In an unscheduled DNA synthesis assay (MRID if available), primary rat hepatocyte cultures were exposed to [Chemical name, (% a.i.), include solvent if appropriate] at concentrations of 0, x, x, x Fg/ml for (duration of exposure).
Chemical name was tested [up to cytotoxic or precipitating concentrations, or limit concentration, 5000 Fg/ml. (include other details as appropriate, quantitation if positive e.g. there was a significant increase in number of cells in repair (60% at top concentration vs 1% in controls))]. The positive controls induced (did not induce) the appropriate response. There was (no) evidence (or a dose related positive response) that unscheduled DNA synthesis, as determined by radioactive tracer procedures [nuclear silver grain counts] was induced.
This study is classified as [acceptable or unacceptable(why)]. This study satisfies (does not satisfy) the requirement for Test Guideline OPPTS 870.5550; OECD 482/486 for other genotoxic mutagenicity data. [If it does not satisfy the requirement, concisely list only major deficiencies or refer to deficiency section.]