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.
The scoring system is the standard method used in both the EU regulatory schemes (e.g. REACH Regulation).
However, Klimisch score 3 and 4 data can still be used as supporting studies or as part of a weight of evidence approach.
[4] Klimisch score does not assess a number of study design criteria: randomization, blinding, sample size calculation, ….