Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro: HFO-1234yf was only mutagenic in S. typhimurium strain TA100 and E. coli WP-2 (in the presence, but not in the absence of S9) and not in other S. typhimurium strains (TA 1535, TA 1537, TA 98). It was found not to be clastogenic in cultured human lymphocytes, but did induce gene mutations in an in vitro mammalian cell gene mutation test.

In vivo: HFO-1234yf was negative in the following three in vivo genotoxicity studies: micronucleus – mice (acute inhalation exposure) and rats (4-week inhalation exposure) and UDS test (unscheduled DNA synthesis) in rats following 4-week inhalation exposure. Furthermore, the substance was also found to be negative in a combined micronucleus and comet assay in rats following inhalation exposure.

Based on these results of this battery of in vitro and in vivo studies it is concluded that HFO-1234yf is not genotoxic in mammalian systems.

Short description of key information:
In vivo genetic toxicity studies indicate polyhaloalkene is not genotoxic in mammalian systems.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

HFO-1234yf was shown to be nongenotoxic in all in vivo studies. Therefore the substance does not need to be classified for genetic toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) N0. 1272/2008.