Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In vitro: HFO-1234ze was not mutagenic in S. typhimurium strains TA100, TA1535, 1537, TA98 and E. coli WP-2 (with or without S9). It was found not to be clastogenic in cultured human lymphocytes.

In vivo: HFO-1234ze was negative in the following three in vivo genotoxicity studies: micronucleus – mouse (acute inhalation exposure) and rats (4-week inhalation exposure) and UDS test (unscheduled DNA synthesis) following 4-week inhalation exposure.

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

Short description of key information:
In vivo and in vitro genetic toxicity studies indicate HFO-1234ze is nongenotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

HFO-1234ze was not shown to be genotoxic in in vitro or in vivo genotoxicity studies. No classification is deemed necessary