• Title/Summary/Keyword: no-observed-adverse-effect level

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Acute Toxicity of Leuconostoc kimchii GJ2, An Exopolysaccharide-Producing Lactic Acid Bacteria Isolated from Kimchi, in Mice (김치로부터 분리한 Exopolysaccharide생성 유산균 Leuconostoc kimchii GJ2의 마우스에 대한 급성독성)

  • Lee, Jae-Joon;Lee, Yu-Mi;Chang, Hae-Choon;Lee, Myung-Yul
    • Journal of Life Science
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    • v.17 no.4 s.84
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    • pp.561-567
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    • 2007
  • The present study was carried out to investigate the acute toxicity of Leuconostoc kimchii GJ2(Leu. kimchii GJ2), an exopolysaccharide-producing lactic acid bacteria isolated from kimchi, in ICR male and female mice. The test article was intraperitoneally or orally administered to both sexes of mice. Then followed a 14-day period of observation. In intraperitoneal acute toxicity test, mice were injected intraperitoneally with dosage of 0, 700, 900, 1,100, 1,300, 1,500, 1,700, 1,900, 2,100, 2,300 and 2,500 mg/kg. Intraperitoneal 50% lethal doses($LD_{50}$) of Leu. kimchii GJ2 was >2,500 mg/kg in male and female mice. In oral acute toxicity test, male and female mice were gavaged with Leu. kimchii GJ2 of five doses(0, 625, 1,500, 2,500 and 5,000 mg/kg). Oral $LD_{50}$ of Leu. kimchii GJ2 was consider to be higher than 5,000 mg/kg. Furthermore, no significant changes in general conditions, body weights, clinical signs and any gross lesions were observed in both sexes of mice administered intraperitoneally or orally with Leu. kimchii GJ2. In conclusion, our results suggest that no adverse effect level of Leu. kimchii GJ2 is estimated to be over 2,500 mg/kg in the intraperitoneal route and 5,000 mg/kg in the oral route, respectively.

Acute Toxicity of Lactobacillus plantarum AF1 Isolated from Kimchi in Mice (김치로부터 분리한 Lactobacillus plantarum AF1의 마우스에 대한 급성독성)

  • Lee, Hwan;Lee, Jae-Joon;Chang, Hae-Choon;Lee, Myung-Yul
    • Food Science and Preservation
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    • v.19 no.2
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    • pp.315-321
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    • 2012
  • The $in$ $vivo$ single-dose acute toxicity of $Lactobacillus$ $plantarum$ AF1, a lactic acid bacterium isolated from kimchi, in ICR male and female mice was investigated. The test article was intraperitoneally or orally administered once to both sexes of mice. The motalites, clinical findings, autopsy findings, and body weight changes were monitored daily for 14 days. In the oral acute toxicity test, the male and female mice were gavaged with four doses (5.0, 2.5, 1.25 and 0.625 g/kg) of $Lb.$ $plantarum$ AF1. The oral $LD_{50}$ of the $Lb.$ $plantarum$ AF1 was considered higher than 5.0 g/kg. In the intraperitoneal acute toxicity test, mice were injected intraperitoneally with dosages of 0.7, 0.9, 1.1, 1.3, 1.5, 1.7, 1.9, 2.1, 2.3 and 2.5 g/kg. The intraperitoneal 50% lethal dose ($LD_{50}$) of the $Lb.$ $plantarum$ AF1 was >2.5 g/kg in the male and female mice. No significant changes in the general conditions, body weights, clinical signs, and gross lesions were observed in both sexes of mice to which $Lb.$ $plantarum$ AF1 was administered intraperitoneally or orally. The results suggest that the no-adverse-effect level of $Lb.$ $plantarum$ AF1 is estimated to be more than 5.0 g/kg in the oral route and 2.5 g/kg in the intraperitoneal route.

Subacute Oral Toxicity Evaluation of Freeze-Dried Powder of Locusta migratoria

  • Kwak, Kyu-Won;Kim, Sun Young;An, Kyu Sup;Kim, Yong-Soon;Park, Kwanho;Kim, Eunsun;Hwang, Jae Sam;Kim, Mi-Ae;Ryu, Hyeon Yeol;Yoon, Hyung Joo
    • Food Science of Animal Resources
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    • v.40 no.5
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    • pp.795-812
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    • 2020
  • Novel food sources have enormous potential as nutritional supplements. For instance, edible insects are considered as an alternative food source due to their higher protein content; moreover, they are economically efficient reproducers and have high in nutritional value. In this study, we investigated the toxicity of the freeze-dried powder of Locusta migratoria (fdLM), known to contain rich proteins as well as fatty acids. The objective of the present study was to evaluate the subacute toxicity of fdLM in male and female Sprague-Dawley (SD) rats. The SD rats were divided into four groups based on the dosage of fdLM administered: dosage of 0 (vehicle control), 750, 1,500, and 3,000 mg/kg/day were administered for 28 days. Toxicological assessments including observations on food consumption, body and organ weights, clinical signs, mortality, ophthalmologic tests, urinalyses, hematologic tests, clinical chemistry tests, gross findings, and histopathology tests were performed. Clinical signs, urinalyses, hematology, serum biochemistry tests, and organ weight examinations revealed no fdLM-related toxicity. The no-observed-adverse-effect level for fdLM was higher than 3,000 mg/kg/day in rats of both sexes; therefore, fdLM, in conclusion, can be considered safe as an edible alternative human and animal food source material.

