Registration Dossier

Administrative data

Description of key information

Acute inhalation toxicity:
LC50 (4h, rats) > 49500 ppm v/v (i.e. > 379 mg/L air).
LC50 (4h, rats) > 45000 ppm v/v (i.e. > 348 mg/L air), read-across from 1,1,1-trichloro-2,2,2-trifluoroethane
LC50 (2h, rats) > 110000 ppm v/v, read-across from 1,1,1-trichloro-2,2,2-trifluoroethane
Acute oral toxicity (indicative data):
LD50 (rat) >> 232 mg/kg bw
LD50 (rat) = 43000 mg/kg bw, read-across from 1,1,2-trichloro-1,2,2-trifluoroethane

Key value for chemical safety assessment

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
0.379 mg/m³

Additional information

For 1,1,1-trichloro-2,2,2-trifluoroethane (liquid, high vapour pressure, volatile) the inhalation route is more relevant for human exposure than the oral route.

The acute inhalation toxicity was assessed in tests with rats with 1,1,1-trichloro-2,2,2-trifluoroethane and with 1,1,2-trichloro-1,2,2-trifluoroethane (read-across):

LC50 (4h, rats) > 49500 ppm v/v (i.e. > 379 mg/L air).

LC50 (4h, rats) > 45000 ppm v/v (i.e. > 348 mg/L air), read-across

LC50 (2h, rats) > 110000 ppm v/v, read-across

All values show a low acute inhalation toxicity. The first value obtained from the test with 1,1,1-trichloro-2,2,2-trifluoroethane is selected as the key parameter and carried forward for risk assessment, and classification and labelling.

The acute inhalation toxicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is partly determined by read-across from an in vivo test (rats) with the source chemical 1,1,2-trichloro-1,2,2-trifluoroethane. The analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf).

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2, the available data for acute inhalation toxicity is considered to be adequate for the purposes of risk assessment, and classification and labelling, based on the weight-of-evidence.

For the acute oral toxicity no adequate data are available for its definitive assessment. However the available data indicate a low toxicity (i.e. LD50 (oral) = 43000 mg/kg bw and LD50 (oral) >> 232 mg/kg bw.). One result originates from read read-across: the analogue approach is justified in Section 13 (Assessment Reports_Read-Across, in attachment CAS_354-58-5_Read-Across.pdf).

Justification for classification or non-classification

The substance shows a low acute inhalation toxicity. As a result the substance does not meet the criteria for classification (acute toxicity, inhalation route) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.

The substance shows a low acute inhalation toxicity. As a result the substance does not meet the criteria for classification (acute toxicity, inhalation route) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.1.2.

No conclusive assessment on the acute toxicity for the oral route can be made. However there is no indication that a corresponding classification would be required.