環保專案成果報告查詢系統

專案計畫編號	109A012
經費年度	109
計畫經費	16,636 千元
預算科目	化學物質評估與管理-化學物質登錄審查
專案開始日期	2020/04/09
專案結束日期	2020/12/20
專案主持人	賴允傑
主辦單位	化學局
承辦人	崔君至
執行單位	瑞昶科技股份有限公司
專案分類	化學物質管理
中文關鍵字	毒理及生態毒理資訊、化學物質風險評估、替代測試方法
英文關鍵字	Toxicological and eco-toxicological information, Risk assessment of chemicals, Alternative test methods
協同主持人	王應然；侯文哲
共同主持人
計畫聯絡人	陳歆妤
計畫聯絡電話	02-77306566#164
計畫聯絡信箱	hsinyu.chen@veolia.com

中文摘要	本年度主要協助辦理化學物質毒理及生態毒理資訊與風險評估之技術審查作業，並完善登錄作業所需之風險評估作業流程、評估技術、工具與參數資料。本年度共完成14件新化學物質及5件既有化學物質標準登錄案件審查作業，輔導179家次業者。對於登錄作業所需之化學物質風險評估作業流程與方法，業已藉由案例試行成果與四場次專家諮詢會議，提出暴露評估工具適用性建議、危害評估及暴露評估撰寫指引草案、及登錄作業工具改善建議等，並完成本土性暴露評估參數之律定，以利後續建置本土化暴露評估工具或執行高層次風險評估作業參考。為完備登錄作業所需之國內毒理及生態毒理資訊量能，已盤點國內實驗室檢測缺口，並藉由實際訪查評估可協助發展測試量能之大專院校實驗室。計畫期間亦蒐集國際認可之替代測試方法，完成定量構效關係工具箱（quantitative structure-activity relationships Toolbox，QSAR Toolbox）、評估專案介面套裝軟體（Estimation Programs Interface Suite，EPI Suite）及斑馬魚胚胎體外模式之驗證，提出替代測試方法適用性建議。針對奈米物質之安全管理，則已蒐集各國管理現況及最新測試評估技術，提出奈米物質登錄與源頭管理策略及資料登錄工具說明修訂建議。另持續蒐集瞭解國際最新風險評估技術，包含高通量篩選評估技術與毒理學優先指數（Toxicological Priority Index, ToxPi）工具試行、歐盟混合物風險評估方法與案例研析、及化學物質分群技術應用於風險評估作業之方式。
中文關鍵字	毒理及生態毒理資訊、化學物質風險評估、替代測試方法

中文摘要

本年度主要協助辦理化學物質毒理及生態毒理資訊與風險評估之技術審查作業，並完善登錄作業所需之風險評估作業流程、評估技術、工具與參數資料。本年度共完成14件新化學物質及5件既有化學物質標準登錄案件審查作業，輔導179家次業者。對於登錄作業所需之化學物質風險評估作業流程與方法，業已藉由案例試行成果與四場次專家諮詢會議，提出暴露評估工具適用性建議、危害評估及暴露評估撰寫指引草案、及登錄作業工具改善建議等，並完成本土性暴露評估參數之律定，以利後續建置本土化暴露評估工具或執行高層次風險評估作業參考。為完備登錄作業所需之國內毒理及生態毒理資訊量能，已盤點國內實驗室檢測缺口，並藉由實際訪查評估可協助發展測試量能之大專院校實驗室。計畫期間亦蒐集國際認可之替代測試方法，完成定量構效關係工具箱（quantitative structure-activity relationships Toolbox，QSAR Toolbox）、評估專案介面套裝軟體（Estimation Programs Interface Suite，EPI Suite）及斑馬魚胚胎體外模式之驗證，提出替代測試方法適用性建議。針對奈米物質之安全管理，則已蒐集各國管理現況及最新測試評估技術，提出奈米物質登錄與源頭管理策略及資料登錄工具說明修訂建議。另持續蒐集瞭解國際最新風險評估技術，包含高通量篩選評估技術與毒理學優先指數（Toxicological Priority Index, ToxPi）工具試行、歐盟混合物風險評估方法與案例研析、及化學物質分群技術應用於風險評估作業之方式。

