Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The results of two available Ames tests (Genesys Research, 1995a; Japan Bioassay Laboratory, 1993) with Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 and Echerichia coli strain WP2 uvr A were all negative at exposure concentrations of 1,1,1,2,3,3,3 -heptafluoropropane (HFC 227ea) up to 900000 ppm. Negative results were also observed in an in vitro mouse lymphoma assay (Genesys Research, 1995c) and one in vitro chromosome aberration tests with human peripheral lymphocytes and Chinese hamster lung fybroblasts (Japan Bioassay Laboratory, 1994). The available in vivo mouse micronucleus test (Genesys Research, 1995b) was also negative (highest tested exposure concentration of 1,1,1,2,3,3,3 -heptafluoropropane was 10.5%).

Short description of key information:
The available in vitro studies (Ames test, gene mutation and chromosome aberration studies) were all negative. The available in vivo micronucleus study was also negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, there is no concern for genotoxicity. Classification according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not warranted.