• Title/Summary/Keyword: biological safety

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Micronucleus Test for the Classification of Chemical Mutagenicity according to Globally Harmonized System

  • Rim, Kyung-Taek;Kim, Hyeon-Yeong;Chung, Yong-Hyun
    • Journal of Applied Biological Chemistry
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    • v.56 no.4
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    • pp.191-197
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    • 2013
  • To classify the chemical hazard according to globally harmonized system of classification and labeling of chemicals (GHS), we investigated the genotoxicity of three chemicals, methyl myristate, 2-ethylhexanoic acid zinc salt, N,N,N',N'-tetrakis(2-hydroxyethyl) ethylenediamine, using male ICR mice bone marrow cells for the screening of micronucleus induction. Although these three chemicals have already been tested numerous times, a micronucleus test has not been conducted. The seven week-old male ICR mice were tested at three dosages for the three chemicals, respectively. After 24 h of oral administration with the three chemicals, the mice were sacrificed and their bone marrow cells were prepared for smearing slides. As a result of counting the micronucleated polychromatic erythrocyte (MNPCE) of 2,000 polychromatic erythrocytes, all treated groups expressed no statistically significant increase of MNPCE compared to the negative control group. There were no clinical signs related with the oral exposure of these three chemicals. It was concluded that these three chemicals did not induce micronucleus in the bone marrow cells of ICR mice, and there was no direct proportion with dosage. These results indicate that the three chemicals have no mutagenic potential under each test condition, and it is not classified these chemicals as mutagens by GHS.

Analysis on Urinary N-methylformamide of Korean Workers according to Industrial Classification and Countermeasures for Exposure Control of N,N-dimethylformamide (우리나라 근로자들의 업종별 뇨중 N-methylformamide 분석 및 N,N-dimethylformamide 노출관리 대책)

  • Kim, Dohyung;Byun, Kiwhan;Park, Jae-Oh;Lee, Mi-Young;Kim, Eun-A
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.24 no.3
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    • pp.345-352
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    • 2014
  • Objectives: This study is aimed to describe the current situation about urinary biomarker N-methylformamide(NMF) for workers exposed to N,N-dimethylformamide(DMF) according to industrial classification. Materials: Special health examination records of the workers who had undergone urinary biological monitoring in 2013 were collected. The numbers and percentage of workers, whose urinary NMF values were above the limit of detection(LOD) and above the biological exposure index(BEI) were calculated. Health relatedness with DMF as judged by their doctors was also described. All description was classified according to the $9^{th}$ Korean Standard Industrial Classification(KSIC). Results: It appeared that most workers exposed to DMF belong to manufacturing section(80.7%). The geometric mean(GM) values of urinary NMF were 6.25 mg/L, 3.54, and 3.86 for the manufacturing section, professional, scientific and technical activities section, and for the construction section respectively. In detail, it seemed that division of textiles(except apparel) (GM 7.51 mg/L), division of leather, luggage and footwear(11.59 mg/L), and division of rubber and plastic products(6.89 mg/L) were highly exposed to DMF with a high percentage of workers with urinary NMF values above BEI. This was probably due to the effect of skin absorption that the division of leather, luggage and footwear showed the highest urine NMF GM. Conclusions: It seemed that workers in manufacture industries such as textile, leather, luggage, footwear, rubber and plastic products were highly exposed to DMF. So, efforts should be focused on those industries in order to effectively diminish worker's exposure. Further studies to compare DMF air-monitoring with bio-monitoring according to industrial classification should be considered.

Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products (생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증)

  • Kim, Byung-Chul;Kim, Do-Keun;Hong, Sung-Hwa;Kim, Yeon-Hee;Lim, Jong-Mi;Won, Yun-Jung;Kim, Seok-Hwan;Hong, Ji-Young;Yun, Young-Min;Kim, Jae-Ok
    • YAKHAK HOEJI
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    • v.55 no.4
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    • pp.284-288
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    • 2011
  • The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.

