環保專案成果報告查詢系統

專案計畫編號	TCSB-107-EM01-02-A024
經費年度	107
計畫經費	8,960 千元
預算科目	毒物及化學物質評估與管理-新化學物質登錄審查
專案開始日期	2018/08/13
專案結束日期	2019/12/31
專案主持人	劉宗榮
主辦單位	毒物及化學物質局
承辦人	薛威震
執行單位	社團法人台灣毒物學學會
專案分類	化學物質管理、環境衛生
中文關鍵字	毒理及生態毒理資訊、奈米物質、替代測試方法
英文關鍵字	Toxicological and Ecotoxicological information, Nanomaterials, Alternative Test Methods
協同主持人	王應然
共同主持人	侯文哲
計畫聯絡人	陳煌仁
計畫聯絡電話	02-23123456#88347
計畫聯絡信箱	r02447001@eri.com.tw

中文摘要	本計畫執行日期為107年08月13日至108年12月31日，工作範圍包括協助化學登錄資料毒理及生態毒理資訊審查、檢討研析化學物質登錄資料毒理及生態毒理審查項目及人力、評估化學登錄資料毒理及生態毒理替代測試方法、其他行政支援及臨時交辦事項，工作項目進行說明如下：協助化學登錄資料毒理及生態毒理資訊審查：本計畫協助化學登錄相關資料審查並提出審查報告，截至108年11月30日止，包含提供附以附款、補件及准駁等意見，本計畫已針對38件案件提出審查意見以供主管機關參考，並完成12案諮詢案件。本計畫針對案件數量預估，以供主管機關作成相關審查決定之案例實做數量計價，並於108年11月提交案件數量及人力需求建議報告，提出未來國家審核能量提升建議。檢討研析化學物質登錄資料毒理及生態毒理審查項目及人力：本計畫已於107年度11月舉辦定量結構活性關係諮詢會議、於108年度1月舉辦替代測試的國際發展現況及我國應用方向諮詢會及於108年10月31日完成毒理及生態毒理登錄資料審查原則與方法諮詢會議，藉由專家溝通及討論，蒐集許多關於定量結構活性關係(QSAR)適合使用項目、替代測試未來發展與病理評估及眼睛刺激性分類審查原則之寶貴意見。於108年10月已辦理兩場次（共六小時）相關訓練課程，所安排規模各場次達十五人以上，並提供訓練課程教材（含紙本及電子檔）。課程第一天主要介紹毒理學與環境毒理學基本學識原理，並依據標準登錄中生態毒理須提交資訊進行相關試驗規範說明；第二天則延續毒理學原理，進一步剖析皮膚、眼睛及基因毒性各試驗規範意義及其限制等資訊。為協助主管機關進行對於化學登錄毒理及生態毒理之審查，本計畫已聘任2名具毒理學或生態毒理學相關工作經驗3年以上之審查人員，相關人員均已投入審查工作，積極配合主管機關化學登錄相關作業。為積極配合化學登錄相關作業，毒理、生態毒理、危害及暴露評估資訊項目審查原則與方法須做滾動式評估及修正，根據過往審查經驗，本計畫已提交新化學物質及既有化學物質登錄資料審查原則及管理方案執行初稿建議供化學局參考，以期使審查更符合現行登錄之需求及狀態。由於登錄業者對於危害評估及暴露評估仍需要更清楚之說明，目前已提交化學物質危害評估及暴露評估指引初稿，相關指引涵蓋勞工、消費者及環境三大面向，對相關項目提出登錄工具說明之建議。評估化學登錄資料毒理及生態毒理替代測試方法：依照「取代、減量和精緻化」原則推動非動物試驗方法的發展是目前國內外的趨勢。以電腦模擬和以分子細胞分析為主的生物體外概要分析其預測毒理學方式相比於以動物試驗為主的傳統毒理學可節省大量的時間和資源。而另一方面隨著奈米材料的開發與製造其種類及數量逐漸的增加，發展與調整合適的奈米材料安全評估方法也成為現今的急迫壓力。奈米物質因為其特殊的性質，需有額外辨識資訊以確認其基本特性。本計畫蒐集國際間一般及奈米化學物質之毒理及生態毒理資訊替代測試方法之相關資料，並提供化學登錄資訊審查原則與方法分析報告供化學局參考，並以五氯酚為例討論QSAR應用於毒理及生態毒理資訊的適用性，以期加速相關替代方式發展。其他行政支援及臨時交辦事項：參與2018中華實驗動物學會年會暨學術研討會及2019瑞典臺灣化學品預防管控訓練，並提供毒理及生態毒理相關事項協助。
中文關鍵字	毒理及生態毒理資訊、奈米物質、替代測試方法

