Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4, has not been specifically tested but there is test data on 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 which was tested in the Ames bacterial reverse mutation assay.  There is also data which can be used for read across for another 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.  Both these read across substances are more unsaturated and therefore more reactive than 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4, so they are considered as a worst case for possible genetic toxicology.

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

Additional information

Additional information from genetic toxicity in vitro:

2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4, has not been specifically tested but there is test data on 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 which was tested in a bacterial reverse mutation assay (Ames) and was found 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 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4, would not be expected to have any genotoxic hazard to human health.

Justification for classification or non-classification

2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4, has not been specifically tested but there is test data on two similar substances which are consistently negative and therefore it does not require classification as a mutagen according to the European Union CLP/GHS criteria.