2-ethylimidazole

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:

guideline study with acceptable restrictions

Remarks:

Restriction: E. coli not tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylimidazole

EC Number:

214-011-5

EC Name:

2-ethylimidazole

Cas Number:

1072-62-4

Molecular formula:

C5H8N2

IUPAC Name:

2-ethylimidazole

Method

Target gene:

S. typhimurium

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-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20 ug - 5000 ug/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Remarks:

with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine and 9-aminoacridine chloride monohydrate

Details on test system and experimental conditions:

Standard Plate Test and Preincubation Test

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: No bacteriotoxic effect was observed.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No precipitation of the test substance was found.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table: PreincubationTest (average results of 3 plates, respectively)

Concentration µg/plate	TA 1535*		TA 1535*		TA 1537		TA 98		TA 100
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
Solvent Control	10	11	16	16	7	11	26	43	108	129
20	14	12	23	13	7	5	28	38	108	103
100	12	10	16	17	8	9	26	37	97	99
500	16	13	17	18	8	10	24	37	87	99
2500	11	10	16	14	7	9	26	35	80	96
5000	10	12	20	14	7	10	22	41	80	93
Positive Control	493	50	987	615	163	55	602	545	669	365

*Due to the low spontaneous rate in the 2nd experiment, the preincubation assay using TA 1535 was repeated.

Table: Standard Test (average result of 3 plates, respectively)

Concentration µg/plate	TA 1535		TA 1537		TA 98		TA 100
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
Solvent Control	18	18	11	9	30	42	105	111
20	19	20	10	9	29	47	103	118
100	17	19	11	10	27	35	103	107
500	18	17	9	9	29	35	96	84
2500	17	18	10	11	31	35	117	94
5000	17	19	9	9	30	33	108	96
Positive Control	1637	105	579	99	1347	628	1164	873

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative
According to the results of the present study, the test substance 2-Ethylimidazol is not mutagenic in the Ames test under the experimental conditions chosen here.