中文關鍵字

毒理及生態毒理資訊、化學物質風險評估、替代測試方法

類型	檔名	檔案大小	說明	最新版公開日期
期末報告	化學物質毒理及生態資訊與風險評估技術建置計畫.pdf	18MB		2021/2/1 上午 12:00:00

摘要	The purpose of the project was to assist the competent authority in reviewing the toxicological and eco-toxicological information on chemical substances in registration dossier, and to improve the workflow, techniques, tools and parameters needed when risk assessments for chemical substances are required. A total of 14 cases of new chemical substances and 5 cases of existing chemical substances were reviewed and completed the registration, and 179 consultation meetings (helpdesk) were held this year. Based on the output results of the exposure assessment case trials and the conclusions of four expert consultation meetings, the chemical substance risk assessment procedures and methods were formulated. The applicability of exposure assessment tools, draft guidelines for writing hazard and exposure assessment, and suggestion for improving the registration tools were proposed. The domestic parameters needed for exposure assessment were also formulated. In order to complete the domestic toxicology and ecotoxicology information required for registration, we have checked the gaps in domestic laboratory testing, and evaluated university laboratories that can assist in the development of testing capacity through actual visits. We also collected internationally recognized alternative testing methods, completed the validation of the QSAR Toolbox, EPI Suite, and the in vitro model of zebrafish embryos, and proposed the applicability of alternative testing methods. For the safety management of nano-substances, the current status of management in each country and the latest testing and evaluation techniques were collected, and the proposed strategies for registration and source management of nano-substances and the revised description of the registration tool were proposed. In order to enhance the capability of risk assessment, this project continues to collect and understand the latest international risk assessment techniques, including high-throughput screening techniques, Toxpi tool trials, EU mixture risk assessment methods, and chemical substance grouping techniques applied to risk assessment operations.
英文關鍵字	Toxicological and eco-toxicological information, Risk assessment of chemicals, Alternative test methods

摘要

The purpose of the project was to assist the competent authority in reviewing the toxicological and eco-toxicological information on chemical substances in registration dossier, and to improve the workflow, techniques, tools and parameters needed when risk assessments for chemical substances are required. A total of 14 cases of new chemical substances and 5 cases of existing chemical substances were reviewed and completed the registration, and 179 consultation meetings (helpdesk) were held this year. Based on the output results of the exposure assessment case trials and the conclusions of four expert consultation meetings, the chemical substance risk assessment procedures and methods were formulated. The applicability of exposure assessment tools, draft guidelines for writing hazard and exposure assessment, and suggestion for improving the registration tools were proposed. The domestic parameters needed for exposure assessment were also formulated. In order to complete the domestic toxicology and ecotoxicology information required for registration, we have checked the gaps in domestic laboratory testing, and evaluated university laboratories that can assist in the development of testing capacity through actual visits. We also collected internationally recognized alternative testing methods, completed the validation of the QSAR Toolbox, EPI Suite, and the in vitro model of zebrafish embryos, and proposed the applicability of alternative testing methods. For the safety management of nano-substances, the current status of management in each country and the latest testing and evaluation techniques were collected, and the proposed strategies for registration and source management of nano-substances and the revised description of the registration tool were proposed. In order to enhance the capability of risk assessment, this project continues to collect and understand the latest international risk assessment techniques, including high-throughput screening techniques, Toxpi tool trials, EU mixture risk assessment methods, and chemical substance grouping techniques applied to risk assessment operations.

英文關鍵字

Toxicological and eco-toxicological information, Risk assessment of chemicals, Alternative test methods