Acute and repeated dose 26-week oral toxicity study of 20(S)-ginsenoside Rg3 in Kunming mice and Sprague-Dawley rats

  • Li, Chunmei;Wang, Zhezhe;Li, Guisheng;Wang, Zhenhua;Yang, Jianrong;Li, Yanshen;Wang, Hongtao;Jin, Haizhu;Qiao, Junhua;Wang, Hongbo;Tian, Jingwei;Lee, Albert W.;Gao, Yonglin
    • Journal of Ginseng Research
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    • v.44 no.2
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    • pp.222-228
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    • 2020
  • Background: 20(S)-ginsenoside-Rg3 (C42H72O13), a natural triterpenoid saponin, is extracted from red ginseng. The increasing use of 20(S)-ginsenoside Rg3 has raised product safety concerns. Methods: In acute toxicity, 20(S)-ginsenoside Rg3 was singly and orally administrated to Kunming mice and Sprague-Dawley (SD) rats at the maximum doses of 1600 mg/kg and 800 mg/kg, respectively. In the 26-week toxicity study, we used repeated oral administration of 20(S)-ginsenoside Rg3 in SD rats over 26 weeks at doses of 0, 20, 60, or 180 mg/kg. Moreover, a 4-week recovery period was scheduled to observe the persistence, delayed occurrence, and reversibility of toxic effects. Results: The result of acute toxicity shows that oral administration of 20(S)-ginsenoside Rg3 to mice and rats did not induce mortality or toxicity up to 1600 and 800 mg/kg, respectively. During a 26-week administration period and a 4-week withdrawal period (recovery period), there were no significant differences in clinical signs, body weight, food consumption, urinalysis parameters, biochemical and hematological values, or histopathological findings. Conclusion: The mean oral lethal dose (LD50) of 20(S)-ginsenoside Rg3, in acute toxicity, is above 1600 mg/kg and 800 mg/kg in mice and rats, respectively. In a repeated-dose 26-week oral toxicity study, the no-observed-adverse-effect level for female and male SD rats was 180 mg/kg.

Effect of intravenous deferoxamine in multiply transfused patients (대량 수혈을 받은 환아들에서 정맥 투여한 deferoxamine의 효과)

  • Oh, Sang Min;Kang, Joon Won;Kim, Sun Young
    • Clinical and Experimental Pediatrics
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    • v.50 no.12
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    • pp.1225-1230
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    • 2007
  • Purpose : Multiple transfusions in patients with chronic anemia can result in excessive iron deposition in tissues and organs. Effective iron chelation therapy in chronically transfused patients can only be achieved when iron chelators remove sufficient amounts of iron equivalent to those accumulated in the body from transfusions, thus leading to maintain body iron load at a non-toxic level. This study was retrospectively carried out to investigate the effect of intravenous iron chelation therapy with deferoxamine in patients who have received multiple transfusions. Methods : From March 2005 to January 2007, 15 patients who have received multiple transfusions were included in this study. Transfusion dependent patients were defined as those receiving >1 packed red blood cell (RBC) units/month for at least 6 months. They received intravenous deferoxamine for 7 days (10-30 mg/kg/day, 24 hour continuous infusions). Before and after deferoxamine infusions and 3 months later, we compared serum iron, TIBC, and ferritin in transfusion dependent patients and transfusion independent patients. Results : There were 6 males and 9 females and their age range was 5.6-21.3 (median 8.3) years. Transfusion dependent patients were 7 and 8 were transfusion independent states after stem cell transplantation or chemotherapy. There was no significant change in ferritin level after deferoxamine treatment for the transfusion dependent patients but significant falling of ferritin level was observed for the transfusion independent patients 3 months later compared with baseline ferritin level (P=0.046). Some adverse events were observed but symptoms were mild and tolerable. Conclusion : Seven days of intravenous deferoxamine was safe and effective in transfusion independent patients. In transfusion dependent patients, chelation therapy should be maintained, in order to minimize or prevent iron accumulation and storage in the tissues.

