| 英文摘要 |
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.
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