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Ames test: In a study performed according to OECD and EC test guidelines, the species S. typhimurium TA1535, 1537, 98 and 100 and the species E. coli WP2 uvr A were tested up to the precipitating concentration of 3330 microg/plate with and without metabolic activation. All bacterial strains showed negative responses over the entire dose range with and without metabolic activation, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. Based on the results of this study it is concluded that radialube 7819 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Chromosome aberration test: In a study performed according to OECD and EC test guidelines, human lymphocytes were exposed to the test substance up to 100 microg/ml with and up to 333 migrog/ml without metabolic activation, concentrations at which the substance precipitated. Radialube 7819 did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments. Therefore it was concluded that the substance is not clastogenic in human lymphocytes under the experimental conditions chosen.

Mouse lymphoma test: In a study performed according to OECD and EC test guidelines, L5178Y mouse lymphoma cells were exposed to the test substance up to the precipitating concentration of 100 microg/ml with and without metabolic activation. In the absence or presence of S9-mix, the substance did not induce a significant increase in the mutation frequency. Based on the results of the test it was concluded that Radialube 7819 is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions chosen.


Short description of key information:
The Ames study was performed according to OECD Guideline 471 and GLP principles. The chromosome aberration study was performed according to OECD Guideline 473 and GLP principles. The TK mutation test was performed according to OECD Guideline 476 and GLP principles.The substance tested 'negative' in all three tests performed.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the genotoxicity studies, the substance does not need to be classified according to the CLP Regulation (EC) 1272/2008 and Council Directive 67/548/EEC (DSD).

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