中文摘要

本計畫執行日期為107年08月13日至108年12月31日，工作範圍包括協助化學登錄資料毒理及生態毒理資訊審查、檢討研析化學物質登錄資料毒理及生態毒理審查項目及人力、評估化學登錄資料毒理及生態毒理替代測試方法、其他行政支援及臨時交辦事項，工作項目進行說明如下：協助化學登錄資料毒理及生態毒理資訊審查：本計畫協助化學登錄相關資料審查並提出審查報告，截至108年11月30日止，包含提供附以附款、補件及准駁等意見，本計畫已針對38件案件提出審查意見以供主管機關參考，並完成12案諮詢案件。本計畫針對案件數量預估，以供主管機關作成相關審查決定之案例實做數量計價，並於108年11月提交案件數量及人力需求建議報告，提出未來國家審核能量提升建議。檢討研析化學物質登錄資料毒理及生態毒理審查項目及人力：本計畫已於107年度11月舉辦定量結構活性關係諮詢會議、於108年度1月舉辦替代測試的國際發展現況及我國應用方向諮詢會及於108年10月31日完成毒理及生態毒理登錄資料審查原則與方法諮詢會議，藉由專家溝通及討論，蒐集許多關於定量結構活性關係(QSAR)適合使用項目、替代測試未來發展與病理評估及眼睛刺激性分類審查原則之寶貴意見。於108年10月已辦理兩場次（共六小時）相關訓練課程，所安排規模各場次達十五人以上，並提供訓練課程教材（含紙本及電子檔）。課程第一天主要介紹毒理學與環境毒理學基本學識原理，並依據標準登錄中生態毒理須提交資訊進行相關試驗規範說明；第二天則延續毒理學原理，進一步剖析皮膚、眼睛及基因毒性各試驗規範意義及其限制等資訊。為協助主管機關進行對於化學登錄毒理及生態毒理之審查，本計畫已聘任2名具毒理學或生態毒理學相關工作經驗3年以上之審查人員，相關人員均已投入審查工作，積極配合主管機關化學登錄相關作業。為積極配合化學登錄相關作業，毒理、生態毒理、危害及暴露評估資訊項目審查原則與方法須做滾動式評估及修正，根據過往審查經驗，本計畫已提交新化學物質及既有化學物質登錄資料審查原則及管理方案執行初稿建議供化學局參考，以期使審查更符合現行登錄之需求及狀態。由於登錄業者對於危害評估及暴露評估仍需要更清楚之說明，目前已提交化學物質危害評估及暴露評估指引初稿，相關指引涵蓋勞工、消費者及環境三大面向，對相關項目提出登錄工具說明之建議。評估化學登錄資料毒理及生態毒理替代測試方法：依照「取代、減量和精緻化」原則推動非動物試驗方法的發展是目前國內外的趨勢。以電腦模擬和以分子細胞分析為主的生物體外概要分析其預測毒理學方式相比於以動物試驗為主的傳統毒理學可節省大量的時間和資源。而另一方面隨著奈米材料的開發與製造其種類及數量逐漸的增加，發展與調整合適的奈米材料安全評估方法也成為現今的急迫壓力。奈米物質因為其特殊的性質，需有額外辨識資訊以確認其基本特性。本計畫蒐集國際間一般及奈米化學物質之毒理及生態毒理資訊替代測試方法之相關資料，並提供化學登錄資訊審查原則與方法分析報告供化學局參考，並以五氯酚為例討論QSAR應用於毒理及生態毒理資訊的適用性，以期加速相關替代方式發展。其他行政支援及臨時交辦事項：參與2018中華實驗動物學會年會暨學術研討會及2019瑞典臺灣化學品預防管控訓練，並提供毒理及生態毒理相關事項協助。

