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

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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 Heinonen
Thomas 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

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.

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How to Cite
Krebs, A., Waldmann, T., Wilks, M., van Vugt-Lussenburg, B., van der Burg, B., Terron, A., Steger-Hartmann, T., Ruegg, J., Rovida, C., Pedersen, E., Pallocca, G., Luijten, M., Leite, S., Kustermann, S., Kamp, H., Hoeng, J., Hewitt, P., Herzler, M., Hengstler, J., Heinonen, T., Hartung, T., Hardy, B., Gantner, F., Fritsche, E., Fant, K., Ezendam, J., Exner, T., Dunkern, T., Dietrich, D., Coecke, S., Busquet, F., Braeuning, A., Bondarenko, O., Bennekou, S., Beilmann, M. and Leist, M. (2019) “Template for the description of cell-based toxicological test methods to allow evaluation and regulatory use of the data”, ALTEX - Alternatives to animal experimentation, 36(4), pp. 682-699. doi: 10.14573/altex.1909271.
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