• Title/Summary/Keyword: Acute oral toxicity study

검색결과 242건 처리시간 0.024초

Single Oral Dose Toxicity Study of Aqueous Extracts of Binso-san in ICR Mice

  • Park, Kyung;Kim, Dae-Jun;Byun, Joon-Seok
    • 동의생리병리학회지
    • /
    • 제24권1호
    • /
    • pp.134-142
    • /
    • 2010
  • Although BinSo-San(BSS), a mixed herbal formula consisted of 11 types of medicinal herbs and have been used as anti-inflammatory agent, In the present study, the acute toxicity (single oral dose toxicity) of lyophilized BSS aqueous extracts was monitored in male and female mice after oral administration according to Korea Food and Drug Administration (KFDA) Guidelines (2005-60, 2005). In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2000, 1000, 500, 250 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines (2005-60, 2005). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines (2005-60, 2005) with organ weight and histopathology of 12 types of principle organs. We could not find any mortality, clinical signs and changes in the body weights except for dose-independent increases of body weight and gains restricted in 1000 mg/kg of BSS extracts-dosing female group. Hypertrophic changes of lymphoid organs.thymus, spleen and popliteal lymph nodes were detectedat postmortem observation with BSS extracts dose-dependent increases of lymphoid organ weights, and hyperplasia of lymphoid cells in these all three lymphoid organs at histopathological observations. These changes are considered as results of pharmacological effects of BSS extracts or their components, immunomodulating effects, not toxicological signs. In addition, some sporadic accidental findings such as congestion spots, cyst formation in kidney, atrophy of thymus and spleen with depletion of lymphoid cells, and edematous changes of uterus with desquamation of uterus mucosa as estrus cycles were detected throughout the whole experimental groups including both male and female vehicle controls. The significant (p<0.01) increases of absolute weights of kidney and pancreas detected in BSS extracts 1000 mg/kg-treated female group are considered as secondary changes from increases of body weights. The results obtained in this study suggest that the BSS extract is non-toxic in mice and is therefore likely to be safe for clinical use. The LD50 and ALD of BSS aqueous extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. In addition, the MTD of BSS extracts was also considered as over 2000 mg/kg because no BSS extracts-treatment related toxicological signs were detected at histopathological observation except for BSS or their component-related pharmacological effects, the immunomodulating effects detected in the present study.

Initial Risk Assessment of Acetanilide in OECD High Production Volume Chemical Program

  • Park, Hye-Youn;Park, Yoonho;Sanghwan Song;Kwon, Min-Jeoung;Koo, Hyun-Ju;Jeon, Seong-Hwan;Na, Jin-Gyun;Park, Kwangsik
    • Toxicological Research
    • /
    • 제18권1호
    • /
    • pp.13-22
    • /
    • 2002
  • In Korea, 2,320 tonnes of acetanilide were mostly wed as intermediates for synthesis in phar-maceuticals or additives in synthesizing hydrogen peroxide, varnishes, polymers and rubber. Only small amount of 120 kg were wed as a stabilizer for hydrogen peroxide solution for hair colouring agents in 1998. Readily available environmental or human exposure data do not exist in Korea at the present time. However, potential human exposures from drinking water, food, ambient water and in work places are expected to be negligible because this chemical is produced in the closed system in only one company in Korea and the processing factory is equipped with local ventilation and air filtering system. Acetanilide could be distributed mainly to water based on EQC model. This substance is readily biodegradable and its bioaccumulation is low. Acute toxicity of acetanilide is low since the L $D_{50}$ of oral exposure in rats is 1,959 mg/kg bw. The chemical is not irritating to skin, but slightly irritating to the eyes of rabbits. horn repeated dose toxicity, the adverse effects in rats were red pulp hyperplasia of spleen, bone marrow hyperplasia of femur and decreased hemoglobin, hematocrit and mean corpuscular hemoglobin concentration. The LOAEL for repeated dose toxicity in rats was 22 mg/kg/day for both sexes. Acetanilide is not considered to be genotoxic. In a reproductive/developmental toxicity study, no treatment-related changes in precoital time and rate of copulation, impregnation, pregnancy were shown in all treated groups. The NOAELs for reproduction and developmental toxicity (off-spring toxicity) are considered to be 200 mg/kg bw/day and 67 mg/kg bw/day, respectively. Ecotoxicity data has been generated in a limited number of aquatic species of algae (72 hr- $E_{b}$ $C_{50}$; 13.5 mg/l), daphnid (48hr-E $C_{50}$ > 100 mg/l) and fish (Oryzias latipes, 96hr-L $C_{50}$; 100 mg/l). Form the acute toxicity values, the predicted no effect concentration (PNEC) of 0.135 mg/1 was derived win an assessment factor of 100. On the basis of these data, acetanilide was suggested as currently of low priority for further post-SIDS work in OECD.in OECD.D.

