Table 8. Summary of genotoxicity studies (technical grade).
| Test system | Cells/animals | Dose or concentration | Results | |
|---|---|---|---|---|
| in vitro | Reverse mutation test | Salmonella typhimurium | 20.5 to 5000 µg/plate (−S9) | Negative |
| (TA98, TA100, TA1535, TA1537 strains) | [TA100, TA1535, WP2uvrA] | |||
| Escherichia coli | 10.2 to 2500 µg/plate (+S9) | |||
| (WP2uvrA strain) | [TA98, TA1537] | |||
| 4.1 to 1000 µg/plate (+S9) | ||||
| Mouse lymphoma TK test | Mouse lymphoma cells | 10 to 150 µg/mL (−S9) | Negative | |
| (L5178Y TK +/−) | 10 to 60 µg/mL (+ S9) | |||
| Chromosome aberration test | Human peripheral blood lymphocytes | 114 to 365 µg/mL (−S9) | Negative | |
| 174 to 450 µg/mL (+S9) | ||||
| in vivo | Rodent micronucleus test | ICR mice (bone-marrow cells) | 0, 500, 1000 and 2000 mg/kg bw | Negative |
| (5 males in a group) | (Single oral dose by gavage) | |||
Note) +/−S9: with/without exogenous metabolic activation