Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro gene mutation (bacteria)

The test substance was evaluated for its mutagenic potential according to the OECD test guideline 471 (BASF SE, 2013), based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA were used and the doses ranged from 33 μg/plate to 5200 μg/plate (standard plate test [SPT] and preincubation test [PIT]), both with and without metabolic activation (liver S9 mix from induced rats). No precipitation of the test substance was found up to 5200 µg/plate and a bacteriotoxic effect was observed depending on the strain and test conditions from about 2600 μg/plate. A relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance Aminopropyl Vinyl ether is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

The study was conducted according to the OECD test guideline 471, without any deviations, and is therefore considered reliable to assess the gene mutation potential of the test substance.

 


Short description of key information:
Bacterial gene mutation: negative; OECD test guideline 471, GLP (BASF SE, 2013)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The criteria of EU DSD 67/548/EEC and CLP/EU-GHS are not met.