Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In accordance with section 2 of REACH Annex XI, the study on skin sensitisation need not be condcuted as the substance is a gas. In a non-standard study, Guinea pigs received one single intradermal injection of Freund's complete adjuvant followed by 7 occlusive epicutaneous administrations of 0.5 ml of liquefied HFC-134a, which was applied to the occlusive bandage before it was put in place, every 2 or 3 days over a 15-day period. The treated occlusive bandage was left in place between each application. After a period of 12 days without treatment, the challenge administration was performed by occlusive epicutaneous treatment with 0.5 ml of liquefied HFC-134a. No evidence of skin sensitisation was observed.


Migrated from Short description of key information:
In accordance with section 2 of REACH Annex XI, the study on skin sensitisation need not be condcuted as the substance is a gas. No evidence for skin sensitisation was observed in a non-standard study with HFC 134a in the Guinea pig.

Respiratory sensitisation

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

There was no evidence of respiratory sensitisation in repeated inhalation studies in animals up to 2 years. Additionally, there is no evidence of respiratory sensitisation in humans occupationally exposed to HFC 134a..


Migrated from Short description of key information:
There was no evidence of respiratory sensitisation in repeated inhalation studies in animals up to 2 years. Additionally, there is no evidence of respiratory sensitisation in humans occupationally exposed to HFC 134a.

Justification for classification or non-classification

The gaseous nature of HFC 134a precludes the conductance of conventional skin sensitisation study in animals. In an study using a non-standard protocol there was non-evidence of skin sensitisation in the Guinea pig. Additionally, extensive inhalation studies and human occupational exposure show no evidence of 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.