• Toxicological Research
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• 제25권2호
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• pp.79-84
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• 2009

Cerium oxide nanoparticles (size: 30 nm) were prepared by the supercritical synthesis method, Acute oral toxicity and tissue distribution of the nanoparticles were evaluated by a single administration in rats. Oral administration of the nanoparticles to the rats did not lead to death when the animals were treated by a dose of 5 g/kg (high dose) as well as 100 mg/kg (low dose). Abnormal clinical signs, changes in serum biochemistry and hematology were not observed in high-dose treated group compared to the vehicle control group. Lesions in liver, lung and kidney were not observed in high-dose treated group by histopathological examination. Tissue distribution analysis in liver, kidney, spleen, lung, testis and brain was performed on day 1, day 7 and day 14 after treatment. The average values of the accumulated cerium oxide nanoparticles were elevated in all tissues but statistical significance was only shown in lung. Low levels of tissue distributions after a single oral administration seem to be the low bioavailability of the nanoparticles.

• 동의신경정신과학회지
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• 제23권2호
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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.

• 대한한방내과학회지
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• 제31권3호
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• pp.539-553
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• 2010

Objectives : The object of this study was to obtain accurate information (single oral dose toxicity) of Lonicerae Flos (LF; Dried flower bud parts of Lonicera japonica Thunb (Caprifoliaceae)), which has traditionally been used in Korean medicine for treating various inflammatory diseases. Methods : In order to observe the 50% lethal dose (LD 50), approximate lethal dosage (ALD) and target organs, test articles 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 for 14 days after single oral treatment of LF aqueous extracts with organ weights and histopathological observations of 12 types of principle organs. Results : 1. After single oral treatment of LF aqueous extracts, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents at body and organ weights, clinical signs, gross and histopathological observations. 2. Slight diarrhea was detected in most mice treated with 2,000 mg/kg of LF aqueous extracts and male mice of LF aqueous extracts 1,000 mg/kg within 2 days after end of treatment, respectively. Conclusion : The results obtained in this study suggest that the LD 50 and ALD of LF aqueous extracts 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 2000 mg/kg, the highest dose recommended by KFDA and OECD. However, we also observed the possibility of digestive disorders like diarrhea when over 1,000 mg/kg of LF aqueous extracts were administered in the present study.

• 동의생리병리학회지
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• 제28권1호
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• pp.53-58
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• 2014

The object of this study was to evaluate the single dose toxicity of Choweseuncheng-tang (CWS), a polyherbal formula have been traditionally used as prevention or treatment agent for various diseases as Tae-eumin prescription on Korean medicinal theory, Sasang-euihak, in male and female mice. Aqueous extracts of CWS (yield = 11.00%) was administered to female and male 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 principle organs were also examined. As results, we could not find any CWS treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for some dose-independent accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of CWS 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.

• 치과방사선
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• 제18권1호
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• pp.31-45
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• 1988

The author studied the histopathologic changes according to a single or a split dose and the time after irradiation on the acinar cells of rat parotid gland. 99 Sprague Dawley rats, weighing about l20gm, were divided into control and 3 experimental groups. In experimental groups, GroupⅠ and Ⅱ were delivered a single dose of l5Gy, 18Gy and Group Ⅲ and Ⅳ were delivered two equal split doses of 9Gy, 10.5Gy for a 4 hours interval, respectively. The experimental groups were delivered by a cobalt-60 teletherapy unit with a dose rate of 222cGy/min, source-skin distance of 50㎝, depth of l㎝ and a field size of l2×5㎝. The animals were sacrificed at 1, 2, 3, 6, 12 hours, 1, 3, 7 days after irradiation and examined by light and electron microscopy. The results were as follows: 1. As the radiation dose increased and the acinar cells delivered a single dose exposure were more damaged, and the change of acinar cells appeared faster than those of a split dose exposure. 2. The histopathologic change of acinar cells appeared at 1 hour after irradiation. The recovery from damaged acinar cells appeared at 1 day after irradiation and there was a tendency that the recovery from damage of a split dose exposure was somewhat later than that of a single dose exposure. 3. Light microscope showed atrophic change of acinar cells and nucleus, degeneration and vesicle formation of cytoplasm, widening of intercellular space and interlobular space. 4. Electron microscope showed loss of nuclear membrane, degeneration of nucleus and nucleoli, clumping of cytoplasm, widening and degeneration of rough endoplasmic reticulum, loss of cristae of mitochondria, lysosome, autophagosome and lipid droplet. 5. Electron microscopically, the change of rough endoplasmic reticulum was the most prominent and this appeared at 1 hour after irradiation as early changes of acinar cells. The nuclear change appeared at 2 hours after irradiation and the loss of cristae of mitochondria was observed at 2 hours after irradiation in all experimental groups.

