• Title/Summary/Keyword: 인체위해성 평가

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Distribution and Potential Human Risk Assessment of Trace Metals in Benthic Fish Collected from the Offshore of Busan, Korea (부산 연근해 저서어류 체내의 미량금속 분포 특성과 잠재적 인체 위해성 평가)

  • Choi, Jin Young;Kim, Kyoungrean
    • Journal of Korean Society of Environmental Engineers
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    • v.37 no.6
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    • pp.349-356
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    • 2015
  • Trace metals concentrations in the tissue of edible marine fish (4 species), olive flounder (Paralichthys olivaceus), Korean rockfish (Sebastes schlegelii), file fish (Stephanolepis cirrhifer) and abbysal searobin (Lepidotrigla abyssalis), collected near the Yongho wharf in Busan were determined to assess the potential human health risk (HRA) of trace metals by fish consumption. Levels of Li, Cr, Ni, Cu, Zn, As, Cd, and Pb in the fish tissue were $0.005{\pm}0.009$, $0.77{\pm}0.30$, $0.29{\pm}0.34$, $0.49{\pm}0.14$, $15.96{\pm}2.52$, $10.62{\pm}4.67$, $0.001{\pm}0.002$, and $0.045{\pm}0.06mg/kgdw$ respectively. The estimated daily intakes of Cu and Zn and the estimated weekly intakes of As, Cd, and Pb from the fish collected near the Yongho wharf were 0.0032, 0.054-0.18% of PMTDI (provisional maximum tolerable daily intake) and 13, 0.0041, 0.020% of PTWI (provisional tolerable weekly intake) which were set to evaluate the food safeties by the JFCFA (The Joint FAO/WHO Expert Committee on Food Additives). Lifetime cancer risk and target hazard for local residents due to those fish consumption were found to be negligible.

인체 삽입용 표면처리 임플란트의 인허가 절차

  • Kim, Yeong-Hyeon;Kim, Jun-Gyu;Nam, Hyeon-Sik;Kim, Dong-Rim;Park, So-Jin;Park, Eun-Yeong
    • Proceedings of the Korean Institute of Surface Engineering Conference
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    • 2018.06a
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    • pp.22-22
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    • 2018
  • 의료기기는 사용목적과 사용 시 인체에 미치는 잠재적 위해성의 정도에 따라 4개의 등급으로 분류하며, 두 가지 이상의 등급에 해당되는 제품의 경우에는 가장 높은 등급으로 분류하게 된다. 의료기기 품목허가를 위해서는 기술문서를 작성하여야 하며, 이를 위해서는 기술문서 심사를 신청하는 절차를 이해하여야 한다. 의료기기 기술문서란 의료기기의 성능과 안전성 등 품질에 관한 자료로서 해당 품목의 원자재, 구조, 사용목적, 사용방법, 작용원리, 사용 시 주의사항, 시험규격 등이 포함되는 문서를 말하며, '의료기기 허가 신청서'와 '첨부자료(임상시험자료 포함)'로 구성되어 있다. 의료기기 품목허가 시 제출되는 기술문서를 통하여 해당 의료기기의 안전성 및 성능이 충분히 입증되어야 하며, 인체 삽입되는 표면처리 임플란트를 포함한 인체 접촉 의료기기의 안전성의 경우 '의료기기의 생물학적 안전에 관한 공통 기준규격'에 따라 평가 후 제조 수입품목 허가를 진행해야 한다. 또한 성능의 경우는 해당 규격 또는 자사의 기준 및 시험방법에 따른 성능에 관한 자료, 물리 화학적 특성에 관한 자료를 통하여 평가되어야 하며, 기허가 인증된 제품에 한 번도 사용되지 않은 원재료 또는 적용부위 및 적용방법이 달라 안전성 및 유효성 확인이 필요한 경우 임상시험에 관한 자료가 요구될 수 있다. 본 발표에서는 이러한 인체 삽입용 표면처리 임플란트의 전반적인 인허가 절차에 대해서 안내하고자 한다.

