• Title/Summary/Keyword: single oral toxicity test

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Study on Oral Administration of Egg White Combined Chalcanthite and Bamboo-Salt with Egg White Combined Chalcanthite (난담반 단독제와 난담반과 죽염 혼합제 경구 투여의 독성 연구)

  • Choi, Eun-A;Lee, Jong-Hoon;Youn, Dae-Hwan;Yoo, Hwa-Seung
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.26 no.2
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    • pp.189-198
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    • 2012
  • Our former study indicated efficacy of apoptotic cell death on animal study by using Egg white combined Chalcanthite (EC). Clinically, bamboo salt is using because of safety. Hence we investigated a toxicity study for determining safety by adding bamboo salt in former materiel. We had two studies: toxicity of EC and of Bamboo salt with egg white combined Chalcanthite (BC). Both were studied in 1-week single and 5-week repeated oral dose toxicity tests on male Imprinting Control Region mice. In EC, doses used in 1 week single oral dose toxicity tests were 0, 0.05, 0.5, 5 and 50 mg/kg/day and 0, 0.01, 0.05, 0.25 and 0.5 mg/kg/day. In BC, doses used by 0, 0.08, 8.3, 83.3 and 166.6 mg/kg/day in single oral dose toxicity and 0, 4.2, 8.3, 41.7 and 83.3 mg/kg/day in repeated oral dose toxicity tests. Their blood and urine were assayed and organ morphology were examined. Mann-Whitney U test and ANOVA tests were used by analysing methods. First, significant increased left renal weight in all groups of EC and BC. Second, increased ALT score was found in EC-S2 and increased relative liver weight was found in EC-S3. In addition, increased relative weight and urine bilirubin and urobilinogen were found in EC-R2 and EC-R3. There was no significant toxic change in BC. The Mixture of EC had a possibility of hepatotoxicity in the short and long term. Processed BC appears to be safe and non-toxic in these studies and a no-observed adverse effect level (NOAEL) was established at 83.3 mg/kg/day in mice. Relatively, The BC were safer than The EC.

Single dose toxicity study of Jengjengamiyjintang in rats (정전가미이진탕(正傳加味二陳湯)의 랫드에서의 단회투여독성시험(單回投與毒性試驗))

  • Kim Sang-Chan;Kwon Young-Kyu;Byun Jun-Seok;Kim Han-Kyun;Byun Sung-Hui
    • 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.

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Mouse Single Oral Dose Toxicity Studies of PGB-1, a Novel Polyglucosamine Polymer Produce from Enterobacter sp. BL-2

  • Lee, Yong-Hyun;Son, Mi-Kyung;Jung, Young-Mi;Kim, Tae-Kwon;Park, Dong-Chan;Lee, Hyeung-Sik;Kim, Pan-Soo;Ku, Sae-Kwang
    • Toxicological Research
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    • v.23 no.4
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    • pp.373-382
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    • 2007
  • This study was conducted to obtain acute information of the oral dose toxicity of PGB-1, a novel polyglucosamine polymer produced from a new strain Enterobacter sp. BL-2 in male and female mice. In order to calculated 50% lethal dose ($LD_{50}$) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) ml/kg (body wt.). The mortality and changes on body weight, clinical signs, gross observation and organ weight and histopathology of principle organs were monitored 14 days after dosing with PGB-1. We could not find any mortalities, clinical signs, body weight changes and gross findings. In addition, significant changes in the organ weight and histopathology of principal organs were not observed except for some sporadic findings. The results obtained in this study suggest that PGB-1 may not be toxic in mice and may be therefore safe for clinical use. The $LD_{50}$ and approximate LD in mice after single oral dose of PGB-1 were considered over 2000 mg/kg in both female and male mice.

Toxicity Evaluation of Asarum Sieboldii Extract for Human's Safety (인체안전성을 위한 족두리풀 천연추출물의 독성평가)

  • Kim, Young Hee;Jo, Chang Wook;Hong, Jin Young;Lee, Jeung Min;Kim, Soo Ji;Jeong, So Young
    • Journal of Conservation Science
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    • v.33 no.4
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    • pp.255-266
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    • 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.

Acute Toxicity Study of Modified Je-Ho-Tang in ICR Mice

  • Lee, In-Sun;Lee, Jeong-Hwa;Han, Jae-ll;Song, Woon-Heung;Kim, Mi-Yeon;Jeon, Won-Kyung
    • Korean Journal of Clinical Laboratory Science
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    • v.44 no.2
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    • pp.59-65
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    • 2012
  • Previous studies have shown that modified Je-Ho-Tang (MJHT) has anti-platelet effects. Je-Ho-Tang (JHT), a Korean court beverage, is a traditional Korean herbal medicine that has been used for the treatment of a disease attended by great thirst, and for prevention of illness in hot summers. We made MJHT from JHT by excluding honey. The present study was performed to determine the acute oral toxicity of crude extract of MJHT in male and female ICR mice. We investigated the in vivo single dose acute toxicity of MJHT hot-water extraction. This test was orally administered once by gavage to 20 mice of each sex received doses of 0 (control group), 1250, 2500 and 5000 mg/kg body weight. Mortalities, clinical findings, autopsy findings and body weight changes were monitored daily for 14 days following the administration. We observed survival rates, general toxicities, changes of body weight, and autopsy. No significant lethality was observed after single oral administration of MJHT at the different dosages. Autopsies on the animals revealed no gross abnormalities. Therefore, the LD50 value of MJHT for ICR mice was estimated more than 5000 mg/kg by the oral route. These results suggest that no toxic dose level of MJHT in mice is considered to be more than 5000 mg/kg. Consequently, it was concluded that MJHT have no effect on acute toxicity and side effect in ICR mice.

