• 동의생리병리학회지
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• 제27권4호
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• pp.453-459
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• 2013

The objective of this study was to evaluate the single oral dose toxicity of Polygalae Radix (PR) in male and female mice. PR extract (yield = 18.6%) was administered to 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 (2009-116, 2009). Animals were monitored for the mortality and the changes in body weight, clinical signs and gross observation during 14 days after dosing. Upon necropsy, organ weight and histopathology of 14 principal organs were examined. It was observed that there were no mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs related to PR extract up to 2,000 mg/kg. Therefore, 50% lethal dose ($LD_{50}$) and approximate LD of PR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg the limited dosages recommended by KFDA Guidelines, respectively.

• 대한한의학방제학회지
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• 제21권1호
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• pp.186-199
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• 2013

Objectives : The objectives of this study was to obtain acute information (single oral dose toxicity) of Red-Koji (Monascus purpureus 12002) Fermented Scutellariae Radix Aqueous Extracts (fSR), has been traditionally used in Korean medicine for treating various diseases including inflammatory diseases. Methods : In order to observe the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, fSR powders were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14days after single oral treatment of fSR with organ weights and histopathological observations of 12 types of principle organs. Results : After single oral treatment of fSR, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents, on the body and organ weights, clinical signs, gross and histopathological observations, except for some accidental findings. Conclusions : The results obtained in this study suggest that the LD50 and ALD of fSR in both female and male mice after single oral treatment were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg and can be safety used in clinics.

• Toxicological Research
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• 제21권4호
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• pp.361-365
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• 2005

This study was conducted to obtain the acute information of the oral dose toxicity of Polycan - originated from Aureobasidium pullulans SM-2001 (half of the dry material is -1,3/1,6-glucans), a UV induced mutant of A. pullulans, having various pharmacological effects, in male and female mice. In order to calculate $50\%$ lethal dose $(LD_{50})$, approximate LD and target organs, test article was administered twice by oral gavage to male and female ICR mice at total 1000, 500 and 250mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings. The results obtained in this study suggest that the Polycan is non-toxic in mice and is therefore likely to be safe for clinical use. The L050 and approximate $(LD_{50})$ in mice after single oral dose of Polycan were considered over 1000 mg/kg, respectively.

• Toxicological Research
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• 제28권1호
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• pp.11-18
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• 2012

The aim of this study was to evaluate the single oral dose toxicity of Bupleuri Radix (BR) aqueous extracts, it has been traditionally used as anti-inflammatory agent, in male and female mice. BR extracts (yield = 16.52%) was 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 14 principal organs were examined. As the results, no BR extracts treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principal organs were detected up to 2,000 mg/kg in both female and male mice, except for soft feces and related body weight decrease detected in male mice treated with 2,000 mg/kg. Therefore, $LD_{50}$ (50% lethal dose) and approximate LD of BR aqueous extracts after single oral treatment in female and male mice were considered over 2000 mg/kg, respectively. Although it was also observed that the possibilities of digestive disorders, like soft feces when administered over 2,000 mg/kg of BR extracts in the present study, these possibilities of digestive disorders can be disregard in clinical use because they are transient in the highest dosages male only.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제41권2호
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• pp.90-96
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• 2015

Necrotizing fasciitis (NF) is an infection that spreads along the fascial planes, causing subcutaneous tissue death characterized by rapid progression, systemic toxicity, and even death. NF often appears as a red, hot, painful, and swollen wound with an ill-defined border. As the infective process continues, local pain is replaced by numbness or analgesia. As the disease process continues, the skin initially becomes pale, then mottled and purple, and finally, gangrenous. The ability of NF to move rapidly along fascial planes and cause tissue necrosis is secondary to its polymicrobial composition and the synergistic effect of the enzymes produced by the bacteria. Treatment involves securing the airway, broad-spectrum antimicrobial therapy, intensive care support, and prompt surgical debridement, repeated as needed. Reducing mortality rests on early diagnosis and prompt aggressive treatment.

