Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Based on the findings from in vitro genotoxicity assays Vinyl 2 -ethylhexanoate is not mutagenic or clastogenic.


Short description of key information:
Vinyl 2-ethylhexanoate (VEHA) doses not induce gene-mutation in the Ames/Salmonella bacterial mutation assay. VEHA was evaluated for the potential to induce chromosome aberrations in an O.E.C.D. test guideline 473 study conducted in Chinese hamster ovary cells. VEHA was negtive for the induction of chromosome aberrations in CHO cells in culture with and without a rat liver derived S9 fraction metabolic activation system when tested up to cytotoxic concentrations. Therefore, VEHA is not clastogenic under the conditions of the study.

The test substance Vinyl-2-ethylhexanoate (VEHA) was assessed for the potential to induce gene-mutation in an O.E.C.D. test guideline 476 study conducted with L5178Y Mouse Lymphoma cells with and without a rat liver derive S9 fraction metabolic activation system. The test substance Vinyl-2-ethylhexanoate did not induce a significant increase of the TFT resistant mutant frequency in Mouse Lymphoma cells under the condiditons of the study when tested up to cytotoxic concentrations.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Vinyl 2 -ethylhexanoate does not meet the criteria for Classification and Labeling as a mutagen as established by EU Directive 67/548/eec and the CLP.