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Toxicological information

Genetic toxicity: in vitro

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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
Study period:
August-September 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed guideline study (GLP/OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Method

Species / strainopen allclose all
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0, 0.004, 0.02, 0.1, 0.5, 2.5 and 10 µL
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 9-Aminoacridine, 2-Aminoanthracene, Methylhydrazone Derivative, Streptozotozine, ENNG
Details on test system and experimental conditions:
The tester strains Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 and E. coli WP2 uvrA were maintained in liquid nitrogen and recultivated for the test in fresh nutrient broth.

To 2 mL of molten (45°C) top agar in a sterile test-tube were added 0.1 mL of the tester strain culture, graded quantities of the test compound in 0.1 mL solution and, for the S9 series, 0.5 mL S9 mix. The contents of the test-tube were rapidly mixed and poured onto the surface of previously prepared minimal agar plates with Vogel-Bonner E mixture.
The plates (4 per tester strain and substance concentration) were incubated upside down at 37°C for 2 days, after which the number of revertant colonies appearing was counted.

Control plates without admixture of test compound were prepared in the same way to determine the spotaneous mutation rate.
Evaluation criteria:
No data

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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

Ames Test Ethylene glycol dimethyl ether

 

 

Table 1:Summary of mean number of revertants (mean of at 4 plates) in Salmonella typhimurium with and without metabolic activation (negative and positive controls) and Escherichia coli WP2 uvrA

Concentration

TA 98

TA 100

TA1535

TA 1537

[µL/plate]

- S9 mix

+ S9 mix

- S9 mix

+ S9 mix

- S9 mix

+ S9 mix

- S9 mix

+ S9 mix

0

30

27.8

104.8

114.3

11.8

9.3

8.5

13.5

10

37.5

36.8

130.8

130.5

15.5

13.3

11.5

14.3

2.5

36.3

26.3

122

121

13.8

12.3

9

12.8

0.5

31.5

35

114.3

123.3

15

10.5

9.5

11.3

0.1

35.5

35.5

111.8

126

13.5

9.3

11.3

14

0.02

0.004

35

29.5

29.8

25.8

112.8

110.8

117.3

121.5

16

12

10.8

10.3

9.3

11.5

15

13

 

 

 

 

 

 

 

 

 

Positive:

 

 

 

 

 

 

 

 

9-Aminoacridine

 

 

 

 

 

 

3750

 

2-Aminoanthracene

31

1028

102.5

959.5

11.5

191

12.5

141.5

Methylhydrazone Deriv.

3550

 

3100

 

 

 

 

 

9-Aminoacridine

Streptozotozine

ENNG

 

 

 

 

 

>5000

 

 

 

 

 

Concentration

TA 1538

WP2 uvrA

 

 

[µL/plate]

- S9 mix

+ S9 mix

- S9 mix

+ S9 mix

 

 

 

 

0

19

26.3

18.5

36.3

 

 

 

 

10

19.3

24.5

24.3

38

 

 

 

 

2.5

16.5

25.5

24.5

41

 

 

 

 

0.5

15.8

26.3

19

34.3

 

 

 

 

0.1

16

18

21

33.8

 

 

 

 

0.02

0.004

15.5

21.3

24.8

25.5

25.5

20.8

37.3

38

 

 

 

 

 

 

 

 

 

 

 

 

 

Positive:

 

 

 

 

 

 

 

 

9-Aminoacridine

 

 

 

 

 

 

 

 

2-Aminoanthracene

14.5

1304

34.5

3850

 

 

 

 

Methylhydrazone Deriv.

>5000

 

 

 

 

 

 

 

9-Aminoacridine

Streptozotozine

ENNG

 

 

 

 

582

 

 

 

 

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

Ethylene glycol dimethyl ether did not cause any increase in the number of revertant colonies with any of the tester strains in absence or presence of S9 mix.
Executive summary:

Ethylene glycol dimethyl ether was tested for mutagenicity with the strains TA1538, TA1537, TA1535, TA100 and TA98 of Salmonella thyphimurium and Escherichia coli WP2 uvrA.

The mutagenicity study was conducted in the absence and presence of a metabolising system derived from rat liver homogenate. A concentration of 0.004 to 10 µL Ethylenglycoldimethylether/plate was used.

Control plates without mutagen but with Dimethylsulfoxide did not show an increase in the number of revertant colonies compared to the spontaneous negative control. All positive control compounds gave the expected increase in the number of revertant colonies.

Ethylene glycol dimethyl ether did not show an increase in the number of revertants in any of the bacterial strains in the presence as well as in the absence of metabolic activation.

Therefore, it can be stated that Ethylene glycol dimethyl ether is not mutagenic in these bacterial test systems either with or without metabolic activation.