• The Korean Journal of Community Living Science
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• v.27 no.3
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• pp.437-449
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• 2016

To provide information on the safety of crude antifungal compounds produced by Bacillus subtilus SN7 isolated from Meju, we carried out an acute (single) oral dose toxicity test and 4 week repeated oral dose determination test on crude antifungal compounds in male and female Sprague Dawley rats. In the acute toxicity test, rats were treated with crude antifungal compounds produced by Bacillus subtilus SN7 orally at increasing dose levels (500, 1,000, and 2,000 mg/kg) and observed for 2 weeks. In the repeated-dose 28-day oral dose determination study, rats were orally administered doses of 500, 1,000, and 2,000 mg/kg daily for 4 weeks. There were no test article-related deaths or abnormal clinical signs in the two studies. In the 4 week repeated oral dose determination test, there were also no significant differences in clinical signs, body and organ weight changes, or any other hematological and biochemical parameters between the control and treated groups. The results suggest that the crude antifungal compounds produced by Bacillus subtilus SN7 up to a dosage level of 2,000 mg/kg are not toxic in male and female rats.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.2
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• pp.186-194
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• 2014

The object of this study was to obtain acute toxicity information (single-dose oral toxicity) of Woohwangchungshim-won (WHCSW), a pill type herbal medicine used in Korean Medicine (KM) for treating stroke. In order to obtain the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, WHCSW 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.) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines (Notification No. 2009-116). The mortality and changes in the body weight, clinical signs and gross observation were monitored for 14 days after single-dose oral administration of WHCSW according to KFDA Guidelines with organ weights and histopathological changes were observed in 12 principle organs. After single-dose oral administration of WHCSW, we could not find any mortality and toxicological evidences up to 2,000 mg/kg-administered group, except for some accidental findings and dose-independent increases of body weight gains in female 1,000 and 500 mg/kg-administered female mice. The results obtained in this study suggest that the LD50 and ALD of WHCSW in both female and male mice after single-dose oral administration were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development (OECD), and can be safely used in clinics.

• The Journal of Internal Korean Medicine
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• v.34 no.1
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• pp.46-58
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• 2013

Objectives : The object of this study was to obtain acute information (single oral dose toxicity) of Scutellariae Radix Aqueous Extracts (SR; yield = 27.20%) which traditionally have been used in Korean medicine for treating various diseases including inflammatory diseases. Methods : In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD) and target organs, SR Aqueous Extracts 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.) 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 single oral treatment of SR according to KFDA Guidelines with organ weights and histopathological observations of 14 types of principle organs. Results : After single oral treatment of SR, 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 $LD_{50}$ and ALD of SR in both female and male mice after single oral treatment be considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg that was the highest dose recommended by KFDA and OECD, and can be safely used in clinics.

• Toxicological Research
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• v.15 no.1
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• pp.55-63
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• 1999

This study was carried out to investigate the four-week oral toxicity of the CH-50002 (Vibril vaccine) in beagle dogs. The beagle dogs were orally administered for 28 days, with dosage of 0.5, 5, 50 mg/kg/day, respectively. Animals treated with CJ-50002(Vibrio Vaccine) did not cause any death and show any clinical signs. There were not significantly different from the control group in urinalysis, ocular examination, hematological, serum biochemical value and histopathological examination. Therefore, CJ-50002(Vibrio Vaccine) was not indicated to have any toxic efent in the beagle dogs, when ti was orally administered below the dosage 50mg/kg/day for rour weeks.

• Biomolecules & Therapeutics
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• v.9 no.3
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• pp.231-235
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• 2001

The single oral toxicity of JG-381 was studied in Sprague-Dawley rats of both sexes. In this study, rats were administrated orally with dosages of 267, 400, 600, 900 and 1350 mg/kg of JG-381. We daily examined number of deaths, clinical signs, body weights and gross findings for 14 days after JG-381 administration. When we administered different doses of 267, 400, 600, 900 and 1350 mg/kg, we found 1, 4, 4, 5 and 5 male rats died and 3, 5, 4, 5 and 5 female rats died within 1 day after administration, respectively. Some clinical signs (decrease locomotor activity, salivation, soft stool, prone position, lacrimation, crouching position, convulsion, ataxic gait, incontinence of urine) were also observed during the experimental period. Our findings suggest that oral L $D_{50s}$ (95% confidence limit) for male and female rats are 327 mg/kg (270~396 mg/kg) and 250 mg/kg (256~264 mg/kg), respectively.y.

• Toxicological Research
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• v.17 no.4
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• pp.287-296
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• 2001

The acute oral LD5O toxicity values of isazofos, pyraclofos, diazinon and methomyl were determined for Japanese quail based on OECD guideline. The $LD_{50}$ of isazofos, pyraclofos and diazinon was 16.26 mg/kg, and 7.11mg/kg body weight In female respectively. And the $LD_{50}$ of each chemical in male was 21.44, 35.64, 8.28 mg/kg body weight respectively. Diazinon was the most susceptible compounds to Japanese quail in both sexes. The $LD_{50}$ of methomyl was 21.24 mg/kg body weights in female, and 28.28 mg/kg body weight in male respectively. Diazinon, isazofos and methomyl were more toxic In the female than male. The symptoms of poisoning were similar in quails administrated with each chemicals. The clinical sign in Japanese quail were ataxia, salivation, diarrhea, ruffled feather and convulsion at dead point. There were severe hemorrhage and catarrhal inflammation from duodenum to ileum In all compounds. In Japanese quail treated with organophosphorus and carbamate compounds, brain acetylcholinesterase was inhibited by 88-96. The recovery was not observed after 5 h in sublethal dose.

