Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-03187-0009-0000-0
Chemical Name:	p-Phenylenediamine dihydrochloride
CASRN:	624-18-0
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	G80192
Study Result:	Positive

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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: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	76	91	62	27	26
			76	102	62	27
			88	99	73	28
			92	109	58	21
Test Chemical	p-Phenylenediamine dihydrochloride	1.88	72#	93	60	28	31
			72	88	59	27
			67#	84	78	39
		2.5	85	101	82	32	26
			76	75	55	24
			63	72	42	22
		3.75	74	66	110	50	43*
			66	62	77	39
			83	66	97	39
		5	62	38	115	62	67*
			68	35	177	87
			73	46	114	52
		7.5	72	15	270	125	143*
			60#	8	298.5	167
			69	5	284	138
		10	38	4	254	221	253*
			41	3	292	238
			25	1	227	299
		15


Positive Control	Ethyl Methane Sulfonate	500	46	27	824	599	650*
			37	23	798	725
			49	31	927	626

Nonactivation Trial: 2 Experiment Call: Rejected
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	89	100	25	9	12
			78	96	35	15
			97	112	33	11
			84	93	35	14
Test Chemical	p-Phenylenediamine dihydrochloride	1.25	80	82	51	21	21*
			61	70	35	19
			78	69	50	21
		2.5	85	81	56	22	25*
			78	69	66	28
			85	74	62	24
		3.75	84	69	64	25	20*
			76	67	46	20
			81	84	38	16
		5	100	97	49	16	19
			86	90	42	16
			75	80	57	25
		7.5	78	56	93	40	30*
			73	56	68	31
			75	72	43	19
		10	91	31	65	24	27*
			88	33	80	30
			91	37	71	26
Positive Control	Ethyl Methane Sulfonate	500	31	18	657	703	736*
			24	8	659	928
			43	28	744	577

Nonactivation Trial: 3 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	101	112	20	7	10
			87	85	35	13
			93	103	31	11
Test Chemical	p-Phenylenediamine dihydrochloride	1.25	92	101	42	15	18*
			91	86	35	13
			74	90	59	27
		2.5	87	67	45	17	15
			71	59	33	15
			86	68	28	11
		5	65	16	109	56	43*
			63	17	81	43
			74	31	68	31
		7.5	78	6	140	60	69*
			60#	4	166.5	93
			67	6	111	55
		10


Positive Control	Ethyl Methane Sulfonate	500	32	15	837	886	735*
			28	13	611	732
			42	23	730	586

Nonactivation Trial: 4 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	93	98	54	19	15
			108	107	33	10
			77	95	37	16
Test Chemical	p-Phenylenediamine dihydrochloride	0.625	100	90	26	9	9
			90	75	32	12
			99	118	19	6
		1.25	86	75	50	19	19
			89	87	49	18
			98	110	60	20
		2.5	100	106	52	17	15
			76	85	40	18
			89	86	26	10
		5	93	42	63	23	27*
			98	42	85	29
			77	49	70	30
		7.5	75	7	104	46	58*
			71	6	126	59
			52	4	109	70
		10


Positive Control	Ethyl Methane Sulfonate	500	23	8	701	1023	1067*
			28	14	869	1035
			25	11	858	1144

Induced S9 Trial: 1 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	91	121	137	50	58
			88	93	168	64
			80	95	151	63
			96	91	153	53
Test Chemical	p-Phenylenediamine dihydrochloride	15.6	99	74	210	71	78
			77	87	196	85	78
		31.3	87	50	252	96	96*
			84	44	239	95	96*
		62.5	70	21	300	143	135*
			69	22	263	127	135*
		125	69	12	271	132	156*
			49	11	268	181	156*
		250

Positive Control	3-Methylcholanthrene	5	60	31	587	328	318*
Positive Control			73	31	670	307	318*

Induced S9 Trial: 2 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	77	97	150	65	50
			96	109	115	40
			74	95	99	44
Test Chemical	p-Phenylenediamine dihydrochloride	100	63	27	161	86	89*
			56	19	157	93	89*
		125	49	22	125	85	75*
			68	26	179	88
			71	26	111	52
		150	58	21	179	102	83*
			69	24	190	91
			65	29	108	55
		175	54	22	150	92	94*
			54	20	185	115
			64	22	144	75
		200	68	25	163	80	88*
			68	27	195	96	88*
		250	66	21	224	114	103*
			41	18	114	93
			74	22	230	103
Positive Control	3-Methylcholanthrene	5	41	20	518	421	406*
Positive Control			45	25	524	391	406*

Induced S9 Trial: 3 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	94	95	68	24	26
			88	111	81	31
			118	106	97	27
			103	88	72	23
Test Chemical	p-Phenylenediamine dihydrochloride	50	108	46	123	38	41
			146r	66	144	33
			107	36	143	44
		100	111	30	152	46	50*
			83	29	128	51
			90	26	140	52
		200	75	25	136	61	67*
			90	19	178	66
			88	24	195	74
		250	89	12	229	85	88*
			78	17	212	90
			95	13	251	88
		300	85	9	260	102	105*
			90	14	273	102
			75	13	254	113
		400	48	3	243	168	158*
			44	4	209	159
			54	4	239	149
		500


Positive Control	3-Methylcholanthrene	5	69	28	315	151	169*
			69	29	367	176
			65	23	351	179

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