Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data

Alice Krebs, Tanja Waldmann, Martin F. Wilks, Barbara M.A. Van Vugt-Lussenburg, Bart Van der Burg, Andrea Terron, Thomas Steger-Hartmann, Joelle Ruegg, Costanza Rovida, Emma Pedersen, Giorgia Pallocca, Mirjam Luijten, Sofia B. Leite, Stefan Kustermann, Hennicke Kamp, Julia Hoeng, Philip Hewitt, Matthias Herzler, Jan G. Hengstler, Tuula HeinonenThomas Hartung, Barry Hardy, Florian Gantner, Ellen Fritsche, Kristina Fant, Janine Ezendam, Thomas Exner, Torsten Dunkern, Daniel R. Dietrich, Sandra Coecke, Francois Busquet, Albert Braeuning, Olesja Bondarenko, Susanne H. Bennekou, Mario Beilmann, Marcel Leist

Research output: Contribution to journalArticle

Abstract

Only few cell-based test methods are described by Organisation for Economic Co-operation and Development (OECD) test guidelines or other regulatory references (e.g., the European Pharmacopoeia). The majority of toxicity tests still falls into the category of non-guideline methods. Data from these tests may nevertheless be used to support regulatory decisions or to guide strategies to assess compounds (e.g., drugs, agrochemicals) during research and development if they fulfill basic requirements concerning their relevance, reproducibility and predictivity. Only a method description of sufficient clarity and detail allows interpretation and use of the data. To guide regulators faced with increasing amounts of data from non-guideline studies, the OECD formulated Guidance Document 211 (GD211) on method documentation for the purpose of safety assessment. As GD211 is targeted mainly at regulators, it leaves scientists less familiar with regulation uncertain as to what level of detail is required and how individual questions should be answered. Moreover, little attention was given to the description of the test system (i.e., cell culture) and the steps leading to it being established in the guidance. To address these issues, an annotated toxicity test method template (ToxTemp) was developed (i) to fulfill all requirements of GD211, (ii) to guide the user concerning the types of answers and detail of information required, (iii) to include acceptance criteria for test elements, and (iv) to define the cells sufficiently and transparently. The fully annotated ToxTemp is provided here, together with reference to a database containing exemplary descriptions of more than 20 cell-based tests.

Original languageEnglish (US)
Pages (from-to)682-699
Number of pages18
JournalALTEX
Volume36
Issue number4
DOIs
StatePublished - Jan 1 2019

ASJC Scopus subject areas

  • Pharmacology
  • Medical Laboratory Technology

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    Krebs, A., Waldmann, T., Wilks, M. F., Van Vugt-Lussenburg, B. M. A., Van der Burg, B., Terron, A., Steger-Hartmann, T., Ruegg, J., Rovida, C., Pedersen, E., Pallocca, G., Luijten, M., Leite, S. B., Kustermann, S., Kamp, H., Hoeng, J., Hewitt, P., Herzler, M., Hengstler, J. G., ... Leist, M. (2019). Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data. ALTEX, 36(4), 682-699. https://doi.org/10.14573/altex.1909271