Table IX.
Conclusions of the VMT for the different modules (5)
Conclusion | ||
Test definition | √ | Clear definitions of the scientific basis, description of the end points and the mechanistic basis; protocol requirements available. |
Within-laboratory reproducibility | √ | The within-laboratory reproducibility was in an acceptable range (94–100% assessed per treatment independent from cell model; 97–100% reproducibility per cell line, independent from treatment) |
Transferability | √ | Test method can be easily transferred and no extraordinary facilities are required. Overall, the successful transferability of the in vitro MNT is demonstrated by the satisfactory results for the between-laboratory variability from the two studies evaluated. |
Between-laboratory reproducibility | √ | The between-laboratory reproducibility assessed per treatment, independent from cell line varied between 86 and 100%. The between-laboratory reproducibility assessed per cell model, independent from treatment varies from 79 to 100%. |
Predictive capacity (concordance) | √ | The concordance between in vitro MNT and in vitro CAT ranges from 80.8 to 88.9% in the different studies. The general concordance for all compounds is 83.2%, the concordance for clastogens is 87.3% and the concordance for aneugens is 77.8%. However, all compounds known to induce aneuploidy were detected by the MNT in vitro. |
Applicability domain | √ | Genotoxicity (structural and numerical chromosome aberration); all chemical classes; potential to be used in screening strategy for genotoxicity evaluation (regulatory use). |