• The Korea Journal of Herbology
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• v.39 no.3
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• pp.107-114
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• 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
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• v.26 no.2
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• pp.39-43
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• 2011

Objectives : This study was conducted to evaluate the acute toxicity and safety of Ssanghwa-tang (Shuanhetang in Chinese, Sou-wa-to in Japanese) in Crl : CD Sprague-Dawley (SD) rat though the current regulatory guideline. Methods : In this study, 10 rats of each sex were randomly assigned to two groups of 5 rats each and were administrated singly by gavage at dose levels of 0 and 2000 mg/kg/day of ssanghwa-tang water extract (SHT). After single administration of SHT, mortalities, clinical signs, body weight changes, gross findings were observed for the 15-day period. Results : Acute toxicity tests revealed that a single oral administration of SHT at dose levels of 2000 mg/kg did not affect clinical signs, body weight, and gross findings, evaluating the safety of SHT. The SHT treatment did not result in any toxicologically significant changes in mortality, clinical signs, body weight changes. Conclusions : These results showed that the single oral administration of SHT did not cause any toxic effect at the dose levels of 2000 mg/kg/day in rats. In conclusion, the median lethal dose (LD50) of SHT was considered to be over 2000 mg/kg/day body for both sexes.

• 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.

• The Korea Journal of Herbology
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• v.27 no.3
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• pp.101-106
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• 2012

Objectives : To evaluate the toxicity of KOB03, polyherbal medicine for the treatment of allergic rhinitis, we performed the dose-range finding test of KOB03 by oral supplementation for 4 weeks in Sprague-Dawley rats. Methods : The water extract of KOB03 consisting of five different herbs was supplied from GLP company. KOB03 was supplemented by gavage at 0, 500, 2,500 and 5,000 mg/kg/day for 4-week consecutive days. We recorded the clinical signs of toxicity, body weight, organ weights, hematology, gross and histological changes in target organs of rats, and clinical chemistry analysis. Results : KOB03 at all doses was shown no mortality or abnormal clinical signs in rats during at the observation period. Furthermore, there was no difference in body weight and food-take consumption, organ weight, gross pathological findings, and urine analysis among the groups of rats treated with different doses of KOB03. The hematological analysis and clinical blood chemistry data were revealed no toxic effects from KOB03-supplemented rats. Conclusions : The results suggest that KOB03 is a wide margin of safety on dose-range toxicity in rats. The no observable adverse effect level (NOAEL) of the test, KOB03 in rats is no less than 5,000 mg/kg/day.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.1
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• pp.100-108
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• 2011

The object of this study was two. One was if Polygonati Rhizoma preparata had a benzo(a)pyrene, the other was to evaluate the single dose toxicity of 9 repetitive steaming and fermenting processed Polygonati Rhizoma, dried root parts of Polygonati Rhozoma preparata extract, in male and female mice. We measured a content of benzo(a)pyrene in Polygonati Rhozoma preparata using a method with HPLC/FLD. And for single dose toxicity, aqueous extracts of Polygonati Rhozoma preparata (EPP; Yield = 35.4 %) was administered to female and male ICR 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 12 principle organs were examined. As results, we could not find any mortality, clinical signs, and changes in the body and organ weight except for slight soft feces sporadically detected in EPP treated male mice at 1 day after administration. In addition, no EPP-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that benzo(a)pyrene was not existed in Polygonati Rhozoma preparata and the 50% lethal dose and approximate lethal dose of EPP aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines. However, it also observed that the possibilities of digestive disorders, like soft feces when administered over 500 mg/kg of EPP aqueous extracts in the present study.

• Journal of the Korean Society of Food Science and Nutrition
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• v.45 no.6
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• pp.797-804
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• 2016

In an acute toxicity test for Chrysanthemum indicum Linne, 0.5~10 g/kg of Chrysanthemum indicum Linne extracts were administered. Chrysanthemum indicum Linne did not produce acute toxicity even at high doses of 10 g/kg, making it a highly safe material. In the chronic toxicity test, oral administration of Chrysanthemum indicum Linne up to 2 g/kg was carried out for 13 weeks, showing liver non-toxicity. The gout inhibitory effect of Chrysanthemum indicum Linne extracts was measured by inflammatory cytokine expression and foot thickness after 24 h of monosodium urate crystal (MSU) oral administration when inflammatory cytokine production reached a maximum. The group administered 2~4 g/kg of Chrysanthemum indicum Linne extract showed an inhibitory effect on gout inflammation and edema, whereas the 10 g/kg administered group showed an increase in inflammation. Therefore, the moderate concentration of Chrysanthemum indicum Linne extract for gout inhibitory effect was under 4 g/kg. Chrysanthemum indicum Linne extract showed an anti-inflammatory effect on MSU as a relatively safe material at high capacity. These results indicate that Chrysanthemum indicum Linne extract is thought to be an excellent substance for gout prevention.

