Table 2.

Results of in vitro micronucleus test with Dry Mankai in TK6 cells.

Treatment	Short-term treatment				Continuous treatment
Treatment time (h)	4		4		24
Metabolic activation	-S9		+S9		-S9
Concentration of test article (μg/mL)	RPD (%)	Cells with micronucleus (%)	RPD (%)	Cells with micronucleus (%)	RPD (%)	Cells with micronucleus (%)
Negative controla	100	0.6	100	0.7	100	0.6
62.5	NE		89	NO	NE
125	NE		84	NO	NE
250	86	NO	72	0.9	99	0.6
500	77	NO	68	0.9	102	0.6
750	81	0.7	41	0.8	NE
1000	59	0.7	38	NO	100	0.6
1250	44	0.9	NE		NE
1500	−13	NO	NE		NE
2000	NE		NE		103	0.7
Positive control b, c	NE		49	1.9*	68	4.0*

Significantly different from the negative control by Fisher’s exact test: * p < 0.05.

RPD, Relative population doubling; NE, Not examined; NO, Not observed.

^aWater for injection.

^bCyclophosphamide (1.5 μg/mL) in Short-term treatment with S9 mix.

^cColchicine (0.006 μg/mL) in Continuous treatment.