"ToxRTool", a new tool to assess the reliability of toxicological data

Klaus Schneider, Markus Schwarz, Iris Burkholder, Annette Kopp-Schneider, Lutz Edler, Agnieszka Kinsner-Ovaskainen, Thomas Hartung, Sebastian Hoffmann

Research output: Contribution to journalArticlepeer-review

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, labelling and packaging (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.

Original languageEnglish (US)
Pages (from-to)138-144
Number of pages7
JournalToxicology Letters
Volume189
Issue number2
DOIs
StatePublished - Sep 10 2009

Keywords

  • Data quality
  • In vitro data
  • In vivo data
  • Klimisch categories
  • Relevance
  • Reliability

ASJC Scopus subject areas

  • Toxicology

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