N-benzyl-N-ethylaniline

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication .

Data source

Reference

Reference Type:

publication

Title:

Salmonella Mutagenicity Tests: IV. Results from the Testing of 300 Chemicals

Author:

Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, and Kristien Mortelmans

Year:

1988

Bibliographic source:

Environmental and Molecular Mutagenesis Volume 11, Supplement 12: 1-158 (1988)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

To evaluate the mutagenic potential of N-Ethyl-N-phenyl benzyl amine in Salmonella typhimurium strains TA97, TA98, TA100, and TA1535 by Ames tests.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-benzyl-N-ethylaniline

EC Number:

202-169-8

EC Name:

N-benzyl-N-ethylaniline

Cas Number:

92-59-1

Molecular formula:

C15H17N

IUPAC Name:

N-benzyl-N-ethylaniline

Test material form:

liquid

Details on test material:

- Name of test material: N-benzyl-N-ethylaniline
- Molecular formula: C15H17N
- Molecular weight : 211.306 g/mol
- Smiles notation: N(c1ccccc1)(Cc1ccccc1)CC
- InChl: 1S/C15H17N/c1-2-16(15-11-7-4-8-12-15)13-14-9-5-3-6-10-14/h3-12H,2,13H2,1H3
- Substance type: Organic
- Physical state: Liquid

Specific details on test material used for the study:

- Name of test material: N-benzyl-N-ethylaniline
- Molecular formula: C15H17N
- Molecular weight : 211.306 g/mol
- Smiles notation: N(c1ccccc1)(Cc1ccccc1)CC
- InChl: 1S/C15H17N/c1-2-16(15-11-7-4-8-12-15)13-14-9-5-3-6-10-14/h3-12H,2,13H2,1H3
- Substance type: Organic
- Physical state: Liquid

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA97, TA98, TA100, TA1535

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

Not specified .

Metabolic activation:

with and without

Metabolic activation system:

S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters liver

Test concentrations with justification for top dose:

0.000,100.000,333.000,1000.000,3333.000,6666.000,10000.000 µg/plate

Vehicle / solvent:

DMSO(Dimethyl sulfoxide)

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Positive control in absence of metabolic activation: sodium azide (for strain TA1535 and TA100), 9-aminoacridine (TA97 and TA 1537), and 4-nitro-o-phenylenediamine (TA98). Positive control in presences of metabolic activation: 2-aminoanthracene

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: Preincubation method

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days

Rationale for test conditions:

Not specified

Evaluation criteria:

Number of histidine-independent (his+) colonies

Statistics:

Standard deviation was observed.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA97, TA98, TA100, TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: Chemical was tested by their half life dose intervals up to doses that elicited toxicity, or to a dose immediately below one which was toxic in the preliminary toxicity test and subsequent dose increments and may not have included doses in the toxic range were used.

Any other information on results incl. tables

N-benzyl-N-ethylaniline Result for AMES test

Dose (µg/plate)	TA100
	NA (-)		10% HLI (-)		10% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	103	3.5	105	9.4	128	6.4
100	94	2.9	98	8.6	107	2.4
333	95	1.9	95	3.2	127	5.9
1000	96	4.3	92	5.2	115	8.4
3333	90P	3.5	88P	0.9	98P	1.5
6666	89P	2.8
10000			100P	1.7	110P	1.9
Positive control	601	12.4	2276	47.7	724	34.5

 

Dose (µg/plate)	TA100
	NA (-)		30% HLI (-)		30% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	103	3.5	99	1.9	120	10
100	94	2.9	114	7.0	130	13
333	95	1.9	105	9.3	126	7.3
1000	96	4.3	97	3.8	105	7.2
3333	90P	3.5	88P	1.0	95P	8.7
6666	89P	2.8	-	-	-	-
10000			93P	3.8	88P	6.1
Positive control	601	12.4	2067	38.7	761	7.3

 

Dose (µg/plate)	TA1535
	NA (-)		10% HLI (-)		10% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	9	1.8	9	1.7	12	0.9
100	11	1	6	0.9	8	1.2
333	12	2.8	5	2.0	10	1.2
1000	8	1.2	5	0.9	8	0.3
3333	5P	1.2	5P	2.2	5P	1.2
6666	4P	1
10000			5P	1.5	9P	0.3
Positive control	490	20.9	342	19.1	224	1.5

