• 제목/요약/키워드: animal study guideline

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Review Newly Adopted OECD Acute Oral Toxicity Test Guideline 420 (OECD test guideline 420 고정용량 급성경구독성시험법에 대한 고찰)

  • 정용현;유일재
    • Toxicological Research
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    • v.17 no.3
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    • pp.195-201
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    • 2001
  • The OECD acute toxicity guideline has been revised recently to protect animal welfare. The GLP authority of the Ministry of Environment, the National Institute for Environmental Research, recommended GLP laboratories in Korea to ufo the revised acute toxicity guideline. This study was carried out to optimize newly adopted OECD test guideline 420 (TG 420). Bisphenol A was selected for test chemical. Following TG420, Bisphenol A was classified as class 5/unclassified group. The revised TG 420 was very effective test in minimizing animal number and classifying chemicals. The method, however had short-coming in evaluation of test results statistically because the test had no control group, and the test should be stopped when animals were dead at the lowest dose or alive at the highest dose. TG 420 required at Least 20 animals to complete the test, but it could result in producing unused animals that need to sacrifice.

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Application of 2006 IPCC Guideline to Improve Greenhouse Gas Emission Estimation for Livestock Agriculture (2006 IPCC 가이드라인 축산부문 도입에 따른 온실가스 배출량 계산 개선방안 연구)

  • Ji, Eun-Sook;Yang, Seung-Hak;Cho, Sung-Back;Hwang, Ok-Hwa;Park, Kyu-Hyun
    • Journal of Animal Environmental Science
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    • v.18 no.2
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    • pp.75-84
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    • 2012
  • Current estimation of greenhouse gas (GHG) emissions from livestock agriculture in Korea was based on Revised 1996 IPCC Guidelines for National Greenhouse Gas Inventories (1996 IPCC GL) published in 1996 and emission data were published in National Inventory Report. New guideline book, 2006 IPCC Guidelines for National Greenhouse Gas Inventories (2006 IPCC GL), however, was published in 2006. Hence preparation to apply new guideline for the estimation of GHG emission would be necessary. In this study, 1996 IPCC GL and 2006 IPCC GL for livestock agriculture were compared. Estimated GHG emissions based on Tier 1 methods of 1996 IPCC GL and 2006 IPCC GL between 2000 and 2008 were also compared. Estimated GHG emissions based on 2006 IPCC GL were 1.27~1.33 times higher than those based on 1996 IPCC GL. These results were mainly caused by emission factors of each IPCC GL. More researches should be conducted to decrease uncertainties of national GHG inventories.

Estimation of Temporal Acute Exposure Guideline Levels for Emergency Response - A Brief Case using Formaldehyde - (화학사고 대응을 위한 시간별 급성노출기준 참고치 산정 - 폼알데하이드 사례 -)

  • Kim, Eunchae;Cho, Yong-Sung;Lee, Chung-Soo;Yang, Wonho;Hwang, Seung-Ryul;Park, Jihoon
    • Journal of Environmental Health Sciences
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    • v.47 no.2
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    • pp.166-174
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    • 2021
  • Objectives: This study aimed to provide temporal Acute Exposure Guideline Levels (AEGL) for a hazardous substance as a pilot study. Methods: As one of the substances designated by the Korea Ministry of Environment as requiring preparations for potential accidents, formaldehyde was selected to estimate the AEGLs. The calculation was based on Haber's formula (Cn×t=k) using valid toxicity data (for humans/animals). A total of 96 points of AEGL levels were provided using an interval of five minutes over eight hours. Results: The AEGL-1 and 2 values were constant for the entire exposure duration at 0.9 ppm and 14 ppm, respectively. The values were obtained from clinical/animal tests, and the adaptation effect after a given exposure duration was also considered. AEGL-3 was based on animal toxicity data, and it was estimated from 127 ppm for the initial five minutes to 35 ppm for eight hours. Conclusions: More specific AEGL levels for formaldehyde could be obtained in this study using toxicity data with Haber's formula. Based on this methodology, it would be also possible to estimate AEGL levels that can be used at the scene of a chemical accident for other substances requiring preparation for potential accidents.

