Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

According to the information requirements specified in REACH Annex X, information concerning the potential to induce gene mutations and chromosomal aberrations needs to be provided. Assays are availiable for 1,1,1,2 -tetrafluoroethane (HFC 134a) with respect to gene mutation in bacteria, in-vtiro cytogenicity and gene mutation in mamamalian cells. In vivo studies are also available, included the mouse micronucleus assay. HFC 134a is not mutagenic and did not induce primary DNA damage or cell transformation in any experimental endpoint..

Short description of key information:
1,1,1,2-tetrafluoroethane (HFC 134a) was not genotoxic in vitro or in vivo in a large variety of studies including all important endpoints.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In view of the lack of evidence for mutagenicity in a range of studies covering the important in-vitro and in vivo endpoints, classification for mutagenicity 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.