QuEChERS 법을 이용한 Rat 조직내 Pyraclofos 잔류 분석 및 급성독성 평가 (QuEChERS-based determination of tissue residues and acute toxicity of pyraclofos in rat)

  • 표민정;하도윤;최유정;정귀옥;한창희;박영호;김민희;김원규;정진권;김문기;김의경
    • 한국동물위생학회지
    • /
    • 제38권3호
    • /
    • pp.173-180
    • /
    • 2015
  • Environmental pesticides used for insect control can be transferred from plants to animals even to livestock animals through food chain. Human beings also can be exposed to pesticides by consuming polluted dairy products, including meats, eggs and other milk products. Therefore, the Ministry of Food and Drug Safety (MFDS) established Standard for Pesticide Residue Limits in dairy products. The QuEChERS (quick, easy, cheap, effective, rugged and safe) methods for detecting residual pesticides are relatively well established for fruits and vegetables, however, the methods for meat have not been appropriately studied yet. In the present work, pyraclofos was used as an organophosphate pesticide to examine its tissue residue in experimental animals by QuEChERS methods. For this, pyraclofos (150 mg/kg body weight) was orally administered to male rats once a day for 2 days. After 6, 12, and 24 hr of the treatment, the tissue residues in liver and femoral muscle of the rats were determined using QuEChERS methods followed by HPLC analyses. In preliminary studies, the recovery rates of spiking samples of pyraclofos demonstrated approximately 109~110% from the tissues. In previous study, pyraclofos tissue residues were observed with significantly high levels in livers and muscles at 6 hr of oral treatment. Then, they were almost completely disappeared after 24 hr of the administration, indicating the orally exposed pyraclofos is rapidly absorbed and distributed to body organs, then quickly excreted from the body with a negligible level of tissue residue. The alterations in blood chemistry as well as the histopathology of heart, lung, liver, spleen and kidney have also been investigated in the experimental animals for assessing acute toxic effects of pyraclofos. The obtained blood chemistry indexes (ALT and AST) showed maximum peak values at 12 hr after the oral administration and decreased to the normal levels at 24 hr of the treatment. Histopathologic observation exhibited acute hepatic damages at 24 hr of the treatment. In conclusion, we suggest that QuEChERS method can be adequately optimized for the analysis of pyraclofos residues in animal tissues.

식물추출물 마늘 추출액, 잔톡실럼 정유, 레몬그라스 정유 함유 유제 3종의 생태독성평가 (Acute Ecotoxicity Evaluation of 3 Emulsifiable Concentrates Containing Garlic Extract, Zanthoxylum Extract, and Lemon Grass Oil Originated from Plant)