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Effects of Vinyl Chloride to Human Health and Aquatic Ecosystems (염화비닐(Vinyl Chloride)의 인체 및 수생태계 영향 연구)

  • Nam, Sun-Hwa;An, Youn-Joo
    • Korean Journal of Ecology and Environment
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    • v.42 no.3
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    • pp.271-279
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    • 2009
  • Vinyl chloride (VC) is a known human carcinogen, and it is released to multi-environmental media via several exposure routes. VC was potentially evaluated as a water quality pollutant based on human health risk assessment in Korean water environments. In this study, we investigated physicochemical and toxicological properties of VC, human health and ecological risk assessment, and the regulation of VC as a water quality pollutant in developed countries. Currently there are no standard or guideline values of VC in Korean legal system for the protection of human health and aquatic ecosystem, except that it is designated as a specific toxic substance and a water quality pollutant. Human health risk assessment of VC was previously performed based on the limited water quality monitoring data. The monitoring level of VC in Korean water system is more higher than other countries'. VC was assessed as potential hazardous chemical based on the US EPA's cancer risk assessment. There were a few ecotoxicity data of VC available using very limited kinds of aquatic organisms, and the toxicity results obtained seem to be overestimated without considering the losses of VC in open exposure system. Therefore it is needed to monitor the VC in various areas and to carry out the ecotoxicity research using multi-level organisms. We expect that these results can be useful information for implementing VC as a water quality pollutant in legal system for the protection of human health and aquatic ecosystem in near future.

Human Risk Assessment of Toxic Heavy Metals Around Abandoned Metal Mine Sites (금속광산지역 독성 중금속원소들의 인체 위해성 평가)

  • 이진수;전효택
    • Economic and Environmental Geology
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    • v.37 no.1
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    • pp.73-86
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    • 2004
  • In order to estimate the post-ingestion bioavailability of heavy metals and to assess the risk of adverse health effects on human exposure to toxic heavy metals, environmental geochemical surveys were undertaken around the Dogok Au-Ag-Cu and the Hwacheon Au-Ag-Pb-Zn mine sites. Human risk assessment of toxic heavy metals was performed with the results of the SBET(simple bioavailability extraction test) analysis for soil and chemical analytical data for crop plant and water. Arsenic and other heavy metals were highly elevated in tailings from the Dogok(218 As mg/kg, 90.2 Cd mg/kg, 3,053 Cu mg/kg, 9,473 Pb mg/kg, 14,500 Zn mg/kg) and the Hwacheon(72 As mg/kg, 12.4 Cd mg/kg. 578 Pb mg/kg, 1,304 Zn mg/kg) mines. These significant concentrations can impact on soils and waters around the tailing dumps. The quantities of As, Cd and Zn extracted from paddy soils in the Hwacheon mine using the SBET analysis were 55.4%, 20.8% and 26.4% bioavailability, respectively, and for farmland soils in the Dogok mine, 40.8%, 37.6% and 33.0% bioavailability, respectively. From the results of human risk assessment, HI(Hazard Index) value exceeded 1.0 for As in the Hwacheon mine and for Cd in the Dogok mine. Thus, toxic risks for As and Cd exist via exposure(ingestion) of contaminated soil, water and rice grain in these mine sites. The cancer risk for As by the consumption of rice and groundwater in the Hwacheon mine area was 8E-4 and 1E-4, respectively. This risk level exceeds the acceptable risk(1 in 100,000) for regulatory purpose. Therefore, regular ingestion of locally grown rice and ground-water by the local population can pose a potential health threat due to long-term arsenic exposure.

