• Biomolecules & Therapeutics
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• v.15 no.4
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• pp.245-251
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• 2007

The object of this study was to evaluate the single dose toxicity of Kong-Jin-Dan (KJD), a polyherbal formula in male and female mice. KJD was administered to female and male ICR mice as an oral dose of 2000, 1000 and 500 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, and changes in the body and organ weight except for increases of lymphoid organ weights in KJD-dosing groups. These increases of lymphoid organ weights considered that related to the immune modulate effect of KJD not toxicological signs. In addition, no KJD-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the KJD does not cause any toxicological signs. The $LD_{50}$ and approximate LD of KJD extracts in both female and male mice were considered as over 2000 mg/kg.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.1
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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.

• Biomolecules & Therapeutics
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• v.8 no.2
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• pp.167-170
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• 2000

The present study was conducted to investigate the acute toxicity of plant sterol ester by a single oral dose in Sprague-Dawley rats. Ten males and 10 females aged 5 weeks were randomly assigned to two groups of 5 rats each and were administered by gavage at dose level of 0 or 20 ml/kg body weight. Parameters measured during the 14-day observation period were mortality, clinical signs, body weight changes, and gross findings. No mortality was observed in the present study. Treatment-related clinical signs, such as pasty stool and diarrhea, were observed on the day of treatment and these signs resulted in soiled fur on day 1 after the treatment. However, no clinical signs were observed on days 2-14 after the treatment. There was no significant difference in body weight changes between the control and treatment groups. At necropsy on day 14 after the treatment, no treatment-related gross findings were observed in the treatment group. Based on these results, it was concluded that a single oral dose of plant sterol ester induced pasty stool and diarrhea in Sprague-Dawley rats at dose level of 20 ml/kg and that the lethal doses were considered to be over 20 ml/kg for both sexes.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.6
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• pp.1019-1026
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• 2010

The object of this study was to evaluate the single dose toxicity of Iijintanggami-bang (IJTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various digestive disorders including reflux esophagitis, in male and female mice. Aqueous extracts of IJTGMB (Yield = 8.45%) 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 12 principal organs were examined. As results, we could not find any mortality, clinical signs, and changesin the body and organ weight except for soft feces restricted to IJTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no IJTGMB-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of IJTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.

• The Journal of Korean Obstetrics and Gynecology
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• v.27 no.1
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• pp.28-40
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• 2014

Objectives: This study was to evaluate the single dose toxicity of Sobokchuko-tang (SBC) in male and female mice. Methods: Aqueous extract of SBC (yield=6.60%) 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. Results: we could not find any SBC treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for pharmacological immunomodulatory effects related findings including significant increases of submandibular lymph node weights, hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodes restrictly detected in 2,000 mg/kg treated female and male mice with some sporadic accidental findings. Conclusions: The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of SBC 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.

• The Journal of Korean Medicine
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• v.32 no.3
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• pp.18-24
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• 2011

Objective: Leejung-tang (Rechu-to in Japanese) is a traditional Korean herbal formula used for treatment of gastrointestinal disorders such as vomiting, stomach pain, chronic gastritis and gastrointestinal ulceration. The present study was carried out to investigate the potential acute toxicity of Leejung-tang water extract (LJT) by a single oral dose in Crl:CD (SD) rats in compliance with current guidelines. Methods: In the preliminary study, there were no adverse effects such as death, clinical signs, and body weight changes at dose levels of 500, 1000, and 2000 mg/kg/day body weight. Based on the results, a dose of 2000 mg/kg was selected as the toxicological limited dose. LJT was administered once by gavage to male and female rats at dose levels of 0 and 2000 mg/kg bodyweight. During the study period, mortalities, clinical findings, and body weight changes were observed for 14 days following the administration. On day 14 after the treatment, the animals were sacrificed by carbon dioxide overdose and complete gross postmortem examinations were performed. Results: In present study, no treatment-related deaths were observed. There were no adverse effects on clinical signs and body weight changes. In addition, there were no observed gross findings in all groups except for a kidney cyst in the 2000 mg/kg/day female group. Conclusion: The results indicated that LJT did not induce toxic effects at a dose level up to 2000 mg/kg in rats and its median lethal dose ($LD_{50}$) was considered to be over 2000 mg/kg/day body weight for both genders.

• Asian-Australasian Journal of Animal Sciences
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• v.27 no.11
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• pp.1521-1525
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• 2014

This study investigated heritability for bovine growth estimated with genomewide single nucleotide polymorphism (SNP) information obtained from a DNA microarray chip. Three hundred sixty seven Korean cattle were genotyped with the Illumina BovineSNP50 BeadChip, and 39,112 SNPs of 364 animals filtered by quality assurance were analyzed to estimate heritability of body weights at 6, 9, 12, 15, 18, 21, and 24 months of age. Restricted maximum likelihood estimate of heritability was obtained using covariance structure of genomic relationships among animals in a mixed model framework. Heritability estimates ranged from 0.58 to 0.76 for body weights at different ages. The heritability estimates using genomic information in this study were larger than those which had been estimated previously using pedigree information. The results revealed a trend that the heritability for body weight increased at a younger age (6 months). This suggests an early genetic evaluation for bovine growth using genomic information to increase genetic merits of animals.

• Biomolecules & Therapeutics
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• v.9 no.1
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• pp.46-50
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• 2001

The current study was performed to determine the acute oral toxicity of a crude extract of sanghwang mushroom (Phellinus linteus), in SD rats. 5 rats of each sex were orally treated with a single dose of extract of sanghwang mushroom at doses of 0, 500, 1,000, 2,000 mg/kg, respectively. After the treatment, clinical signs and body weight change, the food and water consumption were observed for 14 days. All animals survived during the study and did not show any clinical signs. Body weight gain showed no significant difference between the control and treated rats. However, body weight gain delayed in high dose group (2,000 mg/kg) on day 1~3 after administration. Another 5 rats of each sex were orally treated with a single dose of extract of sanghwang mushroom at dosages 4,000, 5,000 mg/kg respectively, but all animals survived during the study and did not show any clinical signs. It is suggested that LD$_{50}$ of extract of sanghwang mushroom by oral administration was estimated to be over 5,000 mg/kg in both sexes of rats.s.

• Biomolecules & Therapeutics
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• v.10 no.2
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• pp.114-116
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• 2002

This study was performed to investigate the acute toxicity of PEG-hemoglobin SB1, a blood substitute, in beagle dogs. The male and female dogs were administered intravenously at the doses of 0.4375, 0.875 and 1.75 g/kg body weight, respectively. After a single intravenous administration of SB1 to dogs, we observed them daily for 2 weeks. SB1 did not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of dogs. Based on these results, acute toxicity, dogs SB1 may have no side effect and its $LD_{50}$ value may be over 1.75 g/kg (25 ml/kg) of body weight in dogs.

• Journal of the Korean Society for Precision Engineering
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• v.33 no.11
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• pp.937-941
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• 2016

Stand-alone cervical cage consists of a PEEK body, Ti plate, and screw, which are configured as a single-piece. Through a single operation, this implantable medical device is capable of completely fixing the cervical vertebral body. For example, instead of a plate, which is normally used, the intervertebral disc is removed and replaced with a cervical cage. It should be noted that in Korea, KFDA guidelines for a stand-alone cervical cage have not yet been suggested. Therefore, the aim of this study is to present the systematic study of the static compression test, static torsion test, dynamic compression test, and expulsion test. Further, the test method is designed to refer to the ASTM standard and relative literature.