• Toxicological Research
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• v.23 no.1
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• pp.79-86
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• 2007

The isolated plantamajoside from Plantago asiatica that is often used as a marker compound in chemotaxonomic studies has various bioactivites such as the inhibitions of cyclic AMP phosphodi-esterase and 5-lipoxygenase, microbial growth and inflammation, and currently demands the generation of toxicity data. The purpose of this study was to examine the toxicities of the single and 14 days repeated dose toxicity in Sprague-Dawley rats orally administrated with plantamajoside at dose levels of 0, 500, 1000, and 2000 mg of dried material/kg body weight/day. The results showed that there was no difference in body weight change, food intake, water consumption, or relative organ weight among different dose groups. Also we observed no death and abnormal clinical signs were observed during the experimental period. Between the groups orally administered Plantago asiatica and the control group, there was no statistical significance in hematological test or serum biochemical values. There were no gross findings at final sacrifice. There was no evidence of histopathological alteration mediated by 14 days treatment with Plantago asiatica. These results suggest that no observed adverse effect level (NOAEL) of the oral application was considered to be more than 2000 mg/kg in rats under the conditions employed in this study. Another observation was performed to investigate the safety of Plantago asiatica in respect of genotoxicity. This substance was examined that Salmonella typhimurium reversion assay (Ames test) in strain TA98, TA100, TA1535. In the reverse mutation test, Plantago asiatica did not induce mutagenicity in Samonella typhimurium with and without metabolic activation. These results indicated that Plantago asiatica had no genotoxicity.

• 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.12 no.1
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• pp.101-111
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• 1996

The local irritation studies of DA-3285, recombinant human erytropoietin(rHu-EPO), were carried out in rabbits after the following treatment; single application into the conjunctival sac of the eye, single subcutaneous injection, 7-day repeated subcutaneous injection and 8-day repeated infusion into the ear vein. Also, the local irritancy of DA-3285 leaked around vein was studied in mice by single perivascular injection. The results obtained were as follows. In the result of ocular irritation test, DA-3285 could be considered as a non-irritating material. In single and 7-day repeated subcutaneous irritation test, the irritancy of DA-3285 was not so much different from that of saline. The vascular irritancy of DA3285 by 8-day repeated infusion was negligible and similar to that of saline. And the irritancy of DA3285 by perivascular injection was comparable to that of saline. These results indicate that DA-3285 has no irritating activity when injected through subcutaneous or intravenous route for clinical practice as 3.5% solution.

• 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.35 no.3
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• pp.225-232
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• 2019

Thymus vulgaris L. is widely used as an ingredient in cooking and in herbal medicine. However, there is little information about its toxicity. The present study was performed to evaluate the acute and repeated 28-day oral dose toxicity of thyme essential oil in rats. For the acute toxicity test, two groups of three rats were used. The rats received a single dose of essential oil: 300 or 2,000 mg/kg of body weight (bw). The rats were observed individually during the first four hours, and then daily until day 14. For the toxicity test with repeated doses, four groups of 10 rats were used. Doses of 100, 250, and 500 mg/kg/day were tested for 28 days. At the end of the experiment, blood was collected and the animals were sacrificed. Histopathological examination showed that in the lungs of rats given the 2,000 mg/kg bw dose, polymorph nuclear infiltrates, hemosiderin macrophages, and interstitial space thickening were present. In the repeated dose study, all rats survived the 28-day treatment period and apparently showed no signs of toxicity. The hematological and biochemical parameters were not altered. The histopathological study of the organs showed severe changes in the lung, with the dose of 500 mg/kg/day; in the other organs, no alterations were observed or the changes were slight. The body weight was only altered in male rats given the 500 mg/kg dose. The relative weight of the organs did not show any significant changes. Our studies revealed that the essential oil of Thymus vulgaris has moderate oral toxicity according to the results of the acute test, whereas the results of the 28-day oral toxicity test suggest that the no-observed-adverse effect level (NOAEL) is greater than 250 mg/kg/day.

