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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

According to the results of the presently available data, the test substance is not mutagenic in the Ames test under the experimental conditions chosen.

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
S. typhimurium
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
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
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'.

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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

In a reverse gene mutation assay in bacteria (Ames-test), strains TA 1535, TA 100, TA 1537 and TA 98 of S. typhimurium were exposed to the test substance at concentrations of 20, 100, 500, 2500 and 5000 µg/plate (BASF AG, 1993). Standard plate test and preincubation test both were conducted with and without metabolic activation (Aroclor induced rat liver S-9 mix). The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.According to the results of the present study, the test substance is not mutagenic in the Ames test under the experimental conditions chosen here.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result based on this Ames test the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008.