• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.1
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• pp.124-133
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• 2010

The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.

• Toxicological Research
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• v.20 no.2
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• pp.123-129
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• 2004

The present study was conducted to investigate the single and 2-week repeated dose toxicity of DHP2, a hydrophobic drug delivery vehicle, in ICR mice. The test article was administered orally to mice at the dose levels of 2.5, 12.5 and 37.5 g/kg for single dose toxicity study and at the dose levels of 0, 2.5, 5, and 10 g/kg for repeated dose toxicity study. In both studies, there were no treatment-related effects on mortality, clinical signs, food and water consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings and organ weights of all animals treated DHP2. Based on these results, it was concluded that the 2-week repeated oral dose of DHP2 may have no toxic effect in mice at a dose level of 10 g/kg. In the condition of this study, the no-observed-adverse-effect level (NOAEL) was considered to be 10 g/kg/day for both sexes.

• Herbal Formula Science
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• v.28 no.2
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• pp.169-177
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• 2020

Objectives : This experiment was designed to assess the single oral toxicity of Ethanol Extract Inulae Flos (IF) ethanol extracts. IF is one of the important herbs to remove phlegmy which is the viscous turbid pathological product that can accumulate in the body, causing a variety of diseases. Nevertheless, there has been a lack of research on the pharmacology toxicity of IF. Methods : In this study, IF was orally administered to 5 weeks ICR mice as an oral dose of 2,000 or 3,000 or 5,000 mg/kg. The condition of the mice was observed for 14 days and their weights were measured every two days. Results : None of the mice died for 14 days. The abnormal clinical symptoms and anatomical signs of toxicity were not found in any treatment groups. The gain of net body weight was observed. There was also no significant difference in the organ weight. The serum biochemistry and hematological analysis showed a decrease in BUN, red blood cells, white blood cells and platelets although within the normal ranges. Conclusions : These results suggest that the 50% lethal dose of IF is more than 5,000 mg/kg. This could be thought that IF is a safe drug without acute toxicity and side effects. However, IF showed some weight loss and change in blood test, so it will need to be careful when using it for high doses.

• The Korea Journal of Herbology
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• v.32 no.4
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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.

• Biomolecules & Therapeutics
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• v.9 no.4
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• pp.307-310
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• 2001

The hair-growth effect of Illite was suggested by some people who were using Illite as a beautifying material. We investigated the hair-growth effect of Illite powder. The hair-growth effects were investigated by two methods; the activity of hair-growth after shaving the hairs on the black mouse (C57BL/6) and the recovery activity of hair-growth after hair-loss induced by cyclophosphamide treatment. Suspension of Illite powder was applied to the back of the black mouse by method of skin paste. Illite promoted significantly the hair growth of mouse in both conditions of shaving and hair-loss. And then we investigated the toxicity which may be induced by Illite when it was administrated orally as a single dose. We could not fond out any significant toxicity induced by single dose oral administration of Illite.

• Toxicological Research
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• v.24 no.1
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• pp.79-86
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• 2008

This study was conducted to obtain information of the oral dose toxicity of low molecular fucoidan (LMF) in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) mg/kg (body wt.). The mortality and the changes on body weight, clinical signs, gross observation and organ weight and histopathology of principle organs were monitored 14 days after LMF treatment. We could not find any mortalities, clinical signs, body weight changes and gross findings. In addition, significant changes in the organ weight and histopathology of principal organs were not observed except for some sporadic findings. The results obtained in this study suggest that LMF may not be toxic in mice and may be therefore safe for clinical use. The $LD_{50}$ and approximate LD in mice after single oral dose of LMF were considered over 2000 mg/kg in both female and male mice.

• Toxicological Research
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• v.25 no.3
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• pp.147-157
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• 2009

This study was conducted to obtain acute information of the oral dose toxicity of lyophilized water extract of Pinelliae Rhizoma, a dried tuber of Pinellia ternata (PR) in male and female mice. In order to calculated 50% lethal dose (LD$_{50}$) and approximate lethal dose (ALD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) ml/kg (body weight). The mortality and changes in body weight, clinical signs, gross observation, organ weight and histopathology of principle organs were monitored 14 days after treatment with PR extract. We could not find any mortalities, clinical signs, changes in the body and organ weights, gross and histopathological findings except for dose-dependent increases in the hepatic fatty change frequencies detected in PR extract 2000 and 1000mg/kg treated in both male and female mice. The results obtained in this study suggest that LD$_{50}$ and approximate LD in mice after single oral dose of PR extracts were considered over 2000 mg/kg in both and female male mice, but more than 1000mg/kg of PR extracts treatment could induce slight hepatotoxicity the fatty changes in mice.