• Biomolecules & Therapeutics
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• v.6 no.3
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• pp.328-336
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• 1998

The subacute oral toxicity study of DWP-311 was carried out in Sprague-Dawley rats of both sexes. We daily examined clinical signs, body weights, hematological and biochemical parameters, and histopathological examinations for 30 days after administration of DWP-311 with different dose levels (0, 0.04, 0.2, and 1.0 g/kg). There were no clinical signs and pathological changes compared with control group except slight decreases in spontaneous motor activities and locomotions at high dose group of DWP-311. Body weights were not significantly changed in animals treated with DWP-311, In histopathological examinations, there were 2 cases of pneumonia in control group for one male and one female, but it was not directly related to DWP-311. These results indicate that subacute oral toxicities of DWP-311 were low and the no-observed a dverse effect level (NOAEL) was considered to be 1.0 g/kg in rats.

• Toxicological Research
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• v.17 no.4
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• pp.273-277
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• 2001

Though the bamboo salt, called as "JUKYUM" has been widely used in Korea as panacea, it's toxicity were not screened completely. To investigate the toxicity of bamboo salt, we compared with the toxicity of crude salt and reagent-grade NaCl by performing single dose oral toxicity test in SD rats. Crude salt, natural sun-dried salt (crude salt) production, was purchased from the western seashore of Korean peninsular, and reagent-grade NaCl was purchased from Sigma company. Results of the single dose oral toxicity tests on bamboo salt, crude salt and reagent-grade NaCl to SD rats are as follows, $LD_{50}$ of bamboo salt was 4174mg/kg (male) and 4074mg/kg (female), that of crude salt was 4871mg/kg (male) and 4898mg/kg (female) and that of reagent-grade NaCl was 4247mg/kg (male) and 4025mg/kg (female), respectively. There were little differences in clinical signs and gross legions among groups. Finding of gross autopsy and necropsy of bamboo salt treated group were similar to other groups.er groups.

• Korean Journal of Veterinary Research
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• v.43 no.2
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• pp.195-202
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• 2003

Chitosan is known to have antibacterial, antitumorogenic, hypolipidemic and immunopotentiating activities, hence finding diverse uses as a component in varying functional foodstuffs. However, some investigators reported it caused mineral absoiption inhibition and excess coagulation. From the chemical viewpoint, conventional chitosans are high-molecule polymers lacking water solubility, which could be related with their possible toxicity. A newly developed low- molecule water soluble chitosan is thought to have low toxicity compared to conventional chitosans. But no investigation was carried out to evaluate its toxicity. In this study, a 28-day subacute oral toxicity study of the water-soluble chitosan was performed in Sprague-Dawley rats of both sexes. Each 36 male and female rats were orally administered with 500, 1,000 and 2,000 mg/kg/day for 28 consecutive days, respectively. Clinical parameters (growth rate, feed and water consumption, daily inspection, urine analysis) during the 28 days indicated the water-soluble chitosan did not induce any abnonnal changes. There were no abnormal findings due to the administration of the test substance in gross and microscopic findings. We had not found alteration in absolute and relative organ weight between the control and treated groups, with only exception in the liver but lacking dose-dependency. The results of hematology and serum biochemistry examination revealed that no treatment related changes were between control and all dose groups. In conclusion, it was suggested that subacute toxicity of the water-soluble chitosan was low and the no-observed adverse effect level was considered to be over 2,000 mg/kg in rats.

• Toxicological Research
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• v.20 no.3
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• pp.263-272
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• 2004

This study was to investigate single and repeated-dose toxicities of DFA IV, a new candidate of nutraceutical which has preventive effect on anemia and osteoporosis. In single-dose oral toxicity study, the test article were administered once by gavage to rats at dose level of 0, 2,000 and 5,000 mg/kg. No dead animal, abnormal sign and abnormal necropsy finding was found in control and treated groups. Thus the approximate lethal dose of DFA IV was considered to be higher than 5,000 mg/kg in rats. In four week repeated dose oral toxicity study, the test article was administered once daily by gavage to rats at dose levels of 0, 500, 1,000 and 2,000 mg/kg. No abnormality was observed in mortality, clinical findings, body weight changes, food and water consumptions, opthalmoscopic findings, hematological findings, necropsy findings, organ weights and histopathological findings. In urinalysis, specific gravity was increased in 2,000 mg/kg groups of male rats. In serum biochemical analysis, creatine phosphokinase was increased in all treatment groups of male rats. These increases in urine specific gravity and serum creatine phosphokinase activity were not accompanied with related signs such as histopathological changes or clinical findings. In conclusion, four week repeated oral dose of DFA IV to rats did not cause apparent toxicological change at the dose of 500, 1,000 or 2000 mg/kg body weight. Thus it is suggested that no-observed-adverse-effect level (NOAEL) of DFA IV in rats would be 2,000 mg/kg/day body weight.