  • 유아선;홍순성;정미혜;박경훈;장희섭;이제봉;박재읍
    • 농약과학회지
    • /
    • 제16권4호
    • /
    • pp.376-382
    • /
    • 2012
  • 식물추출물 함유(마늘추출액, 잔톡실럼오일, 레몬그라스오일 30%) 유제의 물벼룩급성독성 결과 마늘추출액 함유 30% 유제의 $EC_{50}$$3.3mg\;L^{-1}$로 EPA 기준으로 보통독성정도이었고, 레몬그라스오일, 잔톡실럼(Zanthoxylum)오일 함유 30% 유제의 $EC_{50}$$10mg\;L^{-1}$ 이상으로 저독성이었다. 송사리급성독성 시험의 경우, 마늘추출액 함유 30% 유제의 $LC_{50}$ 값이 $3.0mg\;L^{-1}$으로 나타났으며 나머지 두 유제는 모두 $10mg\;L^{-1}$ 이상으로 확인되었다. 꿀벌급성독성시험은 접촉과 섭식 시험으로 나누어서 실시하였고, 접촉독성의 경우 모두 100 a.i ${\mu}g\;bee^{-1}$ 이상으로 확인되었다. 섭식독성의 경우 마늘추출액 함유 30% 유제의 $LD_{50}$ 값이 44.3 a.i ${\mu}g\;bee^{-1}$ 이었으며 잔톡실럼(Zanthoxylum)오일과 레몬그라스오일 함유 30% 유제의 경우 $LD_{50}$ 값이 100 a.i ${\mu}g\;bee^{-1}$ 이상으로 나타나 독성이 낮은 것으로 판단되었다. 지렁이급성독성시험의 경우, 마늘추출액, 잔톡실럼(Zanthoxylum)오일, 레몬그라스오일 함유 30% 유제의 $LC_{50}$ 값이 각각 267, 592, $430mg\;kg^{-1}$ 로 나타났는데 이는 제품살포물량을 확정한 뒤 환경추정농도를 이용한 위해성평가를 통해 안전성을 확보한다면 친환경 농자재로서 활용이 가능할 것으로 판단하였다.

다시마 (Laminaria japonicus) Alginate의 가열가수분해에 따른 물리$\cdot$화학적 및 생물학적 특성에 관한 연구 8. 저분자 Alginate투여에 의한 랫드의 혈청지질의 성분 변화 및 경구급성독성 실험 (Studies on Physicochemical and Biological Properties of Depolymerized Alginate from Sea tangle, Laminaria japonicus by Thermal Decomposition 8. Effects of Depolymerized Alginate on Serum Lipid Composition and Its Single-Dose Toxicity yin Oral Route in Rats)

  • 김육용;조영제
    • 한국수산과학회지
    • /
    • 제34권3호
    • /
    • pp.173-178
    • /
    • 2001
  • 저분자 alginate인 HAG-10, HAG-50, HAG-100 및 alginate를 랫드에 35일간 섭취시켰을 때, 혈청중의 지질성분과 동맥경화지수의 측정으로 특성이 가장 좋은 저분자 alginate인 HAG-50의 안전성을 확보하기 위해 랫드에 경구급성독성실험을 실시하였다. 혈청중 total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides 및 phospholipid 함량과 동맥경화지수는$5\%$$10\%$HAG-50에서 모두 유의적으로 뚜렷히 감소하여 지질대사 개선효과를 나타내었다. HAG-50의 경구급성독성실험을 검토한 결과, 투여할 수 있는 최고 용량인 랫드 체중 kg당 5.0g의 용량에서도 암$\cdot$수 모두 일반상태의 이상 반응과 폐사 및 병리$\cdot$조직학적 이상을 나타내는 예는 전혀 관찰되지 않아서 $LD_{50}$치의 산출이 불가능하였으므로 HAG-50은 아주 안전한 제재임이 검증되었다. 이상의 결과를 종합해 볼 때, 평균분자량 50,000 정도의 저분자 alginate인 HAG-50이 가장 우수한 지질대사 개선효과의 기능적 특성을 발휘하였으며, 경구급성독성실험 에서도 독성이 전혀 없었고, alginate가 가지고 있는 고유의 생리적 기능을 유지 향상시키면서 이용에 제한이 되고 있는 점성을 줄이고 용해도를 높혀서 alginate의 이용성을 높일 수 있는 새로운 형태의 식품소재라고 사료된다.

