• 한국환경성돌연변이발암원학회:학술대회논문집
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• 한국환경성돌연변이발암원학회 2004년도 춘계학술대회
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• pp.96-96
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• 2004

• Toxicological Research
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• 제28권2호
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• pp.99-102
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• 2012

Bee venom (Apis mellifera L. BV) has been used as a cosmetic ingredient for anti-ageing, anti-inflammatory and antibacterial functions. The aim of this study was to evaluate the acute toxicity after a single dermal administration of BV, BV was administered to 2 groups of Sprague-Dawley (SD) male and female rats (5 animals/group) at doses of 0 and 1,500 mg/kg body weight (BW). Mortality, clinical signs, body weight changes and gross findings were continually monitored for 15 days following the single dose. There were no unscheduled deaths in any groups during the study period. No BV related clinical signs and body weight changes were observed in any groups during the study period. There were no abnormal gross findings at necropsy on day 15 after the treatment. On the basis of the above results, it was concluded that there were no treatment-related effect on mortality, clinical signs, body weight changes and gross findings in SD rats treated with a single dermal dose of BV at dose of 1,500 mg/kg BW. Therefore, the approximate lethal dose of BV was considered to be over 1,500 mg/kg/day for both sexes of rats. BV may provide a developmental basis for a cosmetic ingredient or external application for topical uses.

• Biomolecules & Therapeutics
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• 제15권4호
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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.

• 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.

• Biomolecules & Therapeutics
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• 제9권1호
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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.

• 한방재활의학과학회지
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• 제25권3호
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• pp.1-9
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• 2015

Objectives To evaluate Shinbaro Pharmacopuncture safety through analysis of potential single-dose intramuscular toxicity of Sinbaro Pharmacopucture in SD rats and Beagle dogs. Methods Single-dose intramuscular toxicity of Shinbaro Pharmacopuncture was assessed in accordance with Korea Food and Drug Administration Guidelines for toxicity testing of Medicinal Products. The SD rats were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 0, 4.6, 9.2, and 18.5 mg/kg, respectively. The Beagle dogs were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 2.3, and 4.6 mg/kg, respectively, and after 3 days, the procedure was repeated a second time at doses of 0.6, and 1.2 mg/kg, respectively, for toxicity testing. Mortality, change in body weight, and necropsy findings were examined for the study period. Results There were no mortalities, general symptoms, or body weight changes in the SD rats. While pyelectasis of the left kidney was observed in a male rat in the 4.6 mg/kg administration group, natural occurrence is common, and does not appear to be related with the test substance. No mortalities were observed in the Beagle dogs. In assessment of general symptoms, a female dog in the 9.2 mg/kg group displayed body weight decrease due to leftover food, but the change in body weight was within the normal range seen at 6~7 months, and the necropsy findings were not significant. The toxicity of the test substance appears to be minimal. Conclusions The results suggest that the lethal dose 50 ($LD_{50}$) and approximate lethaldose (ALD) value in single intramuscular administration of Shinbaro Pharmacopuncture in SD rats and Beagle dogs are higher than 18.5 mg/kg.

• 농업과학연구
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• 제43권1호
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• pp.109-115
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• 2016

Silk has had a reputation as a luxurious and sensuous fabric but it is not popular due to the expensive price and poor durability. To develop the silk materials that apply the various industries, the artificially synthesized gene can be introduced into the silkworm and expressed in the silk gland. Transgenic silkworms for the mass production of green fluorescent silks are generated using a fibroin H-chain expression system. For commercial use, safety assessment of the transgenic silkworms is essential. The purpose of this study was to examine the potential acute oral toxicity of EGFP protein expressed in genetically modified (GM) fluorescence silkworm and to obtain the approximative lethal dose in the male and female at 6-weeks ICR mice. EGFP protein was fed at a dose of 2,000 mg/kg body weight in five male or five female mice. Mortalities, clinical findings and body weight changes were monitored for 1, 3, 7, 14 days after dosing. At the end of 14 day observation period, all mice were sacrificed, and the postmortem necropsy were performed. The test group was not observed death case. Also the effect was not admitted by test substance administration in common symptoms, the body weight and postmortem. The results of single-dose oral toxicity test showed that approximative lethal dose of EGFP protein expressed in fluorescence silkworm was considered to exceed the 2,000 mg/kg body weight in both sexes.

