Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 was tested in a bacterial reverse mutation assay () 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 2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 would not be expected to have any genotoxic hazard to human health.

Short description of key information:

2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 was tested in three in-vitro genotoxicty studies to current protocol and carried out to GLP with well defined test substance.  All three test were negative.

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'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 does not require classification as a mutagen according to the European Union CLP/GHS criteria.