N,N-dimethylaniline

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)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals

Author:

Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E.

Year:

1986

Bibliographic source:

Environmental Mutagenesis; Volume 8, Issue Supplement S7, pages 1–55, 1986

Reference 2

Reference Type:

other: Authoritative data base

Title:

NTP No.: 840758

Author:

National Toxicological Program

Year:

2012

Bibliographic source:

NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The Salmonella Ames Test: Preincubation method

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylaniline

EC Number:

204-493-5

EC Name:

N,N-dimethylaniline

Cas Number:

121-69-7

Molecular formula:

C8H11N

IUPAC Name:

N,N-dimethylaniline

Details on test material:

- Name of test material: N,N-dimethylaniline
- Substance type: Organic
- Physical state: liquid

Method

Target gene:

histidine-manufacturing gene

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

other: histidine deficient strain

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

other: histidine deficient strain

Metabolic activation:

with and without

Metabolic activation system:

10% HLI/RLI

Test concentrations with justification for top dose:

3, 10, 33, 100, 333, 1000 µg/Plate

Vehicle / solvent:

Dimethyl Sulfoxide

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Remarks:

in the absence of S9 activation

Positive control substance:

sodium azide

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Remarks:

in the presence of S9 activation by 10% HLI/RLI

Positive control substance:

other: 2-aminoanthracene

Details on test system and experimental conditions:

RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

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

Test results 2

Species / strain:

S. typhimurium TA 1535

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

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	85	2.7	93	3.7	123	10	87	3.1	97	2.2	94	9
3	107	3.2	107	8.5			104	4.7			108	11.7
10	89	5.6	102	8	112	8.7	89	6	110	7.9	108	4.8
33	104	11.3	97	10.3	113	1.8	104	3	110	6.2	101	6.2
100	109	12.5	95	9.9	102	9.3	87	3.3	113	4.5	105	2.6
333	102	3.5	81	3.7	122	12.7	93	2.7	119	11.1	102	8.1
1000					40s	9.3			78s	13.4
Positive Control	382	7.7	345	17.7	1336	56.6	1132	40.3	461	26.6	441	9.1

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	23	1.9	28	3.7	9	1.9	6	0.3	8	0.6	10	1.2
3	14	0.9	20	3.8			7	1			9	0.3
10	14	3.2	21	2.2	10	1.2	7	2.8	7	0.7	8	2.2
33	16	1.5	18	1.9	8	0.3	4	1.2	6	0	7	0.7
100	15	0.3	18	2.8	6	0.3	7	0.6	7	0.9	6	1
333	15	2.1	20	2.9	7	1.2	6	1	6	1	5	0.9
1000					2s	1			3s	1.2
Positive Control	519	6.8	324	21.2	438	43	452	9.8	158	11.5	187	9.9

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

N,N-dimethylaniline gives negative result for genetic toxicity in Ames test conducted on to S. typhimurium TA 100 and TA1535 with and without metabolic activation by 10% HLI/RLI S9 system.

Executive summary:

N,N-dimethylaniline gives negative result for genetic toxicity in Ames test conducted on to S. typhimurium TA 100 and TA1535 with and without metabolic activation by 10% HLI/RLI S9 system.