• Toxicological Research
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• 제22권4호
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• pp.431-438
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• 2006

The object of this study was to obtain acute toxicity information (single oral dose toxicity) of lyophilized water extract of Puerariae Radix (PR) in both male and female mice. In order to investigate the 50% lethal dose $(LD_{50})$, approximate lethal dosage (ALD), test substances were once orally administered to female and male ICR mice at dose levels of 2000 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines [2005-60, 2005]. The mortality and body weight changes, clinical signs and gross observation were monitored during 14 days after dosing. Organ weight and histopathology of 12 principal organs were measured. As the results, we could not find any mortality, clinical signs, body weight changes and gross findings except for PR extracts unrelated sporadic findings. In addition, no abnormal changes related PR extracts treatment on the organ weight and histopathology of principal organs were detected except for some sporadic findings including hyperplasia of lymphoid follicles in the popliteal lymph nodes and spleen as pharmacological effects of PR extracts. The results obtained in this study suggest that the PR extracts does not cause any toxicological signs except for pharmacological effects of enhancement of Immune system. The $LD_{50}$ and ALD of PR extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected up to 2000mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development.

• 대한약침학회지
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• 제18권2호
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• pp.60-66
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• 2015

Objectives: This study was carried out in order to find both the single-dose intramuscular injection toxicity and the approximate lethal dose of samjeong pharmacopuncture (SP) in Sprague-Dawley (SD) rats. Methods: The SD rats in this study were divided into four groups, one control group (1.0 mL/animal, normal saline) and three experimental groups (0.25, 0.5, and 1.0 mL/animal, SP). All groups consisted of five male and five female rats. SP was injected as a single-dose intramuscularly at the thigh. After the injection, general symptoms and weight were observed for 14 days. After the observations had ended, hematologic and serum biochemical examinations, necropsy and a local tolerance test at the injection site were performed. The experiments were carried out at the Good Laboratory Practice firm, Biotoxtech Co. (Cheongwon, Chungbuk). Animal experiments were approved by the Ethics Committee (Approval Number: 130379). Results: No deaths occurred in any of the three experimental groups. The injection of SP had no effects on the general symptoms, body weights, results of the hematologic, and serum biochemical examinations, and necropsy findings. In local tolerance tests at the injection sites, mild inflammation was observed in the experimental group, but it did not appear to be a treatment related effect. Conclusion: Under the conditions of this test, the results from the injection of SP suggest that the approximate lethal dose of SP is above 1.0 mL/animal for both male and female SD rats. Therefore, the clinical use of SP is thought to be safe.

• 한방재활의학과학회지
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• 제31권1호
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• pp.95-108
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• 2021

Objectives This study was conducted to investigate the beta-glucan, ginsenoside content, antioxidant activity and safety of modified Kyungohkgo added to Sparassis crispa and Hericium erinaceum. Methods The marker compounds contents, antioxidant activity and safety of modified Kyungohkgo were tested. The contents of beta-glucan and ginsenoside Rb1, Rg1, and Rg3 marker compounds were measured, the antioxidant activity was measured using 2,2-diphenyl-1-picrylhydrazyl (DPPH) free radical scavenging activity, and a safety test was conducted via single dose toxicity assessment. Results Analyzing the contents of marker compounds showed 351.75 mg/g of beta-glucan, 0.0327 mg/g of ginsenoside Rb1 and 0.0802 mg/g of ginsenosai Rg3. In the DPPH free radical scavenging activity, the inhibition concentration 50% of modified Kyungohkgo was 0.2880%. The scavenging activity of modified Kyungohkgo was 5.49% activity at 0.05% concentration, 89.66% activity at 0.5% concentration, 94.68% activity at 1% concentration, and 96.06% activity at 5% concentration. In the single dose toxicity test of modified Kyungohkgo, a dose of 2,000 mg/kg B.W. was set at its highest capacity and observed after oral administration to female and male rats. No toxicological findings were recognized. It was observed that the resulting lethal dose can be set to 2,000 mg/kg B.W. or higher for both females and males. Conclusions The results of the experiment on modified Kyungohkgo showed that the marker compounds contents were beta-glucan and ginsenoside Rb1 and Rg3, that antioxidant activity was observed through the DPPH free radical scavenging activity, and safety was confirmed through the single dose toxicity assessment.