• 대한예방한의학회지
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• 제20권1호
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• pp.125-144
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• 2016

Objectives : About 13% of the medicines used by traditional korean medicines(TKM), are called animal medicines and are derived from non-herbal sources such as animals and insects. However, the clinical use of these preparations from animal medicines is often based on tradition and belief, rather than on evidence of toxicity and efficacy. As a result, animal medicines containing toxin have caused serious problems from injecting patients with venom. Here, various venoms frequently used as TKM were reviewed in terms of their instinct toxity and tried to estimate their safety classification. Methods : The estimation of safety classification was based on human equivalent dose(HED)-based MOS (margin of safety) and clinical dose applied for patients. Results and Conclusions : Except that of snake venom due to no clinical dose, they were evaluated as class 3 for bee venom, class 4 for cantharidin, toxin from blister beetle, and class 1 for venom from scolopendrid. In conclusion, animal medicines showed a wide range of safety classification from class 1 to class 4. This wide range is estimated to result from extremely limited applications of each venom for patients because of their strong toxicity. However, it should be cautious for application in clinics since animal medicines can produce anaphylactic reactions particularly after veinous administration even with a tiny amount of venom.

• 대한한의학회지
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• 제35권1호
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• pp.114-123
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• 2014

Objectives: Evidence-based medicine(EBM) advocates the use of up-to-date "best" scientific evidence from health care research as the basis for making medical decisions. EBM also has been applied to traditional Korean medicine(TKM), especially in the field of safety. Recently, the standard prescription for TKM by Korea Institute of Oriental Medicine was published based on toxic index from various toxicity tests. However, there are some limitations when the results from the study based on EBM are applied in clinics. To overcome these imitations, the term "evidence-based practical medicine" was developed and defined as clinically applicable results from the study based on EBM. And safety classification for TKM was suggested as an example of evidence-based practical medicine. Methods: For safety classification for TKM, the data for $LD_{50}$(50% lethal dose), which was transformed to theoretical $LD_1$(1% lethal dose), was analyzed as one of tools for EMB study and divided by maximum dose used in clinics. Results and Conclusions: As a result, human equivalent dose(HED)-based MOS(margin of safety) for korean traditional medicine was calculated and used for safety classification with 5 categories. These categories would be helpful for oriental medicine clinicians to decide the increase and decrease of dosage according to various factors such as patient's sensitivity, potential toxicity of herbal medicines, clinician's experience for better cure. Thus, this safety classification provides some evidences enough that evidence-based practical medicine should be not the same with EBM and defined differently from EBM.

• Environmental Analysis Health and Toxicology
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• 제15권1_2호
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• pp.31-37
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• 2000

아세트아닐리드는 그의 생산 및 이용 공장에서 환경으로 방출된 다음 인체에 노출될 수 있다. 아세트아닐리드는 진통효과클 나타내는 것으로 알려져 과도 노출시에는 건강에 부작용을 초래할 수 있다. EUSES시스템에 의하면 아세트아닐리드는 지역노출의 경우 6$\times$$10^4$을 초과하는 높은 MOS 값(안전성 마진)을 보여주어 공중보건상 충분히 안전한 것으로 나타났다 국지수준(작업장)에서 경피노출에 의한 MOS최저 값은 3$\times$$10^{-4}$으로 추정되었지만 작업장에서 개인장비나 환기와 같은 예방조치에 의하여 그 위험을 부분적으로 경감시킬 수 있다. 아세트아닐리드는 분진 흡입하는 작업자에게 위험 가능성이 나타날 수 있다. 작업장에서 건강보호를 위해서는 산업보건 측면에서의 안전함이 증명될 수 있도록 반복투여독성, 생식독성 및 발육독성에 관한 자료가 보완되어야 할 것이며, 따라서 이에 대한 실험이 진행되어야 할 것으로 사료된다.

• 농약과학회지
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• 제16권4호
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• pp.343-349
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• 2012

