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系統識別號 U0026-2307201214110700
論文名稱(中文) 氯乙烯暴露工人之生物偵測指標開發研究
論文名稱(英文) The development of Biological monitoring index for vinyl chloride exposure workers
校院名稱 成功大學
系所名稱(中) 環境醫學研究所
系所名稱(英) Institute of Environmental and Occupational Health
學年度 100
學期 2
出版年 101
研究生(中文) 沈穎
研究生(英文) Ying Shen
學號 s76991021
學位類別 碩士
語文別 中文
論文頁數 127頁
口試委員 召集委員-石東生
口試委員-汪禧年
口試委員-陳秀玲
指導教授-李俊璋
中文關鍵字 氯乙烯單體  硫代二乙酸  生物偵測  風險評估 
英文關鍵字 Vinyl chloride monomer  thiodiglycolic acid  biological monitoring  risk assessment 
學科別分類
中文摘要 根據環保署毒性化學物質申報資料庫顯示,台灣氯乙烯單體 (Vinyl Chloride Monomer, VCM)平均年產量將近200萬公噸,由於VCM具肝毒性,已在1987年被IARC (International Agency for Research on Cancer)訂為第一類人類致癌物 (Group 1)。VCM易經由吸入途徑進入人體,並代謝成主要代謝產物TDGA (Thiodiglycolic Acid, TDGA)由尿液排出。過去研究曾使用氣相層析質譜儀 (GC/MS)進行尿中TDGA之分析,但受限於偵測極限偏高 (1 mg/L),無法對低濃度暴露情境進行完整之生物偵測與暴露評估。因此,本研究之目的為開發一套更精準的VCM尿中代謝物分析技術,降低TDGA之偵測極限,以利職業族群之低劑量VCM暴露及健康風險評估研究。研究採用液相層析串聯質譜儀 (Liquid Chromatography-Tandem Mass, LC-MS/MS)進行尿液樣本中TDGA定性與定量分析方法開發,同時彙整毒性化學物質申報數據、固定污染源排放數據、以及工商名錄等資料,依據每年運作量 (≧500 噸)、員工數、及製程內容等篩選條件,挑選三間適當之 VCM 運作工廠,進行現場訪視及會議討論,最後選取配合意願及運作量較高之兩間VCM製造廠為研究對象,採集VCM製造現場作業勞工之尿液樣本,進行分析方法之驗證。另以尿中TDGA濃度推估空氣中VCM暴露濃度,進行勞工健康風險之計算。且尿中TDGA分析條件最佳化測試結果顯示,HPLC移動相為 Acetonitrile與LC級水 (含0.2%甲酸),分離管柱為Atlantis HILIC Silica (2.1 x150mm, 3μm)。檢量線建置範圍5~1000 ng/mL (R2 > 0.995),基質添加回收率70%~130%,空白樣品分析結果皆小於檢量線最低點 (<5 ng/mL),分析方法偵測極限 (method detection limit, MDL)為1.34 ng/mL。本方法開發後共完成2廠40名VCM職業暴露勞工工作前、後共80個尿液樣本之採集。經檢視問卷結果挑選無肝臟病史、無每日服用綜合維它命,且工時正常之員工共27位,分析其工作前、後尿中TDGA濃度中位數(範圍)分別為311.23 g/g-Cre (15.44-1232.66)與 347.22 g/g- Cre (48.41-1914.17),員工個人下班後尿中TDGA濃度顯著高於上班前 (p<0.05, paired t-test)。本研究亦整理文獻所載VCM各暴露途徑代謝比例,以尿中TDGA濃度回推VCM每日暴露劑量及空氣中VCM暴露濃度,以供進行勞工健康風險之推估。由於VCM為確認之人類致癌物質,本研究進一步計算作業勞工VCM暴露可能導致之致癌與非致癌風險,結果發現VCM暴露之非致癌風險(危害指數 (Hazard index, HI))之中位數及範圍為 0.033 (0.0044-0.18) ,個體終生致癌風險於工作時間假設30、35及40年情況下,其致癌風險分別為9.0×10-5 (1.26×10-5-5.06×10-4)、1.09×10-4 (1.47×10-5-5.91×10-4)及1.24×10-4 (1.68×10-5-6.75×10-4),顯示勞工VCM 暴露之非致癌風險皆落於可接受範圍 (HI<1),且大部分勞工之致癌風險應低於可接受風險 (1×10-3)。本研究是第一個建立以尿中TDGA濃度推估空氣中VCM暴露濃度之研究,所建立之公式仍須日後更多實際測值,以進行公式適用性之驗證。
英文摘要 According to the Toxic Chemicals Database of Environmental Protection Administration, the production quantity of Vinyl Chloride Monomer (VCM) in Taiwan was 2 million tons per year. VCM exposure has been associated with toxicity of the liver and was classified as a group 1 carcinogen by IARC (1987). Due to the extremely volatile property, the major exposure route is inhalation. The main urinary metabolites of VCM is thiodiglycolic acid (TDGA). Urinary TDGA could be detected by GS/MS method, but the higher detection limit (>1 mg/L) was the limitation for low exposure workers. In order to assess the relationship of low exposure level of VCM and health risk, the development of a precise and accurate analytical method for measurement of urinary TDGA is needed. The high performance liquid chromatography electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) was used as qualitative and quantitative analytical instrument. Two VCM