• The Journal of Korean Obstetrics and Gynecology
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• v.27 no.1
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• pp.28-40
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• 2014

Objectives: This study was to evaluate the single dose toxicity of Sobokchuko-tang (SBC) in male and female mice. Methods: Aqueous extract of SBC (yield=6.60%) was administered to female and male mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (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 14 principle organs were also examined. Results: we could not find any SBC treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for pharmacological immunomodulatory effects related findings including significant increases of submandibular lymph node weights, hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodes restrictly detected in 2,000 mg/kg treated female and male mice with some sporadic accidental findings. Conclusions: The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of SBC aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.

• Herbal Formula Science
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• v.28 no.2
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• pp.169-177
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• 2020

Objectives : This experiment was designed to assess the single oral toxicity of Ethanol Extract Inulae Flos (IF) ethanol extracts. IF is one of the important herbs to remove phlegmy which is the viscous turbid pathological product that can accumulate in the body, causing a variety of diseases. Nevertheless, there has been a lack of research on the pharmacology toxicity of IF. Methods : In this study, IF was orally administered to 5 weeks ICR mice as an oral dose of 2,000 or 3,000 or 5,000 mg/kg. The condition of the mice was observed for 14 days and their weights were measured every two days. Results : None of the mice died for 14 days. The abnormal clinical symptoms and anatomical signs of toxicity were not found in any treatment groups. The gain of net body weight was observed. There was also no significant difference in the organ weight. The serum biochemistry and hematological analysis showed a decrease in BUN, red blood cells, white blood cells and platelets although within the normal ranges. Conclusions : These results suggest that the 50% lethal dose of IF is more than 5,000 mg/kg. This could be thought that IF is a safe drug without acute toxicity and side effects. However, IF showed some weight loss and change in blood test, so it will need to be careful when using it for high doses.

• Korean Journal of Agricultural Science
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• v.43 no.1
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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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• v.29 no.4
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• pp.263-278
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• 2013

The silkworm extract powder contain 1-deoxynojirimycin (DNJ), a potent ${\alpha}$-glycosidase inhibitor, has therapeutic potency against diabetes mellitus. Therefore, natural products containing DNJ from mulberry leaves and silkworm are consumed as health functional food. The present study was performed to evaluate the safety of the silkworm extract powder, a health food which containing the DNJ. The repeated toxicity studies and gentic toxicity studies of the silkworm extract powder were performed to obtain the data for new functional food approval in MFDS. The safety was evaluated by a single-dose oral toxicity study and a 90 day repeated-dose oral toxicity study in Sprague-Dawley rats. The silkworm extract powder was also evaluated for its mutagenic potential in a battery of genetic toxicity test: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration test, and in vivo mouse bone marrow micronucleus assay. The results of the genetic toxicology assays were negative in all of the assays. The approximate lethal dose in single oral dose toxicity study was considered to be higher than 5000 mg/kg in rats. In the 90 day study, the dose levels were wet at 0, 500, 1000, 2000 mg/kg/day, and 10 animals/sex/dose were treated with oral gavage. The parameters that were monitored were clinical signs, body weights, food and water consumptions, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathological examination. No adverse effects were observed after the 90 day administration of the silkworm extract powder. The No-Observed-Adverse-Effect-Level (NOAEL) of silkworm extract powder in the 90 day study was 2000 mg/kg/day in both sexes, and no target organ was identified.

• Biomolecules & Therapeutics
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• v.9 no.4
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• pp.307-310
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• 2001

The hair-growth effect of Illite was suggested by some people who were using Illite as a beautifying material. We investigated the hair-growth effect of Illite powder. The hair-growth effects were investigated by two methods; the activity of hair-growth after shaving the hairs on the black mouse (C57BL/6) and the recovery activity of hair-growth after hair-loss induced by cyclophosphamide treatment. Suspension of Illite powder was applied to the back of the black mouse by method of skin paste. Illite promoted significantly the hair growth of mouse in both conditions of shaving and hair-loss. And then we investigated the toxicity which may be induced by Illite when it was administrated orally as a single dose. We could not fond out any significant toxicity induced by single dose oral administration of Illite.

• Journal of Acupuncture Research
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• v.31 no.1
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• pp.105-110
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• 2014

Objectives : The objective of this study is to analyze the single-dose toxicity of horse placenta hydrolysate extracts. Methods : Sprague-Dawley rats were chosen for the study. Doses of horse placenta hydrolysate extracts, 2,000 mg/kg, 1,000 mg/kg and 500 mg/kg, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : In all 4 groups, no deaths occurred, and the horse placenta hydrolysate extracts administered by oral was over 2,000 mg/kg. No significant changes in the weight between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ, the results showed no significant differences in any organs or tissues. Conclusions : The above findings suggest that treatment with horse placenta hydrolysate extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

• Toxicological Research
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• v.25 no.2
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• pp.107-111
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• 2009

The alcohol extract of the larvae of Bombus ignitus, otherwise known as the Bumblebee, was orally administered to rats at doses of 0, 0.04, 0.2, 1 or 2 g/kg as a single oral dose. There were no observed clinical signs or deaths related to treatment in all the groups tested. Therefore, the approximate lethal dose of the alcohol extract of B. ignitus was considered to be higher than 2 g/kg in rats. Mild decreases in body weight gain in male rats were observed dose-dependently within the B. ignitus treated groups over 2 weeks. Throughout the administration periods, no significant changes in diet consumption, ophthalmologic findings, clinical pathology (hematology, clinical chemistry and coagulation) or gross pathology were detected. Minor changes in male rats were found with in the hematological parameters in groups treated with the 0.04 g/kg, 1 g/kg or 2 g/kg of B. ignitus larvae extract, however, all the changes observed were within the physiological range. From these results, it was concluded that there was no evidence of specific toxicity related to the ingestion of alcohol extract of B. ignitus larvae.

• The Korea Journal of Herbology
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• v.39 no.2
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• pp.19-25
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• 2024

Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats. Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 mg/kg of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD). Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 mg/kg. In addition, no significant necropsy findings related to JGT administration were observed. Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 mg/kg.

• 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.

• Toxicological Research
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• v.22 no.4
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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.