• Title/Summary/Keyword: Single-dose toxicity

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Single-Dose Oral Toxicity of the Gardenia Yellow Pigment in Rate and Rabbits (랫드 및 토끼에 대한 치자 황색색소에 관한 단회 투여 경구 독성 시험)

  • 김희구;이상준
    • The Korean Journal of Food And Nutrition
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    • v.11 no.1
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    • pp.77-81
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    • 1998
  • This study was performed to evaluate single-dose toxicity of the gardenia yellow pigment in Sprague-Dawley rats and New-Zealand White rabbits via oral routes. The yellow pigment was administered in rats at does levels of 5,000, 2,500, 1,250, 625, 312.5mg/kg and 9mg/kg. And also yellow pigment was administered in rabbits at does levels of 5,000, 2,500, 1,250mg/kg 0 unit /kg. The rats and rabbits of both sexes were observed daily for 14 days after single oral administration. Yellow pigment treated rats and rabbits did not induce any mortalities and abnormal signs in clinical findings, body weights, gross findings and histopathological finding. Based on these results, it is impossible to estimate LD50 values in rats and rabbits. Therefore, it was concluded that gardenia yellow pigment have no effect on acute toxicity and side effect in rats and rabbit.

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Single Oral Dose Toxicity Test of Blue Honeysuckle Concentrate in Mice

  • Kim, Hyung-Soo;Park, Sang-In;Choi, Seung-Hoon;Song, Chang-Hyun;Park, Soo-Jin;Shin, Yong-Kook;Han, Chang-Hyun;Lee, Young Joon;Ku, Sae-Kwang
    • Toxicological Research
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    • v.31 no.1
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    • pp.61-68
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    • 2015
  • The objective of this study was to obtain single oral dose toxicity information for concentrated and lyophilized powder of blue honeysuckle (Lonicera caerulea L., Caprifoliaceae; BHcL) in female and male ICR mice to aid in the process of developing natural origin medicinal ingredients or foods following proximate analysis and phytochemical profile measurement. The proximate analysis revealed that BHcL had an energy value of 3.80 kcal/g and contained 0.93 g/g of carbohydrate, 0.41 g/g of sugar, 0.02 g/g of protein, and 0.20 mg/g of sodium. BHcL did not contain lipids, including saturated lipids, trans fats, or cholesterols. Further, BHcL contained 4.54% of betaine, 210.63 mg/g of total phenols, 159.30 mg/g of total flavonoids, and 133.57 mg/g of total anthocyanins. Following administration of a single oral BHcL treatment, there were no treatment-related mortalities, changes in body weight (bw) or organ weight, clinical signs, necropsy or histopathological findings up to 2,000 mg/kg bw, the limited dosage for rodents of both sexes. We concluded that BHcL is a practically non-toxic material in toxicity potency.

Antiarrhythmic effects of ginsenoside Rg2 on calcium chloride-induced arrhythmias without oral toxicity

  • Gou, Dongxia;Pei, Xuejing;Wang, Jiao;Wang, Yue;Hu, Chenxing;Song, Chengcheng;Cui, Sisi;Zhou, Yifa
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.717-724
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    • 2020
  • Background: Malignant arrhythmias require drug therapy. However, most of the currently available antiarrhythmic drugs have significant side effects. Ginsenoside Rg2 exhibits excellent cardioprotective effects and appears to be a promising candidate for cardiovascular drug development. So far, the oral toxicity and antiarrhythmic effects of Rg2 have not been evaluated. Methods: Acute oral toxicity of Rg2 was assessed by the Limit Test method in mice. Subchronic oral toxicity was determined by repeated dose 28-day toxicity study in rats. Antiarrhythmic activities of Rg2 were evaluated in calcium chloride-induced arrhythmic rats. Antiarrhythmic mechanism of Rg2 was investigated in arrhythmic rats and H9c2 cardiomyocytes. Results: The results of toxicity studies indicated that Rg2 exhibited no single-dose (10 g/kg) acute oral toxicity. And 28-day repeated dose treatment with Rg2 (1.75, 3.5 and 5 g/kg/d) demonstrated minimal, if any, subchronic toxicity. Serum biochemical examination showed that total cholesterol in the high-dose cohort was dramatically decreased, whereas prothrombin time was increased at Day 28, suggesting that Rg2 might regulate lipid metabolism and have a potential anticoagulant effect. Moreover, pretreatment with Rg2 showed antiarrhythmic effects on the rat model of calcium chloride induced arrhythmia, in terms of the reduced duration time, mortality, and incidence of malignant arrhythmias. The antiarrhythmic mechanism of Rg2 might be the inhibition of calcium influx through L-type calcium channels by suppressing the phosphorylation of Ca2+/calmodulin-dependent protein kinase II. Conclusion: Our findings support the development of Rg2 as a promising antiarrhythmic drug with fewer side effects for clinical use.

