Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

During studies in animals exposed whole body to TFE for up to 2 years, clinical observations did not show any signs of skin sensitisation.


Migrated from Short description of key information:
In accordance with section 2 of REACH Annex XI, the study on skin sensitisation need not be conducted as the substance is a gas.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

During studies in animals exposed whole body to TFE for up to 2 years, clinical observations did not show any signs of respiratory sensitisation.


Migrated from Short description of key information:
During studies in animals exposed whole body to TFE for up to 2 years, clinical observations did not show any signs of respiratory sensitisation.

Justification for classification or non-classification

The gaseous nature of TFE precludes the conductance of a skin sensitisation study in animals. Additionally, extensive inhalation studies on TFE by whole body exposure for up to 2 years showed no evidence of skin or respiratory sensitisation. Therefore, classification for skin and respiratory senstisation 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.