• Journal of Oriental Neuropsychiatry
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• v.23 no.2
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• pp.121-128
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• 2012

Objectives : This research investigates the single oral dose toxicity of ACM in SD rats. Methods : ACMs were administered to female and male SD rats, as an oral dose of 5000 mg/kg. Animals were monitored for the mortality and changes in the body weight, clinical signs and gross observation during the 14 days after dosing, upon necropsy. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. First day after administration, compound-colored stool was observed in all rats. After the second day of administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. [ED NOTE: highlight: given the context, this is very vague] Conclusions : The results obtained in this study suggest that the approximate lethal dose of ACM in both female and male rats were considered as over 5000 mg/kg.

• Toxicological Research
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• v.14 no.3
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• pp.385-391
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• 1998

The study was carried out to evaluate the acute toxicity of enrofloxacin-colistin combination via a single oral(p.o.)and intravenous(i.v.) administration in ICR mice. All procedures of the test were performed by the established regulation of Korean National Institute of Safety Research (1994. 4.14). The maximal dose of oral and intravenous routes was 5,000mg/kg and 90mg/kg, consisting with each 6 groups including control of male and female, respectively. As the results, $LD_{50}$m}'s of the combinations showed 3,075mg/kg (f)and 2,564mg/kg(m) after oral administrations, together with 48mg/kg(f) and 40mg/kg(m) after intravenous administration. These facts indicated that acute toxicitiy of enrofloxacin-colistin combination were different depending on the administration routes and sexes in ICR mice. In conclusion, the route of enrofloxacin-colistin combination must not choose as i.v. route administration in terms of acute toxicity based on $LD_{50}$.

• Herbal Formula Science
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• v.25 no.1
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• pp.11-28
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• 2017

Objectives : The contents of aconitine in aconiti radix lateralis preparata, purified hot water extract of Aconiti Radix lateralis preparata, and purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata was analyzed to compare toxicity. Toxicity of Sambutang-P that contains Aconiti Radix lateralis preparata was assessed with a single oral toxicity test on 6-week-old male and female Sprague-Dawley rats. Methods : 1. The contents of aconitine in Aconiti Radix lateralis preparata, purified hot water extract of Aconiti Radix lateralis preparata, and purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata was analyzed using the purity test according to the "Korean Herbal Pharmacopoeia". 2. 2,000mg/kg was injected for the single oral toxicity test of purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata, and the test was done for a test group (injection) and a control group, each with 5 male and 5 female rats. For 14 days after injection, rats were observed for general symptoms and changes in weight. Afterwards, blood biochemical test, autopsy, and histophathological exam of the liver was conducted. Results : 1. The contents of aconitine was 0.0785% for Aconiti Radix lateralis preparata, 0.1510% for purified hot water extract of Aconiti Radix lateralis preparata, and 0.1248% for purified hot water extract of Sambutang-P that contains Aconiti Radix lateralis preparata. 2. There was no death of either male or female rats in both the control group and the test group (injection of 2,000mg/kg). 3. No unusual symptom was observed in both the control group and the test group (injection of 2,000mg/kg). 4. No significant change in weight was observed for both male and female rats in the test group (2,000mg/kg). 5. The histopathological exam of ALT, AST, ALP, GGT and LDH showed no significant changes for both male and female rats in the test group (2,000mg/kg). 6. According to the autopsy results, no visible abnormality of organs or tissues was found in both the control group and the test group (2,000mg/kg). 7. According to the histopathological exam of the liver, the effect of the injected material was not observed for either male or female rats in the test group (2,000mg/kg). Conclusions : The contents of aconitine in Aconiti Radix lateralis preparata was lower for decoction of Sambutang-P with ginseng radix alba than for decoction of only Aconiti Radix lateralis preparata. This suggests that ginseng radix alba can dilute toxicity of Aconiti Radix lateralis preparata. As for a single oral toxicity test of Sambutang-P that contains Aconiti Radix lateralis preparata, no abnormal reaction was observed even when the injection amount far exceeded a toxic dose or a lethal dose. Thus, it is deemed that using Sambutang-P at a clinically prescribed dose would not lead to hepatoxicity.