Registration Dossier

Administrative data

Description of key information

Clinical observations during whole body exposure of animals to TFE vapour concentrations of up to 625 ppm (male rats) and 1250 ppm (mice and female rats) in the two year study and higher concentrations of 5000 ppm (rats and mice) in subchronic and subacute studies did not show any skin, respiratory or occular irritation. 

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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.

Clinical observations during whole body exposure of animals to TFE vapour concentrations of up to 625 ppm (male rats) and 1250 ppm (mice and female rats) in the two year study and higher concentrations of 5000 ppm (rats and mice) in subchronic and subacute studies did not show any skin, respiratory or occular irritation.

Justification for classification or non-classification

The gaseous state of TFE precludes the conduct of conventional skin and eye irritation studies in animals. Clinical observations during whole body exposure of animals to TFE vapour concentrations of up to 625 ppm (male rats) and 1250 ppm (mice and female rats) in the two year study and higher concentrations of 5000 ppm (rats and mice) in subchronic and subacute studies did not show any skin, respiratory or occular 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.