In a mammalian cell cytogenetics assay [Ch’some aberration or SCE] (MRID if available), CHO/V79/L5178Y cell cultures/primary lymphocyte cultures were exposed to [Chemical name, (% a.i.), include solvent if appropriate] at concentrations of 0, x, x, x Fg/ml with and/or without metabolic activation [specify].

 

Chemical name was tested (up to cytotoxic or precipitating concentrations, or limit concentration, 5000 Fg/ml). [include other details as appropriate, quantitate if positive (e.g. a dose related increase to 80% cells with aberrations at the top concentration, or large increase in deletions, rearrangements, etc. vs controls].  Positive controls induced (did not induce) the appropriate response.  There was (no) evidence (or a concentration related positive response) of [Ch’some aberration or SCE] induced over background.

 

This study is classified as [acceptable or unacceptable(why)].  This study satisfies (does not satisfy) the requirement for Test Guideline [In vitro mammalian cytogenetics [specify assay] OPPTS 870.5375; OECD 473 or in vitro sister chromatid exchange assay in  (name species/cell type); OPPTS 870.5900; OECD 479] for in vitro cytogenetic mutagenicity data.  [If it does not satisfy the requirement, concisely list only major deficiencies or refer to deficiency section.]