Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs .wastested for mammalian cell gene mutation in the L5178Y TK +/- Mouse lymphoma assay and was not mutagenic. In addition it was tested in a Chromosomal aberration test in human lymphocytes in-vitro and was found to be not clastogenic. Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs .was not tested in a bacterial reverse mutation assay (Ames) as there was a test on the read across substance 2,2’-(Octadec-9-enylimino) diethanol CAS No 25307-17-9 which was not mutagenic with or without S9 mix

All tests were to current OECD/EU protocols carried out to GLP and with a clearly defined and described test substance. Based on this it can be concluded thatPropanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs . CAS No 1309955-79-0 would not be expected to have any genotoxic hazard to human health.

Justification for selection of genetic toxicity endpoint

All three in-vitro genetic toxicity studies are negative

Short description of key information:

Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs . CAS No 1309955-79-0 was tested in two in-vitro genotoxicity studies and read across data are available for the third test, all to current protocol and carried out to GLP with well defined test substance. All studies were negative, therefore Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs . would not be expected to have any genotoxic hazard to human health.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the three negative in-vitro tests for genotoxicity, Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs. CAS No 1309955-79-0 does not require classification as a mutagen according to the European Union CLP/GHS criteria.