ACUTE TOXICITY OF HANTABAX (HFRS-VACCINE) IN RATS AND MICE

  • Moon, Chang-Kiu;Park, Kwang-Sik;Mock, Myung-Soo;Jung, Myung-Kiu;Kim, Ji-Young
    • Toxicological Research
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    • v.5 no.2
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    • pp.105-109
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    • 1989
  • Single dose of Hantabax, HFRS-vaccine, was given to both sexes of Sprague-Dawley rats and ICR mice, subcutaneously and intraperitoneally. Any toxic symptom was not noted in the treated animals. Macroscopic examination on the organs of tested animals showed no abnormal findings. In general toxicological aspects Hantabax was practically nontoxic in rats and mice upto a single dose of 1000 times of human clinical dose equivalent via subcutaneous and intraperitoneal administration.

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Single dose toxicity study of Injinhotang in rat (茵蔯蒿湯의 랫드에서의 單回投與毒性試驗)

  • Kim, S.C.;Byun, J.S.;Park, J.H.;Jee, S.Y;Byun, S.H.;Lee, H.S.
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.14 no.2
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    • pp.118-124
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    • 2001
  • The single dose toxicity of Injinhotang, a herbal drug for treatment of hepatic injuries. was evaluated in Sprague-Dawley rats. Injinhotang was once administered to both sexes of rats at the dose levels of 2000, 1000, 500, 250 and 125 mg/kg for oral route. After single administration, clinical signs were observed every day for 14 days and body weights were measured 5 times including initial measurement on day 0 (the days of administration). When observation period was over, the animals were sacrificed and macroscopic examination of major organs was conducted. In addition, the histopathological profiles of these major organs were also conducted. Neither significant clinical signs nor death after administration was observed during the observation periods except for soft feces or diarrhea. In addition, no abnormal necropsy findings, changes of body weight and histopathological profiles were observed at terminal necropsy in both sexes. From these results, it is considered that $LD_{50}$ of Injinhotang is over 2000 mg/kg in oral administration in both sexes of rats.

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Single Oral Dose Toxicity Studies of Polycan, β-Glucan Originated from Aureobasidium in Mice

  • Lee, Hyeung-Sik;Yang, Kun-Ju;Shin, Hyun-Dong;Park, Bok-Ryeon;Son, Chang-Woo;Jang, Hee-Jeong;Park, Dong-Chan;Jung, Young-Mi;Ku, Sae-Kwang
    • Toxicological Research
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    • v.21 no.4
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    • pp.361-365
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    • 2005
  • This study was conducted to obtain the acute information of the oral dose toxicity of Polycan - originated from Aureobasidium pullulans SM-2001 (half of the dry material is -1,3/1,6-glucans), a UV induced mutant of A. pullulans, having various pharmacological effects, in male and female mice. In order to calculate $50\%$ lethal dose $(LD_{50})$, approximate LD and target organs, test article was administered twice by oral gavage to male and female ICR mice at total 1000, 500 and 250mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings. The results obtained in this study suggest that the Polycan is non-toxic in mice and is therefore likely to be safe for clinical use. The L050 and approximate $(LD_{50})$ in mice after single oral dose of Polycan were considered over 1000 mg/kg, respectively.

