Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

1) In a bacterial reverse mutation assay (Ames test) performed to OECD Test Guideline 47, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was not mutagenic in all strains tested (Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and Escherichia coli strain WP2 uvrA) in both the absence and the presence of metabolic activation (S9-mix).

2) In an in-vitro chromosome aberration test performed to OECD Test Guideline 473, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was not clastogenic to Chinese Hamster Ovary (CHO) cells, both in the presence and absence of metabolic activation (S9- mix).

3) In an in-vitro mammalian cell gene mutation assay performed to OEDC Test Guideline 476, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was not mutagenic at the TK locus of Mouse Lymphoma L5178Y cells in both the presence and absence of metabolic activation (S9 -mix).


Short description of key information:
PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was not mutagenic both in the presence and absence of metabolic activation in a bacterial reverse mutation assay, an in-vitro chromosome aberration test and an in-vitro mammalian cell gene mutation assay. All tests were performed to OECD protocols and GLP standards.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was not mutagenic both in the presence and absence of metabolic activation in a bacterial reverse mutation assay, an in-vitro chromosome aberration test and an in-vitro mammalian cell gene mutation assay. All tests were performed to OECD protocols and GLP standards. Therefore, classification for mutagenicity is not warranted according to EU Directive 67/548/EEC or to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.