Registration Dossier

Administrative data

Description of key information

The NOAEL for repeated dose toxicity is higher than 731690 mg/m3 (105000 ppm) in rats exposed for a period of 90 days.

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
731 690 mg/m³

Additional information

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

Repeated administration of 1,1,1,2,3,3,3-heptafluoropropane (HFC 227ea) to rats by inhalation over 90 days (WIL Research Laboratories, 1993a) did not induce treatment-related effects at any dose tested (139370, 348420 and 731690 mg/m3 (20000, 50000 and 105000 ppm). All treated animals survived until termination. The NOAEC for systemic toxicity was established to be > 731690 mg/m3 (105000 ppm), 6 hr/day.

The NOAEC of 731690 mg/m3 observed in the subchronic inhalation toxicity study with rats will be used for DNEL derivation for repeated dose toxicity.

Justification for classification or non-classification

Based on the absence of any adverse effects in a subacute and semichronic toxicity study with rats, classification for repeated dose toxicity is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.