tert-butylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test comparable to guideline test.

Data source

Reference

Reference Type:

publication

Title:

Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals

Author:

Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K., and Speck, W. et al.

Year:

1987

Bibliographic source:

Environ. Mol. Mutagen. 9: 1-110

Materials and methods

Principles of method if other than guideline:

Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

tert-butylamine

EC Number:

200-888-1

EC Name:

tert-butylamine

Cas Number:

75-64-9

Molecular formula:

C4H11N

IUPAC Name:

2-methylpropan-2-amine

Details on test material:

CAS 75-64-9 (tert-butylamine), purity not indicated

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

deficiency: histidine

Metabolic activation:

with and without

Metabolic activation system:

rat and hamster S9 (10% Aroclor 1254-induced)

Test concentrations with justification for top dose:

0, 33, 100, 333, 1000, 1666 and 3333 ug/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

- Positive control groups and treatment: without S9: Sodium azide (TA1535, TA100), 9-aminoacridine (TA1537), 4-nitro-o-phenylenediamine (TA98). With S9: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

Positive if a reproducible dose related response over the solvent control was obtained.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 1000 ug/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Precipitation concentration: not indicated
Cytotoxic concentration: 1000 ug/plate

Mutagenicity:
- With metabolic activation: negative
- Without metabolic activation: negative

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

TA1535

Dose	No Activation (Negative)		No Activation (Negative)		10% HLI (Negative)		10% HLI (Negative)		10% RLI (Negative)		10% RLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	4	1.2	7	2.1	5	1.2	22	2	5	0.9	15	2.2
33					5	0.9	20	3.2	5	1	15	0.7
100	3	0.6	4	1.2	4	2.1	14	2.9	5	1.9	12	2.1
333	1	1	4	0.6	5	0.7	21	6.1	6	1.2	12	0.7
1000	4	0.9	6	0.9	5	1.2	8	0.7	5	0.7	10	2.1
3333	4	0.7	5	1.2	9	0.9	t		4	1.5	t
10000	4	1.2	0t	0
Positive Control	1280	127.7	742	30.7	93	4.3	290	19.1	96	4.7	188	17.8

 

TA100

Dose	No Activation (Negative)		No Activation (Negative)		10% HLI (Negative)		10% HLI (Negative)		10% RLI (Negative)		10% RLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	160	6.8	97	3.6	146	3	179	1.3	111	4.8	159	5.7
33					105	3.1	188	14.2	93	10	171	5.3
100	155	5.2	86	4.3	114	13.3	181	12.9	86	5.5	184	9.6
333	161	8.2	96	10.5	100	7	170	10.9	96	3.8	182	11.4
1000	147	0	101	8.5	84	6.2	186	5	83	4.1	173	10
3333	165	11.9	94	7	77t	6.5	134	5.2	80	3.6	138	10.9
10000	11	10.7	t
Positive Control	1032	16.4	1616	45.9	2049	77.5	1971	201.8	1621	142.2	2183	283.7

 

TA98

Dose	No Activation (Negative)		No Activation (Negative)		10% HLI (Negative)		10% HLI (Negative)		10% RLI (Negative)		10% RLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	13	0.9	10	0.3	23	4.4	44	2.6	25	1	18	3.5
33					23	3.8	40	1.5	24	2.6	19	3.8
100	11	0.9	10	0.9	16	3	37	2.2	23	0.9	23	1.8
333	12	1	12	1.3	22	4.7	34	1.7	29	0.9	23	4
1000	11	2.2	9	0.7	18	2.4	33	1.2	19	1.5	20	1.7
3333	14	1	12	2.3	t		17	1.9	15	1.5	17	1.2
10000	13	1.8	3	2.5
Positive Control	155	17.2	171	9	838	36.6	1176	67	425	46.3	696	31.1

 

TA1537

Dose	No Activation (Negative)		No Activation (Negative)		10% HLI (Negative)		10% HLI (Negative)		10% RLI (Negative)		10% RLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	6	1.9	3	0.9	4	0.6	11	1.8	4	0.7	7	0.7
33					4	1.2	13	1.2	5	1	5	1.5
100	7	1.7	6	0.9	4	1.2	12	2.5	8	1.9	8	1.5
333	5	1.5	4	1.2	8	3.5	9	2.5	7	1	7	0.7
1000	4	0.7	3	0.9	5	1.9	13	5.5	3	0.7	6	1.5
3333	6	0.7	4	0.7	5	0.7	4	1.5	5	1.2	5	1
10000	4	1	1t	0.5
Positive Control	82	5.2	129c	33.5	162	25.4	212	26	262	29.7	337	12.8

 

Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination