Butyl(ethyl)amine

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1987

Report date:

1987

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Method: other: acc. to Haworth et al. 1983

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Butyl(ethyl)amine

EC Number:

236-415-0

EC Name:

Butyl(ethyl)amine

Cas Number:

13360-63-9

Molecular formula:

C6H15N

IUPAC Name:

butyl(ethyl)amine

Details on test material:

- Name of test material (as cited in study report): Ethyl-N-Butylamine
- Source: Aldrich
- Purity: 99%

Method

Species / strain

Species / strain / cell type:

other: TA 98, 100, 1535, 1537

Metabolic activation:

with and without

Metabolic activation system:

microsomes from rat liver and hamster liver

Test concentrations with justification for top dose:

0, 10, 33, 100, 333, 1000, 3333 µg/plate

Vehicle / solvent:

DMSO

Details on test system and experimental conditions:

Standard Salmonella typhimurium reverse mutation assay

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:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: preincubation

Any other information on results incl. tables

Strain 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	139	8.7	108	7.9	197	19.2	157	5.7	174	7.2	169	16.1
33	131	11.7	115	5.6	175	8.4	172	11.6	211	8.1	167	16.9
100	136	5	108	9.6	177	3.5	146	2.8	205	11.9	176	2.2
333	132	8.4	110	1.2	171	13.3	159	8.6	197	6.1	164	14.9
1000	128	6	94	3	168	3.4	143	4.8	190	5.6	158	15
3333	141	4.1	102	7.8	142	8.4	121	9.5	165	11.6	133	4.9
Positive Control	1165	54.9	1226	71.9	1416	138.1	1972	90.9	2061	147.8	1595	129

Strain 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	20	0.9	10	1.9	28	2.1	16	0.3	26	1.5	13	2.2
10			14	1.8			22	2.3			9	1.5
33	19	1.9	18	4.7	32	2.5	19	0.9	20	0.6	13	2.7
100	25	3.8	13	1.7	28	3.2	24	1.5	20	2.1	14	0.7
333	24	2.3	11	0.7	28	2.9	20	2.1	23	2.6	12	1.3
1000	17	1.2	9	1.5	27	1.2	15	1.3	19	0.3	10	1.5
3333	0	0			0	0			0	0
Positive Control	1322	31.2	1002	81.7	371	29.4	244	5.9	670	139.1	161	7.7

Strain 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	13	1.5	13	0.6	23	2.8	22	0.9	19	0.9	16	1.8
10							22	5.2
33	11	0.6	10	1	26	2.1	18	2.1	19	2	24	1.2
100	15	1.8	14	1.9	24	3.5	22	1.3	17	0.9	21	0.9
333	11	1.9	6	4.1	23	2.3	22	1.5	19	1.5	18	2.2
1000	20	1.3	10	3.5	26	0.9	23	4.5	13	1.5	19	2.9
3333	0	0.3	t		0	0			2	0.9	2	0.9
Positive Control	363	39.1	631	81	220	20.1	289	14.8	364	31.3	634	10.1

Strain TA98

Dose	No Activation (Negative)		No Activation (Equivocal)		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	20	2	14	1.2	34	3.2	27	3.6	33	3.2	25	2.1
33	31	3.2	19	2	27	2.6	29	2.9	33	2.5	25	1.5
100	24	4	25	2.3	21	4	23	0.6	32	3.5	28	2.3
333	29	3.3	25	3.5	17	2.8	21	1.7	28	3.7	22	1.2
1000	23	3.8	20	4.3	22	0.6	28	2.6	29	4.4	25	2
3333	19	4.1	26	0.3	19	5.8	16	0.7	17	2.6	19	0.9
Positive Control	221	14	242	17.8	1348	172.6	2062	65	854	139.4	1671	36.3

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

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Butylethylamine (10 -3333 µg/plate) was negative in a bacterial reverse mutation assay (Ames test; preincubation), with and without metabolic acitivation using liver microsomes from Syrian hamster and rat liver. The Salmonella typhimurium test strains were TA100, TA1535, TA1537, and TA98. Cytotoxicity was seen at 1000 or 3333 µg/plate, depending on the test strain (Zeiger, 1987).

The study is fully reliable and suitable for assessment.