Registration Dossier

Administrative data

Description of key information

A low order of toxicity was demonstrated for 1,1,1,2-tetrafluoroethane (HFC 134a) in repeated inhalation studies with no adverse effects observed at exposure concentrations of up to 50000ppm (208000mg/m3).

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
208 000 mg/m³

Additional information

In accordance with section 2 REACH Annex XI, studies via the oral and dermal route do not need to be conducted as the substance is a gas.

In a combined chronic toxicity / carcinogenicity study in rats exposed at 0, 2500, 10000 or 50000ppm v/v 1,1,1,2 -tetrafluoroethane (HFC 134a) for 2 years there was no evidence of any toxicity or compound related effects in the blood and clinical chemistry parameters investigated. The NOAEC concentration in this study was judged to be 50000ppm.

The chronic toxicity of HFC 134a was also investigated in rats exposed by inhalation to concentrations of up to 50000ppm (208000mg/m3) for 2 to 52 weeks. No toxicologically significant effects were seen in these studies. No treatment related non-neoplastic lesions were seen in rats or in mice exposed to 1 hour /day to concentrations of 0, 2500, 10000, or 50000ppm for 108 or 106 weeks respectively.

Justification for classification or non-classification

Based on the NOAEC of 208000mg/m3 in air in a 2 year chronic toxicity study in rats (Hext 1993), classification of 1,1,1,2 -Tetrafluoroethane (HFC 134a) is not warranted for repeat inhalation toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.