Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The test substance 1,1,2-trichloro-1,2,2-trifluoroethane (source chemical of read-across) demonstrated negative results in several in vitro bacterial gene mutation tests (Ames) with and without metabolic activation.

The bacterial mutagenicity of the target chemical 1,1,1-trichloro-2,2,2-trifluoroethane is determined by read-across from the Ames test 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 considered to have negative results in the Ames test.

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


Short description of key information:
several negative Ames tests on 1,1,2-trichloro-1,2,2-trifluoroethane with and without metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance demonstrated (via read-across) negative results in several in vitro bacterial gene mutation tests (Ames). As a result the substance does not meet the criteria for classification (mutagenic substances) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 4.2.2.

The substance demonstrated (via read-across) negative results in several in vitro bacterial gene mutation tests (Ames). As a result the substance does not meet the criteria for classification (germ cell mutagenicity) under Regulation (EC) 1272/2008, Annex I, Part 3, 3.5.2.