Indoxacarb 수화제 및 입상수화제 살포액 조제 시 농작업자의 노출량 측정을하여 두 제형 간 노출 양상을 비교하였으며 위해성 평가를 실시하였다. 손 노출량 측정은 면 장갑을 사용하였고 호흡노출량은 personal air monitor를 이용하였으며, 노출량 측정을 위한 다양한 분석/시험방법을 검증하였다. 분석 기기의 검출한계는 0.25 ng, 정량한계는 1 ng로 설정하였고, 표준 검량선의 직선성은 $R^2$이 0.9999 이상이었으며, 분석재현성은 C.V값이 0.7~6.0이었다. 또한 3수준으로 수행한 노출 시료(장갑, 고체 흡착제, 유리섬유필터)에서 indoxacarb의 분석법의 회수율은 81.5-108.8% 이었고, 호흡 노출 실험의 검증 중에서 포집효율 및 파과실험 결과 90.4-112.0%의 회수율을 보였다. Indoxacarb 수화제 및 입상수화제 조제 시 30반복의 손 노출량의 75percentile 값은 수화제는 459.8 mg/kg a.i이며, 입상수화제는 81.4 mg/kg a.i로, 수화제가 입상수화제에 비해 6배 이상 노출이 되었다. 호흡노출량은 조제 약량의 $10^{-8}-10^{-7}%$, 손 노출량의 $10^{-4}-10^{-3}%$이었으며 호흡노출량은 수화제 및 입상수화제 사이의 유의성 있는 차이는 보이지 않았다. Indoxacarb의 위해성평가를 위한 margin of safety (MOS) 계산 시 중요한 노출 인자로서 한국인 남성 평균체중과 농작업자 노출 허용량을 사용하였다. 위해성 평가 결과 두 제형 모두 조제 작업 시 MOS가 1이상으로 위해성이 낮음을 확인하였다.

• Toxicological Research
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• 제35권2호
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• pp.103-117
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• 2019

The mixture of 5-chloro-2-methylisothiazol-3(2H)-one (CMIT) and 2-methylisothiazol-3(2H)-one (MIT), CMIT/MIT, is a preservative in cosmetics. CMIT/MIT is a highly effective preservative; however, it is also a commonly known skin sensitizer. Therefore, in the present study, a risk assessment for safety management of CMIT/MIT was conducted on products containing 0.0015% of CMIT/MIT, which is the maximum MIT level allowed in current products. The no observed adverse effect level (NOAEL) for CMIT/MIT was 2.8 mg/kg bw/day obtained from a two-generation reproductive toxicity test, and the skin sensitization toxicity standard value for CMIT/MIT, or the no expected sensitization induction level (NESIL), was $1.25{\mu}g/cm^2/day$ in humans. According to a calculation of body exposure to cosmetics use, the systemic exposure dosage (SED) was calculated as 0.00423 mg/kg bw/day when leave-on and rinse-off products were considered. Additionally, the consumer exposure level (CEL) amounted to $0.77512{\mu}g/cm^2/day$ for all representative cosmetics and $0.00584{\mu}g/cm^2/day$ for rinse-off products only. As a result, the non-cancer margin of safety (MOS) was calculated as 633, and CMIT/MIT was determined to be safe when all representative cosmetics were evaluated. In addition, the skin sensitization acceptable exposure level (AEL)/CEL was calculated as 0.00538 for all representative cosmetics and 2.14225 for rinse-off products; thus, CMIT/MIT was considered a skin sensitizer when all representative cosmetics were evaluated. Current regulations indicate that CMIT/MIT can only be used at concentrations 0.0015% or less and is prohibited from use in other cosmetics products. According to the results of this risk assessment, the CMIT/MIT regulatory values currently used in cosmetics are evaluated as appropriate.

• 농촌의학ㆍ지역보건
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• 제29권2호
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• pp.249-263
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• 2004

본 연구에서 시험한 두 가지 농약에 대한 피부노출 측정 및 분석방법을 시험하였고 두 가지 농약에 대한 측정 및 분석방법으로써 모두 적정함을 확인하였다. 두 가지 농약에 대하여 호흡노출의 측정 및 분석법에 관한 타당도를 시험한 결과 본 연구방법으로 chlorpyrifos는 만족하였고 chlorothalonil의 경우 피부노출 측정 및 분석법만 타당하였다. 이와 같이 확정한 노출 측정방법으로 배 방제작업과 노지고추 방제작업시 농약노출량을 측정하였고 여러 가지 요인별로 비교하였나 두 가지 농약에 대하여 각 작목, 살포시기, 노출평가(피부,호흡기)와 작업용 변수로하여 노출평가를 실시하였다. 피부노출량은 과수 동력분무기, 노지고추 동력분무기 > 과수 SS기 > 동력분무기 보조의 순서로 나타났다. 과수 동력분무기와 노지고추 동력분무기 살포간 노출량의 차이는 유의하지 않았다. 과수나 노지고추의 방제만을 볼 때 다른 요인보다는 살포기기가 피부노출에 영향을 주는 주된 요인인 것으로 파악된다. 피부노출에서 작목은 주로 노출부위에 영향을 주는 것으로 평가되었다. 보조작업의 경우 손노출이 66%로 가장 높게 나타났다. 호흡기노출량은 각각의 노출이 서로 다르다고 할 수 없었다. 위험도 평가결과 chlorpyrifos 살포작업은 위험한 것으로 나타났으며 노출농도를 약 1/5 이하로 감소시킬 필요가 있는 것으로 밝혀졌다.

