Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxocity has been tested on the similar substance alkene hydroformilated, sulphosuccinated, sodium salt for the three in vitro genetic end points.

In the Bacterial Reverse Mutation Test on Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material (max 5000 µg/plate) with or without metabolic activation.

AL5178Y mouse lymphoma cell line study was performed with and without metabolic activation for different duration (4 and 24 hours) and doses in the range between 18.75 and 600 µg/ml.

The test material did not induce any toxicologically significant or dose-related increases in the mutant frequency at any dose level, either with or without metabolic activation, in any of the exposure groups.

The test material was considered to be non-mutagenic to L5178Y cells under the conditions of the test.

The test item, suspended in deionised water, was assessed for its potential to induce structural chromosomal aberrations in human lymphocytes in vitro in five independent experiments. The highest applied concentration in this study was chosen as 5000.0 µg/mL.

No evidence of an increase in polyploid metaphases was noticed after treatment with the test item as compared to the control cultures.

Justification for selection of genetic toxicity endpoint
No selection is made because the assessment of the genotoxicity is performed as a weight of evidence and the evaluation performed on the basis of the redukt of the three in vitro tests, mutagenesis on bacteria, on mammalian cells and chromosomal aberration

Short description of key information:
Not mutagenic
Not clastogenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance is not classified genetic mutagen because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

- Category 1 (1A; 1B): substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans;

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