manufacturing plants were selected based on the recruited criteria with operation amount of VCM (> 500 tons/ year), number of employees, and process conditions. Pre- and post-shift urine samples were collected from each VCM exposed worker and urinary TDGA were analyzed as analytical method field validation. We also used urinary TDGA to calculated VCM exposure dose for health risk assessment. Atlantis HILIC Silica (2.1 x150mm, 3μm) was used to separate TDGA, and 4-nitrobenzoic acid (internal standard, IS). The mobile phases were acetonitrile and LC grade water (containing 0.2% formic acid). The calibration curve was ranged from 5 to 1000 ng/mL (R2 > 0.995), spike recovery was set between 70% and 130%, the method detection limit (MDL) is 1.34 ng/mL, and TDGA concentration of blank sample was lower than twice of MDL. Forty workers in two VCM operating plants were recruited as subject, and 80 urine samples (pre- and post-shift urine sample for each subject) had been collected. The median (range) of the urinary TDGA levels in the post-shift (347.22 g/g- Cre, 48.41-1914.17) were significantly higher than those of pre-shift (311.23 g/g-Cre, 15.44-1232.66) (p<0.05). We also use the metabolic percentage of urinary TDGA of different exposure routes to back-estimate the daily intake (DI Urine) and airborne exposure levels of VCM for each worker. Du to the carcinogenicity of VCM, it is important to assess the noncarcinogenic and carcinogenic risk of VCM exposure workers. The noncarcinogenic hazard index (HI) is 0.033 (0.0044-0.18) and carcinogenic risk were 9.0×10-5 (1.26×10-5-5.06×10-4)、1.09×10-4 (1.47×10-5-5.91×10-4)及1.24×10-4 (1.68×10-5- 6.75×10-4) (for working 30, 35 and 40 year respectively ). The non-carcinogenic risk of VCM exposure is acceptable (HI<1). And, the carcinogenic risk of VCM exposure for some workers were lower than acceptable level (1×10-3). We first set up the calculating model to assess VCM daily exposure dose with urinary TDGA. In the future, this model need to validate using more measured data.
論文目次 摘要 ii
Abstract iv
誌謝 vi
表目錄 xi
圖目錄 xiv
第一章 緒論 1
1.1 研究源起 1
1.2 研究目的 3
第二章 文獻回顧 4
2.1 VCM之物化特性 4
2.2 VCM之使用及製造 4
2.3 VCM之吸收及代謝 5
2.4 VCM之毒理特性 6
2.4.1 動物研究 6
2.4.2 職業族群之暴露評估 8
2.4.3人類流行病學研究 10
2.5 VCM致癌分類及職業暴露管制規範 12
2.6 VCM之生物偵測指標 12
2.6.1 VCM生物指標之代表性及特異性 13
2.6.2 TDGA之物化特性及應用 14
2.7 尿液中VCM代謝物 (TDGA)分析方法 14
第三章 材料與方法 18
3.1 研究架構 18
3.2 分析方法建立與測試 18
3.3 研究對象選取 22
3.4 採樣策略 23
3.4.1 問卷設計與調查 23
3.4.2 尿液樣本採集 23
3.5 VCM日攝取劑量之推估 24
3.6 健康風險評估 25
3.7 統計分析方法 27
第四章 結果與討論 28
4.1 液相層析質譜儀之條件測試 28
4.1.1 質譜條件 28
4.1.2 液相層析分析條件 29
4.2 檢量線建置及查核 35
4.3 尿液中TDGA分析偵測極限建置 36
4.4 TDGA分析方法之比較 36
4.5 VCM現場作業工人採樣分析結果 37
4.5.1 研究對象問卷調查及基本資料 37
4.5.2工作前後尿液樣品中TDGA分析結果 38
4.6 實際尿液樣品中TDGA貯存安定性分析 39
4-7 數據品保品管規範 39
4-8 VCM 暴露勞工健康風險計算 40
4.8.1 VCM日攝取劑量及VCM暴露濃度之推估 40
4.8.2 健康風險評估 40
第五章 結論與建議 42
5.1 結論 42
5.2 建議 43
研究限制 45
參考文獻 46
附件一 人體試驗委員會審核准證明 116
附件二 個人基本資料問卷 117
附件三 個人病史問卷 119
附件四 時間活動模式問卷 120
附件五 稀釋10倍、20倍之測試結果 121
附件六 尿中TDGA分析方法草案 122
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