• The Korea Journal of Herbology
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• v.23 no.2
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• pp.81-85
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• 2008

Objectives : The aim of this study is to collect data for toxicity and safety of Mud chrysanthemum indicum. Methods : In this study, we investigated the acute toxicity for buthanol-extracted Mud schrysanthemum indicum, 25 male and 25 female mice were observed for 14days after one day oral administration of Mud chrysanthemum indicum at the respective doses of 0(control group), 1024, 1280, 1600 and 2000mg/kg. Results : We observed survival rates, general toxicity, change of body weight and autopsy. No abnormality was found for all cases. Conclusions : The data confirmed that Mud chrysanthemum indicum is free from, the toxicity and safety problems. Compared with the control group, we could not find any toxic alteration in all treated groups (1024, 1280, 1600 and 2000mg/kg), In conclusion, LD50 of Mud chrysanthemum indicum was over 2000 mg/kg and it is very safe to mice.

• Biomolecules & Therapeutics
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• v.9 no.2
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• pp.140-142
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• 2001

This study was performed to evaluate an single dose oral toxicity of a new hepatotherapeutic agent GODEX (HEPADIF-S) in Sprague-Dawley rats. Male and female rats were administered dosages of 5, 2.5, 1.25 ,0.625, 0.3125, and 0 g/kg B.W. of GODEX, respectively. After single oral administration of GODEX to rats, we observed them daily for 2 weeks. GODEX slid not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of rats. Based on these results, it is concluded that GODEX may have no side effect and its LD$_{50}$ value may be over 5 g/kg B.W, in rats.s.

• The Journal of Internal Korean Medicine
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• v.34 no.2
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• pp.155-164
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• 2013

Objectives : This study aimed to evaluate the single oral dose toxicity of Jaeumganghwa-tang (Ziyinjianghuo-tang) and Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acidophyllus in male and female ICR mice. Methods : In this single oral toxicity study, non-fermented and fermented Jaeumganghwa-tang (Ziyinjianghuo-tang) were administered to male and female ICR mice as an oral dose of 500, 1000 and 2000 mg/kg. After single administration, body weight changes, general behavior, adverse effects and mortality were determined for 14 days. Serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity for 14 days. There were also no significant differences in body weights, organ weights, or serum chemistry values between treatment and control groups. Conclusions : These results indicate that the 50% lethal dose of Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acipophullus may be over 2000 mg/kg. This finding can be expected to provide scientific evidence for the safety of Jaeumganghwa-tang (Ziyinjianghuo-tang) fermented with Lactobacillus acidophyllus.

• Applied Chemistry for Engineering
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• v.20 no.2
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• pp.145-153
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• 2009

The acute oral and genetic toxicity of ASCO EAQ80 was established in this study. ASCO EAQ80, a novel cationic surfactant produced by Aekyung Speciality Chemicals Co. LTD. is currently commercialized as a clear fabric softener. In acute oral toxicity study, the 50% lethal dose $(LD_{50})$ of ASCO EAQ80 was determined to be higher than 5000 mg/kg and this product could be classified as Category 5 or Unclassified by Globally Harmonized Classification System. Also, to establish the gene-toxicity of ASCO EAQ80, we performed bacterial reversion assay against Salmonella typhimurium TA98, TA100, TA1535, TA1537, Escherichia coli WP2uvrA, and in vitro chromosomal aberration assay against Chinese hamster lung cells in the presence and absence of S-9 metabolic activation system. From these experiments, ASCO EAQ80 revealed nonmutagenic potential in S. typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2uvrA both in the absence and presence of metabolic activation system. No clastogenicity of ASCO EAQ80 was observed in chromosomal aberration assay in vitro.

• Journal of Food Hygiene and Safety
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• v.26 no.4
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• pp.377-382
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• 2011

This test was performed to evaluate the acute oral toxicity and skin irritation of Lamia-Kill$^{(R)}$, disinfectant, containing 20% benzalkonium chloride and 10% citric acid. In acute oral toxicity, Lamia-Kill$^{(R)}$ was orally administered at dose levels of 2,000, 1,000, 500, 250 and 0 mg/kg body weight. After single oral administration to both sexes of SD rats, the rats were observed for 14 days. In primary skin irritation test, New Zealand white rabbits were dermally treated with Lamia-Kill$^{(R)}$ for 24 hr and observed for 3 days. All rats treated with Lamia-Kill$^{(R)}$ were induced no toxic signs in mortalities, clinical findings, body weights and gross findings. Also, the disinfectant did not induce any adverse reactions such as erythema and edema on intact skin sites for the most part rabbits, but on abraded skin sites, some rabbits showed very slight erythema on 24 hr after topical application. With the results of this study, Lamia-Kill$^{(R)}$ have no effect on acute toxicity and side effect in SD rats and was classified as a practically non-irritating material based on the score 0.50 of primary irritation index.