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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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Acute Oral Toxicity Test of Oriental Medical Prescription SH21-B (복합한방처방 SH21-B의 랫드와 Beagle 견에 대한 단회 경구투여 독성시험)

  • Kim, Seon-Hyeong;Park, Seong-Jin;Yoon, Yoo-Sik
    • Korean Journal of Oriental Medicine
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    • v.9 no.2
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    • pp.131-148
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    • 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.

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Single Oval Dose Toxicity Study of the Extract of Aralia elata in Mice (마우스에서 두릅 추출물의 단회경구투여 독성시험)

  • Yang, Hee-Kyoung;Jin, Ju-Youn;Kim, Ji-Min;Ko, Mun-Su;Hong, Hyun-Ju;Kim, Sang-Chul;Lee, Young-Jae
    • Toxicological Research
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    • v.22 no.4
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    • pp.439-443
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    • 2006
  • This study was conducted to investigate the potential acute toxicity of Aralia elata by a single oral dose in ICR mice. Thirty mice of each sex were randomly assigned to three groups of 10 mice each. The test articles were administered once by the gavage to mice at dose levels of 0, 2,500 and 5,000 mg/kg body weight. The mortality and changes on body weight and clinical signs of gross observation were monitored for 14 days after dosing. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem examinations were performed. There were no dead animal and adverse effects on clinical signs, the body weight and the gross finding. As the results, we could not find any toxic effect at the dose levels of 2,500 or 5,000 mg/kg in mice and the minimal lethal dose was considered to be over 5,000 mg/kg body weight in mice.

Acute Oral Toxicity of Extract Derived from Fruiting Body of Phellinus gilvus in Rats

  • Bae, Jae-Sung;Jang, Kwang-Ho;Park, Sung-Guk;Jo, Woo-Sik;Rhee, Man-Hee;Kwon, Oh-Deog;Kim, Young-Hoan;Kim, Eun-Young;Park, Seung-Chun
    • Toxicological Research
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    • v.19 no.3
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    • pp.211-215
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    • 2003
  • This study was carried out to investigate the acute oral toxicity of a crude extract derived from fruiting body of Phellinus gilvus (PGE) using male and female SD rats. Groups consisted of five male and female rats were treated with a single dose of the test substance intragastrically at 0, 500, 1,000, 2,000, and 5,000 mg/kgaj, respectively. Clinical signs, body weight change, and food and water consumption change were observed for 14 days after administration. No mortality or abnormal clinical signs in animals were shown during the observation period at the dose used in this study. Also there was no difference in net body weight gain, water and food consumption or gross pathological findings at terminal sacrifice among the groups of rat treated with different doses of the test substance. The results suggested that acute oral toxicity of PGE in rats is very low at the conditions employed in this study and $LD_{50}$ of PGE was estimated to be over 5,000 mg/$\textrm{m}{\ell}$ in both sexes of rats.

Single Oral Dose Toxicity Study of the Methylcyclohexane in Female Rats (암컷 랫드에서 Methylcyclohexane의 단회 경구투여 독성시험)

  • Kim, Sung-Hwan;Lim, Jeong-Hyeon;Shin, In-Sik;Moon, Changjong;Kim, Sung-Ho;Shin, Dong-Ho;Kim, Jong-Choon
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.21 no.1
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    • pp.33-39
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    • 2011
  • The present study was carried out to investigate the potential acute toxicity of methylcyclohexane (MCH) by a single oral dose in female rats. The test chemical was administered once by gavage to female rats at dose levels 0, 1,250, 2,500, and 5,000 mg/kg. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following the administration. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem and histopathological examinations were performed. Treatment-related clinical signs, as evidenced by depression, soft feces, decreased locomotion activity, solid perineal region, crouching position, and anorexia were observed in all treatment groups in a dose-dependent manner. At the dose level of 5,000 mg/kg, decreased or suppressed body weight gain was found during the study period. At the scheduled necropsy, one case of congestion of the intestine and an increase in the weights of liver and kidney were observed in the 5,000 mg/kg group. Histopathological examinations exhibited an increased incidence of glomerular atrophy, congestion/hemorrhage, and focal degeneration/necrosis in the liver and an increased incidence of congestion, and inflammatory cell infiltration in the kidney. On the basis of the results, it was concluded that a single oral administration of MCH resulted in some adverse effects on clinical sign, body weight gain, and organ weight and histopathology in the liver and kidney in female rats. In the experimental conditions, the minimal lethal dose ($LD_{10}$) of MCH was greater than 5,000 mg/kg.