  • PDF

피리미설판(Pyrimisulfan)의 독성평가와 일일섭취허용량 설정 (Toxicity Assessment and Establishment Acceptable Daily Intake of Pyrimisulfan)

  • 정미혜;박경훈;박재읍;곽승준;김용범;한범석;손우찬
    • 농약과학회지
    • /
    • 제15권2호
    • /
    • pp.208-217
    • /
    • 2011
  • 피리미설판에 대한 독성을 평가하고 일일섭취허용량을 설정하기 위하여 다양한 인축독성 시험성적서를 검토하였다. 대사시험결과, 주로 대변을 통해 배설되었으며, 급성독성은 낮았고, 피부, 안점막자극성과 피부감작성은 없었다. 랫드 90일 반복투여 경구독성시험결과에서 피리미설판 투여에 따른 영향은 혈액학적지표 및 간장에서 확인되었고 발암성은 없었으며, 번식독성, 기형독성 등에서 번식능력 몇 기형에 대한 영향 및 유전독성은 확인되지 않았다. 최대무작용량은 개 90일 반복투여 경구독성시험 10 mg/kg/day였으며, 안전계수 100으로 나눈 0.1 mg/kg/day을 일일섭취허용량(ADI)으로 설정하였다.

Pathogenicity and Single Dose Toxicity of a Potential Probiotic Lactobacillus spp. PSC101 in Mice

  • Hwang, Mi-Hyun;Kim, Young-Hwon;Kim, Eun-Young;Song, Jae-Chan;Lee, Keun-Woo;Jeong, Kyu-Shik;Kim, Kil-Soo;Rhee, Man-hee;Kwon, Oh-Deok
    • Toxicological Research
    • /
    • 제20권2호
    • /
    • pp.173-177
    • /
    • 2004
  • This study was conducted to investigate the pathogenicity and acute single toxicity of Lactobacillus spp. PSC101 (PSC101) isolated from pigs and L. acidophilus (LA) at 2.5$\times$$10^9$CFU or 2.5$\times$$10^{12}$colony forming units (CFU) in mice for 14 days. After oral administration of the bacteria into mice, we could not find their any specific pathogenicity from the standpoints of clinical signs, and changes in body weight and body temperature, as compared with the control group during 14 days. We further investigated the toxicity of concentrated culture broth ($\times$10) after fermentation of them for safe industrial process. As the results, we could not find any clinical signs, changes in body weight and body temperature, as compared with the control group (MRS broth) for 14 days. The results obtained in this study suggest that the potentially probiotic, PSC101, is non-toxic in mice and is therefore likely to be safe for pig use.

폴리카프로락톤 실리카 나노 복합체를 이용한 골이식대체재 개발에 관한 연구 (Study on the development of polycaprolacton silica nanohybrid for bone substitutes)

  • 정근식;임성빈;정진형;홍기석;김종여
    • Journal of Periodontal and Implant Science
    • /
    • 제34권2호
    • /
    • pp.425-448
    • /
    • 2004
  • A bioactive and degradable poly(epsilon -caprolactone)/silica nanohybrid(PSH) was synthesized for the application as a bone substitute. PSH was manufactured by using silica and polycaprolacton. PSH was manufactured in some composition after low crystaline apatite had been formed in simulated body fluid and, was used this study. The safety of the PSH was established by test of acute, and subacute toxicity, sensitization cytotoxicity and sterility. In order to assess activity of osteoblast, the test for attaching osteoblast, proliferation test for osteoblast, differentiating gene expression test are performed in vitro. And bone substitutes were grafted in rabbit's calvarium, during 8 weeks for testing efficacy of bone substitutes. Degree of osteogenesis and absorption of substitutes were evaluated in microscopic level. In result, it was not appeared that acute and subacute toxicity, sensitization in intradermal induction phase, topical induction phase and challenge phase. It was shown that the test can not inhibit cell proliferation. adversely, it had some ability to accelerate cell proliferation. The result of sterility test described bacterial growth was not detected in most test tube. The attaching and proliferation test of osteoblast had good results. In the result of differentiating gene expression test for osteoblast, cbfa1 and, alkaline phosphatase, osteocalcin and GAPDH were detected with mRNA analysis. In the PSH bone formation test, ostgeoblastic activity would be different as material constitution but it had good new bone formation ability except group #218. futhermore, some material had been absorbed within 8 weeks. Above studies, PSH had bio-compatibility with human body, new bone formation ability and accelerate osteoblastic activity. So it would be the efficient bone substitute material with bio-active and biodegradable.

