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Theme 2: Project 6 - UVCB Grouping
One of the most challenging areas in regulatory toxicology is assessment of the UVCBs (Unknown or Variable composition, Complex reaction products and Biological materials). UVCBs are substances with few solutions for science-informed regulatory decisions. Regulators and registrants have a common interest to understand how to evaluate UVCBs under current chemical regulatory policy and ensure that there is no underestimation of hazard. The CAT-APP project tackles the challenge of UVCBs and will provide regulators and registrants with a cost-effective integrative approach to solving the similarity challenges of UVCBs and will define the best practical strategies for the read-across and grouping approaches.
This project is conducted entirely in vitro and is funded by CONCAWE the European Association of Oil refiners. Its output contributes to a direct need of regulators in Europe and has further application for the regulatory assessment of other UVCB products.
The project is a collaboration with Texas A&M University (TAMU), North Carolina State University and the University of Ulster.
Aim To develop a workflow for category read-across for UVCBs consisting of an intelligent integrated testing strategy, using experimental, computational, integrative analysis, and transparent outcome communication elements to meet the regulatory information requirements.