Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-01931-0031-0000-0
Chemical Name:	Cyclophosphamide
CASRN:	50-18-0
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	G40430
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	94	103	133	47	45
Vehicle Control			97	106	126	44	45
Test Chemical	Cyclophosphamide	313	109	89	140	43	37
			96	83	90	31	37
		625	88	79	127	48	47
			89	85	122	46	47
		1250	80#	69	114	47	63
			89	73	210	79	63
		2500	95	60	352	124	135*
			77	63	338	147	135*
		5000	45	17	743	548	457*
			61	23	663	365	457*
Positive Control	Ethyl Methane Sulfonate	500	87	69	955	365	375*
Positive Control			73#	54	840	384	375*
Negative Control	Negative (Not Specified)	0	114#	102	78	23	24*
Negative Control			94	89	74	26	24*

Nonactivation Trial: 2 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	87#	95	96	37	40
Vehicle Control			79	93	104	44	40
Test Chemical	Cyclophosphamide	313	92	190	76	27	33
			92	189	108	39	33
		625	102	167	105	34	32
			84#	149	76.5	31	32
		1250	89	128	180	68	74*
			65	98	156	80	74*
		2500	84	101	293	117	109*
			84	125	256	102	109*
		5000	84	52	641	254	336*
			36	20	455	417	336*
		9999.9

Positive Control	Ethyl Methane Sulfonate	500	65	29	1285	659	660*
Positive Control			65	29	1279	661	660*
Negative Control	Negative (Not Specified)	0	86	109	112	44	35*
Negative Control			105	103	83	26	35*

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	102	88	63	21	15
			96	102	36	13
			95	98	43	15
			91	112	31	11
Test Chemical	Cyclophosphamide	313	102	100	75	25	28*
			105	68	97	31	28*
		625	88	94	87	33	27*
			102	94	64	21	27*
		1250	75	72	109	49	51*
			89	66	140	53	51*
		2500	75	50	212	95	105*
			86	50	298	115	105*
		4000	76	27	332	146	165*
			70#	19	390	185	165*
		5000	42	9	370	294	306*
			47	9	449	318	306*
Positive Control	Ethyl Methane Sulfonate	500	65	61	572	295	288*
			82	61	711	289
			86	66	723	279

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	93	115	105	38	47
Vehicle Control			80	83	135	56	47
Test Chemical	Cyclophosphamide	0.39	86	64	113	44	47
			94#	37	141	50	47
		1.56	61	65	129	70	78*
			64	85	167	87	78*
		3.13	72	65	302	141	131*
			48#	48	175.5	121	131*
		6.25	28	17	234	280	254*
			40#	16	269	227	254*
		12.5	6r	2	80	457
			7r	1	136	618
Positive Control	3-Methylcholanthrene	5	68	40	386	190	189*
Positive Control			68	39	383	188	189*
Negative Control	Negative (Not Specified)	0	91	97	103	38	39*
Negative Control			82	105	100	41	39*

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	79	102	90	38	42
Vehicle Control			104	98	142	46	42
Test Chemical	Cyclophosphamide	0.78	89#	84	176	66	67
			86	79	173	67	67
		1.56	67#	58	235	117	124*
			64	75	250	131	124*
		3.13	65	59	340	175	190*
			52	47	323	205	190*
		6.25	33#	19	354	363	319*
			39	27	321	276	319*
		12.5	5r	1	65	433
			4r	1	49	392
Positive Control	3-Methylcholanthrene	5	82#	50	423	173	172*
Positive Control			75	39	384	171	172*
Negative Control	Negative (Not Specified)	0	98	96	135	46	39*
Negative Control			92	103	86	31	39*

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	109	85	66	20	19
Vehicle Control			106	115	56	18	19
Test Chemical	Cyclophosphamide	1	74	51	158	71	76*
			47	34	114	82	76*
		2	45	30	191	142	146*
			40	29	180	151	146*
		3	39	14	313	265	242*
			37	17	243	218	242*
		4	35	9	279	266	289*
			25	7	232	311	289*
		6	19	2	226	407
			11r	1	139	415
		8
			4r	0	42	350
		10

Positive Control	3-Methylcholanthrene	5	53	22	454	284	305*
			58	20	564	325
			50	24	464	307

Induced S9 Trial: 4 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Water	0	105	100	117	37	36
			79	103	73	31
			100	103	117	39
			87	94	96	37
Test Chemical	Cyclophosphamide	1	52	60	138	88	83*
			69	59	162	79	83*
		2	34	21	144	143	132*
			54	25	197	121	132*
		3	17	6	150	291	266*
			24	8	170	241	266*
		4	6r	2	43	226
			9r	2	47	184
		6	1r	0	40	1333
			3r	0	17	212
Positive Control	3-Methylcholanthrene	5	40	22	392	324	306*
			44	25	405	305
			55	25	473	288

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