Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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

Additional information

The evaluation of the mutagenic potential of the substance has been based on a study conducted on the Similar Substance 01. The complete hypothesis and justification for the read across approach has been attached in section 13.

The test substance was tested for mutagenic effects in vitro in histidine-requiring strains of Salmonella typhimurium, according to the OECD Guideline 471 (1983).

The following strains of Salmonella typhimurium were used: TA 98, TA 100, TA 1535 and TA 1537. The test was performed with and without the addition of rat-liver post mitochondrial supernatant (S9 fraction) as an extrinsic metabolic activation system. The compound was dissolved in DMSO and tested at five concentrations in the range of 61.7 to 5000.0 µg/plate in the presence and absence of a metabolic activation system. In order to confirm the results, the experiments were repeated with and without metabolic activation at the same concentrations. Each strain was additionally tested in the presence and in the absence of a metabolic activation system with a suitable, known mutagen as positive control.

The original experiment with and without metabolic activation and the confirmatory experiment without activation were performed as standard plate incorporation assay. The confirmatory experiment with metabolic activation was carried out as preincubation assay.

In both experiments, performed with and without metabolic activation, none of the tested concentrations of the test substance led to an increase in the incidence of histidine-prototrophic mutants by comparison with the negative control.

Justification for selection of genetic toxicity endpoint

The study was performed according to an internationally accepted testing guideline and it met the endpoint requirements fully.

Short description of key information:

Non genotoxic (bacterial reverse mutation assay)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:

- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans (Category 1) or

- substances, which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans (Category 2).


Based on the results of the salmonella mutagenicity test, it is concluded that the test substance and its metabolites did not induce gene mutations in the strains of Salmonella typhimurium used.

Therefore, the substance does not meet the criteria to be classified for genetic toxicity according to the CLP Regulation (EC n. 1272/2008).