1. Classification or non-classification of substances with positive tumor findings in animal studies: Guidance by the German MAK commission.
- Author
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Laube B, Michaelsen S, Meischner V, Hartwig A, Epe B, and Schwarz M
- Subjects
- Air Pollutants, Occupational toxicity, Animals, Carcinogens toxicity, Germany, Government Agencies, Humans, International Agencies, Neoplasms chemically induced, Occupational Diseases chemically induced, Occupational Exposure, Risk Assessment, Species Specificity, Air Pollutants, Occupational classification, Carcinogens classification, Guidelines as Topic
- Abstract
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., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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