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Carcinogenicity

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Description of key information

2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 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 2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 would not be expected to have any genotoxic hazard to human health.

Key value for chemical safety assessment

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.

Based on these results which indicated that it is unlikely that 2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 could be a genotoxic carcinogen and the absence of any systemic organ toxicity that might raise the possibility of none genotoxic carcinogenic mechanism due to perturbation of normal organ functions, this substnace is not expected to have a carcinogenic hazard.

 

Justification for classification or non-classification

There are three negative in-vitro tests for genotoxicity 2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9. These results which indicated that it is unlikely that 2,2'(Octadec-9-enylimino)bisethanol CAS NO 25307-17-9 could be a genotoxic carcinogen and the absence of any systemic organ toxicity that might raise the possibility of none genotoxic carcinogenic mechanism due to perturbation of normal organ functions. There are no data to indicate a classification for carcinogenicity is required and a carcingenicty test is not scientifically justifed.