• 약학회지
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• 제43권2호
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• pp.180-197
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• 1999

Acute and subacute oral toxicity of $HELIKIT^{TM}$ ($^{13}C-urea$) were carried out in Sprague-Dawley rats of both sex. The toxicity of $HELIKIT^{TM}$ was compared with urea($^{12}C-urea$ which is used for control). In acute toxicity studies, we daily examined number of deaths, clinical signs, body weights and pathological examination for 14 days after single oral administration of HELIKIT or urea($^{12}C-urea$) at a dose of 5000 mg/kg. The subacute oral toxicity was investigated in Sprague-Dawley rats treated with $HELIKIT^{TM}$ at a dose of 40, 200 and 1,000 mg/kg/day or $^{12}C-urea$ at a dose of 1,000 mg/kg/day for 4 weeks. In acute toxicity studies, $HELIKIT^{TM}$ and urea did not show any toxic effect in rats and oral LD50 value was over 5,000 mg/kg rats. In subacute toxicity studies, no death occured and no drug-related changes were found in clinical observations; body weight, food consumption, opthalmoscopy. auditory test, urinalysis, hematology, blood chemistry, gross pathological examination or organ weight between $HELIKIT^{TM}$, urea and control groups. In histopathological examinations, the slight thickening of mucosa of the limiting ridge in the stomach was noted in the animals treated with $HELIKIT^{TM}$ at a dose of 1,000 mg/kg/day and also the changes in urea group at a dose of 1,000 mg/kg/day was found, but all of these changes in the changes in ures group at a dose of 1,000 mg/kg/days was found, but all of these changes in the stomach regressed after withdrawal of the test article for 2 weeks and reversibility of the effect was revealed. These results indicate that the non toxic dose level of $HELIKIT^{TM}$ was 1,000 mg/kg/day in the 4 weeks-repeated dose study, suggesting that the substitution of $^{13}C$ for carbon in urea molecule has no effect on the toxicity of urea and changes in stomach are reversible.

• Preventive Nutrition and Food Science
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• 제20권3호
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• pp.190-197
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• 2015

The aim of this study was to investigate the acute and subacute oral toxicity of crude antifungal compounds produced by Lactobacillus plantarum HD1 in Sprague-Dawley rats. In the acute toxicity study, the crude antifungal compounds (0.625, 1.25, 2.5, and 5.0 g/kg) did not produce mortality, significant changes in general behavior, or changes in the gross appearance of the organs. In the subacute toxicity study, the crude antifungal compounds were administered orally to rats at doses of 0, 0.5, 1.0, and 2.0 g/kg daily for 28 days. There were no test article-related deaths, abnormal clinical signs, or body weight changes. The study also showed no significant differences between the control and treated groups in hematological and serum biochemical parameters, histopathological examination, or any other findings. These results suggest that acute or subacute oral administration of crude antifungal compounds from L. plantarum HD1 is not toxic in rats.

• Toxicological Research
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• 제12권2호
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• pp.323-330
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• 1996

Subacute toxicity study was performed in Sprague-Dawley rats after daily oral administration of KDRD-002 0.23, 0.7, 2.1 g/kg for one month. There were no clinical signs and pathological changes compared with control group but slight decrease in spontaneous motor activities and locomotions at high dose group of KDRD-002. Body weights were not significantly changed between control and KDRD-002 treated groups. In histopathological examinations, however, two animals (1 male, 1 female) showed abnormal increases in the weights of spleen tissues at middle dose group of KDRD-002. Also, there were some hemorrhages in lung tissues at low dose group of KDRD-002, but it was not considered to be caused by KDRD-002. These results suggest that KDRD-002 does not induce any significant subacute oral toxicity in Sprague-Dawley rats.

• Biomolecules & Therapeutics
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• 제6권3호
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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.

• Molecular & Cellular Toxicology
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• 제5권2호
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• pp.153-159
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• 2009

In this study, we assessed the acute and subacute toxicity of Angelica gigas Nakai (A. gigas Nakai) extracts, which are comprised of decursin and decursinol angelate (D/DA) in rats. For the oral acute toxicity test, Sprague-Dawley (SD) male and female rats were gavaged with two doses of D/DA (200 and 2,000 mg/kg body weight) and then observed for any toxic symptoms for 2 weeks. The LD$_{50}$ value for the rats was greater than 2,000 mg/kg body weight for both male and female rats, which indicates that there were no toxic symptoms induced by doses of up to 2,000 mg/kg body weight. For the subacute toxicity study, rats were treated with D/DA at doses of 2 and 20 mg/kg body weight once a day for 30 days. There were no significant changes in body weight and food intake observed during the subacute toxicity study. In addition, no differences were observed between the control and treated groups when urinalysis was conducted or when hematology and biochemical parameters were evaluated. Finally, histopathological examination of the organs did not reveal any lesions in the control or treated groups. Taken together, these findings indicate that D/DA is safe and non-toxic.