Safety of a Traditional Korean Medicine, Cheonggan extracts (CGX): A 2-week Single-dose Toxicity Study in SD Rats and Beagle Dogs

  • Shin, Jang-Woo;Cho, Jung-Hyo;Seo, Dong-Seok;Sung, Nak-Won;Kwon, Min;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.30 no.6
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    • pp.27-34
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    • 2009
  • Objectives: To evaluate the acute toxic effects and approximate lethal dose of Cheonggan extracts (CGX) in SD rats and beagle dogs. Methods: Male and female rats were divided into 4 groups (Control, CGX 1250, CGX 2500, CGX 5000) respectively and male and female dogs were divided into two groups respectively (Control, CGX 5000) respectively. A single oral dose of CGX was treated to the rats and dogs. Mortality, signs of gross toxicity, and behavioral changes were observed over 14 days. All animals were observed every hour for 4 hours after administration and once a day thereafter for 14 days. Body weights were determined at $0_{th}$, $7_{th}$, and $14_{th}$ days. All surviving animals were sacrificed and necrotized. Major organs were inspected visually for gross findings. Results: No animals died in any of the groups during the experimental period (2 weeks), rats or dogs. Body weights of rats and dogs during the experiment continuously increased in all groups but there was no significant change. No abnormal clinical signs were observed for 2 weeks after a single administration of CGX in any dose group of CGX, rats or dogs. No abnormal findings in major organs were observed in any group of rats or dogs. Conclusion: CGX does not have acute toxic effects in rats or dogs. Therefore, an approximate lethal dose is assumed to exceed 5000 mg/kg in both rats and dogs.

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Mouse Single Oral Dose Toxicity Test of Chongmyung-tang Aqueous Extracts (총명탕(聰明湯) 열수(熱水) 추출물의 마우스 단회 경구투여 독성 실험)

  • Hwang, Ha-Yeon;Jang, Woo-Seok;Baek, Kyung-Min
    • The Journal of Internal Korean Medicine
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    • v.35 no.1
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    • pp.37-49
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    • 2014
  • Objectives & Methods : The objective of this study was to evaluate the single oral dose toxicity of Chongmyung-tang (CMT) in ICR mice. Korean traditional herbal prescription CMT has traditionally been used as a neuroprotective for treatment of learning disability and memory improvement. CMT, lyophilized aqueous extracts (yield=9.7%) were administered to female and male mice with 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 mortality, changes in body weight, clinical signs and gross observation during 14 days after administration upon necropsy; organ weight and histopathology of 14 principle organs were examined. Results : We could not find any CMT extracts treatment related mortalities, clinical signs, changes in body and organ weight, or gross and histopathological observations against 14 principle organs up to 2,000 mg/kg in both female and male mice, except for some accidental sporadic findings which did not show any obvious dose-relations and most of which also demonstrated in both the female and male vehicle control mice in this experiments. Conclusions : Based on the results of this experiment, the 50% lethal dose ($LD_{50}$) and approximate lethal dose (ALD) of CMT extracts after single oral treatment in female and male mice can be considered to be over 2,000 mg/kg, and is likely to be safe in humans.

Study on the Anti-allergic Effect of Armeniacae Semen Herbal Acupuncture Solution (행인약침(杏仁藥鍼)이 항알레르기에 미치는 영향)

  • Kim, Yu-Seung;Song, Choon-Ho
    • Korean Journal of Acupuncture
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    • v.24 no.4
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    • pp.151-162
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    • 2007
  • Objectives : The purpose of this study was to examine the anti-allergic effect in vivo, and to observe single toxicity in mice of Armeniacae Semen herbal acupuncture solution (ASHA). Methods : We investigated anti DNP IgE-mediated passive cutaneous anaphylaxis in rodents and compound 48/80-induced active systemic anaphylatic shock in mice after treatment at both BL13 with ASHA of 25 ${\mu}{\ell}$(mice) or 50 ${\mu}{\ell}$(rats) 3 times for 5 days. To ascertain safety and toxicity of ASHA, we examined single toxicity test. In single test, three groups were treated with different dosages of ASHA (ASHA250, ASHA500 and ASHA1000) according to on Korean Food and Drug Administration, respectively. We observed attentively motality, abnormal clinical sign, body weight change, and organ weight of mice after ASHA treatment. Results : ASHA inhibited passive cutaneous anaphylaxis and active systemic anaphylatic shock by oral administration. During toxicity experiment period, there was no difference in body weight change, and organ weight among different dose groups. Death were not found in single test i.p. group. (ASHA250, ASHA500 and ASHA1000). Several individuals of single test i.p. group were observed yellow brown discharge around anus in early period after administration. Conclusions : These results indicate that ASHA have inhibition effects on passive cutaneous anaphylaxis and active systemic anaphylatic shock, and suggest that has some toxicity in high dosage.

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