Acute Oral Toxicity Study of Kami-honghwa-tang (가미홍화탕의 단회 경구 투여 독성 연구)

  • Sung, Hyun-Jea;Moon, Geun-Ah;Ryoo, Choong-Ryeol;Yoon, Yoo-Sik
    • Korean Journal of Oriental Medicine
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    • v.9 no.2
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    • pp.95-105
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    • 2003
  • Kami-honghwa-tang(KH-19) is a prescription for reducing the side effect of radiotherapy. In this study, safety of KH-19 was evaluated by GLP guideline of Korea Food and Drug Administration. In acute oral toxicity study on rat, transient inhibition of weight increase was shown, but change in general symptom was not detected. No dead animal was observed up to 5,000 mg/kg in both male and female animals. In acute oral toxicity study on Beagle dog, transient vomiting, diarrhea, anorexia, and weight reduction was observed. However, no dead animal was observed up to 2,000 mg/kg in both male and female animals.

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Treatment of acute bovine theileriosis in grazing Korean native cattle (방목중인 한우에서 발생한 급성 타일레리아증 치료)

  • Lim, Yeoun-Su;Kim, Young Jun;Kim, Jongho;Kong, JooYeon;Song, Kunho
    • Korean Journal of Veterinary Service
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    • v.42 no.2
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    • pp.113-116
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    • 2019
  • Bovine theileriosis caused by Theileria sergenti is a tick-borne hematoprotozoan disease that is characterized by chronic anemia and fever in cattle. In this study, results of microscopic examination and PCR detection confirmed 17 Korean native cattle with emaciation and fever as acute bovine theileriosis caused by T. sergenti. Buparvaquone was injected as treatment, but was proved to be an inappropriate measure according to our study. After 6 months of injection, clinical signs and hematological values were recovered, but T. sergenti was still identified in blood sample as a result of microscopic exam and PCR. These results suggest that continuous management is necessary to control bovine theileriosis. Therefore, findings of this study may provide significant guideline on the control of bovine theileriosis.

Permitted Daily Exposure for Diisopropyl Ether as a Residual Solvent in Pharmaceuticals

  • Romanelli, Luca;Evandri, Maria Grazia
    • Toxicological Research
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    • v.34 no.2
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    • pp.111-125
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    • 2018
  • Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.

A Review on Reporting Quality of Acupuncture Intervention for Visceral Pain: Assessment with STRICTA (내장 통증에 사용된 침 중재 분석 및 보고의 질 평가)

  • Lee, In-Seon;Cheon, Soyeon;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.36 no.1
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    • pp.19-35
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    • 2019
  • Objectives : The purpose of this study is to review which acupoints and meridians are selected to treat visceral pain in articles published in international journals and to investigate quality of reporting acupuncture intervention according to the STRICTA guidelines. Methods : Electrical and hand search were conducted in PubMed, EMBASE, MEDLINE, and Cochrane Library for acupuncture studies on visceral pain in human and animals. Reporting quality of intervention was evaluated using the revised STRICTA guidelines. Results : We included 51 articles (7 clinical studies and 44 animal studies) in this study. The most frequently adopted meridians and acupoints were Stomach meridian, Spleen meridian, Conception Vessel meridian, and ST36, CV4, SP6, LI4, PC6, SP9, ST25, ST37 in clinical studies. In animal studies, Stomach meridian, Conception Vessel meridian, Pericardium meridian and ST36, ST37, CV12, PC6 were most frequently used. Animal studies showed significantly lower quality of reporting compared to clinical studies. According to the analysis on the effect of year of publication of articles, announcement of STRICTA guidelines did not improve the quality of reporting for studies on visceral pain. Conclusions : These results suggest that both proximal and distal acupoints based on meridian theory were used to study the underlying mechanisms of visceral pain both in human and animal studies. Guidelines of acupuncture intervention reporting for animal study is necessary to improve the quality of evidence, and it will also allow us the integrative understanding of the mechanisms and clinical effects of acupuncture treatment in human and animal.

Studies on the Establishment of Tolerance Level of Radioactive Compounds in Livestock Feeds (가축 사료 중 방사성 물질 허용 기준 설정에 관한 연구)

