Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-01465-0015-0000-4
Chemical Name:	4,4'-Methylenebis(2-chloroaniline)
CASRN:	101-14-4
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	G10679
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
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	121r	161	87	24
Vehicle Control			113	124	88	26
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	98#	68	85.5	29	30
			95	46	90	32	30
		10	77	41	104	45	36
			93	50	74	26	36
		20	82#	57	102	42	36
			86	54	78	30	36
		40	62	24	86	46	42
			65	19	75	38	42
		60	81	10	71	29	32
			78	8	83	36	32
		80

Positive Control	Ethyl Methane Sulfonate	500	51	32	751	488	444*
Positive Control			62	32	750	401	444*
Negative Control	Negative (Not Specified)	0	79	89	65	27	33*
Negative Control			78	87	91	39	33*

Nonactivation Trial: 2 Experiment Call: No Call
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	99	89	48	16	16
Vehicle Control			107#	104	53	16	16
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	86	82	77	30	29*
			62	54	51	27	29*
		10	85#	64	66	26	19
			94	88	36	13	19
		20	112#	96	55.5	16	20
			99#	83	67.5	23	20
		40	94#	69	72	25	23
			101#	63	64	21	23
		60	114#	57	67	20	22
			95	58	70	25	22
		80

Positive Control	Ethyl Methane Sulfonate	500	46	23	809	588	583*
Positive Control			40	31	700	579	583*
Negative Control	Negative (Not Specified)	0	108	118	59	18	24*
Negative Control			102	89	92	30	24*

Nonactivation Trial: 3 Experiment Call: No Call
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	78	101	71	30	33
			123r	118	101	27
			111	99	122	37
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	12.5	111	145	46	14	22
			102	133	95	31	22
		25	117	112	65	19	20
			108#	126	72	22	20
		50	104	86	71	23	22
			109	89	70	21	22
		70	121r	61	113	31
			118	65	84	24
		75	120	53	129	36
		80	117	34	131	37	36
			111	67	117	35	36
Positive Control	Ethyl Methane Sulfonate	500	66	31	1255	634	683*
Positive Control			51	37	1120	732	683*

Nonactivation Trial: 4 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	95	90	32	11	12
			86	102	23	9
			102	115	52	17
			94	93	35	12
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	86	98	31	12	10
			75	79	22	10
			91	98	26	10
		10	103	92	35	11	12
			69	65	25	12
			92	67	38	14
		20	85	79	31	12	12
			97	84	32	11
			94	86	39	14
		40	77	50	46	20	17
			96	70	35	12
			81	54	43	18
		60	78	19	25	11	10
			101	22	22	7
			103	61	36	12
		80	86	10	27	10	14
			91	8	46	17

		100


Positive Control	Ethyl Methane Sulfonate	500	31#	16	821	876	900*
			40#	24	919	771
			27	15	864	1054

Nonactivation Trial: 5 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	83	94	182	73	65
			90	87	188	70
			72#	100	135	62
			98	119	160	55
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	111	114	160	48	51
			94	99	127	45
			93	112	166	59
		10	91	101	177	65	57
			71	95	104	49
			90	91	153	57
		20	99	110	153	51	60
			65	76	133	69
			88	105	161	61
		40	117	79	182	52	60
			94	84	160	57
			79	74	169	71
		60	100	46	173	58	85
			81	8	260	107
			92	20	245	89
		80



Positive Control	Ethyl Methane Sulfonate	250	50#	35	862	575	604*
Positive Control			46	30	872	634	604*

Induced S9 Trial: 1 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	109	106	59	18	18
Vehicle Control			91	89	51	19	18
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	80	31	156	65	68*
			67	34	143	71	68*
		10	66	47	183	93	92*
			75#	35	207	92	92*
		20	87	36	113	43	63*
			64	39	161	83	63*
		40	89	40	152	57	60*
			86	42	161	62	60*
		60	88	13	164	62	69*
			69	23	157	76	69*
		80	85	13	169	66

		100

Positive Control	3-Methylcholanthrene	5	44	14	538	411	350*
Positive Control			56	28	482	289	350*
Negative Control	Negative (Not Specified)	0	81	121	57	24	24*
Negative Control			89#	84	66	25	24*

Induced S9 Trial: 2 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	72	116	82	38	44
Vehicle Control			73	83	111	51	44
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	79	112	72	30	37
			85	96	111	43	37
		10	81	55	107	44	49
			72	48	114	53	49
		20	76	22	148	65	62
			81	23	146	60	62
		40	40	4	170	142	124*
			51	5	164	106	124*
		60

Positive Control	3-Methylcholanthrene	5	30#	8	315	348	422*
Positive Control			10	2	151	495	422*
Negative Control	Negative (Not Specified)	0	82	101	78	32	34*
Negative Control			104	100	115	37	34*

Induced S9 Trial: 4 Experiment Call: Positive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	65	75	83	43	38
			74	96	82	37
			78	107	90	38
			69	122	71	34
Test Chemical	4,4'-Methylenebis(2-chloroaniline)	5	43#	46	103	80	64*
			57	75	106	62
			65	54	100	51
		10	63	41	151	80	72*
			58	46	112	64
			71	50	151	71
		20	80	27	249	104	107*
			64	26	230	120
			70	34	205	98
		30	50	20	232	156	142*
			57	18	214	125
			61	21	267	146
		40	60	16	217	121	142*
			54	16	227	141
			50	15	244	163
		60
			70	8	222	106

		80

Positive Control	3-Methylcholanthrene	5	44	33	505	381	438*
			36	28	529	490
			37	21	495	442

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