Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

From the OECD toolbox prediction on cetrimonium bromide and from read-across to genotoxicity data on structurally closely related substances there is no concern for mutagenic effects in relation to cetrimonium bromide. No in vivo testing on Annex IX level is warranted.

Short description of key information:

Gene mutation predicted for cetrimonium bromide  from the OECD QSAR Toolbox, for salmonella typhimurium assays with and without S9 is negative.

Data on cetrimonium chloride from testing in salmonelle typhimurium with and without S9 was negative.

Data on cetrimonium chloride from testing in in vitro chromosome aberration test (OECD 473) was negative.

Data on dodecyl(C12)trimethylammonium chloride from testing in an in vitro mouse lymphoma assay (comparable to OECD 476) with and without S9 was negative.

Data on dodecyl(C12)trimethylammonium chloride from testing in an in vitro rat hepatocytes UDS assay (comparable to OECD 482) was negative.

In vivo test with dodecyl(C12)trimethylammonium chloride in rats in a bone marrow  chromosome aberration test (comparable to OECD 475) was negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Cetrimonium bromide should not be classified in relation to mutagenicity.