Registration Dossier
Registration Dossier
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EC number: 425-320-1 | CAS number: 690-39-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Gene mutation (Bacterial Reverse Mutation Assay/Ames test):
The substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) was tested in one in vitro gene mutation study in bacteria (Bacterial Reverse Mutation Assay/Ames Test). In the key study (OECD 471 and 472/GLP), bacterial strains (Salmonella typhimurium TA100, TA1535, TA98, TA97 and Escherichia coli/ WP2uvrA(pKM101)) were exposed to the 100% of the substance and additional lower concentrations of 0% (air), 20%, 40%, 60%, 70% and 80% in the presence and absence of mammalian metabolic activation (Aroclor induced rat-liver S9) in duplicate. The substance was negative in the presence and absence of metabolic activation in the Bacterial Reverse Mutation Assay/Ames test.
Chromosome aberration (in vitro mammalian cell cytogenicity):
The substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) was tested in one in vitro mammalian cytogenicity (Chromosome aberration) study. In the mammalian cell cytogenetic key study (Chromosome aberration; OECD 473/GLP), human lymphocytes were exposed to the substance in dry compressed air at concentrations of 0 – 100% (2 assays with varying increasing concentrations) with (3 hrs) and without (3 hrs) metabolic activation (rat liver induced with Aroclor 1254). The substance was negative in the presence and absence of metabolic activation in the in vitro mammalian cell cytogenicity (Chromosome aberration) assay.
Chromosome aberration (in vivo micronucleus assay):
The substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) was tested in an in vivo micronucleus assay (Chromosome aberration) study. In the micronucleus assay (OECD 474/GLP), the mice were exposed to the substance at doses of 5000 ppm, 20000 ppm and 50000 ppm. The results of this study did not give an indication on the potential of the substance to induce chromosomal aberrations in vivo.
Justification for selection of genetic toxicity endpoint
No key study was selected as all three studies were negative.
Short description of key information:
In vitro:
Gene mutation (Bacterial Reverse Mutation Assay/Ames test): the substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) does not induce mutagenicity using S. typhimurium TA100 TA1535 TA98 TA97 and Escherichia coli/ WP2uvrA(pKM101) in the presence or absence of Aroclor 1254 rat liver-induced S9 metabolic activation (OECD 471/472, GLP);
Chromosome aberration (in vitro mammalian cell cytogenicity): the substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) does not induce chromosome aberrations in Human lymphocytes in the presence or absence of Aroclor 1254 rat liver-induced S9 metabolic activation (OECD 473, GLP);
In vivo:
Micronucleus assay: the substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) does not induce chromosome aberrations in vivo after administration to Crl:CD-1(ICR)BR mice (OECD 474, GLP).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available information in the dossier, the substance 1,1,1,3,3,3-Hexafluoropropane (CAS No. 690-39-1) does not need to be classified for germ cell mutagenicity when the criteria outlined in Annex I of 1272/2008/EC are applied
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