• Toxicological Research
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• 제35권2호
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• pp.137-154
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• 2019

Triclosan (TCS) is an antimicrobial compound used in consumer products. The purpose of current study was to examine toxicology and risk assessment of TCS based on available data. Acute toxicities of oral, transdermal and inhalation routes were low, and phototoxicity and neurotoxicity were not observed. Topical treatment of TCS to animal caused mild irritation. TCS did not induce reproductive and developmental toxicity in rodents. In addition, genotoxicity was not considered based on in vitro and in vivo tests of TCS. It is not classified as a carcinogen in international authorities such as International Agency for Research on Cancer (IARC). No-observed-adverse-effect level (NOAEL) was determined 12 mg/kg bw/day for TCS, based on haematoxicity and reduction of absolute and relative spleen weights in a 104-week oral toxicity study in rats. Percutaneous absorption rate was set as 14%, which was human skin absorption study reported by National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (2009). The systemic exposure dosage (SED) of TCS has been derived by two scenarios depending on the cosmetics usage of Koreans. The first scenario is the combined use of representative cosmetics and oral care products. The second scenario is the combined use of rinse-off products of cleansing, deodorants, coloring products, and oral care products. SEDs have been calculated as 0.14337 mg/kg bw/day for the first scenario and 0.04733 mg/kg bw/day for the second scenario. As a result, margin of safety (MOS) for the first and second scenarios was estimated to 84 and 253.5, respectively. Based on these results, exposure of TCS contained in rinse-off products, deodorants, and coloring products would not pose a significant health risk when it is used up to 0.3%.

• Toxicological Research
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• 제35권2호
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• pp.131-136
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• 2019

Ethylhexyl dimethyl para-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl dimethyl PABA is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5-2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that ethylhexyl dimethyl PABA is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that ethylhexyl dimethyl PABA inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of ethylhexyl dimethyl PABA following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of ethylhexyl dimethyl PABA in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% ethylhexyl dimethyl PABA, which is the maximum level allowed by the relevant domestic authorities.

• 농약과학회지
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• 제20권3호
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• pp.271-279
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• 2016

전신복장법(whole body dosimetry, WBD)을 이용한 사과 과수원 농약 살포자의 살포농약 조제 및 살포 과정 중 imidacloprid 수화제 사용에 의한 노출 특성 및 위해성을 평가하기 위하여 농약 살포 전 방제복, 장갑, 마스크, 호흡 노출량 측정 장치를 착용한 후 speed sprayer를 이용하여 acephate+imidacloprid 25(20+5)% 1,000배 희석액을 3,000 L/ha/살포자의 비율로 청주 인근의 10개 사과 과수원에 살포하였다. 노출시험은 조제자와 살포자에 대하여 각각 나누어 수행하였다. 시험농약은 HPLC-DAD를 이용하여 분석하였으며, 부위별 평균 회수율은 81.5-108.6%, 평균 포장회수율은 73.8-86.7%로서 모두 적합하였다. 조제자 및 살포자의 노출량은 imidacloprid 총량 대비 0.0014-0.0279%이었으며, 조제자와 살포자 모두 장갑의 노출량이 가장 높았다. 또한 농약 살포자의 농약 사용에 대한 위해성을 측정하기 위한 안전한계(margin of safety, MOS)는 조제자와 살포자 각각 97-355, 46-196으로서 speed sprayer를 이용한 imidacloprid 살포 시 사과 과수원 농약 살포자에 대한 위해도는 매우 낮았다.

• 한국산림과학회지
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• 제107권2호
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• pp.229-236
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• 2018

도시림, 생활림, 가로수, 도시공원 등 국민들의 일상생활을 하는 구역이나 장소에 위치한 생활권 수목 식재지에서의 농약 살포는 농약 살포자의 농약 노출 문제뿐만 아니라 농약의 살포 후 생활권 수목과 접촉하는 불특정 시민들도 지속적인 농약 노출이 문제가 될 수 있다. 본 연구에서는 생활권 수목의 관리를 위해 관행적으로 가장 많이 살포되는 살충제인 Fenitrothion을 회양목에 살포하고 일정시간별로 손 노출량, 잎 잔류량, 호흡 노출량을 측정한 뒤, 위해성 평가 수식(MOS: margin of safety)을 이용하여 체중별 안전 노출시간을 분석하였다. 그 결과, 살포된 Fenitrothion의 손을 통한 전이량이 급격하게 떨어지고 호흡노출량이 측정되지 않는 48시간 이전까지는 농약노출에 대한 주의가 필요할 것으로 판단되었다.