Genetic Toxicology - Mammalian Cell Mutagenicity

Study Information
Study Attribute	Value
CEBS Accession Number:	002-02373-0010-0000-8
Chemical Name:	Lithocholic acid
CASRN:	434-13-9
NTP Study Type:	Genetic Toxicology - Mammalian Cell Mutagenicity
NTP Study ID:	G78265
Study Result:	Negative

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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:
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	54	89	43	26	23
			55	72	33	20
			40r	47	71	59
			51	138	36	24
Test Chemical	Lithocholic acid	3.9	70	47	49	23	22
			60	43	38	21	22
		7.8	61	43	45	24	24
			57	43	39	23	24
		15.6	69	56	28	13	15
			61	58	30	16	15
		31.3	61#	61	28.5	16	16
			50	31	24	16	16
		62.5	38	5	52	45	36
			39	5	32	28	36
		93.8

Positive Control	Ethyl Methane Sulfonate	500	7r	6	516	2345	571*
Positive Control			24	18	411	571	571*

Nonactivation Trial: 2 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	90	88	37	14	15
			97	91	45	15
			98	120	49	17
Test Chemical	Lithocholic acid	25	91	87	49	18	18
			93	97	50	18	18
		50	94	99	44	16	15
			102	116	45	15	15
		62.5	110	98	51	15	16
			111	106	56	17	16
		80	94	81	35	12	17
			104	70	69	22	17
		100	97	61	62	21	21
			93	49	56	20	21
Positive Control	Ethyl Methane Sulfonate	500	54	23	734	457	493*
			54	28	829	515
			52	33	797	508

Nonactivation Trial: 3 Experiment Call: Negative and Non-Toxic
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	93	99	30	11	13
			87	100	33	13
			94	107	35	12
			98	94	47	16
Test Chemical	Lithocholic acid	3.13	94	111	45	16	14
			99	118	47	16
			107	123	29	9
		6.25	110	104	44	13	12
			115	151	32	9
			88	101	37	14
		12.5	97	141	63	22	17
			103	125	38	12
			94	96	48	17
		25	86	93	47	18	17
			85	97	43	17
			102	79	47	15
		50	91	67	44	16	16
			80	71	44	18
			100	75	42	14
		100


Positive Control	Ethyl Methane Sulfonate	500	65	36	773	397	588*
			35	23	824	789
			52	36	900	579

Non-Induced S9 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	67	111	61	30	35
			92	81	115	42
			94	111	116	41
			66	97	53	27
Test Chemical	Lithocholic acid	6.25	86	125	114	44	42
			84	111	101	40	42
		12.5	78	107	111	48	47
			89	107	124	46	47
		25	82	98	72	29	33
			69	99	75	36	33
		50	88	52	61	23	29
			76	33	80	35	29
		70

Positive Control	3-Methylcholanthrene	7	64	55	290	152	166*
			61	79	314	173
			64	70	331	172

Non-Induced S9 Trial: 2 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	62	77	71	38	30
			82	97	59	24
			70	101	82	39
			87	125	50	19
Test Chemical	Lithocholic acid	5	94	133	67	24	36
			70	125	119	57
			68	114	57	28
		10	67	112	83	41	40
			57	99	57	33
			63	96	86	46
		20	74	124	86	39	44
			70	112	70	33
			59	74	106	60
		30	72	81	71	33	34
			98	130	94	32
			73	121	82	38
		40	92	42	103	37	40
			74	42	106	48
			87	45	92	35
		50


Positive Control	3-Methylcholanthrene	7	78	61	302	129	148*
			55	67	217	133
			69	48	377	183

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	Dimethyl Sulfoxide	0	50r	44	96	64	49
			71	133	94	44
			56	89	93	55
			51	79	71	46
Test Chemical	Lithocholic acid	1.88	58	79	91	53	55
			68	88	119	58	55
		3.75	96	126	115	40	45
			66	107	100	50	45
		7.5	59	94	102	57	50
			80	84	104	43	50
		15	78	89	124	53	68
			57	56	141	82	68
		30	80	72	128	53	60
			62	71	124	67	60
Positive Control	3-Methylcholanthrene	5	29	15	501	569	500*
Positive Control			35	19	448	431	500*

Induced S9 Trial: 2 Experiment Call: Inconclusive
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	79	95	84	35	37
			89	100	120	45
			92	98	102	37
			91	107	86	31
Test Chemical	Lithocholic acid	1.88	79	87	76	32	32
			80	92	77	32	32
		3.75	77	99	80	35	36
			73	97	82	37	36
		7.5	79	110	98	42	46
			76	101	113	50	46
		15	73	76	94	43	44
			79	104	105	44	44
		30	69	72	80	39	42
			68	60	91	45	42
		45	76	22	146	64	56
			74	21	108	48	56
		60

Positive Control	3-Methylcholanthrene	5	67	59	431	214	208*
			63	62	354	187
			63	49	419	221

Induced S9 Trial: 3 Experiment Call: Negative
		Conc. ug/mL	Cloning Efficiency	Relative Total Growth	Mutant Colonies	Mutant Frequency	Avg Mutant Frequency
Vehicle Control	Dimethyl Sulfoxide	0	98	99	98	33	32
			92#	94	75	27
			85	88	82	32
			104	118	105	34
Test Chemical	Lithocholic acid	3.8	83	83	107	43	43
			77	54	98	43	43
		7.5	76	90	127	56	52*
			83	84	121	49	52*
		15	85	84	114	45	44
			77	78	100	43	44
		30	113	47	166	49	27
			98	33	12	4	27
		37.5	97	14	114	39	48

			102	20	175	57
		45	80	8	101	42	45

			96	9	136	47
		52.5


Positive Control	3-Methylcholanthrene	5	52#	23	445.5	287	338*
			43	26	477	373
			39	19	416	356

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