Registration Dossier

Administrative data

Description of key information

Both 4-week and 13 week inhalation toxicity studies have been conducted with 1,1,1-trifluoroethane (HFC-143a).  Exposures were conducted 6-hrs/day, 5 days/wk at levels upto 138000 mg/m3 (40000 ppm).  This represents 50% of the lower flamability limit.  No adverse effectss were seen even at 138000 mg/m3.  Since this substance is a gas at room temperature, all toxicology studies were conducted by the inhalation route.

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
138 000 mg/m³

Additional information

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

Both 4-week and 13 week OECD guideline inhalation toxicity studies have been conducted with 1,1,1-trifluoroethane (HFC-143a). Exposures were conducted 6-hrs/day, 5 days/wk at levels upto 138000 mg/m3 (40000 ppm). This represents 50% of the lower flamability limit. No adverse effects were seen even at 138000 mg/m3. Since this substance is a gas at room temperature, all toxicology studies were conducted by the inhalation route.

Justification for classification or non-classification

Based on a NOEL of 138,000 mg/m3 in air in a 13 week inhalation toxicology study in rats, classification of 1,1,1 -trifluoroethane (HFC-143a) is not warrented according to EU Directive 67/548/EEC.