ToxTemp: A Standardized Framework and Database for Documenting and Assessing Readiness of In Vitro Test Methods

ToxTemp is a web-accessible template and database designed for documenting in vitro test methods while integrating different readiness levels and a structured review workflow. It was developed initially under the EU-ToxRisk and developed further under RISK-HUNT3R (both EC-funxded Horizon 2020 projects).

The test method template (ToxTemp) provides a standardized framework for documenting test methods and assessing their readiness status, guided by a structured questionnaire.

By offering a user-friendly approach, ToxTemp helps test developers, especially those less familiar with regulatory requirements to describe their assays in sufficient detail. It also facilitates the comparison of different testing methods, including those targeting the same endpoint. Widespread adoption of ToxTemp could not only support test developers by providing clear documentation guidance but also drive a cultural shift toward more consistent and transparent method documentation.

Reference

Krebs A, Waldmann T, Wilks MF, Van Vugt-Lussenburg BMA, Van der Burg B, Terron A, Steger-Hartmann T, Ruegg J, Rovida C, Pedersen E, Pallocca G, Luijten M, Leite SB, Kustermann S, Kamp H, Hoeng J, Hewitt P, Herzler M, Hengstler JG, Heinonen T, Hartung T, Hardy B, Gantner F, Fritsche E, Fant K, Ezendam J, Exner T, Dunkern T, Dietrich DR, Coecke S, Busquet F, Braeuning A, Bondarenko O, Bennekou SH, Beilmann M, Leist M. Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data. ALTEX. 2019;36(4):682-699. doi: 10.14573/altex.1909271. Erratum in: ALTEX. 2020;37(1):164. doi: 10.14573/altex.1909271e. PMID: 31658359.