• Proceedings of the Korean Society of Toxicology Conference
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• 2002.11b
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• pp.158-158
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• 2002

The potential toxicological effects of aristolochic acid (AA), a natural component in Aristolochiaceae family, were investigated. The 13-week toxicity study consisted of groups of 10 SD rat/sex administrated water containing 0, 0.05, 0.5, or 5 mg/kg per day AA (Study 1). The tested groups were terminated on Test Day 90 due to mortality and overt clinical signs of toxicity.(omitted)

• Proceedings of the Korea Environmental Mutagen Society Conference
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• 2002.11a
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• pp.158-158
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• 2002

• Journal of the Korean Society of Food Culture
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• v.34 no.6
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• pp.801-809
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• 2019

Abeliophyllum distichum Nakai is a deciduous shrub of a flowering plant in Oleaceae. It is an important plant resource and consists of only one species in the entire world. A. distichum Nakai is well known an edible, medicinal herb in its habitat districts, but the toxicological evaluation for the safe use of its extract is still insufficient. The study characterized the toxicity of an Abeliophyllum distichum Nakai ethanol extract in Sprague-Dawley (SD) rats and determined the safe dosage levels in a 13 weeks toxicity study. Abeliophyllum distichum Nakai ethanol extract was orally administered once daily for 2 weeks at 0, 500, 1,000 and 2,000 mg/kg/day to male and female SD rats. while recording the clinical signs of toxicity, body weight, food intake/consumption, eye test and urine analysis. Only the total protein frequency in the urine of male SD rats (p<0.05), the right ovary of the 500 mg/kg group (p<0.01) and the right adrenal gland of the 1,000 mg/kg group (p<0.05) in the female rats showed statistically significant changes. But no toxic effects were noted from repeated-dose administration of the Abeliophyllum distichum Nakai ethanol extract in the SD rats during the observation period. The post-mortem examinations showed no test substance-mediated changes. The hematological analysis and clinical blood chemistry data demonstrated no toxic effects from repeated-dose administration of Abeliophyllum distichum Nakai ethanol extract in the SD rats during the observation period. Based on these results, this data suggests that a dose of 1,000 mg/kg/day is a highest treatment to administer when conducting a further 13 weeks toxicity study.

• YAKHAK HOEJI
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• v.43 no.2
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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.

• Proceedings of the Korean Society of Toxicology Conference
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• 2003.10b
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• pp.132-132
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• 2003

In this GLP study, 4 study groups of 12 Sprague-Dawley (SD) rats/sex were given vehicle, or 1,000, 1,500, or 2,000 mg/kg/day Sophora Japonica Linne Seed Extract (SE) for 13 weeks. Standard endpoints in this study included mortality, clinical observations, body weight, food and water consumption, ophthalmoscopic examination, urinalysis, hematology, serum biochemistry, organ weights, gross anatomic pathology and histopathology.(omitted)

• Nutrition Research and Practice
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• v.11 no.6
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• pp.452-460
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• 2017

BACKGROUD/OBJECTIVES: Turanose, ${\alpha}$-D-glucosyl-($1{\rightarrow}3$)-${\alpha}$-D-fructose, is a sucrose isomer which naturally exists in honey. To evaluate toxicity of turanose, acute and subchronic oral toxicity studies were conducted with ICR mice. MATERIALS AND METHODS: For the acute oral toxicity study, turanose was administered as a single oral dose [10 g/kg body weight (b.w.)]. In the subchronic toxicity study, ICR mice were administered 0, 1.75, 3.5, and 7 g/kg b.w. doses of turanose daily for 13 weeks. RESULTS: No signs of acute toxicity, including abnormal behavior, adverse effect, or mortality, were observed over the 14-day study period. In addition, no changes in body weight or food consumption were observed and the median lethal dose (LD50) for oral intake of turanose was determined to be greater than 10 g/kg b.w. General clinical behavior, changes in body weight and food consumption, absolute and relative organ weights, and mortality were not affected in any of the treatment group for 13 weeks. These doses also did not affect the macroscopic pathology, histology, hematology, and blood biochemical analysis of the mice examined. CONCLUSION: No toxicity was observed in the acute and 13-week subchronic oral toxicology studies that were conducted with ICR mice. Furthermore, the no-observed-adverse-effect level is greater than 7 g/kg/day for both male and female ICR mice.

