TABLE 4.

Evaluation of the potential clastogenic activity ELP‐004 in the structural chromosomal aberration assay in Chinese hamster ovary (CHO) cells.

Agent	Target concentration	Replicate	Number of cells evaluated	Cells with aberrations (%)		Polyploidy (%)	Endoreduplication (%)
				One a	Multiple
Chromosome aberration assay without metabolic activation: summary
Negative control—DMSO (%)	1	A	150	0.0	0.0	0.0	0.0
		B	150	0.0	0.0	2.0	0.0
		A + B b	300	0.0	0.0	1.0	0.0
Test article—ELP‐004 (mg/mL)	0.032	A	150	0.0	0.0	0.0	0.0
		B	150	0.0	0.0	2.0	0.0
		A + B	300	0.0	0.0	1.0	0.0
	0.063	A	150	0.0	0.0	0.0	0.0
		B	150	0.0	0.0	0.0	0.0
		A + B	300	0.0	0.0	0.0	0.0
	0.13	A	150	0.0	0.0	2.0	0.0
		B	150	0.0	0.0	1.0	0.0
		A + B	300	0.0	0.0	1.5	0.0
Positive control—Mitomycin C (μg/mL)	0.5	A	25	7.3	2.7	1.0	2.0
		B	25	36.0	20.0	0.0	3.0
		A + B	50	11.4	5.1	0.5	2.5
Chromosome aberration assay with metabolic activation: summary
Negative control—DMSO (%)	1	A	150	0.0	0.0	2.0	0.0
		B	150	0.0	0.0	0.0	0.0
		A + B b	300	0.0	0.0	1.0	0.0
Test article—ELP‐004 (mg/mL)	0.032	A	150	0.0	0.0	0.0	0.0
		B	150	0.0	0.0	0.0	0.0
		A + B	300	0.0	0.0	0.0	0.0
	0.063	A	150	0.0	0.0	0.0	1.0
		B	150	0.0	0.0	1.0	0.0
		A + B	300	0.0	0.0	0.5	0.5
	0.13	A	150	0.0	0.0	0.0	2.0
		B	150	1.3	0.7	1.0	4.0
		A + B	300	0.7	0.3	0.5	3.0
Positive control—Mitomycin C (μg/mL)	10	A	25	80.0	64.0	1.0	0.0
		B	25	56.0	44.0	2.0	0.0
		A + B	50	68.0	54.0	1.5	0.0

^a Parameter is analyzed by ANOVA for the test article groups versus the negative control group; No differences were observed.

^b Reported value is a sum for the column entitled “Number of Cells Evaluated.” For all other columns, an average value is presented.