Registration Dossier
Registration Dossier
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EC number: 825-258-9 | CAS number: 1226892-46-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
As explained in the category justification, For cross-reading in general use is made with data of same or lower EA-length where available, and that of Tall oil + DETA representing the worst case. This dossier is for the substance "Fatty acids C16-18 and C18-unsatd., reaction products with tetraethylenepentamine”. As for the substance itself no toxicological information is available, cross-reading has been applied to TO + DETA.
Tall oil diethylenetriamine imidazoline was tested in theSalmonella typhimuriumreverse mutation assay with five histidine-requiring strains ofSalmonella typhimurium(TA1535, TA1537, TA98, TA100 and TA102). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced with Aroclor 1254). The study followed the most recent OECD and EU protocols and was performed under GLP.
There was no significant or dose-related increase in the number of revertant colonies in any of the applied strains, both with and without S9-mix. This was confirmed in an independently repeated experiment.
It is concluded that Tall oil diethylenetriamine imidazoline is not mutagenic in theSalmonella typhimuriumreverse mutation assay.
Tall oil diethylenetriamine imidazolinewas studied for its effect on the number of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (phenobarbital and ß-naphthoflavone induced rat liver S9-mix), in two independent experiments.
The study was performed under GLP and according to the most recent OECD and EU guidelines.
Tall oil diethylenetriamine imidazolinedid not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments.
It was noted that Tall oil diethylenetriamine imidazoline increased the number of polyploid cells both in the absence and presence of S9-mix in the first cytogenetic assay and in the presence of S9-mix in the second cytogenetic assay. This may indicate that Tall oil diethylenetriamine imidazoline has the potential to inhibit mitotic processes.
No effects of Tall oil diethylenetriamine imidazoline on the number of cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix in both cytogenetic assays.
Therefore, it is concluded thatTall oil diethylenetriamine imidazolineis not clastogenic in human lymphocytes.
Tall oil diethylenetriamine imidazoline was evaluated for its possible induction of forward mutations at the thymidine-kinase locus (TK-locus) in L5178Y mouse lymphoma cells. The test was performed in two independent experiments in the absence and presence of S9-mix. The study was performed under GLP and according to the most recent OECD and EU guidelines.
In both the presence and absence of S9-mix, Tall oil diethylenetriamine imidazoline did not induce a significant increase in the mutation frequency in the first experiments. This result was confirmed in a repeat experiment with modifications in the duration of treatment time (without S9-mix) or S9 concentration (with S9-mix). Therefore, Tall oil diethylenetriamine imidazoline is not mutagenic in the TK mutation test.
Also other AAI (TEPA, and PolyEA based AAI, including a substance consisting of only Amidoamine without imidazoline) have similarly been tested, with the same results. AAI substances in general therefore are considered to be not genotoxic.
Short description of key information:
Tall oil + DETA was not mutagenic in a bacterial mutagenicity study
(Ames test), induced no chromosomal aberrations in a study in human
lymphocytes, and was not mutagenic in a mammalian mutagenicity study in
mouse lymphoma cells.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Tall oil diethylenetriamineis not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay, is not clastogenic in human lymphocytes, and not mutagenic in the TK mutation test with L5178Y mouse lymphoma cells.
It can therefore be concluded that Tall oil diethylenetriamine is not genotoxic.
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