Risk Assessment of Arsenic-Contaminated Groundwater in Multiple Scenarios in a Rural Area of Gyeongnam Province, Korea (경남 농촌 지역 비소 오염 지하수의 시나리오별 위해성 평가)

  • Oh, Serim;Lee, Jin-Yong;Moon, Sang-Ho;Jang, Jiwook;Jeong, Eunju
    • The Journal of Engineering Geology
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    • v.32 no.4
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    • pp.437-448
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    • 2022
  • This work aims to assess the threat to human health of hazardous materials in groundwater that is used domestically and for drinking. Two distinct sub-assessments are considered: cancer and non-cancer risk. The studied groundwater is in an agricultural area of Gyeongnam Province, Korea, and is contaminated by arsenic at a mean level of 16.27 ㎍/L, far greater than the WHO guideline (10 ㎍/L for drinking water). We collected groundwater data from the National Groundwater Information Center (gims.go.kr) and assessed the risk to human health following the methodology of the United States Environmental Protection Agency. We considered three exposure scenarios: domestic use (scenario 1) and drinking use with different doses (scenarios 2 and 3). Scenario 1 had a median hazard quotient (HQ) of 0.77 and a cancer risk (CR) of 0.013. Scenario 2 had a median HQ of 0.08 and a CR of 3.69 × 10-5, and the values for scenario 3 were 0.11 and 4.82 × 10-5, respectively. Scenario 1 is likely the most hazardous to human health. Further study of the origin of arsenic in groundwater in the study area is required, as are remedial measures to mitigate its health effects.

Study on the methods of risk assessment of human exposure by using of PVC flooring (PVC 바닥재 인체 노출에 따른 위해성 평가 연구)

  • Kim, Woo Il;Cho, Yoon A;Kim, Min Sun;Lee, Ji Youmg;Kang, Young Yeul;Shin, Sun Kyoung;Jeong, Seong Kyoung;Yeon, Jin Mo
    • Analytical Science and Technology
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    • v.27 no.5
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    • pp.261-268
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    • 2014
  • In advanced countries, a variety of consumer exposure assessment models including CONSEXPO, are developed to manage risks of consumer products containing hazardous materials. The models are used to assess the risks of exposure to hazardous chemicals in consumer products, which serves as a foundation for regulation standards. In this study, exposure assessment models applicable for various scenarios were reviewed and a proper model was applied for the selected products and risk assessment was conducted at each stage to establish a risk assessment procedure for different types of products. Based on the exposure scenario, exposure factor was selected and according to the algorithm produced based on CONSEXPO exposure model, some level of phthalates were detected from some types of PVC flooring. However, a correlation between phthalate content and migration rate showed r-square 0.0065, little correlation, which is inadequate for estimating standard value. For this reason, it seems valid that the current standard be in place. Additionally, any new standard was not suggested as VOCs were not found harmful to human health, allowing the existing standard to be continuously applied. No migration rate was found for heavy metals and risk assessment was not performed accordingly. In this aspect, it is presumed that hazards to health through dermal exposure would be very little.

A Study on the Field Application through the Improvement of Scoring System for HACCP Evaluation Items of Cattle Farm (소 농장 HACCP 평가항목의 점수부여 체계 개선을 통한 현장 적용 연구)

  • Baek, Seung-Hee;Nam, In-Sik
    • Korean Journal of Organic Agriculture
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    • v.26 no.4
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    • pp.759-774
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    • 2018
  • This study was conducted to establish scores according to the importance levels of each HACCP evaluation item in cattle farm. The importance levels and score of each HACCP evaluation item was derived through the non-compliance rate and severity levels of hazard. In order to change the score criteria according to the importance of each HACCP evaluation item, we analyzed the importance of each HACCP evaluation item by using the portfolio mapping method according to the occurrence frequency and severity levels of hazard. The scores were classified into 3 point, 2 point, and 1 point, respectively, by classifying the importance of each category as 'high', 'middle' and 'lower'. Accordingly, we have established a now scoring system of each HACCP evaluation item through this study. Through the result of this study, the objectivity of the comparative evaluation was verified by implementing the currently used HACCP evaluation item to the cattle farm. In conclusion, Implementation of the result of this study to cattle farm may help to increase the objectivity and also improve more safety and hygienic cattle management and raw milk production.

