A prevalidation of in-vitro photo genotoxicity tests and the effort to find a useful statistical prediction model.
2005
Schmidt,E. | Aeby,P. | Brendler-Schwaab,S. | Epe,B. | Frötschl,R. | Gocke,E. | Hertel,C. | Kasper,P. | Kirchner,S. | Liebsch,M. | Meurer,K. | Plappert-Helbig,U.
allemand. Two in-vitro tests - the photo micronucleus test (PMNT) and the photo Comet assay (PCA) - were evaluated to proof their ability to identify the photogenotoxicological potential of chemicals. Thirteen photoactive substances were tested under blind conditions in three to five laboratories in the years 2002 to 2004 in a ring trial coordinated by the Federal Institute for Drugs and Medical Devices (BfArM), Bonn in two independent runs.Statistical methods used in this validation study will be discussed:(1) The definition of useful toxicological endpoints and the handling of the data as a first and very important step in the process of the statistical analysis.(2) The repeatability and reproducibility must be given for the test to be of practical use and has to be assessed.For the interpretation of the results, "individual" prediction models were developed by all of the participating laboratories.(3) Comparison of the experimental findings with the classification of photogenotoxicity shows the sensitivity and specificity of the tests. A 2x2-contingency table proved to be most useful for this purpose.(4) Despite the small number of laboratories, the limited number of replicates, and chemicals used, an attempt is made to develop a general prediction model.
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