環保專案成果報告查詢系統

專案計畫編號
經費年度	110
計畫經費	2,050 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	2021/09/09
專案結束日期	2022/11/30
專案主持人	羅宇軒
主辦單位	化學局
承辦人	謝泊諺
執行單位	國立臺灣大學
專案分類	化學物質管理
中文關鍵字	未知可變複雜混合物、相似性、化學－生物交叉參照
英文關鍵字	Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs), Similarity, Chemical-biological read-across (CBRA)
協同主持人	吳焜裕
共同主持人
計畫聯絡人	羅宇軒
計畫聯絡電話	02-33668087#
計畫聯絡信箱	ysluo@ntu.edu.tw

中文摘要	近年來，我國政府推動台灣版的「註冊、評估、許可和限制法案(REACH)制度」以達成我國化學品源頭管理的目標。我國政府亦於西元2019年3月11日修正發布「新化學物質及既有化學物質資料登錄辦法」，規範新化學物質及既有化學物質的資料登錄，包括新化學物質的少量登錄、簡易登錄與標準登錄等。未知可變複雜混合物(Substances of unknown or variable composition, complex reaction products, or biological materials, UVCB)的登記管理為化學管理當局的重要挑戰，主要原因為其成分未知且複雜，且具批次變異性。UVCB的物質組成與危害辨識為資料登錄者及管理當局亟欲解決的課題。交叉參照法(Read-across)為取得UVCB毒理替代資料實務上較為可行的方法。然而我國利用交叉參照的評估管理仍在起步階段。本計畫主要目標為促進我國建立關於UVCB的評估管理架構。本計畫團隊已蒐集研析歐盟與美國現行關於UVCB的評估管理架構、關於UVCB近期發表的評估管理方法如化學-生物活性交叉參照(Chemical-Biological Read Across, CBRA)，並設計符合我國實務上的UVCB個案研究，結合高內涵影像分析以及未知物化學分析，以驗證利用實驗方法促進UVCB交叉參照，乃至於利用交叉參照法協助新興UVCB化學登錄資料的可行性。本計畫結果顯示，結合蒸餾分析資料與生物活性資料，並運用無母數的方法協助分群分類，為建立潤滑油UVCB交叉參照前相似性基礎的最佳方法。
中文關鍵字	未知可變複雜混合物、相似性、化學－生物交叉參照

中文摘要

近年來，我國政府推動台灣版的「註冊、評估、許可和限制法案(REACH)制度」以達成我國化學品源頭管理的目標。我國政府亦於西元2019年3月11日修正發布「新化學物質及既有化學物質資料登錄辦法」，規範新化學物質及既有化學物質的資料登錄，包括新化學物質的少量登錄、簡易登錄與標準登錄等。未知可變複雜混合物(Substances of unknown or variable composition, complex reaction products, or biological materials, UVCB)的登記管理為化學管理當局的重要挑戰，主要原因為其成分未知且複雜，且具批次變異性。UVCB的物質組成與危害辨識為資料登錄者及管理當局亟欲解決的課題。交叉參照法(Read-across)為取得UVCB毒理替代資料實務上較為可行的方法。然而我國利用交叉參照的評估管理仍在起步階段。本計畫主要目標為促進我國建立關於UVCB的評估管理架構。本計畫團隊已蒐集研析歐盟與美國現行關於UVCB的評估管理架構、關於UVCB近期發表的評估管理方法如化學-生物活性交叉參照(Chemical-Biological Read Across, CBRA)，並設計符合我國實務上的UVCB個案研究，結合高內涵影像分析以及未知物化學分析，以驗證利用實驗方法促進UVCB交叉參照，乃至於利用交叉參照法協助新興UVCB化學登錄資料的可行性。本計畫結果顯示，結合蒸餾分析資料與生物活性資料，並運用無母數的方法協助分群分類，為建立潤滑油UVCB交叉參照前相似性基礎的最佳方法。

中文關鍵字

未知可變複雜混合物、相似性、化學－生物交叉參照

類型	檔名	檔案大小	說明	最新版公開日期
期末報告	以交叉參照法評估管理混合物危害特性資訊先期計畫.pdf	8MB		2023/1/11 上午 12:00:00

摘要	In recent years, our government has facilitated the local version of “Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)” to achieve the source control of chemicals in Taiwan. Our government amended the administrative law, “Regulations of New and Existing Chemical Substances Registration,” on March 11th, 2019, to regulate the chemical registration for new and existing chemical substances, including the new chemicals’ small quantity registration, simplified registration, and standard registration. The registration and management of unknown or variable composition, complex reaction products or biological materials (UVCBs) is a critical challenge for regulatory agencies because UVCBs usually have unknown components, complex and variable composition, and batch-to-batch variability. Substance characterization and hazard identification of UVCBs becomes a critical issue to resolve by the registrants and regulatory agencies. Read-across is a practical approach to filling toxicity gaps of UVCBs. However, we are still at the initial stage of applying read-across in chemical management and assessment. This project aims to establish the assessment and regulatory framework of UVCBs in Taiwan. We investigated the current regulatory frameworks for UVCB registration in the European Union and the United States. We reviewed the latest development of UVCB assessment and management (e.g., chemical-biological read-across, CBRA). We designed a UVCB case study in Taiwan to demonstrate how to facilitate the read-across of UVCBs using experimental approaches such as high-content imaging and untargeted chemical analyses. Herein, we evaluated the feasibility of establishing the similarity of UVCBs using chemical and biological data, which would facilitate the chemical registration of UVCBs. Results from this project show that using boiling point data and bioactivity data with nonparametric clustering methods provides the best grouping results of the lubricant UVCBs.
英文關鍵字	Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs), Similarity, Chemical-biological read-across (CBRA)

摘要

In recent years, our government has facilitated the local version of “Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)” to achieve the source control of chemicals in Taiwan. Our government amended the administrative law, “Regulations of New and Existing Chemical Substances Registration,” on March 11th, 2019, to regulate the chemical registration for new and existing chemical substances, including the new chemicals’ small quantity registration, simplified registration, and standard registration. The registration and management of unknown or variable composition, complex reaction products or biological materials (UVCBs) is a critical challenge for regulatory agencies because UVCBs usually have unknown components, complex and variable composition, and batch-to-batch variability. Substance characterization and hazard identification of UVCBs becomes a critical issue to resolve by the registrants and regulatory agencies. Read-across is a practical approach to filling toxicity gaps of UVCBs. However, we are still at the initial stage of applying read-across in chemical management and assessment. This project aims to establish the assessment and regulatory framework of UVCBs in Taiwan. We investigated the current regulatory frameworks for UVCB registration in the European Union and the United States. We reviewed the latest development of UVCB assessment and management (e.g., chemical-biological read-across, CBRA). We designed a UVCB case study in Taiwan to demonstrate how to facilitate the read-across of UVCBs using experimental approaches such as high-content imaging and untargeted chemical analyses. Herein, we evaluated the feasibility of establishing the similarity of UVCBs using chemical and biological data, which would facilitate the chemical registration of UVCBs. Results from this project show that using boiling point data and bioactivity data with nonparametric clustering methods provides the best grouping results of the lubricant UVCBs.

英文關鍵字

Substances of unknown or variable composition, complex reaction products, or biological materials (UVCBs), Similarity, Chemical-biological read-across (CBRA)