環保專案成果報告查詢系統

專案計畫編號	110A011
經費年度	110
計畫經費	6,583 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	2021/02/04
專案結束日期	2021/11/30
專案主持人	黃怡鳳
主辦單位	化學局
承辦人	張容蓉
執行單位	育成環保有限公司
專案分類	化學物質管理
中文關鍵字	毒理及生態毒理資訊、替代測試方法、預測毒理學
英文關鍵字	Toxicological and Ecotoxicological Information, Alternative Test Methods , Predictive Toxicology
協同主持人
共同主持人
計畫聯絡人	黃怡鳳
計畫聯絡電話	02-23142000#200
計畫聯絡信箱	yifeng.huang9@eri.com.tw

中文摘要	本計畫執行日期為110年2月4日至110年11月30日止，工作範圍包括協助化學物質登錄毒理及生態毒理資料審查作業、提供毒理與生態毒理相關輔導與諮詢服務以及建置定量結構活性關係推估及交叉參照應用之支援文件等，工作項目說明情形如下：（一）協助化學物質登錄毒理及生態毒理資料審查作業審查技術支援業務統計截至本年度11月中旬，新化學物質標準登錄審查通過並核發登錄碼者總計為25件；既有化學物質標準登錄審查通過並核發完成碼者總計為180件，包含了72種化學物質。既有化學物質今年度提交之案件數相較於去年增加了6倍，而審查完畢的案件數比去年增加了16倍，顯示今年審查流程優化與修訂審查標準對提升效率有顯著的幫助。（二）提供毒理與生態毒理相關輔導與諮詢服務既有化學物質標準登錄之輔導諮詢課程，與「登錄資訊系統及業務推動計畫」共同推動輔導，統計至11月中旬，包含物質專班及共通項目設計之共同大班制課程，及與公協會合作辦理輔導課程等方式進行，總計共辦理34堂輔導課程，總共參與業者419家次，出席人數547人，已交件者有301件，其中共同登錄申請案件為33件，涉及10種物質。此301件扣除代理人申請與共同登錄案，共有162件由登錄人進行個別登錄，其中參與輔導之案件有123件，有76%業者在輔導後8個月內提交案件，顯示今年之開班輔導與後續追蹤輔導對促進案件登錄有顯著的效益。（三）建置定量結構活性關係推估及交叉參照應用之支援文件本計畫選定經濟合作暨發展組織發布的定量結構活性關係工具箱(OECD QSAR Toolbox)為主要研析的工具，建立1份執行推估工具的使用者手冊初稿，並參考國際間物質分群與推估相關指引內容，整理出推估結果合理性的判斷標準的相關文件初稿，包括1份化學物質分群原則、1份定量結構活性關係模型驗證方法概述及1份交叉參照評估架構，以作為個案輔導與審查之輔助文件。並於9月30日辦理1場次定量結構活性關係推估與交叉參照的專家諮詢線上會議。
中文關鍵字	毒理及生態毒理資訊、替代測試方法、預測毒理學

中文摘要

本計畫執行日期為110年2月4日至110年11月30日止，工作範圍包括協助化學物質登錄毒理及生態毒理資料審查作業、提供毒理與生態毒理相關輔導與諮詢服務以及建置定量結構活性關係推估及交叉參照應用之支援文件等，工作項目說明情形如下：（一）協助化學物質登錄毒理及生態毒理資料審查作業審查技術支援業務統計截至本年度11月中旬，新化學物質標準登錄審查通過並核發登錄碼者總計為25件；既有化學物質標準登錄審查通過並核發完成碼者總計為180件，包含了72種化學物質。既有化學物質今年度提交之案件數相較於去年增加了6倍，而審查完畢的案件數比去年增加了16倍，顯示今年審查流程優化與修訂審查標準對提升效率有顯著的幫助。（二）提供毒理與生態毒理相關輔導與諮詢服務既有化學物質標準登錄之輔導諮詢課程，與「登錄資訊系統及業務推動計畫」共同推動輔導，統計至11月中旬，包含物質專班及共通項目設計之共同大班制課程，及與公協會合作辦理輔導課程等方式進行，總計共辦理34堂輔導課程，總共參與業者419家次，出席人數547人，已交件者有301件，其中共同登錄申請案件為33件，涉及10種物質。此301件扣除代理人申請與共同登錄案，共有162件由登錄人進行個別登錄，其中參與輔導之案件有123件，有76%業者在輔導後8個月內提交案件，顯示今年之開班輔導與後續追蹤輔導對促進案件登錄有顯著的效益。（三）建置定量結構活性關係推估及交叉參照應用之支援文件本計畫選定經濟合作暨發展組織發布的定量結構活性關係工具箱(OECD QSAR Toolbox)為主要研析的工具，建立1份執行推估工具的使用者手冊初稿，並參考國際間物質分群與推估相關指引內容，整理出推估結果合理性的判斷標準的相關文件初稿，包括1份化學物質分群原則、1份定量結構活性關係模型驗證方法概述及1份交叉參照評估架構，以作為個案輔導與審查之輔助文件。並於9月30日辦理1場次定量結構活性關係推估與交叉參照的專家諮詢線上會議。

