Registration Dossier

Administrative data

Description of key information

In accordance with section 2 of REACH Annex XI, studies on skin and eye irritation do not need to be conducted as the substance is a gas.
When HFC 134a is in contact with cutaneous or ocular mucosal membranes, it causes slight irritation, which is possibly a physical consequence of the non-standard test procedures used, for example, freezing effects of vaporizing liquefied gas.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

In accordance with section 2 of REACH Annex XI, studies on skin and eye irritation do not need to be conducted as the substance is a gas.

In two studies in the rabbit, HFC 134a was judged to cause slight irritation to the skin and eye. These minimal effects were possibly a consequence of the test procedure, and may have resulted from local freezing effects of the vaporizing liquefied gas. Clinical observations during exposure of animals to vapour concentrations of up to 50000ppm in the two year study and much higher concentrations in acute studies did not show any respiratory or occular irritation.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The gaseous state of HFC 134a precludes the conduct of conventional skin and eye irritation studies in animals. The effects observed in studies conducted under non-standard protocols for skin and eye irritation were minimal and possibly the result of local freezing effects. Very high single vapour exposures of HFC 134a and repeated exposures of up to 50000ppm for two years did not result in any occular or respiratory irritation. Therefore, classification for skin, eye and respiratory irritation is not warranted under EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.