Registration Dossier
Registration Dossier
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EC number: 212-377-0 | CAS number: 811-97-2
Endpoint summary
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 a mammalian cell mutagenicty assay in
mouse lymphoma L5178Y cells, the close structural analogue 1,1,1 -trifluoroethane (HFC 143a) was negative with and without S9 metabolic activation.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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