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Key value for chemical safety assessment

Additional information

As the acetate will dissociate from the substance during the process of absorption, there is no principal difference between systemic exposure to the polyamines acetate and the polyamine without the acetate. Consequently, cross-reading is applied for this endpoint the corresponding polyamine substance without acetate. (Full justification for cross-reading can be found in the document attached to Chapter 13 of this IUCLID: "Category approach justification for polyamine acetates 29 03 2012.pdf")

Oleyl dipropylene triamine (C18dipropylene triamine) was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia 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 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 Oleyl dipropylene triamine (C18 dipropylene triamine) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

Additionally, polyamines do not react with DNA or react to protein (indicated by OECD Toolbox profiling).

Short description of key information:
All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. The results are read across from Oleyl dipropylene triamine (C18 dipropylene triamine). Read across is justified by structural similarities .

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Available information from bacterial mutagenicity studies on the corresponding polyamine shows no signs of genotoxicity.