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Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro:

The test substance was tested for mutagenicity in the Salmonella typhimurium / Escherichia coli reverse mutation assay both in the standard plate test and in the preincubation test with and without the addition of a metabolizing system (S9 mix) obtained from rat liver using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA in a dose range of 33 - 5000 µg/plate (BASF SE, 2012). The study was performed according to OCD guideline 471 in compliance with GLP.

The test substance did not lead to a biologically relevant increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay). A bacteriotoxic effect was observed depending on the strain and test conditions from about 2500 μg/plate onward. Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study.

Conclusion: Under the experimental conditions of this study, the test substance was not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.


Short description of key information:
Ames test: negative with and without metabolic activation (BASF SE, 2012)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

No classification warranted due to lacking data.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

No classification warranted due to lacking data.