Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data

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.

KREBS Alice;  WALDMANN Tanja;  WILKS Martin;  VAN VUGT-LUSSEMBURG Barbara;  VAN DER BURG Bart;  TERRON Andrea;  STEGER-HARTMANN Thomas;  RUEGG Joelle;  ROVIDA Costanza;  PEDERSEN Emma;  PALLOCCA Giorgia;  LUIJTEN Mirjam;  BATISTA LEITE Sofia;  KUSTERMANN Stefan;  KAMP Hennicke;  HOENG Julia;  HEWITT Philip;  HERZLER Matthias;  HENGSTLER Jan;  HEINONEN Tuula;  HARTUNG Thomas;  HARDY Barry;  GANTNER Florian;  FRITSCHE Ellen;  FANT Kristina;  EZENDAM Janine;  EXNER Thomas;  DUNKERN Torsten;  DIETRICH Daniel;  COECKE Sandra;  BUSQUET Francois;  BRAEUNING Albert;  BONDARENKA Olesja;  BENNEKOU Susanne;  BEILMANN Mario;  LEIST Marcel; 

2022-09-09

SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH

JRC121102

1868-596X (online),   

https://www.altex.org/index.php/altex/article/view/1433,    https://publications.jrc.ec.europa.eu/repository/handle/JRC121102,   

10.14573/altex.1909271 (online),