Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test item had no mutagenic activity on the applied bacterial strains under the test conditions used in the study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test item was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay.

The experiments were carried out using histidine-requiring auxotroph strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537) and the tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia coli WP2 uvrA) in the presence and absence of a post mitochondrial supernatant (S9 fraction) prepared from the livers of phenobarbital/b-naphthoflavone-induced rats.

 

In the Initial Mutation Test and Confirmatory Mutation Test, the number of revertant colonies did not show any biologically relevant increase compared to the solvent control. There were no dose-related trends and no indication of any treatment-related effect.

Precipitate/slight precipitate was observed on the plates in the main tests in all examined bacterial strains with and without metabolic activation at the concentrations of 5000 and 1581 μg/plate. Due to the observed precipitate, on the plates at 5000 μg/plate concentration with and without metabolic activation, it was difficult to clearly evaluate the background lawn at that concentration. The precipitation did not adversely affect the colony counting.

No inhibitory or toxic effects of the test item were detected in the study.

The data from this mutagenicity assay show that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the bacterial strains used.

In conclusion, the test item BAL0001026 (Batch Number: 017) had no mutagenic activity on the applied bacterial strains under the test conditions used in this study.

Justification for classification or non-classification

The data from this mutagenicity assay show that under the experimental conditions applied, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the bacterial strains used.

No classification/labelling is triggered according to Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 7) 2017.