• Toxicological Research
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• 제14권2호
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• pp.273-283
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• 1998

Single and 4 weeks oral administration of New wonbangwoohwangchungsimwon (NSCH) which was used l-muscone as substitutive material qf musk, to beagle dogs of both sexes were per-formed to investigate both acute and subacute toxicity. Beagle dogs (3 males and 3 females) in acute experiments were administered orally with single dose of 2,000 mg/kg and groups of 9 male and 9 female beagle dogs in subacute experiments were given daily different dosage of NSCH, 160 mg/kg/day (low dosage group), 400 mg/kg/day (middle dosage group), 1,000 mg/kg/day (high dosage group) once a day for 4 weeks by oral route according to the Established Regulation of Korea Food and Drug Ad-ministration (l996. 4. 16). $LD_{50}$ value for beagle dogs was more than 2,000 mg/kg per oral for both male and females. In animals administered with NSCH, there were neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical sign, urinalysis, eye examination, hematology, serum chemistry, organ weight and other fingings. No histological lesions were observed in both control and treatment groups. Above data strongly suggset that NSCH in beagle dogs is considered to be safe.

• Toxicological Research
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• 제14권2호
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• pp.249-260
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• 1998

Single and 4 weeks oral administration of New Woohwangchungsimwon (NWCH) which was used l-muscone as substitutive material of musk, to beagle dogs of both sexes were performed to investigate both acute and subacute toxicity. Beagle dogs(3 males and 3 females) in acute experiments were administered orally with single dose of 2,000 mg/kg and groups of 9 male and 9 female beagle dogs in subacute experiments were given daily different dosage of NWCH, 160 mg/kg/day (low dosage group), 400 mg/kg/day (middle dosage group), 1,000 mg/kg/day (high dosage group) once a day for 4 weeks by oral route according to the Established Regulation of Korea Food and Drug Administration (1996. 4. 16). $LD_{50}$/ value for beagle dogs was more than 2,000 mg/kg per oral for both male and fe-males. In animals administered with NWCH, there were neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical sign, urinalysis, eye examination, hematology, serum chemistry, organ weight and other fingings. No histological lesions were observed in both control and treatment groups. Above data strongly suggset that NWCH in beagle dogs is considered to be safe.

• Biomolecules & Therapeutics
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• 제4권4호
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• pp.314-322
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• 1996

The subacute toxicity was investigated in Sprague-Dawley rats orally treated with KDRD-010 at the doses of 0.056, 0.28, and 1.4 g/kg for one month. There were no clinical signs and pathological changes compared with control group. Body weights were not significantly changed between control and treatment groups. In hematological and biochemical serum parameters, all mean values appear to be within the normal range. In pathological examinations, hemorrhages of lung was observed in one male rat at low dose group and one female rat at high dose group of KDRD-010, but it was not considered to be caused by KDRD-010. These results suggest that KDRD-010 dose not induce any significant subacute oral toxicities in Sprague-Dawley rats.

• Toxicological Research
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• 제13권4호
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• pp.449-460
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• 1997

Single and 4 weeks oral administration of l-muscone, a major active ingredient of musk, to beagle dogs of both sexes were performed to investigate both acute and subacute toxicity. Beagle dogs(3 males and 3 females) in acute experiments were administered orally with single dosage of 2,000 mg/kg and groups of 9 male and 9 female beagle dogs in subacute experiments were given daily different dosage of l-muscone, 0.2 mg/kg/day(low dosage group), 2 mg/kg/day(middle dosage group), or 20 mg/kg/day(high dosage group) once a day for 4 weeks by oral route according to the Established Regulation of Korean Food and Drug Administration(1996.4.16). $LD_{50}$ value for beagle dogs was more than 2,000 mg/kg on oral route for both male and females. In animals administered with l-muscone, there were neither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical signs, urinalysis, eye examination, hematology, serum chemistry, organ weight and other findings. No histolopathological lesions were observed in both control and treatment groups. Above data strongly suggest that l-muscone in beagle dogs is considered to be safe.

• Natural Product Sciences
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• 제17권4호
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• pp.291-295
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• 2011

The present investigation evaluated the safety of the methanol extract from the fruit body of Phellinus pini Ames (PPA) by determining its potential toxicity after a subacute administration in rats. The extract was orally administered in doses of 1 g/kg, 2 g/kg, and 4 g/kg daily for 14 days to rats. Body weight, biochemical, and hematological parameters were determined at the end of 14 days of daily administration. The no-observed adverse effect levels (NOAEL) of the extract were 4 g/kg, when given by gavage routes. Daily oral administration of PPA extract for up to 14 days did not result in the death of significant changes in the body weight, hematological, and mainly biological parameters. In biological analysis, some significant changes occurred, including triglyceride and blood urea nitrogen (BUN), indicating that the PPA extract has liver and kidney-modulating activity. The PPA extract was found to be low or non-toxic in rats.