• Journal of Physiology & Pathology in Korean Medicine
• /
• v.24 no.1
• /
• pp.134-142
• /
• 2010

Although BinSo-San(BSS), a mixed herbal formula consisted of 11 types of medicinal herbs and have been used as anti-inflammatory agent, In the present study, the acute toxicity (single oral dose toxicity) of lyophilized BSS aqueous extracts was monitored in male and female mice after oral administration according to Korea Food and Drug Administration (KFDA) Guidelines (2005-60, 2005). In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2000, 1000, 500, 250 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines (2005-60, 2005). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines (2005-60, 2005) with organ weight and histopathology of 12 types of principle organs. We could not find any mortality, clinical signs and changes in the body weights except for dose-independent increases of body weight and gains restricted in 1000 mg/kg of BSS extracts-dosing female group. Hypertrophic changes of lymphoid organs.thymus, spleen and popliteal lymph nodes were detectedat postmortem observation with BSS extracts dose-dependent increases of lymphoid organ weights, and hyperplasia of lymphoid cells in these all three lymphoid organs at histopathological observations. These changes are considered as results of pharmacological effects of BSS extracts or their components, immunomodulating effects, not toxicological signs. In addition, some sporadic accidental findings such as congestion spots, cyst formation in kidney, atrophy of thymus and spleen with depletion of lymphoid cells, and edematous changes of uterus with desquamation of uterus mucosa as estrus cycles were detected throughout the whole experimental groups including both male and female vehicle controls. The significant (p<0.01) increases of absolute weights of kidney and pancreas detected in BSS extracts 1000 mg/kg-treated female group are considered as secondary changes from increases of body weights. The results obtained in this study suggest that the BSS extract is non-toxic in mice and is therefore likely to be safe for clinical use. The LD50 and ALD of BSS aqueous extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. In addition, the MTD of BSS extracts was also considered as over 2000 mg/kg because no BSS extracts-treatment related toxicological signs were detected at histopathological observation except for BSS or their component-related pharmacological effects, the immunomodulating effects detected in the present study.

• Journal of Society of Preventive Korean Medicine
• /
• v.15 no.1
• /
• pp.37-47
• /
• 2011

Objectives : Previous studies have shown that Fructus mume (FM) has anti-platelet effects. The present study was performed to determine the acute oral toxicity and quality control of a crude extract of FM in ICR mice. Methods : We investigated the in vivo single dose acute toxicity of FM 95% ethanol extract. This test was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000mg/kg body weight, respectively. Mortalities, clinical findings, autopsy findings and body weight changes were monitored daily for the 14 days following the administration. HPLC analysis was performed for the simultaneous determination of ursolic acid and p-hydroxycinnamic acid in FM. Reverse-phase chromatography using a C18 column and photodiode array detection at 211 nm was used for quantification of the two maker components. The mobile phase for gradient elution consists of water and acetonitrile. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. The mice did not die after single oral administration of maximum dose of FM. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of FM for ICR mice was more than 5000mg/kg on oral route. The HPLC analysis showed that ursolic acid and p-hydroxycinnamic acid amounts to 9.75- and 0.12% in the extract with the retention times of 47.99- and 15.38 minutes, respectively. Conclusions : These results suggest that no toxic dose level of FM in mice is considered to be more than 5000mg/kg. Consequently, it was concluded that FM have no effect on acute toxicity and side effect in ICR mice. For the quality control of FM extract, simultaneous determination of ursolic acid and p-hydroxycinnamic acid was established.

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.45 no.10
• /
• pp.1406-1413
• /
• 2016

This study was carried out to evaluate the toxicity of ethanolic extracts of Morus alba L. branch (ME). In the reverse mutation test, Salmonella Typhimurium TA98, TA100, TA1535, TA1357, and Escherichia coli WP2uvrA were used to estimate the mutagenic potential of ME. Sprague-Dawley rats were orally administered ME at levels of 1,250, 2,500, and 5,000 mg/kg for the single-dose toxicity test and 500, 1,000, and 2,000 mg/kg/d for the repeated-dose toxicity test for 28 consecutive days. As expected, reverse mutation was not detected at any concentration of ME, regardless of application of the metabolic activation system with or without S9 mix. In the single-dose toxicity test, ME caused neither significant visible signs of toxicity nor mortality in rats, and $LD_{50}$ was estimated to be over 5,000 mg/kg. In the repeated-dose toxicity test, ME administration at 500, 1,000, and 2,000 mg/kg for 28 days to male or female rats did not result in mortality. Similarly, no toxicologically significant treatment-related changes in body weight, food intake, or organ weights were noted. Several hematological and biochemical parameters in both genders showed significant differences, but these were within normal ranges. These results support the safe use of ME.

