| 英文摘要 |
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.
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