• Journal of Society of Preventive Korean Medicine
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• v.17 no.3
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• pp.19-30
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• 2013

This study was aimed to develop a new formula for herbal medicine-safety classification in terms of evidence-based medicine. Recently, human equivalent dose(HED)-based therapeutic index was developed for herbal medicine-safety classification by transforming $LD_{50}$ to HED. However, the use of the $ED_{50}$ and $LD_{50}$ to derive the therapeutic index may be misleading as to safety, depending on the slope of the dose-response curves for therapeutic and lethal effects. To overcome this deficiency, HED-based MOS(Margin of Safety)was developed and suggested in this study. The HED-based MOS developed by using $LD_1$, changing to ALD(approximate lethal dose), and $ED_{99}$. The HED-based MOS seems to be more useful and safer than HED-based therapeutic index since its values for several herbal medicines are basically two times less than the values from HED-based therapeutic index. Thus, HED-based MOS can be a good example of Evidence-based approach for herbal medicine-safety classification.

• Journal of Korean Society on Water Environment
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• v.26 no.1
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• pp.168-176
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• 2010

This study proposes the improvement of the present Total Maximum Daily Load (TMDL) management system of MOE (Ministry of Environment). The margin of safety (MOS) is calculated by a method using standard error and a method using variability and uncertainty. The allocation of pollutant loads are calculated using three methods, equal load reduction method, equal percent removal method and method using equity standards. This study applied the improved TMDL management system to the Anyangcheon watershed. Since MOS varies from 12% to 44% due to the high variability of measured and simulated data, it must not be ignored in the TMDL. The method using equity standards is the most proper in this application since the others produced unrealistic allocations. Area, runoff, water use quantity, population and budget are considered for equity standards. This study shows that this allocation method can be also applicable for the administrative units as well as the sub-watersheds. Finally, Hydrologic Simulation Program-FORTRAN (HSPF) with the allocated pollutant load was used to confirm whether it satisfy the water quality standard or not. This study will be helpful to improve the MOS and allocation system TMDL in the future.

• Journal of Korean Society on Water Environment
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• v.22 no.6
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• pp.977-981
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• 2006

In order to improve water quality in drinking water sources, Ministry of Environment (MOE) was implemented total water pollution load management (TWPLM) in all the major river basins. From the experience of the application of TWPLM, we could find some problems relating the target watershed, standard operating procedure (SOP) of establishment and implementation plan, water quality and flow rate, design flow, water quality model, margin of safety (MOS), and estimation of wasteload were found. The authors were reviewed ongoing TWPLM and presented the improvement schemes for a successful TWPLM. For the application of these suggestions, further detailed studies should be done to implement TWPLM in the future.

• Proceedings of the Korea Water Resources Association Conference
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• 2017.05a
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• pp.359-359
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• 2017

하천관리청은 유량변동이 큰 환경에서도 평상시 하천의 기능을 유지하고 안정적인 용수공급이 이루어지도록 하천수 허가관리를 수행하고 있다. 이때, 하천수 사용허가 검토시 기준으로 사용되는 유량은 자연상태의 기준갈수량에서 하천유지유량을 감안하여 적용하고 있는데, 이는 하천유량의 변동에도 최대 용수수요를 만족할 수 있게끔 관리하기 위한 것으로 최대 사용량일 때의 물의 과부족을 계산하여 허가 여부를 결정한다. 본 연구에서는 Park et al.(2016)이 제안한 시기별(홍수기/이수기, 비관개기/관개기 고려) 하천수 사용허가 기준유량 설정방법을 기반으로, 수질오염총량제(Total Maximum Daily Loads, TMDLs)에서 적용하는 안전율(Margin of Safety, MOS)의 개념을 접목하여 허가기준유량의 불확실성을 정량적으로 고려할 수 있는 방법을 제시하였다. 허가기준 유량은 수문모델에 의해 자연상태의 모의유량을 유황분석하여 도출하게 되므로 유량의 연도별 변도성(Margin of Variability, MOV)과 예측모델 매개변수의 불확실성(Margin of Uncertainty, MOU)을 고려하는 Walker Jr.(2003)의 안전율 산정방법을 적용하였다. 본 연구에서는 금호강 유역을 대상으로 시기별 자연유량 산정시 고려한 SWAT 모형결과를 기반으로 하였으며, 모의자료의 변이계수를 산정하여 시간적 변동성에 의한 불확실성을 도출하고 SWAT-CUP모형을 활용하여 모형의 불확실성을 도출하여 안전율을 계산하였다. 단, 기준갈수량이 허가기준유량으로 사용되는 기간(1월 1일~3월 31일)에는 안전율까지 고려할 경우 지나치게 보수적이라고 판단되어 적용에서 제외하였다. 본 연구에서 제안된 불확실성을 고려한 하천수 관리방법론은 시기별 하천수 허가기준유량 설정에 대한 의사결정자들의 판단을 지원하는데 기여함으로써 정책적 활용도를 높일 뿐만아니라 탄력적인 하천유량관리를 위한 기초연구로 활용될 수 있을 것이며, 타 분야 기술과의 융합이라는 점에서도 의의를 가질 수 있을 것으로 생각된다.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.2
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• pp.123-133
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• 2015

