Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The reverse mutation assay (Ames test) was performed in accordance with OECD test guideline 471 and EU B13/14. Test methods used included plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of rat liver homogenate metabolizing system (10% liver S9 in standard co-factors).

The dose range was determined in a preliminary toxicity assay and was 50 to 5000 ug/plate in the first experiment. The experiment was repeated on a separate day (pre-incubation method) using the same dose range, fresh cultures of the bacterial strains and fresh PC2414 formulations.

No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of PC2414, either with or without metabolic activation per exposure method, hence PC2414 was found to be non-mutagenic.


Short description of key information:
PC2414 was found to be non-mutagenic in the reverse mutation assay (Ames Test) using Salmonella Typhimurium and Escherichia Coli with and
without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In summary, PC2414 was shown not to have genotoxic properties in the reverse mutation assay (Ames Test). Based on the results, PC2414 is not hazardous and is not classified according to GHS and DSD-DPD and in accordance with the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008.