Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-02171-0010-0000-4
Chemical Name:	FD & C yellow no. 6
CASRN:	2783-94-0
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	030453
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: Negative and Non-Toxic
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Fischer Medium	0	94	102	129	46	51
			103	104	145	47
			113	92	185	55
			103	102	178	58
Test Chemical	FD & C yellow no. 6	312.5	100	99	93	31	39
			107	111	148	46	39
		625	80	84	69	29	35
			92	85	112	41	35
		1250	96#	84	126	44	38
			87	92	86	33	38
		2500	100	106	87	29	44
			84	93	149	59	44
		5000	86	104	68	27
Positive Control	Methyl Methane Sulfonate	15	50	31	393	265	248*
			56	36	388	232	248*
	Methyl Methane Sulfonate	250	92	87	630	230	246*
			81	72	641	263	246*

Nonactivation 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	Fischer Medium	0	75	94	106	47	43
			84	89	131	52
			81	101	94	39
			82	115	86	35
Test Chemical	FD & C yellow no. 6	1000	69	90	117	56	44
			91	102	89	32	44
		2000	70	70	141	67	56
			64	75	86	45	56
		3000	71	80	76	36	42
			79	75	115	48	42
		4000	77	95	107	46	48
			66	76	98	50	48
		5000	88	91	91	34	42
			68	80	103	51	42
Positive Control	Methyl Methane Sulfonate	15	36	32	169	157	158*
			49	33	234	158	158*
	Methyl Methane Sulfonate	250	60	76	361	199	210*
			63	65	418	221	210*

Induced S9 Trial: 1 Experiment Call: Negative and Non-Toxic
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Fischer Medium	0	123r	93	198	54	55
			127r	97	206	54
			108	102	183	57
			113#	98	184.5	54
Test Chemical	FD & C yellow no. 6	1000	99	70	146	49	56
			97	95	181	62	56
		2000	109	132	161	49	60
			103	109	217	70	60
		3000	108	94	174	54	60
			102	100	201	66	60
		4000	118	97	190	53	68
			87	88	216	83	68
		5000	115	109	171	50	51
			97	102	150	51	51
Positive Control	3-Methylcholanthrene	2.5	70	36	906	429	429*

Induced S9 Trial: 2 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Fischer Medium	0	106	106	136	43	39
			93	108	87	31
			101	95	106	35
			89	91	122	46
Test Chemical	FD & C yellow no. 6	1000	95	64	226	80	76*
			91	79	196	72	76*
		2000	94	81	263	93	107*
			80	77	286	120	107*
		3000	90	79	248	92	99*
			89	79	282	106	99*
		4000	91	73	297	109	101*
			90	79	249	92	101*
		5000	77	80	221	96	90*
			85	88	214	84	90*
Positive Control	3-Methylcholanthrene	2.5	45	24	623	458	432*
Positive Control			54	19	651	406	432*

Induced S9 Trial: 3 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Fischer Medium	0	81	88	93	39	39
			82	87	105	43
			85	108	110	43
			75	117	71	32
Test Chemical	FD & C yellow no. 6	1000	78	80	141	61	60
			76	73	135	59	60
		2000	78	86	185	79	66*
			76	65	118	52	66*
		3000	73	84	203	93	95*
			76	70	224	98	95*
		4000	71	86	188	88	89*
			64	84	172	90	89*
		5000	70	81	213	102	97*
			71	86	196	92	97*
Positive Control	3-Methylcholanthrene	2.5	32	13	456	470	476*
Positive Control			26	8	380	481	476*

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