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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 C18 unsat, reaction products with polyethylene amines. As for the substance itself no toxicological information is available, cross-reading has been applied to TO + TEPA.

Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine was tested in the Salmonella typhimurium reverse mutation assay with five histidine-requiring strains of Salmonella 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 Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine is not mutagenic in theSalmonella typhimuriumreverse mutation assay.

 

Tall oil, reaction products with tetraethylenepentamine was 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, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline) did 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, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline) increased the number of polyploid cells both in the absence and presence of S9-mix in the first cytogenetic assay, in the absence of S9-mix at the 24 h exposure time and in the presence of S9-mix in the second cytogenetic assay. This may indicate that Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline) has the potential to inhibit mitotic processes.

No effects of Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/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 conclude that Tall oil, reaction products with tetraethylenepentamine (Amidoamine/Imidazoline) is not clastogenic in human lymphocytes.

 

Tall oil, reaction products with tetraethylene-pentamine (Amidoamine/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, reaction products with tetraethylene-pentamine (Amidoamine/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, reaction products with tetraethylene-pentamine (Amidoamine/Imidazoline)is not mutagenic in the TK mutation test.

 Also AAI DETA have been tested with the same results.

These studies are valid for the evaluation of Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

All substances within the AAI group show the same reactive groups, show similar composition of amide, imidazoline, and some dimer structures of both, with the length of original EA amines used for production as biggest difference. Inherent reactivity and toxicity is not expected to differ much between these substances, aspects which determine genotoxicty.

AAI substances in general therefore are considered to be not genotoxic.

 


Short description of key information:
All AAI substances tested were not mutagenic in a bacterial mutagenicity study (Ames test), induced no chromosomal aberrations in a study in human lymphocytes, and were not mutagenic in a mammalian mutagenicity study in mouse lymphoma cells. Similar results would be expected for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All AAI substances tested were not mutagenic in a bacterial mutagenicity study (Ames test), induced no chromosomal aberrations in a study in human lymphocytes, and were not mutagenic in a mammalian mutagenicity study in mouse lymphoma cells. Similar results would be expected for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).