Table 3.
In vitro mammalian gene mutation results
| Type of test | Experimental test system | Test substance | Exposure conditions | Result | WG considerations and conclusion | Reference |
|---|---|---|---|---|---|---|
| In vitro mammalian gene mutation | CHO/hprt assay |
Triazine amine IN‐A4098 (98.7%) Vehicle DMSO 1% |
5 h treatment +/− S9 10, 25, 50, 150 μg/mL |
+S9: no increase in mutation frequency −S9: Increase in mutation frequency with large variability between replicate cultures |
GLP study compliant with OECD TG 476 (1997) Insufficient number of treated cells with respect to the recommendations by the OECD 476 (2016) Inconclusive |
Clarke (2009) |
| In vitro mammalian gene mutation | V79/HGPRT assay |
Triazine amine IN‐A4098 (99.5%) Vehicle DMSO 2% |
4 and 24 h treatment +/− S9 at 12.5, 25, 50, 100, 200 μg/mL |
No increase in mutation frequency at any concentration tested Precipitation at 200 μg/mL |
GLP study compliant with OECD TG 476 (1997) Deviation from OECD 476 (2016): Final DMSO concentration 2% instead of 1% Negative |
Flügge (2011b) |
| In vitro mammalian gene mutation | Mouse Lymphoma L5178Y assay |
Triazine amine IN‐A4098 (97%) Vehicle DMSO 2% |
3 and 24 h treatment +/− S9 at 38.5, 77, 154, 308 μg/mL |
3 h +/−S9: no increase in mutation frequency 24 h −S9: Increase in mutation frequency not exceeding the GEF of 126 × 10−6 mutants above the mean concurrent vehicle control mutant frequency |
GLP study compliant with OECD TG 476 (1997) Deviation from OECD 490 (2016): Final DMSO concentration 2% instead of 1% Negative |
Woods (2011a) |
| In vitro mammalian gene mutation | Mouse Lymphoma L5178Y assay |
Triazine amine IN‐A4098 (98.7%) Vehicle DMSO 1% |
3 and 24 h treatment +/− S9 at 2.5, 5, 10, 20, 30, 35, 40 μg/mL | No increase in mutation frequency at any concentration tested |
GLP study compliant with OECD TG 490 (2016) Negative |
Lloyd (2016) |
| In vitro mammalian gene mutation | CHO/hprt assay |
Triazine amine IN‐A4098 (98.7%) Vehicle DMSO (1%) |
5 h treatment − S9 10, 25, 50, 100, 150 μg/mL |
No increase in mutation frequency at any concentration tested |
GLP study compliant with OECD TG 476 (2016) Negative |
Pant (2019) |
| In vitro mammalian gene mutation | Mouse Lymphoma L5178Y assay |
Triazine amine IN‐A4098 (98.7%) Vehicle DMSO 1% |
3 and 24 h treatment +/− S9 at 18,75, 37.5, 75, 150, 300 μg/mL | No increase in mutation frequency at any concentration tested |
GLP study compliant with OECD TG 490 (2016) Negative |
Woods (2019) |
DMSO: dimethyl sulfoxide; S9: metabolic activation; GEF: global evaluation factor.