Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a GLP/OECD Test Guideline 471 study to determine the mutagenic potential of Fatty acids, C18-unsatd., dimers, polymers with oleic acid 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.

Studies on the genotoxicity of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine in mammalian cells are not available. Based on existing datasets and structural and chemical considerations, read-across from this substance to genotoxicity studies using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. Read-across is scientifically justified and also enables the REACH requirements to be adequately addressed, while avoiding unnecessary animal testing in accordance with EU Directive 86/609/EEC.

The clastogenic and aneugenic potential of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was investigated in anin vitromicronucleus study in cultured human peripheral blood lymphocytes in accordance with OECD Test Guideline 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.

Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine was not found to be genotoxic in mammalian cells in vitro .Based on these results, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is also not expected to be genotoxic to mammalian cells in vitro.


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, polymers with oleic acid and triethylenetetramine in a bacterial reverse mutation assay (Ames test). Based on existing datasets and structural and chemical considerations, read-across from the substance to genotoxicity studies on Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. Negative results were obtained in in vitro mammalian cytogenicity and gene mutation studies with Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine. Based on read-across to these studies, the substance is not predicted to be genotoxic in vitro in mammalian cell systems.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative results were obtained for C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine in an in vitro study conducted using bacterial cells. Negative results were obtained for the read across substance, Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine, in in vitro studies in mammalian cells. Based on these results, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is not predicted to have any genotoxic potential. The substance does not meet the criteria for classification for genetic toxicity according to Regulation No.1272/2008/EC or Directive 67/548/EEC.