Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-02879-0009-0000-7
Chemical Name:	Tetracycline hydrochloride
CASRN:	64-75-5
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	615800
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: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	92	94	104	38	40
			99	111	108	36
			107	104	109	34
			79	92	124	53
Test Chemical	Tetracycline hydrochloride	40	112	77	119	35	42
			102	96	127	41
			74	89	108	49
		50	82	98	97	39	42
			83	66	118	47
			86	82	100	39
		60	86	82	143	55	45
			69	82	82	40
			106	83	123	39
		80	92	65	94	34	35
			74	69	66	30
			89	67	109	41
		100	84	61	107	42	48
			75	39	121	54
			75	37	106	47
		200


Positive Control	Methyl Methane Sulfonate	5	72	44	973	449	401*
			63	68	744	395
			61	77	661	360

Nonactivation Trial: 2 Experiment Call: Equivocal
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	113	105	99	29	32
			110	102	86	26
			114	102	134	39
			98	92	96	33
Test Chemical	Tetracycline hydrochloride	50	82	56	81	33	31
			77	82	73	32
			103	75	90	29
		60	99	84	97	33	35
			86	83	93	36
			86	80	94	36
		80	123r	70	87	24	31
			88	78	83	31
			87	71	78	30
		100	107	53	111	35	35
			94	67	84	30
			87	63	107	41
		150	77	26	97	42	37
			80	35	93	39
			100	32	88	29
		200	64	6	136	70	62*
			64	6	107	56
			78	7	139	59
Positive Control	Methyl Methane Sulfonate	5	71	44	582	273	280*
			67	36	526	261
			58	38	534	305

Nonactivation Trial: 3 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	53	90	53	33	29
			59	96	64	36
			71	103	41	19
			81	112	66	27
Test Chemical	Tetracycline hydrochloride	25	88	138	56	21	23
			116	146	74	21
			79	110	62	26
		50	88	117	56	21	24
			102	107	66	21
			77	117	69	30
		75	98	111	59	20	19
			82	98	58	24
			106	131	40	13
		100	79	72	66	28	25
			87	70	79	30
			105	84	56	18
		150	60	23	97	54	37
			72	30	61	28
			68	33	56	28
		200	66	7	79	40	76*
			82	13	64	26
			18	2	88	163
		300


Positive Control	Methyl Methane Sulfonate	5	73	79	334	152	143*
			65	68	269	139
			53	59	222	139

Non-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	69	115	115	56	35
			90	82	79	29
			71	102	48	22
			62	101	58	31
Test Chemical	Tetracycline hydrochloride	20	53	91	60	38	38
			45	115	56	41
			61	82	63	35
		30	62	86	97	52	48
			55	55	83	50
			68	75	83	41
		40	64#	70	53	28	44
			48	41	102	70
			59	71	60	34
		50

		60	65	34	94	48	66*
			42	20	84	66
			34	31	83	83
		80					72*
			49	17	102	70
			44	12	98	75
		100


Positive Control	3-Methylcholanthrene	3.5	66	51	487	246	218*
			85	80	523	206
			100	35	607	202

Non-Induced S9 Trial: 2 Experiment Call: Equivocal
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	111	98	119	36	38
			93	106	118	42
			119	100	128	36
			92	96	108	39
Test Chemical	Tetracycline hydrochloride	40	92	48	92	33	32
			105	56	112	36
			96	65	76	26
		50	89	47	127	48	44
			105#	61	135	43
			88	58	110	42
		60	90	32	131	49	39
			94	41	92	33
			107	43	117	37
		80	116	19	116	33	36
			100	22	83	28
			114	23	156	46
		100	90	14	148	55	50
			94	15	135	48
			84	18	116	46
		120	74	9	159	71	63*
			87	12	141	54
			75	11	146	65
Positive Control	3-Methylcholanthrene	3.5	85	48	593	233	209*
			99	54	619	208
			95	67	529	185

Non-Induced S9 Trial: 3 Experiment Call: Equivocal
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	112	112	123	37	41
			89	103	125	47
			101	86	105	35
			92	100	126	46
Test Chemical	Tetracycline hydrochloride	40	78	60	99	42	35
			78	62	65	28	35
		60	78	39	83	36	32
			85	31	72	28
			64#	37	63	33
			71	23	68	32
		80	76	21	57	25	43
			76	19	170	74
			86#	18	114	44
			84	21	71	28
		100	85	14	137	54	49
			98	18	177	60
			87	14	110	42
			98	16	123	42
		120	63	8	118	62	65*
			71	8	126	59
			78	11	184	78
			66	8	115	58
Positive Control	3-Methylcholanthrene	3.5	122r	71	708	194	220*
			102	70	711	233
			96#	80	594	206

Induced S9 Trial: 1 Experiment Call: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	94	88	67	24	32
			92	87	92	33
			104	104	103	33
			97	121	110	38
Test Chemical	Tetracycline hydrochloride	10	81	76	62	26	29
			74	78	63	28
			98	77	94	32
		20	97	68	50	17	18
			70	75	42	20
			79	96	43	18
		30	70	62	58	28	25
			102	65	77	25
			89	53	58	22
		40	80	70	70	29	28
			100	81	77	26
			102	99	85	28
		50	93	62	55	20	24
			78	50	66	28
			81	59	59	24
		60	104	41	104	33	24
			86	56	53	21
			104	49	60	19
Positive Control	3-Methylcholanthrene	2.5	58	40	410	234	224*
			83	48	609	246
			86	37	497	192

Induced S9 Trial: 2 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	94	100	90	32	33
			86	96	94	37
			92	91	77	28
			94	113	97	35
Test Chemical	Tetracycline hydrochloride	40	83	55	95	38	40
			92	66	113	41	40
		50	110	56	70	21	24
			104	66	92	30
			108	63	67	21
		60	104	51	81	26	29
			105	42	122	39
			108	58	76	23
		80	100	26	98	33	38
			117	24	119	34
			90	24	126	47
		100	96	16	121	42	41
			72	10	88	41
			87	15	105	40
		120	77	10	147	63	49*
			103	12	102	33
			82	8	122	50
Positive Control	3-Methylcholanthrene	2.5	42	15	524	419	326*
			72	25	568	265
			65	18	575	293

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