中文關鍵字

毒理及生態毒理資訊、替代測試方法、預測毒理學

類型	檔名	檔案大小	說明	最新版公開日期
期末報告	110年化學物質登錄資料毒理與生態毒理技術審查計畫-成果報告(無附件-1216).pdf	16MB	毒理審查計畫成果報告(公開版)	2022/1/31 上午 12:00:00

摘要	The project period spans from 4th February to 30th November, 2021. The main tasks are to provide technical support for reviewing toxicological and ecotoxicological information of the chemical substance, to provide toxicology and ecotoxicology related counseling and consulting service (HelpDesk), and to establish guidance documents for quantitative structure activity relationship (QSAR), read-across, etc. The main accomplishments of this project are described accordingly as follows: 1. Technical support for reviewing toxicological and ecotoxicological information of the chemical substance: By the middle of November, a total of 25 standard registration dossiers of the new chemical substance had received registration approval. Regarding the existing chemical substances, 180 standard registration dossiers had been reviewed and received the standard registration completion number. The submitted dossiers of existing chemical substances covered 72 chemical substances. In comparison with number submitted by the middle of November last year, the number of registration dossiers for existing chemical substances increased sixfold, and the cases that completed the standard registration increased sixteenfold. This is an indication of improved efficiency achieved through optimization of review process and modification of standards. 2. Toxicology and ecotoxicology related counseling and consulting service (HelpDesk): The counseling and consulting service of existing chemical substance standard registration was held in various forms, such as providing courses on chemical substance specific demonstration and common registration requirements, as well as involvement of general counseling courses initiated by different associations. There was a total of 419 participation counts, and a total of 547 attendees in 34 courses conducted between February and November. The number of submission dossiers was 301, of which the joint submission was 33 with 10 different chemical substances involved. Among the 301 registrations, a total of 162 cases were individual registrants and 123 of them had taken advantage of the provided consulting service before final submission. Seventy-six percent of the registrants had submitted the dossiers within 8 months of attending the counseling courses, which shows that the counseling and the follow-up services are significant in improving submission rates. 3. Guidance documents for QSAR and read-across: In this project, the OECD QSAR Toolbox was selected as the primary tool for research and analysis, and the draft of the User Manual had been established. By referring to the relevant international information, acceptance criteria for reliability and adequacy of the prediction result were sorted out and the relevant guidance documents were established, including the Guidance on Grouping of Chemicals, the Guidance on the Validation of QSAR Models, and the Guidance of Read-Across Assessment Framework. In addition, a virtual expert consultation for QSAR and read-across had been conducted on September 30th.
英文關鍵字	Toxicological and Ecotoxicological Information, Alternative Test Methods , Predictive Toxicology

摘要

The project period spans from 4th February to 30th November, 2021. The main tasks are to provide technical support for reviewing toxicological and ecotoxicological information of the chemical substance, to provide toxicology and ecotoxicology related counseling and consulting service (HelpDesk), and to establish guidance documents for quantitative structure activity relationship (QSAR), read-across, etc. The main accomplishments of this project are described accordingly as follows: 1. Technical support for reviewing toxicological and ecotoxicological information of the chemical substance: By the middle of November, a total of 25 standard registration dossiers of the new chemical substance had received registration approval. Regarding the existing chemical substances, 180 standard registration dossiers had been reviewed and received the standard registration completion number. The submitted dossiers of existing chemical substances covered 72 chemical substances. In comparison with number submitted by the middle of November last year, the number of registration dossiers for existing chemical substances increased sixfold, and the cases that completed the standard registration increased sixteenfold. This is an indication of improved efficiency achieved through optimization of review process and modification of standards. 2. Toxicology and ecotoxicology related counseling and consulting service (HelpDesk): The counseling and consulting service of existing chemical substance standard registration was held in various forms, such as providing courses on chemical substance specific demonstration and common registration requirements, as well as involvement of general counseling courses initiated by different associations. There was a total of 419 participation counts, and a total of 547 attendees in 34 courses conducted between February and November. The number of submission dossiers was 301, of which the joint submission was 33 with 10 different chemical substances involved. Among the 301 registrations, a total of 162 cases were individual registrants and 123 of them had taken advantage of the provided consulting service before final submission. Seventy-six percent of the registrants had submitted the dossiers within 8 months of attending the counseling courses, which shows that the counseling and the follow-up services are significant in improving submission rates. 3. Guidance documents for QSAR and read-across: In this project, the OECD QSAR Toolbox was selected as the primary tool for research and analysis, and the draft of the User Manual had been established. By referring to the relevant international information, acceptance criteria for reliability and adequacy of the prediction result were sorted out and the relevant guidance documents were established, including the Guidance on Grouping of Chemicals, the Guidance on the Validation of QSAR Models, and the Guidance of Read-Across Assessment Framework. In addition, a virtual expert consultation for QSAR and read-across had been conducted on September 30th.

英文關鍵字

Toxicological and Ecotoxicological Information, Alternative Test Methods , Predictive Toxicology