• Korean Journal of Oriental Medicine
• /
• v.9 no.2
• /
• pp.131-148
• /
• 2003

This study was performed to evaluate the acute oral toxicity of an oriental medical prescription for obesity treatment, SH21-B, in Sprague-Dawley rats and Beagle dogs. SH21-B was administered in rats at does of 0mg/kg, 2,000mg/kg, and 5,000mg/kg. And also SH21-B was administered in Beagle dogs at does of 150mg/kg, 300mg/kg, and 600mg/kg. The rats and dogs of both sexes were observed daily for 14 days after single oral administration. Two female rats, one administered at 2,000mg/kg and the other administered at 5,000mg/kg, died, but no dead animal was observed among male rats. Therefore LD50 in the female rat is observed to be 8,710mg/kg, and MLD(Minimum Lethal Dose) of the male rat is observed to be more than 5,000mg/kg. Among dogs, no dead animal was observed up to 600mg/kg and MLD is observed to be more than 600mg/kg.

• Journal of Life Science
• /
• v.24 no.2
• /
• pp.191-195
• /
• 2014

Essential oils extracted or purified from various plants have shown various beneficial effects. Seed parts of Schizandra chinensis Baillon (Schisandrae Semen) have been used as a traditional medicine for thousands of years in parts of Asia, including Korea, China, and Japan. However, the pharmacological mechanisms of essential oils purified from S. fructus (S. chinensis Baillon) remain largely unresolved. The aim of this study was to investigate the safety of Schisandrae Semen essential oil (SSeo) by a single- dose toxicity study in mice. SSeo was orally administered at a dose of 5,000 mg/kg in ICR mice. All animals were sacrificed after 14 days of treatment. After a single administration, mortality, clinical signs, body weight changes, and gross pathological findings were observed for 14 days. We also measured parameters of organ weight, clinical chemistry, and hematology. No toxicological change related to the test substance or mortality was observed after administration of a single oral dose of SSeo. There were no adverse effects on clinical signs, body weight, or organ weight and no gross pathological findings in any treatment group. The clinical chemistry and hematological parameters were within the normal ranges except total bilirubin. Therefore, the approximate lethal dose for oral administration of SSeo in mice was considered to be over 5,000 mg/kg. The results on the single-dose toxicity of SSeo indicate that it is not possible to reach oral dose levels related to death or dose levels with any harmful side effects.

• Korean Journal of Medicinal Crop Science
• /
• v.22 no.4
• /
• pp.276-288
• /
• 2014

The six polysaccharide fractions were prepared by chromatographic procedure from the hot water extracts of the aboveground parts of Astragalus membranaceus. These six polysaccharides from aboveground parts of Astragalus membranaceus Bunge were tested for gut-mucosal immune activity and acute toxicity. In a view of molecular weight, the six fractions were estimated to be 75000, 88000, 129000 and 345000 Da, respectively. Component sugar analysis indicated that these fractions were mainly consisted of galactose (46.3 ~ 11.8%) and arabinose (35.4 ~ 9.9%) in addition to glucose, rhamnose, fucose, arabinose, xylose, mannose, glucuronic acid and galacturonic acid. Among the six major purified polysaccharides, AMA-1-b-PS2 showed highest bone merrow cell proliferation and lymphocyte of Peyer's patch stimulating activity. It may be concluded that intestinal immune system modulating activity of aboveground parts from Astragalus membranaceus Bunge is caused by polysaccharides having a polygalacturonan moiety with neutral sugars such as arabinose and galactose. In single oral dose toxicity study, no differences were observed between control and treated groups in clinical signs. The results indicated that lethal dose 50 ($LD_{50}$) of water extracts from Astragalus membranaceus-aboveground parts was found to be higher than 5000 mg/kg/day in this experiment. From the above results, we may suggest that Astragalus membranaceus-aboveground parts might have useful as a safe material for functional food and pharmaceutics.

