Fatty acids, C18-unsatd., dimers, oligomeric reaction products with triethylenetetramine

Endpoint summary

Additional information

In a GLP/OECD Test Guideline 471 study to determine the mutagenic potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine in bacterial cells in vitro (McGarry, 2012), negative results were obtained in Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537, in the presence and in the absence of metabolic activation (S9 mix). Under the conditions of the study, the test article did not induce mutation in the five histidine-requiring strains of Salmonella typhimurium, in the presence and absence of S9 mix.

The clastogenic and aneugenic potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was investigated in an in vitro micronucleus study in cultured human peripheral blood lymphocytes in accordance with OECD 487 and GLP (Lloyd, 2012a). Duplicate cultures were prepared and the assays were performed in the presence and absence of metabolic activation (S9 mix). Under the conditions of this study, the test article did not induce biologically relevant increases in the frequency of micronuclei in cultured human peripheral blood lymphocytes when tested up to the limit of solubility for 3+21 hours in the absence and presence of S9 mix and for 24+0 hours in the absence of S9 mix.

The potential for Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine to cause gene mutations in L5178Y mouse lymphoma cells was evaluated using a fluctuation protocol according to OECD Guideline 476 and in compliance with GLP (Lloyd, 2012b). The study consisted of two cytotoxicity Range-Finder Experiments followed by two independent experiments, each conducted in the absence and presence of metabolic activation by an Aroclor 1254 induced rat liver post-mitochondrial fraction (S9). The test article was formulated in acetone. A 3 hour treatment incubation period was used for all experiments. Under the conditions of the study, the test article did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells, in the presence and absence of S9 mix.

Justification for selection of genetic toxicity endpoint
No study was selected since negative results were obtained in all in vitro studies.

Short description of key information:
No evidence of mutagenicity was seen for Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine in a bacterial reverse mutation assay (Ames test). Negative results were obtained in in vitro mammalian cytogenicity and gene mutation studies. The substance is not genotoxic in vitro in bacterial or in mammalian cell systems.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is not mutagenic in bacterial cells or in mammalian cells in vitro. The substance does not meet the criteria for classification for genetic toxicity according to or Regulation No.1272/2008/EC or Directive 67/548/EEC.