• 한방비만학회지
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• 제11권2호
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• pp.25-32
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• 2011

Objectives: The purpose of this study was to investigate the acute toxicity with oral administration in ICR mice of Ohyaksungi-san fermented with Lactobacillus sp. Methods: In single oral administered toxic test, four groups were administrated different dosages(0, 1250, 2500, 5000 mg/kg) of fermented Ohyaksungi-san. After single oral administration, we observed number of death, clinical signs, body weight changes, hematological values and autopsy. Results: Compared with the control group, we could not find any toxic signs in the mortalities, clinical signs, body weight changes, necropsy findings and hematological values in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions: These results indicate that the $LD_{50}$ value of fermented Ohyaksungi-san extract might be over 5000 mg/kg and it have no side toxic effect to ICR mice

• Toxicological Research
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• 제33권1호
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• pp.15-23
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• 2017

Acanthopanax divaricatus (Siebold & Zucc.) Seem. var. albeofructus (ADA), a traditional medical herb, has been used to treat arthritis and muscular injury, to strengthen muscle and bone, and to get vital energy. However, information regarding its toxicity is limited. ADA was administered by oral gavage to groups of rats at doses of 0 (control), 1,000, 1,500, 2,000, 2,500, and 3,000 mg/kg five times per week for 13 weeks. Mortality, clinical signs, body weights, food consumption, hematology, serum chemistry, urinalysis, organ weights, necropsy, histopathological finding, vaginal cytology, and sperm morphology were compared between control and ADA-treated groups. Salivation was intermittently observed in both sexes receiving 2,500 and 3,000 mg/kg directly after dosing. Absolute liver weights increased in females receiving 2,000, 2,500, and 3,000 mg/kg ADA (P < 0.05, P < 0.01, and P < 0.01, respectively) and so did the relative liver weights (P < 0.001). Salivation and increased liver weight were ADA-related changes but not considered to be adverse effects. Salivation was intermittent and transient, and the liver weight increase was minor and not accompanied by other changes such as hepatic morphological or functional alterations. The no-observed-adverse-effect-level was determined to be at least 3,000 mg/kg in both sexes of rats.

• Toxicological Research
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• 제28권1호
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• pp.57-65
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• 2012

In this study, the 4-week oral toxicity and anti-cancer activity of the hexane layer of Melia azedarach L. var. japonica Makino's bark extract were investigated. We carried out a hollow fiber (HF) assay and 28-day repeated toxicity study to confirm the anti-cancer effect and safety of the hexane layer. The HF assay was carried out using an A549 human adenocarcinoma cell via intraperitoneal (IP) site with or without cisplatin. In the result, the 200 mg/kg b.w of hexane layer with 4 mg/kg b.w of cisplatin treated group, showed the highest cytotoxicity aginst A549 carcinoma cells. For the 28-day repeated toxicity study, 6 groups of 10 male and female mice were given by gavage 200, 100, or 50 mg/kg b.w hexane layer with or without 4 mg/kg b.w of cisplatin against body weight, and were then sacrificed for blood and tissue sampling. The subacute oral toxicity study in mice with doses of 200, 100, and 50 mg/kg b.w hexane layer showed no significant changes in body weight gain and general behavior. The cisplatin-treated group significantly decreased in body weight compared to the control group but regained weight with 100 and 200 mg/kg b.w of hexane layer. The biochemical analysis showed significant increase in several parameters (ALT, total billirubin, AST, creatinine, and BUN) in cisplatin-treated groups. However, in the group given a co-treatment of hexane layer (200 mg/kg b.w), levels of these parameters decreased. In hematological analysis, cisplatin induced the reduction of WBCs and neutrophils but co-treatment with hexane layer (100 and 200 mg/kg b.w) improved these toxicities caused by cisplatin. The histological profile of the livers showed eosinophilic cell foci in central vein and portal triad in cisplatin treated mice. These results show that hexane layer might have an anti-cancer activity and could improve the toxicity of cisplatin.

• 사상체질의학회지
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• 제22권1호
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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.

• 대한본초학회지
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• 제32권4호
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• pp.33-38
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• 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.