| 英文摘要 |
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.
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