The new formular for herbal medicine-safety classification in terms of evidence-based medicine was developed and applied to evaluate various herbal medicines in the previous study. This study is aimed to evaluate the frequently-used herbal medicines inducing toxic metabolites or reactive intermediates(RI), such as Ligusticum wallichii Franch, Angelica sinensis, Glycyrrhizae Radix, Rehmanniae Radix, based on 6 safety grades calculated from human equivalent dose(HED)-based MOS(margin of safety). HED-based MOS can be explained as the ratio of theoretical ALD(approximate lethal dose) of human as $LD_1$(lethal dose of 1%)/ clinical maximum dose as $ED_{99}$(Effective dose of 99%). The herbal medicine showing the ratio less than 1 belongs to Class 1, but the herbal medicine showing the ratio more than 500 belongs to Class 6 with the lowest toxicity. As a result, they were evaluated as class 2 for Angelica sinensis and Glycyrrhizae Radix, class 3 for Ligusticum wallichii Franch and Rehmanniae Radix. These resultant grades for 4 herbal medicines were lower than the grade expected under consideration that these herbal medicines are used very frequently in oriental clinics. These low grades would be due to their ingredients which is biotransformed to toxic metabolites.

• Journal of Korean Society on Water Environment
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• v.30 no.3
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• pp.351-360
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• 2014

The allocation of margin of safety (MOS) at a uniform rate to all areas of the unit watershed makes it very difficult to keep the load allotment stable in the area for lack of reduction measures like forest land. This study developed an equation to calculate margin of safety differentially according to the regional characteristics. The equation was formulated on the basis of the regional characteristic factors such as a load contribution factor for land use type and a site conversion factor for the unit watershed. The load contribution factor represents a contribution of loads from a particular land use. The site conversion factor was derived from the site conversion ratio of a unit watershed. Margin of safety for the non-point pollution load in the land use sector decreased by 20~25% in three river basins. The margin of safety in the unit watersheds with low site occupation ratios decreased in high rate, while in the unit watersheds with large urban area decreased in low rate. With the application of the differential margin of safety considering regional characteristics, not only the reduction of pollution loads can become lighter but also it can be easier to develop plans for Total Maximum Daily Loads (TMDLs) even where the reduction measures are not available.

• The Korea Journal of Herbology
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• v.33 no.4
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• pp.53-58
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• 2018

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications. Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 mg/kg to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety). Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 mg/kg and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• Toxicological Research
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• v.21 no.4
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• pp.297-301
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• 2005

Farmers are generally expressed to pesticides through mixing loding, application activity and harvesting of crop after application of pesticides. The present work investigated the exposure and risk of furathiocarb to workers when harvesting of cucumber was carried out in green house after application of furathiocarb EC. Glove was used for the hand exposure assessment, socks for foot and dermal patches for the other parts of body. Personal air monitor equipped with a XAD-2 resin was used for the respiratory exposure assessment. During the harvest of cucumber in green house, the initial rate of potential dermal exposure (Day 1) for methidathion was 1.3 mg/hr. The major exposure parts were hand $(78\~83\%),\;thigh\;(5\~7\%)$ and arms $(6\~9\%)$ during 3 days' harvest. No exposure was detected from the respiratory monitoring. For risk assessment, the potential dermal exposure (PDE), the absorbable quantity of exposure (AQE) and the margin of safety (MOS) and margin of exposure (MOE) were calculated. In risk assessment of harvester exposure for 7days, all MOS was > 1 and MOE was > 100 indicating that possibility of risk was little.

• The Korea Journal of Herbology
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• v.32 no.4
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• pp.33-38
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• 2017

Objectives : Termitomyces albuminosus (Berk.) Heim is one of the famous wild edible mushrooms in the southern part of China. It is known that Termitomyces albuminosus, like Aconitum koreanum used in Korean traditional medicine, contains a kind of cerebroside, termitomycesphin, causing a pharmacologic effect on the neuron system. The pharmacologic effect of Termitomyces albuminosus can be used to possibly replace Aconitum koreanum. However, It needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was conducted to obtain acute information of the toxicity of dried-Termitomyces albuminosus powder and to secure its safety in clinical applications. Methods : In order to calculate approximate lethal dose(ALD), test substance was orally administered to male and female SD-rat at dose levels of 5,000 and 0 (vehicle control) mg/kg (body weight). Based on the result of this toxicity, also the estimation of safety classification was calculated using the HED-based (human equivalent dose) MOS (margin of safety). Results : There were no mortalities, test substances treatment-related clinical signs, no changes in the body or organ weights, and no gross or histopathological findings at 14 days after treatment with test substance. Thus, the approximate lethal dose of dried-Termitomyces albuminosus powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the limit dose, 5000 mg/kg, it was estimated that dried-Termitomyces albuminosus powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• The Korean Journal of Pesticide Science
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• v.16 no.4
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• pp.391-394
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• 2012

Exposure and risk assessment during mixing/loading of chlorpyrifos emulsifiable concentrate (EC, 20%) were carried out. Limit of detection and limit of quantitation were 0.02 and 0.1 ng, respectively. Calibration curve linearity and reproducibility were excellent. Recovery of chlorpyrifos from gloves was 72.3-103.4%. During mixing/loading procedure, average hand exposure amount of chlorpyrifos was 3.9 mg which is corresponding to 0.004% of total active ingredient in the prepared spray mixture. In calculation of MOS (Margin of Safety) for risk assessment, male Korean average body weight and AOEL (Acceptable Operator Exposure Level) were used. Nine events of mixing/loading procedure were assumed per day. And 75 percentile of 30 repetition (4.6 mg) was used as for the worst case. MOS was more than 1 for total repetition, indicating mixing/loading work was of least risk. However, MOS of individual repetition was examined, two cases were less than 1 suggesting careful work habit is essential in mixing/loading procedure.