TABLE 3.

Evaluation of the potential mutagenic activity ELP‐004 in the bacterial reverse mutation assay (AMES test).

Revertants/plate (mean ± SD); N = 3
			Strain
Metabolic activation status	Material	Dose (level/plate)	TA98	TA100	WP2 uvr A	TA1535	TA1537
With S9	DMSO	0.1 mL	32 ± 7.6	110 ± 5.3	64 ± 4.2	16 ± 0.6	13 ± 1.0
	ELP‐004	0.05 mg	13 ± 3.1	89 ± 22.9	41 ± 9.7	16 ± 3.5	3 ± 2.6
		0.10 mg	15 ± 2.0	78 ± 13.1	30 ± 10.6	18 ± 6.4	2 ± 1.2
		0.25 mg	22 ± 5.0	103 ± 16.4	33 ± 6.1	13 ± 2.9	2 ± 1.0
		0.50 mg	25 ± 9.5	79 ± 3.1	44 ± 5.0	7 ± 3.8	2 ± 3.2
		1.00 mg	10 ± 2.6	53 ± 4.6	31 ± 1.7	7 ± 1.2	3 ± 1.5
		2.50 mg	9 ± 2.1	16 ± 3.5	19 ± 4.7	12 ± 7.5	5 ± 2.1
		5.00 mg	0 ± 0.0	0 ± 0.0	0 ± 0.0	0 ± 0.0	0 ± 0.0
Without S9	DMSO	0.1 mL	27 ± 5.6	105 ± 17.0	53 ± 10.5	15 ± 5.5	16 ± 1.2
	ELP‐004	0.05 mg	28 ± 8.1	86 ± 11.9	36 ± 7.5	15 ± 4.7	0 ± 0.0
		0.10 mg	19 ± 6.4	72 ± 13.9	28 ± 11.2	15 ± 5.0	2 ± 2.6
		0.25 mg	16 ± 3.8	64 ± 1.0	39 ± 8.4	17 ± 3.1	1 ± 1.2
		0.50 mg	12 ± 3.5	59 ± 16.8	41 ± 8.1	13 ± 4.6	1 ± 0.6
		1.00 mg	5 ± 0.6	38 ± 20.2	32 ± 2.1	13 ± 2.5	1 ± 0.6
		2.50 mg	7 ± 3.1	0 ± 0.6	30 ± 24.3	1 ± 0.6	2 ± 1.2
		5.00 mg	0 ± 0.6	0 ± 0.0	0 ± 0.0	0 ± 0.0	0 ± 0.0