User Guide for TKPlate 1.0: An open access platform for implementing new approach methodologies in chemical risk assessment through toxicokinetic and toxicodynamic modelling.

This technical report provides a user guide for the TKPlate 1.0 platform which allows to implement New Approach Methodologies in the chemical risk assessment process by means of toxicokinetic and toxicodynamic modelling of chemicals in humans, laboratory animals, farm animals and species of ecological relevance. TKPlate 1.0 is available as an open access web‐based tool or a downloadable application. The platform is built as a workflow of 7 modules: 1. Input module for which the user can select the species, kinetic or physiologically‐based kinetic model, the chemical to be modelled, exposure scenarios and simulation times, 2. Forward dosimetry allowing the user to simulate kinetic parameters, body fluid and organ concentrations, 3. Reverse dosimetry for the reconstruction of exposure distributions using internal dose such as biomonitoring data, 4. Benchmark dose modelling using model averaging on an internal dose basis, 5. Dynamic energy budget modelling, 6. Mixture risk characterisation using the methods available from EFSA's Scientific committee guidance document, 7. Automated report where the user can access input and output data in a technical report, graphs and datasets. For each module, the structure and applications are described with examples. The technical development of TKPlate 1.0 is described in an external scientific report which is associated with an EFSA editorial and two technical reports namely a user guide and case studies illustrating applications of TKPlate 1.0. Finally, all models and associated files are also available published in Zenodo (https://zenodo.org/record/7494936). This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.e211101/full This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8440/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8437/full [ABSTRACT FROM AUTHOR]