• The Journal of Internal Korean Medicine
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• v.32 no.3
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• pp.334-344
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• 2011

Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

• The Journal of Korean Medicine
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• v.35 no.2
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• pp.28-33
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• 2014

Background: Samul-tang (Si-Wu-Tang, SMT) is a traditional herbal formula, which has been widely used to treat various diseases such as menstrual irregularity, bleeding and leucorrhea. Although many studies have investigated the pharmacological properties of SMT, its toxicity information has not yet been fully elucidated. Methods: Five Sprague Dawley (SD) rats of each sex were given a single dose (5000 mg/kg) of SMT by gavage; control rats received the vehicle only. After the single administration, mortality, clinical signs, body weight changes and gross findings were monitored for 15 days in accordance with Good Laboratory Practice (GLP) principles. Results: In a single oral dose toxicity study, there was no adverse effect on mortality, clinical sign, body weight change or gross finding in any treatment group. Conclusions: The results indicate that SMT did not induce toxic effects at a dose level up to 5000 mg/kg in rats and its median lethal dose ($LD_{50}$) was considered to be over 5000 mg/kg/day body weight for both genders.

• Toxicological Research
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• v.21 no.4
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• pp.361-365
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• 2005

This study was conducted to obtain the acute information of the oral dose toxicity of Polycan - originated from Aureobasidium pullulans SM-2001 (half of the dry material is -1,3/1,6-glucans), a UV induced mutant of A. pullulans, having various pharmacological effects, in male and female mice. In order to calculate $50\%$ lethal dose $(LD_{50})$, approximate LD and target organs, test article was administered twice by oral gavage to male and female ICR mice at total 1000, 500 and 250mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings. The results obtained in this study suggest that the Polycan is non-toxic in mice and is therefore likely to be safe for clinical use. The L050 and approximate $(LD_{50})$ in mice after single oral dose of Polycan were considered over 1000 mg/kg, respectively.

• Korean Journal of Veterinary Research
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• v.50 no.3
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• pp.187-195
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• 2010

In this study, we investigated the biological activities such as anti-tumor, anti-oxidant and antiinflammatory activities as well as single oral dose toxicity of fermented Rhus verniciflua extract (FRVE). In order to examine anti-tumor activity of FRVE, the sarcoma 180 cells were treated with FRVE at various concentrations (0.03, 0.3, 3 and 30 mg/mL) in microtetrazolium (MTT) assay. In MTT assay, all the cells treated with FRVE at various concentrations have shown a significant difference compared with control (p < 0.05). In xanthine oxidase inhibition assay to examine the antioxidant activity, the xanthine oxidase inhibition rate of FRVE at 1.5 mg/mL and 15 mg/mL was $85{\pm}15.01%$ and $99{\pm}16.02%$, respectively. Nitric oxide production in RAW 264.7 cells showed that FRVE showed a significant anti-inflammation effect at 3 mg/mL (p < 0.05). In single oral dose toxicity study, no differences were observed between control and treated groups in clinical signs, body weight gains, feed and water consumptions. The results indicated that lethal dose 50 ($LD_{50}$) of FRVE was found to be higher than 5,000 mg/kg in this experiment. From the above results, we may suggest that FRVE might have useful as a material for functional food and/or animal pharmaceutics.

• Environmental Analysis Health and Toxicology
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• v.24 no.3
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• pp.181-191
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• 2009

