106年化學物質登錄之毒理及生態毒理資訊項目測試方法評估分析計畫
| 中文摘要 | 化學物質登錄可為我國建立｢源頭登記管理機制｣，依「毒性化學物質管理法」規定，凡在國內製造、輸入之化學物質均須依「新化學物質及既有化學物質資料登錄辦法」進行化學登錄。業者進行化學物品標準登錄時必須繳交包含毒理與生態毒理的測試資料。由於我國化學物質登錄起步不久，制度仍有修正與改善的空間，因此，為分析、評估及建議毒理及生態毒理資訊項目之測試方法、盤查我國化學物質登錄之毒理及生態毒理測試方法結果之審查能量及提出發展建議，以及加強與國際間有關毒理及生態毒理測試方法之執行及其結果審查等學術及實務經驗交流。 本計畫已完成彙整97項國際間可接受之OECD測試規範清單，另建議「化學物質登錄工具說明」加入我國環檢所公告之11項檢測方法。測試規範之執行能量的部分，以TAF GLP實驗室認證項目為基準，調查結果顯示國內TAF GLP實驗室的毒理資訊項目執行能量足夠，然而在生態毒理資訊項目卻較為不足。而我國學術機構之實驗室雖有能力執行但卻不具有GLP認證，因此建議在生態毒理執項目納入我國行政院環境保護署環境檢驗所指定公告的實驗室，以提升生態毒理的執行能量。關於審查能量的調查，目前有41位國內專家學者願意協助毒理、生態毒理與QSAR等資料審查。本計畫並研擬了「國際替代方法審查規範要點」、「國際測試方法及其替代方法結果審查及審查專家之標準要點」、以及完成五項替代方法審查規範建議報告，可作為我國化學物質登錄審查之參考。另一方面，我們進行了「皮膚過敏性」與「皮膚刺激性」的替代方法之初步驗證實驗，結果顯示這些體外試驗與QSAR分析具有良好效用，值得將來進行完整驗證、並建議未來開放於國內使用。 本計畫人員至美國參加「2017年第10屆生命科學領域替代方法與動物使用」研討會，藉由收集國際資訊掌握替代測試方法在研究或法規接受性的發展現況與未來趨勢；同時我們也與國外替代方法研究專家進行經驗交流與輔導課程諮詢，並為國內執行測試與審查人員設計「毒理與生態毒理學之實用替代測試方法」工作坊議程。最後，我們集結專家學者分別舉辦了國內毒理與生態毒理之專家會議。專家學者們審閱本計畫執行內容，並對我國化學物質登錄之現況，針對了法規版本更新、替代方法的使用、推廣訓練課程、建立產官學溝通平台等，提出了許多發展建議。以期解決國內化學物質登錄作業衍生的問題，使台灣化學管理體系與產業發展皆能與國際趨勢接軌。 | ||
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| 中文關鍵字 | 化學登錄;毒理與生態毒理測試方法;替代方法 | ||
基本資訊
| 專案計畫編號 | TCSB-106-EM01-02-A009 | 經費年度 | 106 | 計畫經費 | 3400 千元 |
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| 專案開始日期 | 2017/05/26 | 專案結束日期 | 2017/12/31 | 專案主持人 | 國家環境醫學研究所 林嬪嬪副所長 |
| 主辦單位 | 化學局 | 承辦人 | 孫藝河 | 執行單位 | 國家衛生研究院 |
成果下載
| 類型 | 檔名 | 檔案大小 | 說明 |
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| 期末報告 | 106年化學物質登錄之毒理及生態毒理資訊項目測試方法評估分析計畫期末報告 定稿本 20171226 final.pdf | 14MB |
Assessment and Analysis of Toxicological and Ecotoxicological Information Test Method in Chemical Substance Registration, 2017
| 英文摘要 | Chemical substances registration establishes a mechanism of source control and management for Taiwan. Under the “Toxic Chemical Substances Control Act” (TCSCA), enterprises manufacturing or importing new chemical substances or a given quantity of existing chemical substances shall register those substances in accordance with "Registration of New and Existing Chemical Substances". Undergoing standard registration, the enterprises must submitted papers including the information of toxicity and ecotoxicity to the government. Due to the fact that this registration system has just implemented for more than two years yet, there is still much room for improvements. There are three main objectives in this project. First, updates of internationally-recognized test methods; Second, the execution and review capacities for testing results in Taiwan; Third, enhancement on international exchanges of academic research and practical experience. At the beginning of this project, ninety-seven internationally-recognized OECD test guidelines (TGs) has been reorganized into an inventory of test and alternative methods. In addition, eleven test methods announced by Environmental Analysis Laboratory (EAL) of EPA are also recommended to be added. Our suvey showed that execution capacity of these TAF GLP-accredited laboratories for ecotoxicity test is much inefficient than those for toxicity test. Though some laboratories in domestic academic organizations could also handle the ecotoxicity tests, they have neither TAF GLP accreditation nor consider to gain it. For increasing the execution capacity in ecotoxicity test, the EAL-announced laboratories are suggested to be incorporated. In the respect of result review, there are thirdty-nine experts in Taiwan could assist data review of toxicity testing, ecotoxicity testing, and QSAR analysis for chemical substances registering cases. As review references to alternative test methods for toxicity and ecotoxicity of chemical substances registration, we have further prepared guidelines and requirements for experts to review alternative test methods in this project. On the other hand, we have practically run preliminary validation process of alternative methods, including in vitro assay and QSAR analysis, for “skin irritation” and “skin sensitisation”. The results showed that these alternative test methods could be worthy for further validation researches and suitable to used in Taiwan. Our team members attended “The 10th World Congress on Alternatives and Animals in the Life Sciences” in U.S. for collecting informations about development and trends of alternative test methods either in academic research or regulatory acceptance. During the congress, we also met some international experts of alternative researches for practical experience exchanges and training course consultations. Then we have designed an agenda of “Workshop of Practical Alternative Test Methods for Toxicology and EcoToxicology” for domestic laboratorian and reviewers in chemical substances registrations. At last, we had held two domestic expert meetings of toxicology and ecotoxicology for chemical substances registration respectively. The experts reviewed our works, and further offered their recommendations for current situation and future development, such as regulatory update, use of alternative methods, promotion of training courses and workshops, and establishment of a communication platform between enterprises, regulatory agencies and academia. Expecting to address the related issue of chemical substances registration, so that Taiwan's chemical regulatory system and industrial development could converge with international trends. | ||
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| 英文關鍵字 | Chemical Substances Registration;Toxicity and Ecotoxicity Test Guidelines;Alternative Test Methods | ||