• Biomedical Science Letters
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• v.22 no.2
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• pp.46-52
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• 2016

Salicornia herbacea L. (S. herbacea) is an annual herbaceous plant of Chenopodiaceae. It grows in groups on the coast or mud flat of Korea is known to be rich in minerals. S. herbacea has potent anti-cancer, antioxidant, anti-obesity, bowel function improvement. However, pharmacological mechanisms of S. herbacea extract (SHE) remain poorly understood. The aim of this study was to investigate the potential acute toxicity of SHE in ICR mice administered a single oral dose of 0, 500, 1,000, and 2,000 mg/kg by gavage. After administration of the extract, signs of toxicity were observed every day for 14 days. No mortality, abnormal clinical signs, body weight, organ weight or pathological changes were observed compared to a control group, and there were no differences in the body weights of the control and treatment groups. Biological serum activities and histological tests were not significantly changed in the treatment group compared to the control group. Especially, treatment of SHE was significantly decreased of total cholesterol and triglyceride levels. These results indicated that a single oral administration of SHE does not exerts any toxic effects at a dose of 2,000 mg/kg and that the $LD_{50}$ of SHE is greater than 2,000 mg/kg. Accordingly, SHE appears to have potential in various functional agents of foods, without toxicity.

• 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.

• The Korea Journal of Herbology
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• v.36 no.5
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• pp.109-115
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• 2021

Objectives : 'Johyun' yulmoo which is a new variety of Coix lacryma-jobi var. ma-yuen Stapf sprout was developed and registered by Rural development administration in 2004. This variety was derived from the cross between single cross of Suwon-6 and Okayama and UCN300-25 as F1. It is characterized by early maturity, short plant height, a strong resistance, and a superior yield and is suitable for the central and northern regions. Accordingly, we were performed and evaluated single oral dose toxicity test of 'Johyun' yulmoo sprout (JYS) in Sprague-Dawley (SD) rats. Methods : Single oral dose toxicity test was performed using with male and female rats. Rats were divided into two groups: Group 1, vehicle-treated rats (Control); Group 2, JYS 5000 mg/kg-treated rats. JYS was orally administered to male and female rats at dose levels of 5000 mg/kg. Animals were monitored on the mortality, clinical signs, body weight changes, and necropsy findings for 14 days. groups : Group 1, vehicle-treated rats (Control); Group 2, JYS 5000 mg/kg-treated rats. JYS was orally administered to male and female rats at dose levels of 5000 mg/kg. Animals were monitored on the mortality, clinical signs, body weight changes, and necropsy findings for 14 days. Results : After oral treatment of JYS, we could not find any mortality at 5000 mg/kg. Compared with the control group, there were also no significant differences in clinical sign, weight changes, weight gain, and gross abnormalities in JYS 5000 mg/kg-treated group. Conclusions : Taken together, these results suggest that approximate lethal dose of JYS was considered as over 5000 mg/kg. Results from this study provide scientific evidence for the safety of JYS. Moreover, this study could be used as a basis for dose-setting data of the repeated dose 13-week oral toxicity test of JYS.

• 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.

• Biomolecules & Therapeutics
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• v.8 no.2
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• pp.167-170
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• 2000

The present study was conducted to investigate the acute toxicity of plant sterol ester by a single oral dose in Sprague-Dawley rats. Ten males and 10 females aged 5 weeks were randomly assigned to two groups of 5 rats each and were administered by gavage at dose level of 0 or 20 ml/kg body weight. Parameters measured during the 14-day observation period were mortality, clinical signs, body weight changes, and gross findings. No mortality was observed in the present study. Treatment-related clinical signs, such as pasty stool and diarrhea, were observed on the day of treatment and these signs resulted in soiled fur on day 1 after the treatment. However, no clinical signs were observed on days 2-14 after the treatment. There was no significant difference in body weight changes between the control and treatment groups. At necropsy on day 14 after the treatment, no treatment-related gross findings were observed in the treatment group. Based on these results, it was concluded that a single oral dose of plant sterol ester induced pasty stool and diarrhea in Sprague-Dawley rats at dose level of 20 ml/kg and that the lethal doses were considered to be over 20 ml/kg for 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.