As an effort to prevent serious accidents involving oxygen deficiency and suffocation in confined spaces and to identify the causes of such accidents, the present study investigated relevant accidents and systems in Korea and other countries. This study also conducted a number of experiments at lethal concentration levels of oxygen deficiency using SD rats and observed the changes of experimental animals with humidity, organic gas (toluene), hydrogen sulfide, carbon monoxide and so on at the oxygen deficient environment. The results of the study are as follows. 1. The results from the experiment conducted using SD rats at lethal concentration levels of oxygen showed that there were no casualties at the 7% oxygen concentration level, but the mortality increase to 20% at 6% oxygen, it was jumped to 90% at 5% oxygen, and it was also dramatically reached 100% at 4% oxygen concentration. Therefore, 5.5% was calculated as the $LC_{50}$ (rat, 4hr) from these dose-response experiments with oxygen deficiency. 2. When we changed the level of toluene, $H_2S$, CO, humidity, and so on, in an oxygen deficient environment, it was observed that the small concentrations of $H_2S$ and CO make the highest effect on animals. In case of 350 ppm $H_2S$, it resulted in 30% mortality, and the 100% mortality was shown in 1,200 ppm CO concentration. The mortality increased as an oxygen deficient condition. However in the case of toluene up to 1,000 ppm, it were not affected with oxygen deficiency, and it did not indicate any significant differences in mortality as 20%, 90% humidities.

• Journal of Radiation Industry
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• v.6 no.2
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• pp.189-197
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• 2012

This study was carried out to develop the improved useful mutants for yield or composition of stevia plants using the gamma ray or chemical mutagens treatments. The seeds of stevia 'Suwon No. 11' were irradiated up to 400 Gy of gamma ray. Chemical mutagens were treated on the seeds of the 'Suwon No. 11' using 0.07% colchicine, 10 mM sodium azide, or 10 mM NMU for various durations. The germination rate, and shoot and root growth of seedling were estimated at 30 days after gamma ray irradiation or chemical mutagen treatment, and the plant height, the number of branches, and leaf length and width were examined at 3 months after mutagenesis treatments. In the case of gamma ray treatments, the germination rate and early-stage growth were decreased as the increase of radiation dose, and the 50% lethal dose was found to be 200 Gy. the plant height was decreased as the increase of radiation dose, while the number of branches per plant and leaf length were increased. Leaf shape was modified to the relatively longer one compared to the control, which was identified more apparently at the treatments of higher than 150 Gy. In the treatment of chemical mutagens, the rate of germination and survival were decreased as the increase of incubation time. The 50% lethal dose for germination rate were identified as the conditions of the 15 hours incubation in 0.07% colchicine, the 4 hrs in 10 mM sodium azide, and the 2 hrs in 10 mM NMU, in the three chemical mutagens treatments. Chemical mutagens had no influence on shoot growth, while root growth was increased, especially as the incubation time was extended. The highest root growth occurred in the NMU treatment at 6 hrs incubation time. The plant height was decreased as the increase of incubation time in the chemical mutagens treatments. Among the chemical mutagens, NMU was the most effective to induce the mutants with long-shaped or the least lobed leaves.

• Korean Journal of Plant Resources
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• v.29 no.1
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• pp.128-135
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• 2016

This study examined radiation damage and the optimal gamma-ray dose for mutation breeding in oat (Avena sativa L. cv. Samhan). The seed germination rate decreased as the dose increased over 500 Gy. The median lethal dose (LD₅₀) was approximately 392 Gy. The median reduction dose (RD₅₀) for plant height, tiller number, root length, and flash weight was 411, 403, 394, and 411 Gy, respectively. The optimal dose of gamma irradiation for inducing oat mutation appears to be in the range 300-400 Gy. We performed the comet assay to observe nuclear DNA damage induced by gamma-ray irradiation. This assay showed a clear difference with gamma-ray treatments. DNA damage increased temporarily 7 days after treatment depending on the dose, while no significant difference was identified in response to 300 Gy 30 days after the gamma-ray treatments. The growth characteristics of the M₂ generation decreased as the dose increased over 400 Gy.