An Introduction of Management and Policy of Biological Resources (생물자원의 관리와 정책)

  • Cho, Soon-Ro;Seol, Sung-Soo;Park, Jung-Min
    • Journal of Korea Technology Innovation Society
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    • v.11 no.2
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    • pp.219-240
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    • 2008
  • This paper aims to suggest a policy for biological resource based on a comprehensive understanding on biological resources. Biological resources are different from traditionally recognized viable organisms (Biodiversity) in ecosystems. Biological resources are culturable and replicable resources of living organisms such as tissues, cells and genes. Moreover, biological resources include human-derived biological materials. Biological resources is not simply a matter of science and technology. Biological resources should be dealt with as national resources. There are many international issues regarding biological resources, such as intellectual property rights (IPRs), safety on handling and distribution, material transfer agreements (MTAs) for mutual benefits and biological standards. Ethical debates are also being raised because biological resources are related with human-derived biological materials. Every nation has tendency to adopt its government policies to strengthen its sovereignty on biological resources and international cooperation. In addition, international linkages are essential for providing enhanced worldwide accessibility to biological resources. Japan has shown several international initiatives in the field of biological resources. Korea has just begun to design appropriate policies for the use and R&D of biological resources. Therefore, this paper suggests the following needs: 1) policy at the national level beyond the interests of researchers, 2) inter-ministerial coordination across government ministries, 3) expansion of scope and size of each BRC (Biological Resource Centers), and 4) building networks and systems such as national information center, representative centers by field, and each BRC.

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Assessment of correlation between markers of ambient monitoring and biological monitoring of dimethylformamide for workers in synthetic leather manufacturing factories in Korea (국내 합성피혁제조업 근로자에 대한 디메틸포름아미드의 공기중 농도와 생물학적 노출지표간의 상관성 평가)

  • Hwang, Yang In;Lee, Mi-Young;Chung, Yun Kyung;Kim, Eun A
    • Analytical Science and Technology
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    • v.26 no.5
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    • pp.315-325
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    • 2013
  • The possibility of acute hepatotoxicity caused by dimethylformamide (DMF) requires regular monitoring of the workers who are using DMF to prevent the occupational disease. The authors performed ambient and biological monitoring of workers involved in synthetic leather manufacturing processes using DMF to assess the correlation between the markers of ambient and biological monitoring of DMF. The authors monitored 142 workers occupationally exposed to DMF from 19 workshops in the synthetic leather and ink manufacturing industries located in northern region of Gyeonggi-do. The subjects answered questionnaire on work procedure and use of personal protective equipment to be classified by exposure type. DMF in air samples collected using personal air samplers, diffusive and active sampler, was analysed using gas chromatograph-flame ionization detector (GC-FID) with DB-FFAP column (length 30 m, i.d. 0.25 mm, film thickness 0.25 ${\mu}m$). Urinary N-methylformamide (NMF) was analysed using gas chromatograph-mass selective detector (GC-MSD) at selected ion monitoring (SIM) mode with DB-624 column (length 60 m, i.d. 0.25 mm, film thickness 1.40 ${\mu}m$). Geometric mean (GM) and geometric standard deviation (GSD) of the ambient DMF was $6.85{\pm}3.43$ ppm, and GM and GSD of urinary NMF was $42.3{\pm}2.7$ mg/L. The ratio of subjects with DMF level over 10 ppm was 44%, and those with urinary NMF over 15 mg/L was 87%. NMF in urine adjusted by DMF in air was $4.61{\pm}2.57$ mg/L/ppm and $9.50{\pm}2.41$ mg/L/ppm, respectively, with or without respirator. There was seasonal differences of NMF in urine adjusted by DMF in air, $7.63{\pm}2.74$ mg/L/ppm in summer and $4.53{\pm}2.29$ mg/L/ppm in winter. The urinary NMF concentration which corresponds to 10 ppm of ambient DMF was 52.7 mg/L (r=0.650, n=128). Considering the difference of the route of exposure which resulted from the compliance of wearing personal protective equipment, the estimated contribution of respiratory and dermal exposure route for DMF was 48.5% vs. 51.5%.