• 대한본초학회지
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• 제35권4호
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• pp.45-50
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• 2020

Objective : This study was performed to evaluate the toxicity after a single oral administration of black raspberry extract to male and female Sprague-Dawley (SD) rats and to determine the approximate lethal dose (ALD). Methods : We previously showed that the black raspberry extract repressed the simvastatin-mediated expression of Proprotein convertase subtilisin/kexin type 9 (PCSK9) and improved Low-Density Lipoprotein cholesterol (LDL-C) uptake by hepatocytes through the induction of the Low-Density Lipoprotein Receptor expression in hepatocytes. The groups consisted of black raspberry extract groups, as an oral dose of 2,000 mg/kg and a control group. 5 weeks SD rats were randomly assigned to 4 groups of 5 rats. Each male and female SD rats were administered orally once. For 14 days after the administration, mortality, clinical signs, changes in body weight, and necropsy findings were observed according to the "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity- Fixed Dose Procedure" of OECD Test Guideline. Results : There were no cases of mortality in the group administered with 2,000 mg/kg of male and female, and no abnormalities in body weight change and clinical signs. Also, no gross abnormalities were observed at the autopsy. Conclusions : As a result of a single oral administration of the black raspberry extract to SD rats, the ALD was determined to exceed 2,000 mg/kg for both male and female SD rats.

• 한방비만학회지
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• 제17권2호
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• pp.96-100
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• 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.

• Toxicological Research
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• 제19권3호
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• pp.173-180
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• 2003

The present study was conducted to investigate the single and 2-week repeated dose toxicity of red ginseng acidic polysaccharide (RGAP) in Sprague-Dawley rats. The test article was administered orally to rats at dose levels of 0, and 2000 mg/kg/day for single dose toxicity study and at dose levels of 0, 250, 500, and 1000 mg/kg/day 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 RGAP. Based on these results, it was concluded that the 2-week repeated oral dose of RGAP may have no toxic effect in rats at a dose level of 1000 mg/kg/day. In the condition of this study, the no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day for both sexes.

• Toxicological Research
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• 제20권2호
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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.

• Imaging Science in Dentistry
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• 제33권3호
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• pp.179-185
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• 2003

Purpose: To investigate the effects of irradiation on the phenotypic expression of the MC3T3-El osteoblastic cell line, particularly on the expression of osteocalcin and osteopontin. Materials and Methods: Cells were irradiated with a single dose of 0.5, 1,4, and 8 Gy at a dose rate of 5.38 Gy/min using a cesium 137 irradiator. After the specimens were harvested, RNA was extracted on the 3rd, 7th, 14th, and 21st day after irradiation. The RNA strands were reverse-transcribed and the resulting cDNAs were subjected to amplification by PCR. Results: The irradiated cells demonstrated a dose-dependent increase in osteocalcin and a dose-dependent decrease in osteopontin mRNA expression compared with the non-irradiated control group, The amount of osteocalcin mRNA expression decreased significantly at the 3rd day after irradiation of 0,5, 1,4, and 8 Gy, and also decreased significantly at the 3rd, 14th, and 21 st day after irradiation in the 8 Gy exposed group compared with the control group, The degree of osteopontin mRNA expression increased significantly at the 7th day after irradiation of 0,5, 1,4, and 8Gy, Conclusion: These results showed that each single dose of 0,5, 1, 4, and 8 Gy influenced the mRNA expression of osteocalcin and osteopontin associated with the calcification stage of osteoblastic cells, suggesting that each single dose affected bone formation at the cell level.