• Journal of Pharmacopuncture
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• v.17 no.2
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• pp.18-26
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• 2014

Objectives: This study was performed to check for reversibility in the changes induced by a 13-week, repeated, dose toxicity test of Sweet Bee Venom (SBV) in Sprague-Dawley (SD) rats. Methods: Fifteen male and 15 female SD rats were treated with 0.28 mg/kg of SBV (high-dosage group) and the same numbers of male and female SD rats were treated with 0.2 mL/kg of normal saline (control group) for 13 weeks. We selected five male and five female SD rats from the high-dosage group and the same numbers of male and female SD rats from the control group, and we observed these rats for four weeks. We conducted body-weight measurements, ophthalmic examinations, urinalyses and hematology, biochemistry, histology tests. Results: (1) Hyperemia and movement disorder were observed in the 13-week, repeated, dose toxicity test, but these symptoms were not observed during the recovery period. (2) The rats in the high-dose group showed no significant changes in weight compared to the control group. (3) No significant differences in the ophthalmic parameters, urine analyses, complete blood cell counts (CBCs), and biochemistry were observed among the recovery groups. (4) No changes in organ weights were observed during the recovery period. (5) Histological examination of the thigh muscle indicated cell infiltration, inflammation, degeneration, necrosis of muscle fiber, and fibrosis during the treatment period, but these changes were not observed during the recovery period. The fatty liver change that was observed during the toxicity test was not observed during the recovery period. No other organ abnormalities were observed. Conclusion: The changes that occurred during the 13-week, repeated, dose toxicity test are reversible, and SBV can be safely used as a treatment modality.

• Korean Journal of Acupuncture
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• v.35 no.3
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• pp.139-148
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• 2018

Objectives : This study was performed to examine the toxicity on the long term procedure of Aconitum ciliare Decaisne pharmacopuncture(ADP) solution. Methods : To evaluate the long term toxicity of 3 different repeated doses, 60, 150, and 300 mg/kg/day for 13 weeks were injected into BALB/c mice, respectively. The ADP solution was injected into near ST36 of the right leg and normal saline of the same volume was used for the vehicle control group. To evaluate the toxicity of 60, 150, and 300 mg/kg of repeated doses for 13 weeks, toxic symptoms, weight measurement, hematological test, blood biochemical test, visual examination and weight measurement of major organs, and histopathological test were conducted. Results : No significant changes in toxic symptoms, weight measurement, hematological test, blood biochemical test, visual examination and weight measurement of major organs, and histopathological test were observed in different doses of ADP solution treated groups compared to vehicle control group. Conclusions : As a result, repeated dose at a concentration of 300 mg/kg or less is considered to be not harmful for clinical treatment.

• Biomolecules & Therapeutics
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• v.2 no.2
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• pp.161-172
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• 1994

This study was conducted to examine DA-3002, a biosynthetic human growth hormone, for its acute and subacute toxicities in mice and rats. The drug was administered subcutaneously and orally at a dose level of 1.0, 3.0, 8.9, 26.7 or 80.0 lU/kg once for single dose toxicity and given subcutaneously at a dose level of 0.34, 1.7 or 8.4 lU/kg daily for 13 weeks to investigate repeated dose toxicity. In the acute toxicity study, doses up to 80 lU/kg had no adverse effect on the behavior or body weight gain. Pathological examinations revealed no abnormal changes which could be attributed to toxic effect of DA-3002. In the subacute toxicity study, the growth hormone was tolerated well in broth mice and rats. No drug related deaths occurred and all animals appeared to be normal throughout the dosing period. Increases in body weight gain, food utilisation and absolute organ weights were observed in the rats in the high dose group. Mild changes in the blood chemical parameters were also seen in the treated groups. Histopathologically, however, no abnormal changes were observed in any organ. The changes noted during the treatment periods presumably represent exaggerated pharmacological effects of the growth hormone, and no observed adverse effect level (NOAEL) was considered to be more than 8.4 lu/kg/day.

• Korean Journal of Pharmacognosy
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• v.39 no.1
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• pp.60-67
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• 2008

The subcronic toxicity of BDR-29, a herbal preparation of Cassiae Semen, Prunellae Spica, Tribuli Fructus, and Uncariae Rhamulus et Uncus, was examined in male and female Sprague-Dawley rats. Rats were treated with the test substance at a dose 5 mg/kg, 50 mg/kg and 500 mg/kg intragastrically for 13 weeks. No death and abnormal clinical signs were observed throughout the administration period. There were not significantly different from control group in net body weight gain, food and water consumption, organ weight, gross pathological findings, and urine analysis among the groups rats treated with different doses of the BDR-29. Hematological findings and biochemical examination revealed no evidence of specific toxicity related to BDR-29. From these results, no observation effect level (NOEL) of BDR-29 is 500 mg/kg/day under the condition employed in this study.