• The Journal of Internal Korean Medicine
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• v.31 no.3
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• pp.539-553
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• 2010

Objectives : The object of this study was to obtain accurate information (single oral dose toxicity) of Lonicerae Flos (LF; Dried flower bud parts of Lonicera japonica Thunb (Caprifoliaceae)), which has traditionally been used in Korean medicine for treating various inflammatory diseases. Methods : In order to observe the 50% lethal dose (LD 50), approximate lethal dosage (ALD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.). The mortality and changes on body weight, clinical signs and gross observation were monitored for 14 days after single oral treatment of LF aqueous extracts with organ weights and histopathological observations of 12 types of principle organs. Results : 1. After single oral treatment of LF aqueous extracts, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents at body and organ weights, clinical signs, gross and histopathological observations. 2. Slight diarrhea was detected in most mice treated with 2,000 mg/kg of LF aqueous extracts and male mice of LF aqueous extracts 1,000 mg/kg within 2 days after end of treatment, respectively. Conclusion : The results obtained in this study suggest that the LD 50 and ALD of LF aqueous extracts in both female and male mice after single oral treatment were considered as over 2,000 mg/kg because no mortalities were detected up to 2000 mg/kg, the highest dose recommended by KFDA and OECD. However, we also observed the possibility of digestive disorders like diarrhea when over 1,000 mg/kg of LF aqueous extracts were administered in the present study.

• 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.

• Toxicological Research
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• v.34 no.1
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• pp.55-63
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• 2018

As a part of general toxicity studies of Enterococcus Faecalis 2001 (EF 2001) prepared using heat-treatment bacillus mort body EF 2001 in mice, this study examined the toxicity of EF 2001 in single and repeated administrations following the previous report in order to apply this product to preventive medicine. The safety of oral ingestion of EF 2001 was examined in 6-week-old male and female ICR mice with 1,000 mg/kg, 3,000 mg/kg and 5,000 mg/kg body weight/day administrated by gavage of the maximum acceptable dose of EF 2001. The study was conducted using distilled water as a control following the methods for general toxicity studies described in the "Guidelines for Non-clinical Studies of Pharmaceutical Products 2002". As a control, 1) observation of general conditions, 2) measurement of body weight, 3) determination of food consumption, 4) determination of water consumption, 5) blood test and urinalysis and 6) pathological examination were performed for the administration of EF 2001. Mice received EF 2001 for 13 weeks and results were compared with those of the control group that received distilled water. The results of the above examinations revealed no significant differences between control and EF 2001 groups for both males and females. Thus, no notable toxicity was confirmed with single and repeated oral administrations of EF 2001. Oral administration in the above doses did not result in abnormal symptoms or death during the observation period. No abnormalities in blood cell count or organ weights were seen. Without any evidence of toxicity to cells and organs, EF 2001 is speculated to not adversely affect living organisms. The 50% lethal dose of EF 2001 with oral administration in mice is estimated to be greater than 5,000 mg/kg body weight/day for both male and female mice. Therefore, $LD_{50}$ value for animals was 5,000 mg/kg or more.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.4
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• pp.41-47
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• 2011

Objectives: This study was performed to investigate single oral dose toxicity of TB001, the extract mixture of Purple loosestrife and Aceriphyllum rossii. Methods: The mortality, general symptom, change of weight: and necropcy findings was investigated for 14 days after a dose(2000 mg/kg B.W.) of TB001 was given, using SD rats of both male and female according to "The guideline of toxicity test for medicine and others". Results: The death of rats and abnormal finding was not observed. There was no the significant difference of weight between control group and TB001 group. Conclusions: The abnormalities at the necropsy finding of all survived rats was not detected. The study suggested that there is no toxicity in single dose(2000 mg/kg B.W.) of TB001.