N,N,N',N'-tetramethylethylenediamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Data published in 1987

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Strain TA102, WP2 uvrA or WP2 uvrA pKM101 not tested

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 & Speck W

Year:

1987

Bibliographic source:

Environmental Mutagenesis Volume 9, Supplement 9:1-110

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1989

Deviations:

yes

Remarks:

Salmonella strain TA102 or E.coli strains WP2 uvrA or WP2 uvrA pKM101 not tested

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetramethylethylenediamine

EC Number:

203-744-6

EC Name:

N,N,N',N'-tetramethylethylenediamine

Cas Number:

110-18-9

Molecular formula:

C6H16N2

IUPAC Name:

[2-(dimethylamino)ethyl]dimethylamine

Test material form:

liquid

Details on test material:

clear, colourless to pale yellow

Specific details on test material used for the study:

CAS number: 110-18-9
Supplier: Sigma
Purity: 99%

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S-9 (Sprague Dawley and Syrian Hamster)

Test concentrations with justification for top dose:

10000 ug/plate. The highest concentration was tested above the recommended maximum test concentration of 5000 ug/plate; toxicity was apparent in some strains.

Vehicle / solvent:

Water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylenediamine (strain TA98 in the absence of S-9) and 2-aminoanthracene (all strains in the presence of S-9)

Details on test system and experimental conditions:

Bacterial strains were received from Dr. Ames (University of California). Bacterial cultures were grown overnight at 37 degrees C, with shaking, in Oxoid broth. Phenotypes were analysed. The test material, bacteria and S-9 mix or buffer were incubated at 37 degrees C, with shaking, for 20 minutes. The top agar was added and the resulting contents mixed and poured on to Vogel Bonner test plates. The revertant colonies were counted following 2 days incubation at 37 degrees C. Counting was automatic, or hand-counted if the presence of precipitate.

Evaluation criteria:

Toxicity was considered to be evidence of a decrease in revertant colonies or a diminution of the backgound bacterial lawn. A positive mutagenic response was considered to be a dose related increase in the number of revertant colonies over the concurrent control. Scientific judgement was applied in interpreting increases in revertant numbers at a single concentration or a non-concentration related increase. Reprodubility between two experimental occassions were also considered.

Statistics:

None

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the presence of hamster S-9

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the absence of S-9 and in the presence of hamster S-9

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Any other information on results incl. tables

Revertant numbers in the absence of metabolic activation

	Strain
Concentration (mcg/plate)	TA98	TA100	TA1535	TA1537
0 (water)	16	98	15	6
100	11	98	17	4
333	19	78	16	7
1000	11	89	17	7
3333	13	78	15	6
10000	13	78 S	12	5
Positive control	637	360	340	298

 

Revertant numbers in the presence of 10% metabolic activation (hamster liver)

	Strain
Concentration (mcg/plate)	TA98	TA100	TA1535	TA1537
0 (water)	25	117	7	8
100	31	114	7	5
333	37	115	10	3
1000	28	107	7	7
3333	27	127	15	6
10000	0 S	81 S	17	5
Positive control	579	1207	460	341

 

Revertant numbers in the presence of 10% metabolic activation (rat liver)

	Strain
Concentration (mcg/plate)	TA98	TA100	TA1535	TA1537
0 (water)	24	115	8	5
100	28	107	12	10
333	22	115	9	4
1000	25	109	7	5
3333	17	106	12	4
10000	22	107	6	5
Positive control	131	449	200	129

Applicant's summary and conclusion

Conclusions:

It was concluded that the test material was not mutagenic under the conditions of testing.

Executive summary:

An Ames testr was conducted using pre-incubation methodology. N,N,N'N'-Tetramethylethylenediamine was tested at concentrations of 100, 333, 1000, 3333 and 10000 mcg/plate in the absence of metabolic activation, in the presence of 10% Aroclor-1254 induced rat liver S-9 and in the presence of 10% Aroclor-1254 induced hamster liver S-9. Testing was conducted in strains TA98, TA100, TA1535 and TA1537. There was some evidence of toxicity at the highest concentration tested in some of the tester strains. There was no evidence of increases in the number of revertants for any of the strains in either the absence or in the presence of metabolic activation (rat or hamster).