A Modified Process for Producing High Quantities of Bio-Germanium in Yeast and a Study of Its Oral Toxicity

  • Park, So-Young;Joo, Seong-Soo;Won, Tae-Joon;Chung, Jin-Woong;Lee, Sung-Hee;Oh, Sun-Woo;Lee, Do-Ik;Hwang, Kwang-Woo
    • Food Science and Biotechnology
    • /
    • 제16권1호
    • /
    • pp.78-82
    • /
    • 2007
  • Since germanium has been shown to be beneficial for the treatment of diseases such as cancer and rheumatic arthritis, we developed an adapted process of bio-germanium preparation using inorganic germanium. In the present study we determined the optimal conditions for culturing yeast Saccharomyces cerevisiae (KCTC-1199), and the best concentrations of inorganic germanium for the adaptation process. The resulting method was successful at producing high quantities of germanium yeasts. The following are the culture conditions that obtained the highest level of productivity: an inorganic germanium concentration of 3,000-5,000 ppm, a pH of 6.5, a temperature of $35^{\circ}C$, and 20 hr of incubation time. In addition to this high-yield quantity study, we observed the acute oral toxicity of mice treated with Geranti Bio-Ge $Yeast^{(R)}$. We found no changes in body weight, or in the mortality between the control groups and the bio-germanium yeast group. There were also no digestive problems such as diarrhea that occurred in either group.

님추출물의 경구투여에 따른 랫드의 신장독성 연구 (Study of Kidney Toxicity of Azadirachta Indica Extract for Oral Administration in Rats)

  • 윤현주;최미선;조현조;한범석;박경훈;오진아;조남준;백민경
    • 한국환경농학회지
    • /
    • 제33권2호
    • /
    • pp.103-110
    • /
    • 2014
  • Azadirachta indica는 살충작용을 가진 약용 식물 중 하나로 우리나라에서 유기농업자재로 널리 사용되고 있다. 본 연구에서는 님추출물의 인체 안전성을 확인하기 위하여, SD 랫드를 이용하여 님추출물의 급성경구독성시험과 4주 반복투여 경구독성시험을 수행하여 신장의 조직변화 및 혈액생화학적 지표를 관찰하였다. 급성 독성시험 결과 님추출물의 $LD_{50}$은 2.0 g/Kg이상으로 나타났다. 반복투여 경구독성시험으로 님추출물을 각각 0.5, 1.0, 2.0 g/Kg으로 투여한 결과, 체중변화, 사료 및 물 섭취량에서는 유의적인 차이가 없었으며, 시험물질투여군의 상대 신장중량 또한 유의적인 차이를 보이지 않았다. 혈중 CREA는 수컷에서 님추출물 고용량 투여군에서 유의적으로 증가하였으나 BUN은 투여용량이 증가할수록 유의적으로 감소하였다. 신장과 관련된 혈중 지표인 CHO는 암컷에서 시험물질 투여군의 용량이 증가할수록 유의적으로 증가하였다. 그러나, 조직 병리학적 분석결과 모든 시험물질투여군에서 이상이 관찰되지 않았다. 이상의 결과를 종합하여 볼 때, 님추출물은 암컷에서 혈중 콜레스테롤 증가 경향을 보인 것을 제외하고는 모든 용량처리군에서 신장에 독성 영향을 미치지 않는 것으로 생각된다.