Risk Assessment of Iron dichloride in OECD High Production Volume Chemicals Program (염화제일철에 대한 인체 및 생태 위해성평가)

  • Bae Hee Kyung;Kim Mi Kyoung;Ahn Kyung Sook;Choi Yeon Ki;Koo Hyun Ju;Kim Hyun Mi;Na Jin Gyun;Choi Kwang Soo;Kim Myung Jin
    • Environmental Analysis Health and Toxicology
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    • v.20 no.4 s.51
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    • pp.375-383
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    • 2005
  • 염화제일철은 2004년 OECD SIDS 프로그램으로 한국에서 위해성평가가 수행된 대량생산 화학물질로 1998년 화학물질 유통량조사에 의하면 우리나라에서 연간 100,000톤이 생산되었다. 본 연구에서는 염화제일철의 인체 및 환경적 영향에 대한 독성잠재성을 평가하기 위하여 OECD테스트가이드라인에 따라 독성시험을 수행하였다. 인체영향을 확인하기 위한 급성경구독성시험과 급성경피독성시험에서 랫드의 반수치사량은 각각 300$\sim$2,000 mg/kg b.w.과 >2,000mg/kg b.w.이었다. 반복독성시험의 무유해용량 (NOAEL)은 수컷 랫드는 125mg/kg b.w./day, 암컷 랫드는 250mg/kg b.w./day였고, 생식 및 발생독성시험에서 무유해용량은 암수 랫드 모두 500mg/kg b.w./day로 관찰되었다. 약한 피부자극성을 보였으며, 안부식성 물질임이 관찰되었다. S. typhimurium과 E. coli 균주를 이용한 복귀돌연변이시험에서 최고 농도인 5,000$\mu$g/plate에서 유전독성을 보이지 않았으며, 마우스를 이용한 생체내 (in vivo)소핵시험에서도 최고 농도인 50mg/kg bw/day에서 소핵유발빈도의 증가를 보이지 않아 본 시험물질은 돌연변이 유발 물질이 아닌 것으로 평가되었다. 어류(Oryzis latipes), 물벼룩 (Daphnia magna), 조류 (Pseudokirchneriella subcapitata)를 이용한 수생생물에 대한 급성독성시험 결과, 96시간 Oryzias latires의 반수치사농도는 46.6 mg/L이었고, 48시간 Daphnia magna의 반수영향농도는 19.0 mg/L이었다. 또한 Pseudokirchneriella subcapitata의 72시간 반수영향농도는 성장률을 이용한 계산법으로 6.9mg/L이었으며, 면적계산법으로는 3.8mg/L의 성장저해가 관찰되었다. 어류와 조류의 경우는 부분적으로 pH의 변화에 따른 영향으로 평가할 수 있는데 어류시험에서 pH중성시험용액에서는 100mg/L이상의 독성값을 나타내었고, 조류에서는 농도 12mg/L이상에서 pH 7아래로 떨어짐을 확인할 수 있었다. 염화제일철은 생산 및 사용공정에서 작업자에게 흡입 혹은 피부로 노출될 가능성이 있으나 밀폐공간에서 사용되므로 노출이 적은 것으로 평가되었다. 3종의 수생생물의 독성결과로부터 염화제일철은 수생환경에서 중간정도의 해가 있으며, 우리나라에서는 직접적인 염화제일철의 소비자 노출은 없으나 환경중 노출이 우려됨에 따라 제19차 OECD대량생산화학물질 초기위해성평가회의에서 환경 분야에 대해서는 추가연구 후보물질로 권고되었고, 인체 분야에서는 인체에 대한 유해성과 사용 패턴을 고려하여 추가연구 우선순위가 낮은 물질로 권고되었다.