kg in rats and that the minimal lethal dose were considered to be over 5000 mg/kg body weight for both sexes.

• 대한예방한의학회지
• /
• 제15권2호
• /
• pp.21-38
• /
• 2011

Objective : This study was to evaluate the single dose toxicity of Bojungikki-tang(Buzhongyiqi-tang, BJIKT) in male and female mice. Method : Aqueous extracts of BJIKT were administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy ; organ weight and histopathology of 12 principle organs were examined. Results : we could not find any mortality, clinical signs, and changes in the body and organ weight. In addition, no BJIKT-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Conclusion : The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of BJIKT aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.

• 동의생리병리학회지
• /
• 제25권1호
• /
• pp.122-131
• /
• 2011

The object of this study was to evaluate the single dose toxicity of Yukmijihwangtanggamibang (YMJHTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various lung diseases including chronic obstructive pulmonary disease (COPD), in male and female mice. Aqueous extracts of YMJHTGMB (Yield = 16.33%) wasadministered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. As results, we could not find any mortality, clinical signs, and changesin the body and organ weight except for soft feces restricted to YMJHTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no YMJHTGMB-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of YMJHTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.