• The Korea Journal of Herbology
• /
• v.39 no.3
• /
• pp.107-114
• /
• 2024

Objective : Cicadae Periostracum (CP), which is the discarded shell of the Cryptotympana atrata (Fabricius, 1775), is a recognized component of oriental medicine for treatment sore throat, itching, shock, sedation, edema. However, the safety and toxicity of CP have not yet been established. It has been reported that symptoms of addiction or side effects may occur in patients who take high doses of CP or who are hypersensitive to it. Therefore, we investigated the acute toxicity of an CP extracts in Sprague-Dawley (SD) rats. Methods : To study acute toxicity, five SD rats of each sex per group were treated with CP extracts at single doses of 0, 500, 1000, or 2000 mg/kg administrated by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. At the end of 14-day observation period, all animals were sacrificed and complete hematological and macroscopic examinations were performed. Results : There were no dead animal and test article-related effects on body weight change or the gross finding. No toxicologically significant results were observed between control and treated groups in hematology. Although salivation related to stress at the highest dose was observed in clinical signs immediately after administration, it is considered to have no toxicological significance. Conclusion : As the results, we did not find any adverse effect at the dose levels of 500, 1000, or 2000 mg/kg in rats. The minimal lethal dose was considered to be over 2000 mg/kg body weight in rats.

• The Korea Journal of Herbology
• /
• v.28 no.2
• /
• pp.61-65
• /
• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• Toxicological Research
• /
• v.21 no.1
• /
• pp.51-55
• /
• 2005

To investigate the acute toxicity of adventitious roots extract derived from wild ginseng, it was orally administered to beagle dogs with a single dose. In acute toxicity test, three groups (9 beagle dogs of male) were administered with different dosages of adventitious roots extract (prepared by Biopia Corp.) 500 mg/kg (G2), 1,000 mg/kg (G3), 2,000 mg/kg (G4) and one group (G1, 2 beagle dogs of male) were received by only capsule without the extract according to the Regulation on Korea Food and Drug Administration (1999. 12. 22). There were vomitus for a time and mucous stool at the day, and anorexia and mucous stool at the first day in the group of 2,000 mg/kg administration. There were mucous stool in one and anorexia for a while in two beagle dogs at the first day in the 1,000 mg/kg administration. But no death or abnormal clinical sign was observed through the study period. Therefore, the adventitious roots extract derived from wild ginseng is considered not to have the acute toxicity in the beagle dogs. These results suggest that LD/sub 50/ value of the test substance was considered to be more than 2,000 mg/kg in the beagle dogs.

• Journal of Conservation Science
• /
• v.33 no.4
• /
• pp.255-266
• /
• 2017

Chemically derived pesticides have been used to prevent biological damage to domestic cultural property. However, their use is gradually being restricted due to the harmful effects on the human body and environment. Therefore, there is a growing interest in the search for new antifungal biopharmaceuticals whose safety has been confirmed by toxicity evaluation through animal experiments. This paper presents methods of toxicity evaluation of natural biocides using Sprague-Dawley rats and New Zealand White (NZW) rabbits. Safety of the natural biocide extract of Asarum sieboldii was evaluated using single-dose oral and dermal toxicity tests in Sprague-Dawley rats, and eye and skin irritation tests in NZW rabbits. The extract has proven antimicrobial and insecticidal activities against wood-rotting fungi and termites. After single oral administration to rats, the $LD_{50}$ values were determined to be over 4,000 and 2,000 mg/kg for males and females, respectively. After single dermal administration to rats, the $LD_{50}$ values exceeded 10,000 mg/kg for both males and females. The extract was identified to be non-irritant to the rabbit eye, and only slightly irritant to the rabbit skin. In this study, we confirmed the safety of the A sieboldii extract through animal testing. Due to the harmfulness of humidifier disinfectants, focus is on the safety of chemical pesticides, and toxicity evaluation is suggested as the basic method for hazard evaluation.