Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9 was tested in a bacterial reverse mutation assay (Ames) and was not mutagenic with or without S9 mix. It was also 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 Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9 would not be expected to have any genotoxic hazard to human health.

Justification for selection of genetic toxicity endpoint

No study has been selected as the conclusion that the substance is not genotoxic/mutagenic is based on the three negative studies, the Ames test, the Mouse Lymphoma and the In-vitro human lymphocyte chromosomal aberration studies

Short description of key information:

Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9 will be registered for REACH as 2, 2’-(C12-18 evennumbered alkyl imino) diethanol  CAS No 71786-60-2.

Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9  was tested in three in-vitro genotoxicty studies to current protocol and carried out to GLP with well defined test substance.  There were no indications of any genetic toxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the three negative in-vitro tests for genotoxicity Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9 does not require classification as a mutagen according to the European Union CLP/GHS criteria.