A pilot study on increased blood lead concentration of some foreign workers in lead refining industry (일부 납 제련업 종사 외국인 근로자의 납 노출 실태)

  • Yang, Jeong Sun;Kim, Tae Kyun;Park, In-Jeong;Kim, Min Gi;Lee, Sun Wung;Heo, Kyung-Hwa;Kang, Seong-Kyu
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.18 no.3
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    • pp.248-251
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    • 2008
  • During survey of blood lead concentration of workers who worked in lead refining industry, we found that some foreign workers showed increased blood lead level compared with that of domestic workers. The mean concentration of lead in blood for foreign workers (15%, 13 workers, mean age: 29) was 55.8 ug/dL which was over biological exposure index, while that of Korean workers (85%, 76 workers, mean age: 42) was 28.9 ug/dL. Some other biological markers of lead exposure such as ZPP and ${\delta}-ALA$ also showed elevated levels. Most of foreign workers stayed in dormitories near or in the factories that may cause to let them under the condition of 24 hours exposure of lead. The lack of safety manual on proper prevention of lead exposure in their own language for effective communication may be one of reasons of elevated blood lead concentration of foreign workers.

Applicability of Serum Krebs von den lungen-6 as a Biological Exposure Index for Workers Exposed to Indium (인듐 노출 근로자를 위한 생물학적 노출지표로써 혈청 Krebs von den lungen-6의 활용가능성)

  • Won, Yong Lim;Yi, Gwang Yong;Lee, Mi-Young;Kim, Eun-A
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.23 no.2
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    • pp.108-113
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    • 2013
  • Objectives: Although several cases of lung diseases caused by indium have been reported in Japan, the United States and China, South Korea, which is estimated to have been the world's largest consumer of indium, has not yet established a criteria for the diagnosis of lung diseases caused by indium exposure. In this study, we tried to determine the applicability of the Krebs von den lungen-6, which has been widely recognized for its use with interstitial lung disease in Japan, as a biological exposure index for indium. Methods: Methods: The analysis of indium in serum was conducted by inductively coupled plasma mass spectrometry and the analysis of KL-6 in serum was carried out using enzyme-linked immunosorbent assay kit. Results: The indium levels in serum were distributed from below the detection limit to a peak of $125.78{\mu}g/L$, and the values of the KL-6 were distributed from 104.5 U/mL to 2162.2 U/mL. The serum indium and KL-6 showed good correlation ($R^2$=0.389,pfortrend=0.000) and smoking did not affect the KL-6. Conclusions: The usefulness of KL-6 as a specific biomarker for interstitial lung disease has been recognized. In addition, it is expected that effective prevention of health problems can be achieved by determining the lung-damage progress at an early stage according to individual susceptibility.

In vivo micronucleus test of 4-butylaniline and N-butylaniline to classify a chemical's mutagenicity according to the globally harmonized system of classification and labelling of chemicals (GHS)

  • Kim, Soo-Jin;Shin, Seo-ho;Kim, Hyun-ock;Rim, Kyung-Taek
    • Journal of Applied Biological Chemistry
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    • v.62 no.4
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    • pp.355-359
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    • 2019
  • In vivo micronucleus tests were performed to investigate the mutagenic potential of 4-butylaniline and N-butylaniline, which are used in dye intermediates and organic intermediates respectively. Groups of 5 male ICR mice were treated with vehicle or 4-butylaniline for 2 consecutive days by oral gavage at concentrations of 0 (control), 64, 160, 400, and 1000 mg/kg. Statistically significant and dose-dependent increases were found for micronuclei frequencies in male mice (p <0.05). These results suggest that 4-butylaniline can induce genetic effects in the micronuclei of male mouse bone marrow cells. Based on the positive results obtained in cytogenetic analyses of somatic cells in vivo, Globally Harmonized System of Classification and Labelling of Chemicals Category 2 was assigned. N-butylaniline was administered for 2 consecutive days by oral gavage to male ICR mice at dose of 0 (control), 64, 160, 400, and 800 mg/kg. N-butylaniline tested negative for micronuclei induction in mice, although N-butylaniline was associated with micronucleus induction at the highest dose. Based on the negative results obtained for cytogenetic analyses of somatic cells in vivo, "Not Classified" was assigned.