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Fatty acids, tall-oil, reaction products with polyethylene-polyamines (Amidoamine) was tested in theSalmonella typhimuriumreverse mutation assay with four histidine-requiring strains ofSalmonella typhimurium(TA1535, TA1537, TA98 and TA100) and in theEscherichia colireverse mutation assay with a tryptophan-requiring strain ofEscherichia coli(WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone). The study procedures described in this report were based on the most recent OECD and EC guidelines.

Test substance was dissolved in ethanol, and precipitated on the plates at dose levels of 3330 and 5000 μg/plate. Cytotoxicity was observed in all strains in the absence and presence of S9-mix. (Except in second experiment with WP2uvrA).

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 fatty acids, reaction products with polyethylenepolyamines (Amidoamine)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.

Testsubstance was dissolved in ethanol, andprecipitated in the culture medium at a dose level of 100µg/mL.

The Testsubstance 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 Fatty acids, tall-oil, reaction products with polyethylene-polyamines (Amidoamine) increased the number of polyploid cells in the absence of S9-mix in both cytogenetic assays and in the presence of S9-mix in the first cytogenetic assay. This may indicate that Fatty acids, tall-oil, reaction products with polyethylene-polyamines (Amidoamine) has the potential to inhibit mitotic processes.

No effects of Fatty acids, tall-oil, reaction products with polyethylene-polyamines (Amidoamine) on the number of cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mixin both cytogenetic assays.

 

Tall-oil, reaction products with polyethylene-polyamines (Amidoamine)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(induced by phenobarbital and ß-naphthoflavone). 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 polyethylene-polyamines (Amidoamine)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 polyethylene-polyamines (Amidoamine)is not mutagenic in the TK mutation test.

Next to this amidoamine substance without imidazoline, also other AAI (DETA, TEPA and PolyEA based AAI) with imidazoline formed have similarly 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:
Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine) 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 fatty acids, reaction products with polyethylenepolyamines (Amidoamine) 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. The substance therefore does not need to be classified for genotoxicty.