Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Data are available from reliable studies for all required in vitro and in vivo endpoints. Where there was more than one result for an endpoint, the most recent reliable study available was chosen as the key study.

Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay/Ames test) (OECD 471): positive in selected bacterial strains tested, with or without metabolic activation
Mutagenicity in mammalian cells: positive in HepG2 human hepatoma cell line
Chromosome aberrations in mammalian cells: negative with and without activation
In vivo:
Micronucleus assay in mouse: negative

Endpoint Conclusion:

Justification for classification or non-classification

The body of evidence available for 2-bromopropane indicates that when tested in vitro, 2-bromopropane may induce mutations in bacterial or mammalian cells in certain test strains and cell types, but does not induce chromosome aberrations in mammalian cells. In addition, no significant in vivo increase in frequency of micronucleated polychromatic erythrocytes in bone marrow of mice exposed to 2-bromopropane was observed.  Because the in vivo results were negative, it is considered that classification for mutagenicity is not required as described in EC No 1272/2008.