Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test substance was investigated for bacterial mutagenicity in the in vitro Ames test according to the OECD TG 471 (1987) and under GLP compliance. The following strains were used: S. typhimurium TA98, TA 100, TA 102, TA 1535, TA 1537 and E. coli WP2 uvrA; the test was conducted in absence and presence of S9-mix (Ciba-Geigy Ltd 1996b). Under the experimental conditions used, the test substance was not mutagenic to bacteria.

The test substance was investigated for clastogenicity in the in vitro mammalian chromosome aberration test according to the OECD TG 473 (1983) and GLP compliance using isolated peripheral lymphocytes. Under the experimental conditions used, the test substance was not clastogenic (NOTOX 1997).

The test substance was investigated for mutagenicity in mammalian cells in the in vitro Mouse Lymphoma Assay according to the OECD TG 476 (1997) and GLP compliance. Under the experimental conditions used, the test substance did not induce mutations (RCC 2006).

No in vivo studies are available . However, owing to the REACH data requirements needed for Tier 2 Substances (100 to 1000 t/a) and since in vitro studies (mutagenicity in bacteria, cytogenicity, mutagenicity in mammalian cells) are available which all were negative, no further in vivo studies are needed.


Short description of key information:
Three in-vitro genotoxicity tests were performed to study the mutagenic and clastogenic potential of the substance with and without metabolic activation. None of the test could induce a positive result. The conduct of an in-vivo mutagenicity test can be omitted based on the unequivocal outcome of the in-vitro tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

An in vitro bacteria mutagenicity test (Ames test, OECD 471), an in vitro cytogenicity test (chromosome aberration assay (OECD 473) and an in vitro gene mutation assay in mammalian cells (OECD 476) are available for the test substance. These studies revealed that it is neither clastogenic nor mutagenic to bacteria and to mammalian cells. On the basis of the available data, there is no need to classify the substance according to the EU 67/548/EEC Directive and there is no need to classify the substance according to the European GHS Regulation (EC) No. 1272/2008 (referred to as CLP).