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Key value for chemical safety assessment

Additional information

Chromosome abberation test:

All vehicle controls had frequencies of cells with aberrations within the range expected for normal human lymphocytes.

All the positive control treatments gave significant increases in the frequency of cells with aberrations indicating the satisfactory performance of the test and of the activity of the metobolising system.

The substance induced no significant increases in the frequency of cells with aberrations or polyploid cells. The substance was shown to be non-clastogenic to human lymphocytes in vitro.

Reverse mutation assay (Ames test):

No significant increase in the number of revertant colonies was recorded for any of the bacterial strains with any dose of the substance either with or without metabolic activation. The substance was found to be non-mutagenic under the conditions of this test.

Mouse Micronucleus Test:

The test material was considered to be non-genotoxic under the conditions of the test.


Short description of key information:
A Reverse mutation assay, Chromosome abberation test and Mouse micronucleus test showed no mutagenic effects.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above stated assessment of the two in vitro and one in vivo genetic toxicity studies, the test item may be regarded as non-genotoxic, therefore no classification according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU is needed.