中文關鍵字

毒理及生態毒理資訊、奈米物質、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	公開版.pdf	9MB		2020/1/7 上午 12:00:00

摘要	The project period dates from 13th August, 2018 to 31th December, 2019. There are four main objectives in this project include assisting the toxicological and ecotoxicological information review for chemical substances registration, analyzing and evaluating the information items of toxicity and ecotoxicity for chemical substances registration and human resources need for information review, evaluating the toxicological and ecotoxicological alternative test methods and providing administrative support. The main accomplishments of this project are divided into four aspects and are described as follows: Assisting the toxicological and ecotoxicological information review for chemical substances registration: The main task of this project was providing suggestions for application approval, application rejection or application approval with attaching conditions for standard registration. As of 30th November, 2019, 38 cases of review suggestions have been provided to Toxic and Chemical Substances Bureau and 12 consulting cases were also completed. The estimated number of cases was provided to authority for predicting the case number in the following year. The analysis report for evaluating the development and trends of related industry was summit to Toxic and Chemical Substances Bureau in November. Analyzing and reviewing the information items of toxicity and ecotoxicity for chemical substances registration and manpower need for information review: The expert consultation meeting which topic was quantitative structure activity relationship (QSAR) was conducted in November, 2018 and the expert consultation meeting which topic was the current international development of alternative methods and the application direction in Taiwan was conducted in January, 2019. The recommendations for further application of QSAR and development of alternative methods were collected by hosting expert consultation meeting of toxicologist and ecotoxicologist. The expert consultation meeting which topic was the review principles for toxicological information was conducted in October, 2019. The review principles for pathological examination and eyes irritation hazard classification were discussed in this meeting. For assisting the toxicological and ecotoxicological information review for chemical substances registration, two toxicology and chemistry specialist with toxicology or ecotoxicology-related work experience for more than 3 years were hired in this project and both specialists have all gone into the review work. To cooperate with chemical substances registration affairs, the rolling evaluation and revision for the review principles of toxicological information, ecotoxicological information, hazard assessment and exposure assessment are necessary. Based on the review experience, the review principle and management plan for new and existing chemical substances registration information was summited to Toxic and Chemical Substances Bureau. The guidance for hazard assessment and exposure assessment of new chemical substances (draft) was summited to Toxic and Chemical Substances Bureau. These contents of guidance include the hazard and exposure assessment for worker, consumer and environment. Evaluating the toxicological and ecotoxicological alternative test methods: Promoting the development of non-animal test method based on 3R principle (Replacement, Reduction and Refinement) is the domestic and international trend. Compared with traditional toxicological test method using animal as the experimental materials, in vitro and in silico assay could save significant time and resources. On the other hand, with flourishing development of nano materials, it is imperative to develop suitable safety evaluation methods for nanomaterials. For nanomaterials, it is necessary to collect specific identification information to confirm its basic characteristics. The information of toxicological and ecotoxicological alternative test method for chemical substances including nanomaterials was collected in this project and analysis report of review principles and methods for chemical registration information was summited to Toxic and Chemical Substances Bureau. Pentachlorophenol was used as an example to discuss the applicability of QSAR on toxicological and ecotoxicological information. Providing administrative support: The member in this project participated in 2nd annual general meeting and conference holding by the Chinese-Taipei society of Laboratory Animal Sciences in November, 2018 and participated in the Swedish-Taiwan training program on preventive chemicals control in May, 2019. The member in this project also provided administrative support on toxicological and ecotoxicological related businesses to authority.
英文關鍵字	Toxicological and Ecotoxicological information, Nanomaterials, Alternative Test Methods

