Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-02736-0003-0000-3
Chemical Name:	Progesterone
CASRN:	57-83-0
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	820917
Study Result:	Equivocal

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Table Instructions and Notes:
Studies are indicated to be "Nontoxic" when the observed reductions in relative total growth did not indicate that the maximum tolerated dose was achieved.

Nonactivation Trial: 1 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	89	97	76	29	19
			78	98	42	18
			78	105	23	10
Test Chemical	Progesterone	10	77	86	38	17	19
			82	79	45	18
			73	83	47	21
		20	49#	52	37.5	25	21
			83	71	50	20
			76	82	38	17
		30	72#	51	44	20	20
			69	50	44	21
			66	49	35	18
		40	71	17	44	21	22
			68	21	48	24	22
		50



Positive Control	Ethyl Methane Sulfonate	500	32	17	865	901	1018*
Positive Control			20	13	675	1134	1018*

Nonactivation Trial: 2 Experiment Call: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	80	115	52	22	19
			79#	114	58.5	25
			65	81	26	13
			63	90	33	17
Test Chemical	Progesterone	10	57	70	28	16	19
			79	104	29	12
			59	83	51	29
		20	58	79	32	18	26
			62	61	42	23
			62	63	67	36
		30	67	65	44	22	25
			58	22	57	33
			72	39	43	20
		40
		50



Positive Control	Ethyl Methane Sulfonate	250	37	38	494	445	533*
Positive Control			28#	26	528	621	533*

Nonactivation Trial: 3 Experiment Call: Equivocal
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	72	84	83	38	30
Vehicle Control			103	116	70	23	30
Test Chemical	Progesterone	20	73	84	99	45	34
			95	90	65	23	34
		30	93	97	65	23	25
			83	69	56	22
			68#	72	61.5	30
		40	97	55	88	30	29
			91#	51	61	22
			114#	44	98	29
			99	85	104	35
		50	78#	25	131	56	52*
			69	12	94	45
			115	23	164	48
			75	15	133	59
Positive Control	Ethyl Methane Sulfonate	250	92	53	1115	404	375*
			81#	43	916.5	380
			94	46	961	341

Nonactivation Trial: 4 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	98	112	166	56	49
			89#	92	118	44
			85#	86	136	53
			92	110	116	42
Test Chemical	Progesterone	10	77	78	79	34	36
			87	74	95	37
			78	81	88	38
		20	98	86	89	30	31
			103	75	92	30
			84	86	83	33
		30	79#	63	134	56	49
			88	60	107	41	49
		40	77	11	290	126	103*
			78	13	258	111
			79	15	199	85
			69	13	192	93
		50


			34	2	237	231
		60


Positive Control	Ethyl Methane Sulfonate	250	46#	30	706	517	462*
			55	43	673	409
			44	42	610	460

Induced S9 Trial: 1 Experiment Call: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	113	116	154	46	46
			107	99	141	44
			97	93	122	42
			89	92	140	52
Test Chemical	Progesterone	1.56	82	77	106	43	49
			88#	68	141	54	49
		3.13	108	89	169	52	46
			81	71	99	41	46
		6.25	90	82	188	70	59
			96	76	141	49	59
		12.5	108	96	140	43	40
			68	49	75	37	40
		25	100	89	177	59	50
			103	93	128	41	50
		50	95	85	156	55	54
			85	82	135	53	54
		100

Positive Control	3-Methylcholanthrene	5	33	5	255	256	244*
			29	3	249	288
			40#	7	226.5	187

Induced S9 Trial: 2 Experiment Call: Negative and Non-Toxic
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	66	80	78	39	30
			83#	90	58.5	24
			95	124	84	30
			83	106	68	27
Test Chemical	Progesterone	40	85#	89	43.5	17	22
			81	83	50	21
			93	77	82	29
		50	95	70	82	29	27
			82#	90	73.5	30
			88	83	60	23
		60	83	71	69	28	29
			93	59	83	30
			80	57	72	30
		70	83#	29	88.5	36	38
			87	71	104	40
			75	56	88	39
Positive Control	3-Methylcholanthrene	5	11	3	222	683	521*
			15	4	191	415
			13#	4	174	464

Induced S9 Trial: 3 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	88	81	63	24	24
			96	107	64	22
			107	106	77	24
			92	106	76	28
Test Chemical	Progesterone	40	68#	77	49.5	24	29
			101#	74	100.5	33
			86	16	79	31
		50	65	4	112	57	50*
			79	59	90	38
			75	64	125	56
		60					62*
			75	14	153	68
			78	66	129	55
		70					92*
			61	4	188	103
			64	7	156	81
		80


Positive Control	3-Methylcholanthrene	5	37	8	319	286	299*
			21	3	233	364
			37	6	276	246

Induced S9 Trial: 4 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	92	97	66	24	20
			102	104	68	22
			81	91	50	21
			102	108	37	12
Test Chemical	Progesterone	40	83#	94	38	15	20
			74	81	41	18
			77	79	58	25
		50	102	107	81	26	25
			95#	90	67.5	24	25
		60	94	104	57	20	22
			83	63	51	21
			79	83	58	25
		70	89	85	71	27	34*
			81	65	86	35
			102	107	83	27
			94	24	128	46
		80					36*
			90	27	77	29
			94	36	92	33
			97	18	135	47
		90



Positive Control	3-Methylcholanthrene	2.5	62	43	627	339	310*
Positive Control			67	52	562	280	310*

Induced S9 Trial: 5 Experiment Call: Equivocal
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	73	88	109	50	47
			128r	192	73	19
			77	112	103	44
			120r	182	80	22
Test Chemical	Progesterone	40	70	81	145	69	65
			55#	39	121.5	74
			75	74	117	52
		50	57	72	162	95	79*
			60#	77	132	73
			80#	89	170	71
		60	83	128	61	25	27
			87	101	101	39
			99	125	56	19
		70	81	98	133	55	48
			104	124	143	46
			89	96	117	44
		80	76#	90	125	55	47
			102	43	120	39
			126r	107	133	35
		90


Positive Control	3-Methylcholanthrene	2.5	54	63	399	245	213*
			66	72	430	218
			94	83	492	175

Footnotes:
Asterisks(*) indicate significant responses.
r = rejected value due to quality control criteria
# = reduced sample size because of the loss of one culture dish due to contamination