• The Journal of the Korea Contents Association
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• v.15 no.6
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• pp.529-538
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• 2015

This study was carried out to evaluate the acute oral toxicity of Corydalis turtschaninovii BESS. in Sprague-Dawley(SD) rats. Male and female rats were administered orally with Corydalis turtschaninovii BESS water extract. We measured the number of death by clinical signs and gross findings for 7 days. After 7 days, we measured the whole body and individual organs' weight. We also analyzed hematological changes. The result, no dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. The results indicated that there were no significant changes of gross body and individual organs weight in SD rats. These results suggest that water soluble extract of Corydalis turtschaninovii BESS. has not acute oral toxicity in SD rats.

• Journal of Oriental Neuropsychiatry
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• v.21 no.3
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• pp.87-93
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• 2010

Objectives : The oriental medicine Jangwonhwan originally described in the Korean medical text, DonguiBogam(amnesia chapter). Recently, a modified formula of Jangwonhwan(LMK02-Jangwonhwan), was shown to reduce $\beta$-amyloid deposition in the brain of Tg-APPswe/PS1dE9 mouse model for Alzheimer's disease. This experiment aimed to investigate the acute oral toxicity of LMK02 in SD rats by up-and-down procedure determinations. Methods : Quality control of tablet form of LMK02 was established by estimating indicative components, Ginsenoside Rg3 of Red Ginseng and Decursin of Angelicagigas Nakai. The toxicity of LMK02 was investigated in 6 week old, specific pathogen free(SPF), Sprageu-Dawley rats. 3 female rats received 5,000 mg/10 ml/kg of test substance and their death rate, clinical sings, weight changes and autopsy findings had been observed for 2 weeks. Results : Any specific symptoms or death were resulted in this experiment. No significant changes in rats' weight. No significant differences in atopsy. Conclusions : The minimum lethal dose(MLD) of LMK02 for female Sprauge-Dawley rats were more than 5,000mg/kg in this experiment.

• Herbal Formula Science
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• v.10 no.2
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• pp.73-83
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• 2002

The single dose toxicity of Jengjengamiyjintang, a herbal drug for duodenal ulcer was evaluated in male and female Sprague-Dawley (SD) rats. Jengjengamiyjintang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125mg／kg for oral route according to KFDA guidelines for single dose toxicity test (1999-61). In addition, vehicle control group was added in order to compare clinical signs, body weight changes and abnormal necropsy findings. After single administration, clinical signs were observed every twice a day for 14 days and body weights were measured 5 times including initial measurement on day 0. When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea that were restricted to Day 1 of 2000 and 1000mg/kg-dosing groups. Although some accidental findings such as gross and histopathological changes of lung that were demonstrated in some animals of all experimental groups including vehicle control group, no abnormal necropsy findings and changes of body weight were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Jengjengamiyjintang is over 2000mg／kg in oral administration in both sexes of rats and approximated lethal dose was considered over 2000mg/kg.

• CELLMED
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• v.11 no.1
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• pp.2.1-2.8
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• 2021

The clinical condition Amnesia causes difficulty in learning new information and the inability to recall past events. It is primarily concerned with recent memory loss. Majoon-e-Nisyan (MJN) is a polyherbal Unani formulation, present in a semi-solid form. It is widely used potent drug of the Unani System of Medicine (USM) for treating Nisyan (amnesia). In the present study polyherbal Unani formulation, MJN has been studied for its quality control and acute toxicity. Standardization (quality control) of drugs deals with drug identity, drug quality and purity determination. Standardization of MJN had been done as per the Unani pharmacopoeial parameters approved by World Health Organization (WHO) - Pharmacognostical parameters, Physico-chemical parameters, high-performance thin-layer chromatography (HPTLC), microbial load, aflatoxin, and heavy metals. Solvents and chemicals used in the study were of analytical grade and used instrument were calibrated. By conducting an acute oral toxicity study in rats, the safety of MJN was assessed. The limit test method of OECD guideline 425 was followed in the study. Results of standardization and standard operating procedures (SOPs) for preparation of MJN may serve as the standard reference in the future. The data generated in the study for the quality control of MJN proved the quality of formulation and shows that MJN is not toxic in rats following acute dosing up to 2000 mg/kg bw. The data obtained in the paper for MJN may be used as a standard guideline for preparation of the formulation which can save time, cost, and resources for future research endeavours.