Title: ToxRTool, a new tool to assess the reliability of toxicological data
Authors: SCHNEIDER KlausSCHWARZ MarkusBURKHOLDER IrisKOPP-SCHNEIDER AnnetteEDLER LutzKINSNER-OVASKAINEN AgnieszkaHARTUNG ThomasHOFFMANN Sebastian
Citation: TOXICOLOGY LETTERS vol. 189 no. 2 p. 138-144
Publisher: ELSEVIER IRELAND LTD
Publication Year: 2009
JRC N°: JRC51252
ISSN: 0378-4274
URI: http://www.elsevier.com/locate/toxlet
http://publications.jrc.ec.europa.eu/repository/handle/JRC51252
DOI: 10.1016/j.toxlet.2009.05.013
Type: Articles in Journals
Abstract: Evaluation of the reliability of toxicological data is of key importance for regulatory decision-making. In particular, the new EU Regulations concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification and Labelling (CLP) according to the new Globally Harmonised System (GHS) rely on the integration of all available toxicological information. The so-called Klimisch categories, although well established and widely used, lack detailed criteria for assigning data quality to categories. A software-based tool (ToxRTool) was developed within the context of a project funded by the European Commission to provide comprehensive criteria and guidance for reliability evaluations of toxicological data. It is applicable to various types of experimental data, endpoints and studies (study reports, peer-reviewed publications) and leads to the assignment to Klimisch categories 1, 2 or 3. The tool aims to increase transparency and to harmonise approaches of reliability assessment. The tool consists of two parts, one to evaluate in vivo and one to evaluate in vitro data. The prototypes of the tool were tested in two independent inter-rater experiments. This approach allowed the analysis of the performance of the tool in practice and the identification and minimisation of sources of heterogeneity in evaluation results. The final version, ToxRTool, is publicly available for testing and use.
JRC Institute:Institute for Health and Consumer Protection

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