Effect of sodium stearoyl-2-lactylate supplementation on lactation performance, blood-biochemical profile, and economic efficacy of mid-lactation Holstein cows

  • Kim, Eun Tae;Lee, Sang Suk;Lee, Ji Hoon;Jeong, Jin Suk;Lee, Shin Ja;Jeong, Joon;Park, Jong Kook;Park, Beom Young;Kim, Sang Bum;Jeong, Ha Yeon;Ki, Kwang Seok;Choi, Chang Weon;Kim, Chang Hyun;Kim, Jin Wook;Lee, Sung Sill
    • Asian-Australasian Journal of Animal Sciences
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    • v.31 no.9
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    • pp.1458-1463
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    • 2018
  • Objective: This study was done to evaluate the effect of sodium stearoyl-2-lactylate (SSL) supplementation in a total mixed ration (TMR) on the lactation performance, blood parameters, and economic efficacy of mid-lactation Holstein cows. Methods: Twenty-four cows (body weight $647{\pm}11.7kg$) were randomly divided into 4 treatment groups, with six cows per group. The dietary treatments were as follows: basal diet (CON); CON+17.5 g of top dressed SSL (treatment [TRT] 0.05); CON+35 g of SSL (TRT 0.1); and CON+70 g of SSL (TRT 0.2) per 35 kg TMR. Results: The highest level of SSL supplementation (TRT 0.2) significantly improved milk yield during the second period compared to the TRT 0.05 group (5 to 8 wks; 33.28 vs 31.09 kg/d), during the third period compared to both the CON and TRT 0.05 groups (p<0.05) (9 to 13 wks; 32.59 vs 30.64 and 30.01 kg/d) and during the overall experimental period compared to both the CON and TRT 0.05 groups (p<0.05) (1 to 13 wks; 33.43 vs 32.06 and 31.40 kg/d), respectively. No negative effects on hematological or biochemical parameters were observed due to SSL supplementation. Considering both the milk fat and protein content, the total milk price was set at 1,073.60 (TRT 0.05), 1,085.60 (TRT 0.1), 1,086.10 (TRT 0.2), and 1,064.20 (CON) won/L, with consequent total milk profits of -1.7%, 5.4%, and 3.5% for the TRT 0.05, TRT 0.1, and TRT 0.2 diet, respectively, compared to those in the CON diet. Conclusion: The milk sales revenue related to SSL supplementation of the TRT 0.1 diet was increased by up to 5.4% compared to the milk sales revenue of the CON diet. Therefore, 0.1% SSL supplementation might be effective and profitable during the mid-lactation period of cows, without producing adverse effects.

Anti-inflammatory Effect of Scutellaria baicalensis Hot Water Extracts Containing Baicalin on Modulation of the Immune System in Raw264.7 Cells (Raw264.7 cells에서 바이칼린 함유 황금열수 추출물의 면역계 조절을 통한 항염증 효과)

  • Park, Hye-Jung;Kim, Sang-Min;Kwon, Hyun-Ju;Lee, Hyun-Tae;Kim, Byung-Woo;Kim, Tae Hoon;Kim, Moon-Moo
    • Journal of Life Science
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    • v.24 no.3
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    • pp.219-226
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    • 2014
  • The immune system protects the body from bacterial infection and disease, as well as cancer that develops following the mutation of cells. Aging exerts adverse effects on the immune system, such as chronic inflammation, resulting in rheumatoid arthritis. The purpose of this study was to investigate the anti-inflammatory effectiveness of Scutellaria baicalensis, which contains baicalin. HPLC analysis showed that S. baicalensis hot water extracts (SBWE) contained 42.2 mg/g of baicalin. To evaluate the cytotoxicity of SBWE, an MTT assay was carried out in Raw264.7 cells. No cytotoxicity was observed below 160 ${\mu}g/ml$ of SBWE. SBWE at 40 ${\mu}g/ml$ reduced the amount of nitric oxide produced by macrophages stimulated with lipopolysaccharide by 40%. In addition, SBWE inhibited phagocytosis stimulated with zymosan. Furthermore, the content of tumor necrosis factor-alpha ($TNF-{\alpha}$) produced by the macrophages was decreased in the presence of SBWE in a dose-dependent manner. SBWE also inhibited the production of interleukin-1 beta ($IL-1{\beta}$) in a time course experiment. Moreover, treatment with 20 ${\mu}g/ml$ of SBWE remarkably decreased the expression level of cyclooxynase-2. The results provide evidence that SBWE may exert an anti-inflammatory effect through modulation of the immune system.

