Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 now to be registered under 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 was tested in a bacterial reverse mutation assay (Ames) and was not mutagenic with or without S9 mix. 2,2'(Octadec-9-enylimino)bisethanol CAS No 25307-17-9 a structurally similar substance was tested 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. 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 that 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 would not be expected to have any genotoxic hazard to human health.

Short description of key information:

Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 now to be registered under 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 was tested in the Ames bacterial reverse mutation assay.  There is also data which can be used for read across for a structurally related substance with a very similar carbon chain length distribution, 2,2'(Octadec-9-enylimino)bisethanol CAS No 25307-17-9 which was tested in two additional in-vitro genotoxicty studies to current protocol and carried out to GLP with well defined test substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the three negative in-vitro tests for genotoxicity 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 does not require classification as a mutagen according to the European Union CLP/GHS criteria.