  • Lee, Wanno;Ji, Sang-Yun;Kim, Jin Kyu;Lee, Yun-Jong;Park, Jun Cheol;Moon, Hong Kil;Lee, Ju-Woon
    • Journal of Radiation Industry
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    • v.5 no.4
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    • pp.337-345
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    • 2011
  • In order to provide an effective preparedness for a nuclear or radiological emergency happening in the domestic or neighborhood countries and to solve the vague fear of the people for the ingestion of radioactive livestock products, the establishment of national guideline level for radionuclides in feed is urgently necessary. This is because it is important to secure the safety and to manage the crisis in the agricultural, fishery and food sector by performing the effective safety control during and after nuclear incident. This study was performed to investigate the report cases of international organizations and foreign countries to set up a domestic control standard for managing radioactive substances that may be contaminated in animal feeds due to the nuclear power plant incident. In addition, an attempt was made to provide a useful reference that can help prepare a domestic control standard, using a coefficient that can consider the transfer into livestock through the intake of radioactive contaminated animal feeds. The standard radioisotopes investigated were confined to radioactive cesium ($^{137+134}Cs$) and iodine ($^{131}I$). Guideline level for the radionuclides was calculated by using the transfer coefficient factor and the maximum daily intake of animal feed provided by IAEA. For example, the maximum daily intake of animal feed was set as $25kg\;d^{-1}$ for dairy cows, $10kg\;d^{-1}$ for beef cattle, $3.0kg\;d^{-1}$ for pigs and $0.15kg\;d^{-1}$ for chickens. The result values for radioactive cesium were calculated as $8,696Bq\;kg^{-1}$, $4,545Bq\;kg^{-1}$, $1,667Bq\;kg^{-1}$ and $2,469Bq\;kg^{-1}$, respectively. The results for radioactive iodine showed the ranges between $741Bq\;kg^{-1}$ and $76,628Bq\;kg^{-1}$. These data can be utilized as a scientific reference for the preparation of a crisis management manual for the emergency control due to nuclear power plant accident in Korea and neighboring country. These results will contribute to establish the safe feed management system at national level as manual for responding the radioactive exposure of agricultural products and animal feeds, which are currently not established.

The Effect of Herbal Medicine on Rheumatoid Arthritis Animal Model: A systematic Review of Animal Experiment Studies Published in Korea and Overseas (한약의 류마티스 관절염 동물 모델에 대한 치료효과: 국내 및 국외 논문에 대한 체계적 문헌 고찰)

  • Oh, Seung-Joon;Ha, Hyun Ju;Gu, Ji-Hyang;Park, Yang-Chun;Oh, Min-Seok;Jung, In-Chul;Lee, Eun-Jung
    • Journal of Korean Medicine Rehabilitation
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    • v.30 no.3
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    • pp.103-116
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    • 2020
  • Objectives This study was designed to review the effect of herbal medicine on animal model with rheumatoid arthritis. Methods We reviewed studies published both in Korea and overseas, all published after 2008. We investigated 8 databases, 6 Korean databases and 2 of abroad. Searching was conducted through flowchart and 24 studies met our guideline. Datas were extrated and organized as animal model characteristics, experimental period, study design, herbal medicine used as intervention and rheumatoid arthritis indicator. Results 336 articles were primarily selected. After screening, 24 articles were left in the end. All 24 studies showed that the herbal medicine used in the animal experiment was effective on treating rheumatoid arthris, proven by macroscopic, histological, hematological and osteological indicators. Conclusions The result showed that herbal medicine is effective in treating rheumatoid arthritis through various pathways. However, study design and intervention were all different from each other and we could not specify the certain compound, material or substance of efficacy. Further study should be conducted to figure out the effectiveness of herbal medicine on rheumatoid arthritis.

A Research on the Status of Greenhouse Gas Emission Factors from Livestock Sector to Create a National Greenhouse Gas Inventories (국가 온실가스 인벤토리 축산부문 작성을 위한 온실가스 배출계수 개발 현황에 관한 연구)

  • Lee, Jin Eui;Lee, Hyun Ju;Park, Kyu Hyun;Choi, Byong Yang;Ra, Chang Six
    • Journal of Animal Environmental Science
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    • v.17 no.sup
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    • pp.21-34
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    • 2011
  • In this study, researches on the development of country specific greenhouse gas measurement and sampling methods from the livestock sector were reviewed. Research on greenhouse gas emission factors was started in early 2000 but was not actively involved in the development of livestock sector based emission factor: since 2009, works are underway for the development of livestock sector based emission factor. Most of the research on greenhouse gas emission in the field of animal studies were done by National Institute of Animal Science, because of the uniqueness of the research laboratories. Methods of emission measurement are still not internationally certified and therefore, measurement and sampling methods for Korea livestock sector are being studied, consulting the worldwide research trends. Flux chamber method are commonly using in Korea for green house gas emission factors measurement. In recent years, continuous measurement of the microclimate was introduced to measure greenhouse gases from livestock manure storage facilities and the micrometeorology method should be adapted as recommended by Intergovernmental Penal on Climate Change (IPCC) Guideline.