• Herbal Formula Science
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• v.21 no.1
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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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• v.31 no.1
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• pp.61-68
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• 2015

The objective of this study was to obtain single oral dose toxicity information for concentrated and lyophilized powder of blue honeysuckle (Lonicera caerulea L., Caprifoliaceae; BHcL) in female and male ICR mice to aid in the process of developing natural origin medicinal ingredients or foods following proximate analysis and phytochemical profile measurement. The proximate analysis revealed that BHcL had an energy value of 3.80 kcal/g and contained 0.93 g/g of carbohydrate, 0.41 g/g of sugar, 0.02 g/g of protein, and 0.20 mg/g of sodium. BHcL did not contain lipids, including saturated lipids, trans fats, or cholesterols. Further, BHcL contained 4.54% of betaine, 210.63 mg/g of total phenols, 159.30 mg/g of total flavonoids, and 133.57 mg/g of total anthocyanins. Following administration of a single oral BHcL treatment, there were no treatment-related mortalities, changes in body weight (bw) or organ weight, clinical signs, necropsy or histopathological findings up to 2,000 mg/kg bw, the limited dosage for rodents of both sexes. We concluded that BHcL is a practically non-toxic material in toxicity potency.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.41-47
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• 2011

Objectives: This study was performed to investigate single oral dose toxicity of TB001, the extract mixture of Purple loosestrife and Aceriphyllum rossii. Methods: The mortality, general symptom, change of weight: and necropcy findings was investigated for 14 days after a dose(2000 mg/kg B.W.) of TB001 was given, using SD rats of both male and female according to "The guideline of toxicity test for medicine and others". Results: The death of rats and abnormal finding was not observed. There was no the significant difference of weight between control group and TB001 group. Conclusions: The abnormalities at the necropsy finding of all survived rats was not detected. The study suggested that there is no toxicity in single dose(2000 mg/kg B.W.) of TB001.

• Journal of Korean Medicine for Obesity Research
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• v.11 no.2
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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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• v.22 no.4
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• pp.431-438
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• 2006

The object of this study was to obtain acute toxicity information (single oral dose toxicity) of lyophilized water extract of Puerariae Radix (PR) in both male and female mice. In order to investigate the 50% lethal dose $(LD_{50})$, approximate lethal dosage (ALD), test substances were once orally administered to female and male ICR mice at dose levels of 2000 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines [2005-60, 2005]. The mortality and body weight changes, clinical signs and gross observation were monitored during 14 days after dosing. Organ weight and histopathology of 12 principal organs were measured. As the results, we could not find any mortality, clinical signs, body weight changes and gross findings except for PR extracts unrelated sporadic findings. In addition, no abnormal changes related PR extracts treatment on the organ weight and histopathology of principal organs were detected except for some sporadic findings including hyperplasia of lymphoid follicles in the popliteal lymph nodes and spleen as pharmacological effects of PR extracts. The results obtained in this study suggest that the PR extracts does not cause any toxicological signs except for pharmacological effects of enhancement of Immune system. The $LD_{50}$ and ALD of PR extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected up to 2000mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development.

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.154.1-154.1
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• 2001

• Proceedings of the Korean Society of Applied Pharmacology
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• 2002.07a
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• pp.219-219
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• 2002

The SPP003 is a mixture of water extract from Schizandrae Fructus, Poligoni multiflori Radix, Ginseng Radix Akba and Hoelen. The aim of this study was to investigate the anti-hyperglycemic effect of SPP003 in normal and streptozotocin (STZ)-induced diabetic rats, and to monitor the toxicity of SPP003. Oral glucose tolerance test (OGTT) was performed after oral administration of SPP003 100, 300, 600 and 900 mg/kg in normal rats. Blood glucese concentration was measured at -30 min (vehicle, SPP003 or tolbutamide 60 mg/kg, 0 min (glucose treatment), 60, 120 and 180 min. Rats were administerd STZ 65mg/kg (0.1M citrate buffer, pH 4.5) intraperitoneally to induce diabetes and administered vehicle, Spp003 (100, 300 and 600 mg/kg) or tolbutamide (60 mg/kg) orally once a day for 4 weeks. Blood glucose level was measured a 0, 4, 7, 14, 21 and 29 day after initial drug administration. A single oral toxicity of SPP003 was studied in Sprague-Dawley rats of both sexes. In this study, rats were administered with doses of 1, 2 and 5 g/kg of SPP003. In glucose tolerance test, SPP003 900 mg/kg markedly decreased glucose concentration at 1 hr after glucose treatment. Blood glucose levels were much higher in STZ-diabetic rats. These increases were significantly attenuated by SPP003 600 mg/kg. SPP003 did not show any signigicant toxicity. These findings suggest that SPP003 has hypoglycemic properties in STZ-diabetic rats.

• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.8-15
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• 2016

Objectives: To provide information on the safety of GST (Gami-Sasangja-tang), we carried out a single oral dose-increasing toxicity test of GST in beagle dogs.Materials and Methods: Six beagle dogs (three males and three females) were randomly assigned to two groups (experimental group: n=4, control group: n=2). The experimental group (two males, two females) was given oral doses of GST in increasing order (1,250, 2,500, and 5,000 mg/kg) at three-day intervals. After administration, the participants’ mortality, clinical signs, and body weight changes were monitored for two weeks. After two weeks, all dogs were sacrificed for autopsy.Results: Temporary vomiting was observed according to increasing dosage (n=1, 250 mg/kg; n=4, 2,500 and 5,000 mg/kg). Transient diarrhea was observed on the second and third dosing day (n=1, 2,500 mg/kg; n=2, 5,000 mg/kg). Temporary salivation was noted on the third dosing day (n=3, 5,000 mg/kg). Compound-colored stool was observed in all dogs fed the GST on all dosing days and also on the following days. We found no mortality and no abnormalities in the clinical signs, body weight, and gross findings in any of the dogs tested.Conclusions: The maximum tolerated dose was over 5,000 mg/kg for both male and female dogs.

• Toxicological Research
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• v.28 no.1
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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.

• The Korea Journal of Herbology
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• v.37 no.3
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• pp.21-27
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• 2022

Objectives : Single oral dose toxicity test of Lythri Herba water extracts (LHWE) in Sprague-Dawley (SD) rat was performed to determine approximate lethal dose (ALD) of LHWE. Methods : This test was progressed according to OECD Guidelines for the Testing of Chemicals : acute oral toxicity. After adaptation of 7 days, SD rats were divided into 2 groups : vehicle control and 5000 mg/kg LHWE-treated group. Each group consisted of 5 female rats and 5 male rats. Vehicle or 5000 mg/kg LHWE was orally administrated once a day. Survival rates, general toxicity, and changes of body weight were investigated for 14 days after administration. On the last day of examination, the weight of all animals was measured and an autopsy was performed. All internal organ abnormalities were checked macroscopically and their findings were recorded. Results : In both groups, dead animals were not observed. During 14 days of administration, abnormal clinical signs were not detected. There was also no significant difference in weight gains between each group. Autopsy analysis showed that one case of the LHWE-treated female group had retention of clear fluid in the uterus; however, it was not considered to be affected by LHWE administration. Moreover, abnormal findings were not discovered in the control male group and the LHWE-treated male group. Conclusions : These results suggest that the ALD of LHWE exceed 5000 mg/kg and single oral administration of LHWE below 5000 mg/kg is nontoxic.