Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-03243-0001-0000-5
Chemical Name:	Oxytetracycline hydrochloride
CASRN:	2058-46-0
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	739218
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: 2 Experiment Call: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	60	101	122	68	61
			72	99	116	53
			19r	34	12	21
			30r	53	60	67
Test Chemical	Oxytetracycline hydrochloride	12.5	66	103	116	58	59
			69	113	124	60	59
		25	66	106	121	61	67
			52	96	113	73	67
		50	85	141	90	35	46
			52	94	89	57	46
		100	51	65	87	56	49
			82	91	100	41	49
		200	74	84	82	37	53
			52	66	108	69	53
		400	60	35	95	53	57
			54	44	100	62	57
		800

Positive Control	Ethyl Methane Sulfonate	200	72	73	433	201	208*
Positive Control			85	78	547	216	208*

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	44r	59	193	147	72
			37r	57	145	131
			72	108	181	84
			77	92	139	60
Test Chemical	Oxytetracycline hydrochloride	200	78	35	225	96	128*
			56	35	238	141
			70	32	310	147
		400	18	2	2532	4604	4401*
			24	3	2194	3047
			14	2	2249	5553
		500	7r	1	2785	12953
			9r	1	2012	7316
			11	1	2417	7553
		600	5r	0	2338	16124
			7r	1	2283	11137
			7r	1	2425	12125
		800	9r	1	1647	6459
			6r	1	1938	11074
			8r	1	1889	8038
Positive Control	Ethyl Methane Sulfonate	250	58	73	585	335	351*
Positive Control			57	65	625	367	351*

Nonactivation Trial: 4 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	98	109	133	45	59
			83	91	151	61
			80	95	168	70
			76	105	140	61
Test Chemical	Oxytetracycline hydrochloride	100	102	81	187	61	65
			80	86	164	68	65
		200	73	37	216	98	91
			76	40	190	83	91
		300	23	7	954	1393	2594*
			12	4	1404	3795	2594*
		400	2r	0	2307	35492
			3r	1	1339	14095
		500	3r	0	1613	17922
			1r	0	1338	33450
Positive Control	Methyl Methane Sulfonate	15	63	35	437	231	243*
			58	41	446	256	243*
	Methyl Methane Sulfonate	250	71	79	523	244	244*
			67	71	486	244	244*

Nonactivation Trial: 5 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	115	98	80	23	23
			93	111	67	24
			104	100	79	25
			96	92	58	20
Test Chemical	Oxytetracycline hydrochloride	100	94	73	60	21	25
			91	76	78	29	25
		200	84	51	119	47	38*
			83	42	71	29	38*
		300	49	15	161	110	106*
			52	15	159	102	106*
		400	21	3	225	357
			10r	2	380	1288
		500	5r	1	377	2513
			3r	0	279	3100
Positive Control	Methyl Methane Sulfonate	15	39	25	160	137	120*
Positive Control			39	30	121	103	120*

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	70	118	166	79	86
			76	95	181	79
			65	85	176	91
			54	102	152	94
Test Chemical	Oxytetracycline hydrochloride	25	69	102	204	99	92
			73	98	189	86	92
		50	62	85	179	96	94
			73#	66	201	92	94
		100	46#	34	238.5	175	160*
			71#	29	307.5	144	160*
		200	13#	4	1351	3464
			4r	1	920	8000
		400	4r	1	1651	14676

		800

Positive Control	3-Methylcholanthrene	2.5	38#	33	663	584	498*
Positive Control			58	40	712	412	498*

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	92	170	74	68
			72	103	136	63
			72	101	162	75
			77	104	134	58
Test Chemical	Oxytetracycline hydrochloride	50	73	68	145	66	74
			62	67	151	81	74
		100	103	39	275	89	97
			60	37	186	104	97
		200	63	12	1253	668	804*
			46	10	1284	941	804*
		400	17	2	2770	5431
			8r	1	2467	10498
		800

Positive Control	3-Methylcholanthrene	2.5	31	14	884	940	924*
Positive Control			27	15	735	907	924*

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	95	100	191	67	58
			102	98	171	56
			108	105	166	51
			117	96	197	56
Test Chemical	Oxytetracycline hydrochloride	100	81	31	482	199	200*
			78	28	472	201	200*
		200	11r	2	1548	4691
			7r	1	1533	7130
		300	13r	2	642	1712
			4r	1	626	5962
		400	4r	1	671	5162
			4r	1	545	4192
		500	3r	0	711	7900
			4r	0	624	4800
Positive Control	3-Methylcholanthrene	2.5	59	32	716	402	371*
Positive Control			74	36	756	339	371*

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