Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-01784-0005-0000-7
Chemical Name:	C.I. Direct blue 6
CASRN:	2602-46-2
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	831122
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: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	86	97	258	100	101
			76	108	224	98
			76	94	266	117
			96	101	259	90
Test Chemical	C.I. Direct blue 6	500	112#	105	213	64	75
			62#	73	157.5	85	75
		1000	97	103	175	60	58
			123r	146	190	51
			107	148	176	55
		2000	70	68	224	107	95
			82	98	188	76
			68	75	207	101
		3000	76	104	254	112	90
			91	102	189	69
			77	87	202	88
		4000	110#	123	249	75	105
			90	90	288	107
			68	81	267	131
		5000	72	114	247	115	159*
			82	104	237	96
			56	13	447	266
Positive Control	Ethyl Methane Sulfonate	250	34	16	709	699	600*
			40	19	733	613
			53	26	772	489

Nonactivation Trial: 2 Experiment Call:
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	74	109	140	63	70
			72	92	193	90
			84	97	172	69
			95	102	168	59
Test Chemical	C.I. Direct blue 6	500	107#	104	150	47	54
			60#	73	109.5	61	54
		1000	94	103	120	43	43
			118	144	148	42
			101	144	131	43
		2000	67	68	146	72	63
			80	98	124	51
			65	73	128	66
		3000	74	87	133	60	59
			73	104	164	75
			87	101	111	42
		4000	107#	122	156	49	65
			86	89	173	67
			67	82	161	81
		5000	80	104	147	61	96
			53	13	234	147
			68	111	163	80
Positive Control	Ethyl Methane Sulfonate	250	37	18	550	500	495*
			50	25	582	392
			31	14	542	592

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	107	100	222	69	70
			85#	99	177	70
			81#	101	176	73
Test Chemical	C.I. Direct blue 6	500	105	84	228	72	74
			98	89	220	75
			81	87	186	76
		1000	87#	63	198	76	81
			64	60	176	91
			88#	56	197	75
		2000	78	32	240	102	126*
			80	31	326	137
			85	32	353	139
		3000


Positive Control	Ethyl Methane Sulfonate	250	33#	16	825	833	725*
			41#	19	787	642
			47	20	991	698

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	111	139	147	44	48
			98	100	159	54
			99#	83	130	44
			112	78	168	50
Test Chemical	C.I. Direct blue 6	250	105	93	229	73	73
			103	106	226	73	73
		500	110	77	350	106	104*
			109	106	253	77
			92#	70	354	128
		1000	87	51	292	112	117*
			100	80	322	108
			68	80	271	132
		2000	75#	63	219	97	108*
			82	59	301	123
			95	58	299	105
		5000	104	127	132	43	41
			88#	86	85	32
			106#	125	151.5	48
Positive Control	3-Methylcholanthrene	2.5	91	29	640	235	231*
			100	35	666	223
			87	23	614	235

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	85#	76	88	35	33
			98	123	87	30
			88	101	102	39
			88	100	81	31
Test Chemical	C.I. Direct blue 6	500	69#	73	60	29	34
			53	68	34	22
			53	61	80	50
		1000	55	65	78	48	41
			61#	52	57	31
			61	50	79	43
		2000	79	77	76	32	45
			55	63	74	45
			56	30	96	57
		3000	74#	30	112	50	59*
			64	28	128	67	59*
		4000	46	16	70	50	49
			76	28	109	48
			72	25	105	49
Positive Control	3-Methylcholanthrene	2.5	71	72	114	54	194*
			59	46	501	285
			67	43	489	244

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