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Classification or non-classification of substances with positive tumor findings in animal studies: Guidance by the German MAK commission

Laube, Britta 1; Michaelsen, Sandra 1; Meischner, Veronika 1; Hartwig, Andrea 1,2; Epe, B.; Schwarz, M.
1 Institut für Toxikologie und Genetik (ITG), Karlsruher Institut für Technologie (KIT)
2 Institut für Angewandte Biowissenschaften (IAB), Karlsruher Institut für Technologie (KIT)


One of the important tasks of the German Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (known as the MAK Commission) is in the evaluation of a potential for carcinogenicity of hazardous substances at the workplace. Often, this evaluation is critically based on data on carcinogenic responses seen in animal studies and, if positive tumor responses have been observed, this will mostly lead to a classification of the substance under investigation into one of the classes for carcinogens. However, there are cases where it can be demonstrated with a very high degree of confidence that the tumor findings in the experimental animals are not relevant for humans at the workplace and, therefore, the MAK Commission will not classify the respective substance into one of the classes for carcinogens. This paper will summarize the general criteria used by the MAK Commission for the categorization into “carcinogen” and “non-carcinogen” and compare this procedure with those used by other national and international organizations.

Verlagsausgabe §
DOI: 10.5445/IR/1000098403
Veröffentlicht am 02.10.2019
DOI: 10.1016/j.yrtph.2019.104444
Zitationen: 1
Web of Science
Zitationen: 1
Zitationen: 2
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Angewandte Biowissenschaften (IAB)
Publikationstyp Zeitschriftenaufsatz
Publikationsjahr 2019
Sprache Englisch
Identifikator ISSN: 0273-2300, 1096-0295
KITopen-ID: 1000098403
Erschienen in Regulatory toxicology and pharmacology
Verlag Elsevier
Band 108
Seiten Art.-Nr.: 104444
Schlagwörter Carcinogenicity; Animal tumor studies; Human relevance; Species-specific tumors; Mechanism of tumorigenesis; Organ-specific tumors; Maximally tolerated dose
Nachgewiesen in Dimensions
Web of Science
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