The Klimisch score is a method of assessing the
reliability of
toxicological studies, mainly for regulatory purposes, that was proposed by H.J. Klimisch, M. Andreae and U. Tillmann of the chemical company
BASF in 1997 in a paper entitled ''A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data'' which was published in ''
Regulatory Toxicology and Pharmacology''. It assigns studies to one of four categories as follows:
The applicable guidelines are the (
OECD Guidelines for the Testing of Chemicals OECD Guidelines for the Testing of Chemicals (OECD TG) are a set of internationally accepted specifications for the testing of chemicals decided on by the Organisation for Economic Co-operation and Development (OECD). They were first published in 1 ...
,
EU Test Methods
The Test Methods Regulation is a Regulation (European Union) No. 440/2008 of May 30, 2008. It, and its subsequent amendments, define tests, testing of chemicals for the REACH Regulation. They are based on the OECD Guidelines for the Testing of C ...
), and other such methods. Often studies are performed to more than one test guideline where they are in agreement as to the requirements. GLP is
Good Laboratory Practice.
The scoring system is the standard method used in both the EU regulatory schemes (e.g.
REACH Regulation). Generally, only Klimisch scores of 1 or 2 can be used by themselves to cover an endpoint. However, Klimisch score 3 and 4 data can still be used as supporting studies or as part of a weight of evidence approach. The Klimisch score can be found as a standard field within the
IUCLID database.
ECHA has produced guidance on how to assess the reliability of data
Klimisch score has been criticized for favoring studies conducted under
Good Laboratory Practice guidelines, which are mostly industry-funded studies.
A reliable study according to the Klimisch score can actually be highly flawed.
Klimisch score does not assess a number of study design criteria:
randomization,
blinding,
sample size calculation, ….
ToxRTool
The ToxRTool was developed to assist with Klimisch scoring.
[{{cite web , url=https://eurl-ecvam.jrc.ec.europa.eu/about-ecvam/archive-publications/toxrtool/toxrtool-toxicological-data-reliability-assessment-tool , title=EU Reference Laboratory for alternatives to animal testing ]
References
Toxicology