• Toxicological Research
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• v.31 no.4
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• pp.403-414
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• 2015

Lithospermum erythrorhizon has long been used as a traditional oriental medicine. In this study, the acute and 28-day subacute oral dose toxicity studies of hexane extracts of the roots of L. erythrorhizon (LEH) were performed in Sprague-Dawley rats. In the acute toxicity study, LEH was administered once orally to 5 male and 5 female rats at dose levels of 500, 1,000, and 2,000 mg/kg. Mortality, clinical signs, and body weight changes were monitored for 14 days. Salivation, soft stool, soiled perineal region, compound-colored stool, chromaturia and a decrease in body weight were observed in the extract-treated groups, and no deaths occurred during the study. Therefore, the approximate lethal dose (ALD) of LEH in male and female rats was higher than 2,000 mg/kg. In the subacute toxicity study, LEH was administered orally to male and female rats for 28 days at dose levels of 25, 100, and 400 mg/kg/day. There was no LEH-related toxic effect in the body weight, food consumption, ophthalmology, hematology, clinical chemistry and organ weights. Compound-colored (black) stool, chromaturia and increased protein, ketone bodies, bilirubin and occult blood in urine were observed in the male and female rats treated with the test substance. In addition, the necropsy revealed dark red discoloration of the kidneys, and the histopathological examination showed presence of red brown pigment or increased hyaline droplets in the renal tubules of the renal cortex. However, there were no test substance-related toxic effects in the hematology and clinical chemistry, and no morphological changes were observed in the histopathological examination of the kidneys. Therefore, it was determined that there was no significant toxicity because the changes observed were caused by the intrinsic color of the test substance. These results suggest that the no-observed-adverse-effect Level (NOAEL) of LEH is greater than 400 mg/kg/day in both sexes.

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

• Journal of Society of Preventive Korean Medicine
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• v.17 no.1
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• pp.117-124
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• 2013

Objectives : This study was carried out to investigate the acute toxicity and safety of Palmultang and Fermented Palmultang Extract in Mice. Methods : To evaluate their acute toxicity and safety, 0 (control group), 2000 mg/kg of Palmultang and Fermented Palmultang Extracts were orally administered to 15 male and 15 female ICR mice. After a single administration, we observed survival rates, behavioral pattern, clinical sign, body weight. The results of biochemical analysis and hematological analysis were no any significant change. Results : Compared with the control group, we could not find any toxic alteration in all treated mice. Conclusions : Overall, the results suggest that, the oral administration of Palmultang and Fermented Palmultang extracts did not produce significant toxic effect in mice. Hence, the fermented extract can be utilized for herbal therapy.

• Journal of Periodontal and Implant Science
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• v.25 no.3
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• pp.470-477
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• 1995

Flavonoids from Scutellariae Radix possessed a dual function both as an anti-inflammatory agent and an enhancer of cellular activity in gingival fibroblast. The purpose of this study was to evaluate on the toxicity of ethanolic extract from the root of Scutellariae Radix Georgi and its flavonoids, Wogonin, Baicalein, and Baicalin were isolated and purified by the following method. The crude drug was extracted with ethyl acetate and the residue was dissolved in ethyl alcohol. The ethyl alcohol soluble fraction was separated, concentrated, and then chromatographed on a silica gel column. The acute oral LD 50 in rats was determined for EtOH ex. of Scutellariae Radix and three compounds were evaluated with a single oral gavage at three graded dosage levels. The acute intravenous LD 50 was determined with a single intravenous injection via the jugular vein at three graded dosage levels. Groups of 5 male and 5 female rats, 6 week of age at the start of the study, were fed diets containing 3 graded dosage levels for 14 days. Groups of 5 male and 5 female hamster received O.5ml of the test article at once in a day for 5 days to the buccal cheek pouch for two minutes each. The acute oral LD50 for EtOH ex. of Scutellariae Radix is 1430mg/kg, and for Wogonin 1320mg/kg, for Baicalein 1250mg/kg, for Baicalin 1330mg/kg. The acute intravenous toxicity of EtOH ex. of Scutellariae Radix and its extracts was found to be 27mg/kg body weight No toxic effects were observed in rats fed up to 200mg/kg of EtOH ex. of Scutellariae Radix, Wogonin, Baicalein and Baicalin in the diet for 14 days. The acute Mucouse Membrane LD 50 in hamsters was found to be greater than 100mg/kg. These results suggested that EtOH ex. of Scutellariae Radix and its flavonoids are safe for oral care products using limited amount of extract.

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