• Toxicological Research
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• v.23 no.4
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• pp.405-413
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• 2007

This study was to investigate single and repeated-dose toxicities of Tensolin-$F^{(R)}$, an anti-wrinkle agent, in Sprague-Dawley (SD) rats or ICR mice. In single-dose oral toxicity study, the test materials were administered once by gavage to male and female SD rats at dose levels of 0 and 2,000 mg/kg. No dead animals and abnormal necropsy findings were found in control and Tensolin-$F^{(R)}$ treated group. Therefore, the approximate lethal dose of Tensolin-$F^{(R)}$ was considered to be higher than 2,000 mg/kg in rats. In the 4-week repeated oral toxicity study, the test material was administered once daily by gavage to male and female ICR mice at dose levels of 0, 25, 50 and 100 mg/kg/day for 4-weeks. In the results, no abnormality was observed in mortality, clinical findings, body weight changes, food and water consumptions, opthalmoscopic findings, necropsy findings, histopathological findings. In hematological analysis, there was a trend of increase in reticulocyte at male 25 mg/kg, although such changes were in normal ranges. On the other hand, there was a trend of decrease in hemoglobin at female 50, 100 mg/kg, such changes were in normal ranges. In addition, serum biochemical parameters including sodium, BUN and chloride increased at 25, 50 and 100 mg/kg. Relative organ weights of right testis, brain, lung and left epididymis were increased in 100 mg/kg groups of male rats in contrast to not change in female groups. However, these changes of relative organ weights, hematological and serum biochemical parameters were not accompanied with related signs such as histopathological changes or clinical findings. In conclusion, 4-week repeated oral dose of Tensolin-$F^{(R)}$ to ICR mice did not cause apparent toxicological change at the dose of 25, 50, 100 mg/kg body weight. Consequently the no-observed-adverse-effect level (NOAEL) for Tensolin-$F^{(R)}$ in ICR mice following gavage for at least 4-week is higher than 100 mg/kg/day.

• Korean Journal of Acupuncture
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• v.34 no.4
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• pp.241-250
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• 2017

Objectives : This study was performed to examine the toxicity of Aconitum ciliare Decaisne pharmacopuncture(ADP). Methods : The toxicity was evaluated for lethal dose for 50 percent kill(LD50), single dose and repeated dose for 4 weeks. Toxic symptoms, weight measurement, hematological test, blood biochemical test, visual examination and weight measurement of major organs and histopathological test were observed for 4 weeks. Dose of 300, 600, 1,200, 2,400, 3,600, 4,800, 6,000, 7,200 mg/kg in the LD50 experiment, 300, 600, 1,200 mg/kg/day in the single experiment, 150, 300, 600 mg/kg/day in 4 weeks experiments were injected into BALB/c mice. The ADP was injected into ST36 of the right leg. Normal saline solution of same volume was used for control group. In 24 hours after the last treatment, blood samples were taken after anesthesia by inhalation of ethyl ether. After that, the BALB/c mice were euthanized. Their heart, lungs, kidneys, liver and reproductive organs were removed and weighed. Histopathological evaluation was also performed. Results : ADP's LD50 was measured at 6,000 mg/kg. In both single and repeated dose toxicity test, no BALB/c mouse died during the experiments. ADP treatment for 4 weeks did not show any significant changes in toxic symptoms, weight measurement, hematological test, blood biochemical test, visual examination and weight measurement of major organs and histopathological test. Conclusions : As a result, ADP's LD50 was 6,000 mg/kg and repeated dose at a concentration of 600 mg/kg or less is considered to be not harmful for clinical treatment.

• The Journal of Internal Korean Medicine
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• v.33 no.1
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• pp.62-68
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• 2012

Objectives : This study aimed to evaluate the single oral dose toxicity of Seonpyejeongcheon-tang (SJT) in male and female Sprague-Dawley rats. Methods : In this single oral toxicity study, rats were orally administrated in a single dose of 0 or 5,000 mg/kg SJT. There were 7 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological findings were observed for 14 days. Organ weight, clinical chemistry and hematology were tested after 14 days. Results : There was no mortality or other clinical signs for 14 days. There were also no significant differences in body weight, organ weights, hematological and serum chemical parameters between the SJT and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of SJT is over 5,000 mg/kg, so this finding can be expected to provide scientific evidence for the safety of SJT.