Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

To investigate the potential of lauric acid to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 was performed. The assay was performed with and without metabolic activation.

The potential genotoxicity of refined arachidonic acid-rich trigylceride oil (RAO) was investigated via a bacterial reverse mutation assay in Salmonella thyhymurium (Tester strains TA98, TA100, TA1535 and TA1537) and Eschericha coli (Tester strain WP2uvrA), via a gene mutation study at the TK locus in mouse lymphoma cells, and via a chromosome aberration test in CHO cells.

RAO was negative in all three genotoxicity assays, each which was conducted in the presence and absence of S9 metabolic activation.

In the Ames assay, RAO and lauric acid did not produce a dose-related increase in mean revertants and did not produce a positive response at any of the test concentrations.

In the chromosome aberration assay, RAO induced neither a dose-related increase in the number of structural chromosomal aberrations nor a reproducible positive response at any of the test concentrations.

Finally, in the mouse lymphoma assay, RAO produced no relevant increases in mutant frequency at any of the test concentrations.


Short description of key information:
- negative | Ames test | Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 | with and without | OECD 471 | Lauric acid
- negative | Ames test | Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, E. coli WP2 uvr A | with and without | OECD 471 | refined arachidonic acid-rich trigylceride oil (RAO)
- negative | Chromosome aberration test | Chinese hamster ovary | with and without | OECD 473 | refined arachidonic acid-rich trigylceride oil (RAO)
- negative | Mammalian cell gene mutation test | Mouse lymphoma cells L5178Y | with and without | OECD 476 |refined arachidonic acid-rich trigylceride oil (RAO)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Since neither lauric acid nor refined arachidonic acid-rich triglyceride oil (RAO), which contains Palmitic acid (C16:0) and Stearic acid (C18:0), shows mutagenic effects, a classification is not necessary.