Registration Dossier

Administrative data

Description of key information

not irritating to an in vitro skin model (EpiSkin), tested with 1,1,1-trichloro-2,2,2-trifluoroethane
not corrosive/irritating in in vivo tests with 1,1,2-trichloro-1,2,2-trifluoroethane
not irritating to rabbit eyes, in vivo tests with 1,1,2-trichloro-1,2,2-trifluoroethane

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin corrosion/irritation

The skin irritation potential of 1,1,1-trichloro-2,2,2-trifluoroethane was assessed in an in vitro skin model (EpiSkin). The test substance was not irritant to the in vitro model.

In addition some further tests with the test substance 1,1,2-trichloro-1,2,2-trifluoroethane are available (read-across), which contribute to the assessment of the skin corrosion/irritation potential by the weight-of-evidence.

The corrosion/irritation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed with in vivo tests on rabbits. The test item was not corrosive/irritating to rabbit skin.

The skin corrosion/irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from in vivo tests on rabbits 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). As a consequence 1,1,1-trichloro-2,2,2-trifluoroethane is not considered as corrosive/irritating to the rabbit skin.

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

Eye irritation

The eye irritation potential of the test substance 1,1,2-trichloro-1,2,2-trifluoroethane was assessed with in vivo tests on rabbits. The test item was not irritating to rabbit eyes.

The eye irritation potential of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from in vivo tests on rabbits 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). As a consequence 1,1,1-trichloro-2,2,2-trifluoroethane is not considered as irritating to the rabbit eyes.

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

Justification for classification or non-classification

The substance was not irritant to skin and eyes. As a result the substance does not meet the criteria for classification (corrosive, irritant, inflammation of the skin, ocular lesions) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.5 and 3.2.6.

The substance was not irritant to skin. As a result the substance does not meet the criteria for classification (skin corrosion/irritation) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.2.

The substance was not irritant to eyes. As a result the substance does not meet the criteria for classification (serious eye damage/eye irritation) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.3.