Single and 14-Day Repeated Oral Toxicity Studies of 70% Ethanol Extract of Lindera Obtusiloba Blume Leaves (생강나무(Lindera obtusiloba Blume) 잎 70% 에탄올 추출물의 단회와 14일 반복투여 독성시험의 안전성 평가)

  • Hong, Chung-Oui;SeoMun, Young;Koo, Yun-Chang;Nam, Mi-Hyun;Lee, Hyun-Ah;Kim, Ji-Hoon;Wang, Zeng;Yang, Sung-Yong;Lee, Sung-Hee;No, Su-Hwan;Lee, Kwang-Won
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.38 no.10
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    • pp.1324-1330
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    • 2009
  • Lindera obtusiloba Blume (LO), which is widely distributed in Korea, Japan and China, has traditionally been used as a popular folk medicine for the treatment of fever, abdominal pain, bruise and extravation. The purpose of this study was to examine the toxicities of the single and 14-day repeated doses in Sprague-Dawley rats orally administrated with LO at doses of 0, 500, 1000, 2000 (14-day repeated toxicity test) and 5000 (single toxicity test) mg (dry weight)/kg of body weight/day. The results showed that there was no difference in body weight change, food intake, water consumption, or organ weight among different dose groups. Also we observed no death and abnormal clinical signs during the experimental period. Between the groups orally administered LO and the control group, there was no statistical significance in hematological test or serum biochemical values. There were no evidences of histopathological alteration as well as abnormal gross finding mediated by single and 14 days treatments with LO. These results suggest that no observed adverse effect level (NOAEL) of the oral application of LO was considered to be more than 2000 mg/kg in rats under the conditions employed in this study.

Evaluation of Therapeutic Effect of the Extract from Rhubarb (Rheum officinalis) in Dogs with Chronic Renal Failure (개의 만성 신부전에서 대황 추출물의 치료학적 효과의 평가)

  • Kim, Ye-Won;Hyun, Changbaig
    • Journal of Veterinary Clinics
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    • v.29 no.6
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    • pp.435-440
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    • 2012
  • This study was designed to evaluate the clinical efficacy and safety of Rhubarb extracts ($Rubenal^{(R)}$) in dogs with chronic renal failure (CRF). Client-owned 40 dogs with CRF graded International renal interest Society (IRIS) II-III were enrolled in this study. The dogs were equally allocated and blindly administered with $Rubenal^{(R)}$ or placebo. The following items were evaluated at day 0, 30, 90 and 180: body condition score (BCS), clinical score (appetite, polydipsia/polyuria, quality of life score), hemogram (WBC, RBC, PCV), serum biochemistry (ALT/AST, ALP, Creatinine/BUN, total protein, albumin), serum electrolyte (Na, K, Cl, Ca, P), systolic blood pressure, urinalysis (UPC, USG) and IRIS stage. In this study, we found that the $Rubenal^{(R)}$ preparation was well tolerated by dogs and induced no adverse effects. Statistically significant improvements were observed in clinical score (quality of life score by vet and clients), serum BUN and creatinine levels, serum phosphorus concentration, level of proteinuria, and the IRIS score of CRF in dogs after 6 month of treatment of $Rubenal^{(R)}$. Those findings suggested that the Rhubarb extracts can improve the clinical signs of CRF (i.e. azotemia, hypertension, proteinuria, hyperphosphoremia) and the quality of life (i.e. BCS, clinical score) and can retard the progression of CRF in dogs. Therefore the Rhubarb extracts can be a good supplementary drug for treating dogs with subclinical and clinical renal diseases. However, care should be taken for interpreting our result, because this study is not double-blinded controlled study but pilot study.

Evaluation of 3-week Repeated Dose Oral Toxicity on Amomum tsao-ko Extract in Balb/c Mice (Balb/c 마우스에서 초과 추출물의 3주간 반복 경구투여 독성평가)

  • Park, Ju-Hyeong;Cho, Young-Rak;Ko, Hye-Jin;Jeong, Wonsik;Ahn, Eun-Kyung;Oh, Junho;Oh, Joa Sub
    • Journal of Applied Biological Chemistry
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    • v.58 no.2
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    • pp.139-143
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    • 2015
  • In the present study, we investigated the oral toxicity of Amomum tsao-ko Crevost et Lemaire, (Zingiberaceae) extract in Balb/c mice (BALB, n=60) for 3 weeks. Balb/c mice (10 mice/group, 6 group, $20{\pm}2g$, 6 weeks) were orally administered for 21 days, with dosage of 250, 500, 1000, 2000 mg/kg/day. Ethanol extract of A. tsao-ko did not affect any significant change of mortality, clinical signs, organs and body weights. Also, there were not significantly difference from the naive group (control) in hematological and serum biochemical examination. Consequently, these findings indicate that 3-week treatment with the ethanol extract of A. tsao-ko was not any toxic effects in Balb/c mice and the no-observed adverse effect level (NOAEL) for oral toxicity was determined to be 2000 mg/kg/day under our experimental conditions.