 

 

Dose (µg/plate)	TA1535
	NA (-)		10% HLI (-)		10% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	9	1.8	10	1.5	11	1.2
100	11	1	9	2.8	9	2.1
333	12	2.8	9	0.9	11	2.3
1000	8	1.2	8	1.7	9	0.6
3333	5P	1.2	9P	1.5	8P	1.7
6666	4P	1
10000			4P	0.6	9P	1.5
Positive control	490	20.9	361	25.9	198	12.5

 

Dose (µg/plate)	TA97
	NA (-)		10% HLI (-)		10% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	129	8.7	136	9.4	157	3.5
100	102	5.0	143	4.7	163	7.8
333	88	8.1	147	5.8	166	6.8
1000	84	3.2	135	6.5	142	2.5
3333	73P	7.8	135P	14.4	121P	4.9
6666	73P	7.8
10000			128P	10.2	134P	13.3
Positive control	1165	125.1	1440	66.5	1223	27.1

                                                                          

 

Dose (µg/plate)	TA97
	NA (-)		30% HLI (-)		30% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	129	8.7	188	6.6	187	10.1
100	102	5.0	181	16.6	187	2.0
333	88	8.1	175	10.7	180	12.4
1000	84	3.2	136	6.4	123	8.9
3333	73P	7.8	113P	5.8	134P	19.2
6666	73P	7.8
10000			112P	6.2	120P	5.3
Positive control	1165	125.1	500	3.2	1251	49.7

 

Dose (µg/plate)	TA98
	NA (-)		10% HLI (-)		10% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	13	2.3	27	1	30	2.8
100	13	0	30	2.7	32	0.9
333	12	2.3	22	2.1	30	1.5
1000	12	2	20	2.7	29	1.2
3333	13P	3.5	19P	1.2	25P	1.7
6666	8P	0.6
10000			22P	3.4	27P	2
Positive control	1115	88.9	1482	54.2	389	17.5

 

Dose (µg/plate)	TA98
	NA (-)		30% HLI (-)		30% RLI (-)
	Mean	SEM	Mean	SEM	Mean	SEM
0.000	13	2.3	19	2.1	19	0.9
100	13	0	24	2.6	32	0.6
333	12	2.3	25	4.3	19	1.2
1000	12	2	23	3.2	27	2.5
3333	13P	3.5	27P	3.5	20P	4.1
6666	8P	0.6
10000			18P	1.5	23P	3.5
Positive control	1115	88.9	1492	153.8	483	12.2

 

 

Applicant's summary and conclusion

Conclusions:

The endpoint for the genetic toxicity in vitro of N-ethyl-N phenyl benzyl amine (92-59-1) was considered to be negative in the presence and absence of metabolic activator in Salmonella typhimurium strains TA97, TA98, TA100, and TA1535 by Preincubation method.

Executive summary:

In vitro genetic toxicity test for N-ethyl-N phenyl benzyl amine (92-59-1) was performed on Salmonella typhimurium strains TA97, TA98, TA100, and TA1535 by Preincubation method. The test chemical (0.05 ml), Salmonella culture (0.10 ml), and S-9 mix or buffer (0.50 ml) was incubated at 37°C, without shaking, for 20 min. After that histidine-independent (his⁺) colonies were counted on plates by machine unless there was any precipitate was present which interfered with the count, or the color of the test chemical on the plate reduced the contrast between the colonies and the background agar.The test material was exposed at the concentration of 0.000 ,100.000, 333.000, 1000.000,3333.000,6666.000,10000.000 µg/plate. There are some variations in protocol as the first test of a chemical was without activation and with 10% S-9 in the S-9 mix. If a positive result was obtained the test was repeated.If the tests were negative they were repeated without S-9 and with 30% S-9.Concurrent solvent and positive controls were run with each test. After exposure no mutagenic effect were observed.Therefore N-ethyl-N phenyl benzyl amine (92-59-1) was considered to be non mutagenic in Salmonella typhimurium strains TA97, TA98, TA100, and TA1535in the presence and absence of metabolic activation.

Hence it is not likely to be classified as genetic mutant in vitro.