摘要

The project period dates from 13th August, 2018 to 31th December, 2019. There are four main objectives in this project include assisting the toxicological and ecotoxicological information review for chemical substances registration, analyzing and evaluating the information items of toxicity and ecotoxicity for chemical substances registration and human resources need for information review, evaluating the toxicological and ecotoxicological alternative test methods and providing administrative support. The main accomplishments of this project are divided into four aspects and are described as follows: Assisting the toxicological and ecotoxicological information review for chemical substances registration: The main task of this project was providing suggestions for application approval, application rejection or application approval with attaching conditions for standard registration. As of 30th November, 2019, 38 cases of review suggestions have been provided to Toxic and Chemical Substances Bureau and 12 consulting cases were also completed. The estimated number of cases was provided to authority for predicting the case number in the following year. The analysis report for evaluating the development and trends of related industry was summit to Toxic and Chemical Substances Bureau in November. Analyzing and reviewing the information items of toxicity and ecotoxicity for chemical substances registration and manpower need for information review: The expert consultation meeting which topic was quantitative structure activity relationship (QSAR) was conducted in November, 2018 and the expert consultation meeting which topic was the current international development of alternative methods and the application direction in Taiwan was conducted in January, 2019. The recommendations for further application of QSAR and development of alternative methods were collected by hosting expert consultation meeting of toxicologist and ecotoxicologist. The expert consultation meeting which topic was the review principles for toxicological information was conducted in October, 2019. The review principles for pathological examination and eyes irritation hazard classification were discussed in this meeting. For assisting the toxicological and ecotoxicological information review for chemical substances registration, two toxicology and chemistry specialist with toxicology or ecotoxicology-related work experience for more than 3 years were hired in this project and both specialists have all gone into the review work. To cooperate with chemical substances registration affairs, the rolling evaluation and revision for the review principles of toxicological information, ecotoxicological information, hazard assessment and exposure assessment are necessary. Based on the review experience, the review principle and management plan for new and existing chemical substances registration information was summited to Toxic and Chemical Substances Bureau. The guidance for hazard assessment and exposure assessment of new chemical substances (draft) was summited to Toxic and Chemical Substances Bureau. These contents of guidance include the hazard and exposure assessment for worker, consumer and environment. Evaluating the toxicological and ecotoxicological alternative test methods: Promoting the development of non-animal test method based on 3R principle (Replacement, Reduction and Refinement) is the domestic and international trend. Compared with traditional toxicological test method using animal as the experimental materials, in vitro and in silico assay could save significant time and resources. On the other hand, with flourishing development of nano materials, it is imperative to develop suitable safety evaluation methods for nanomaterials. For nanomaterials, it is necessary to collect specific identification information to confirm its basic characteristics. The information of toxicological and ecotoxicological alternative test method for chemical substances including nanomaterials was collected in this project and analysis report of review principles and methods for chemical registration information was summited to Toxic and Chemical Substances Bureau. Pentachlorophenol was used as an example to discuss the applicability of QSAR on toxicological and ecotoxicological information. Providing administrative support: The member in this project participated in 2nd annual general meeting and conference holding by the Chinese-Taipei society of Laboratory Animal Sciences in November, 2018 and participated in the Swedish-Taiwan training program on preventive chemicals control in May, 2019. The member in this project also provided administrative support on toxicological and ecotoxicological related businesses to authority.

英文關鍵字

Toxicological and Ecotoxicological information, Nanomaterials, Alternative Test Methods