Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Various in-vitro genetic toxicity studies have been conducted on three structural analogues of the registered substance, one containing linear C8 alcohol side chains, one containing linear C8 to C10 alcohol side chains and one containing branched C8 alcohol side chains.

Bacterial reverse mutation assays (Ames test) on three structural analogues have shown them not to induce reverse mutation in Salmonella typhimurium or Escherichia coli.

 

The ability to cause chromosomal damage in cultured human lymphocytes, following in-vitro treatment has been investigated and the same three substances found not to induce chromosomal aberrations in human lymphocytes after in-vitro treatment.

 

Potential mutagenic activity of two structural analogues has been examined by assaying for the induction of 5‑trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells after in vitro treatment. The substances do not induce mutation in mouse lymphoma L5178Y cells.

 

A single substance has been investigated in a dominant lethal assay conducted in the mouse and did not induce unscheduled DNA synthesis in primary rat hepatocytes

 

REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriate in-vivo mutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.


Short description of key information:
Genetic toxicity in-vitro: Negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non-classification is justified on the basis of negative findings in 3 separate in-vitro tests for gene mutation / mutagenicity, supporting information from additional in-vitro assays, in-vivo assay and (Q)SAR tecniques.