Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Vinylidene fluoride has shown some activity in an Ames test (Haskell Laboratory, 1979), but was negative in the in vitro chromosomal aberration (Haskell Laboratory, 1986) and gene mutation study (Haskell Laboratory, 1986) in mammalian cells. In vivo, vinylidene fluoride was negative in a mouse micronucleus and Drosophila SLRL test (Life Science Research, 1988; Hazelton Laboratories America, 1989).

The marginal but positive finding in Salmonella typhimurium TA1535 at ≥ 100000 ppm vinylidene fluoride (260000 mg/m3) in the presence of an activation system cannot be explained. It may indicate that some metabolite of vinylidene fluoride interferes directly or indirectly with the genomic integrity of some selected protocaryotic organisms.

Based on all available data regarding genotoxicity, it can be concluded that vinylidene fluoride does not significantly interfere with the genome of organisms.


Short description of key information:
Vinylidene fluoride has shown some activity in an Ames test, but was negative in the in vitro chromosomal aberration and gene mutation study in mammalian cells. In vivo, vinylidene fluoride was negative in a mouse micronucleus and Drosophila SLRL test. Thus there is no evidence of genotoxicity in vivo.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on all available data on genotoxicity, classification for genotoxicity for vinylidene fluoride is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.