• Journal of Pharmacopuncture
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• v.19 no.2
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• pp.155-162
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• 2016

Objectives: Bufonis venonum (BV) is toad venom and is the dried, white secretions of the auricular and the skin glands of toads. This study was performed to evaluate the toxicity of intravenous injection of Bufonis venonum pharmacopuncture (BVP) through a single-dose test with sprague-dawley (SD) rats. Methods: Twenty male and 20 female 6-week-old SD rats were injected intravenously in the caudal vein with BVP or normal saline. The animals were divided into four groups with five female and five male rats per group: the control group injected with normal saline, the low-dosage group injected with 0.1 mL/animal of BVP, the medium-dosage group injected with 0.5 mL/animal of BVP and the high-dosage group injected with 1.0 mL/animal of BVP. We performed clinical observations every day and body weight measurements on days 3, 7 and 14 after the injection. We also conducted hematology, serum biochemistry, and histological observations immediately after the observation period. Results: No mortalities were observed in any experimental group. Paleness occurred in the medium- and the high-dosage groups, and congestion on tails was observed in females in the medium- and the high-dosage groups. No significant changes in weight, hematology, serum biochemistry, and histological observations that could be attributed to the intravenous injection of BVP were observed in any experimental group. Conclusion: The lethal dose of intravenously-administered BVP in SD rats is over 1.0 mL/animal.

• Journal of Pharmacopuncture
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• v.18 no.4
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• pp.51-58
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• 2015

Objectives: Bufonis venonum (BV) is the dried white secretions of the auricular and skin glands of the toads Bufo bufo gargarizans or Bufo melanosticus Schneider. This study was performed to evaluate the toxicity of intramuscularly-administered Bufonis venonum pharmacopuncture (BVP) and to calculate its approximate lethality through a single-dose test with Sprague-Dawley (SD) rats. Methods: Twenty male and 20 female 6-week-old SD rats were injected intramuscularly with BVP or normal saline. The animals were divided into four groups with five female and five male rats per group: the control group injected with normal saline at 0.5 mL/animal, the low-dosage group injected with 0.125 mL/animal of BVP, the medium-dosage group injected with 0.25 mL/animal of BVP and the high-dosage group injected with 0.5 mL/animal of BVP. All injections were in the left thighs of the rats. After administration, we conducted clinical observations everyday and body weight measurements on days 3, 7 and 14 after the injection. We also carried out hematology, serum biochemistry, and histological observations on day 15 after treatment. Results: No mortalities were observed in any experimental group. No significant changes in weight, hematology, serum biochemistry, and histological observations that could be attributed to the intramuscular injection of BVP were observed in any experimental group. Conclusion: Lethal dose of BVP administered via intramuscular injection in SD rats is over 0.5 mL/animal.

• Journal of Pharmacopuncture
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• v.17 no.2
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• pp.41-45
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• 2014

Objectives: This study was performed to analyze the single-dose toxicity of neutral natured blood stasis pharmacopuncture extracts. Methods: All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies, under the regulations of Good Laboratory Practice (GLP). Sprague-Dawley rats were chosen for the pilot study. Doses of neutral natured blood stasis pharmacopuncture extracts, 0.1, 0.5 and 1.0 mL, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: In all 4 groups, no deaths occurred, and the neutral natured blood stasis pharmacopuncture extracts administered by intramuscular (IM) injection was over 1.0 mL/animal. No significant changes in the body weights between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any organs or tissues. Conclusion: The above findings suggest that treatment with neutral natured blood stasis pharmacopuncture extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

• Biomolecules & Therapeutics
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• v.15 no.2
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• pp.127-132
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• 2007

The object of this study was to evaluate the acute toxicity of lyophilized water extract of Radix Araliae Cordatae (RA) in male and female mice. The extract was administered to female and male ICR mice as an oral dose of 2000 mg/kg (body wt.) according to the recommendation of 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, changes in the body weight and gross findings except for increases of hypertrophy of lymph nodes in male RA extracts-dosing group. In addition, no RA extracts-treatment related abnormal changes in the organ weight and histopathology of principle organs except for some sporadic accidental findings. The results obtained in this study suggest that the RA extracts does not cause any toxicological signs. The LD$_{50}$ and approximate LD of RA extracts in both female and male mice were considered as over 2000 mg/kg.

• Toxicological Research
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• v.22 no.4
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• pp.439-443
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• 2006

This study was conducted to investigate the potential acute toxicity of Aralia elata by a single oral dose in ICR mice. Thirty mice of each sex were randomly assigned to three groups of 10 mice each. The test articles were administered once by the gavage to mice at dose levels of 0, 2,500 and 5,000 mg/kg body weight. The mortality and changes on body weight and clinical signs of gross observation were monitored for 14 days after dosing. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. There were no dead animal and adverse effects on clinical signs, the body weight and the gross finding. As the results, we could not find any toxic effect at the dose levels of 2,500 or 5,000 mg/kg in mice and the minimal lethal dose was considered to be over 5,000 mg/kg body weight in mice.