Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically reliable study. Well reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-(2-methoxyethoxy)ethoxy)ethanol
EC Number:
203-962-1
EC Name:
2-(2-(2-methoxyethoxy)ethoxy)ethanol
Cas Number:
112-35-6
Molecular formula:
C7H16O4
IUPAC Name:
2-[2-(2-methoxyethoxy)ethoxy]ethanol
Constituent 2
Reference substance name:
Methyltriglycol
IUPAC Name:
Methyltriglycol
Details on test material:
- Name of test material (as cited in study report): Methyltriglycol
- Molecular weight: 164
- Physical state: colourless, clear liquid
- Analytical purity: >95%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254
Test concentrations with justification for top dose:
4 to 10,000 microgram/plate. 5,000 microgram/plate was chosen as the highest dose in the second experiment.
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Remarks:
Without metabolic activation
Positive control substance:
other: NA-azide (TA 100, TA 1535), 9-aminoacridine (TA 1537), 2-Nitroflourene (TA 98, TA 1538), N-Metnyl-N-nitro-N-nitrosoguanidine (WP2uvrA).
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Remarks:
With metabolic activation
Positive control substance:
other: Benzo[a]pyrene: TA 98, TA 100, TA 1535, TA 1537, TA 1538. WP2uvrA, 2-Aminoanthracene: TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA
Details on test system and experimental conditions:
METHOD OF APPLICATION: Top agar is prepared for the Salmonella strains by mixing 100 ml agar (0.6 % agar, 0.5 ~ NaCl) with 10 m1 of a 0.5 % histidine-biotin solution. With E. coli histidine is replaced by tryptophan (2.5 ml, 0.5 mM). The following ingredients are added (in order) to 2 ml of molten top agar at 45 degrees C:
- 0.1 ml of an overnight nutrient broth culture of the bacterial tester strain
- 0.1 ml test compound solution
- 0.5 ml S-9 Mix (if required) or buffer
After mixing, the liquid is poured into a petridish with minimal agar (1.5 % agar, Vogel-Bonner E medium With 2 % glucose).


DURATION
- Incubation period: 46 to 72h @ 37 degrees C in the dark. Colonies (his+ revertants) are counted .

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not examined
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

The test compound did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence of 5-9 Mix. No dose dependent effect was obtained.

Surviving colonies per plate – experiment one

Without metabolic activation

ug/plate

TA100

TA1535

TA1537

TA1538

TA98

WP2uvrA

0

200

15

10

14

22

62

4

226

19

11

12

26

65

20

217

20

12

13

24

63

100

211

18

8

16

25

67

500

206

15

8

18

25

62

2500

207

18

9

14

31

59

10000

209

21

12

17

26

67

+ve control

627

465

154

500

373

357

Sterility contr

0

0

0

0

0

0

 

With metabolic activation

ug/plate

TA100

TA1535

TA1537

TA1538

TA98

WP2uvrA

0

175

16

9

20

34

67

4

167

11

10

19

29

74

20

192

10

11

21

26

74

100

191

16

7

21

33

75

500

211

11

8

19

39

64

2500

228

17

13

22

37

72

10000

205

17

8

20

43

72

2-aminoanthr

668

177

97

436

426

233

Benzo[a]pyr.

614

20

144

192

648

92

S9 mix

0

0

0

0

0

0

Sterility contr

0

0

0

0

0

0

 

Surviving colonies per plate – experiment two

Without metabolic activation

ug/plate

TA100

TA1535

TA1537

TA1538

TA98

WP2uvrA

0

198

16

9

16

27

53

4

185

16

9

11

26

57

20

189

17

9

10

30

43

100

204

18

10

13

23

60

500

193

20

7

11

25

55

2500

215

13

12

18

28

61

5000

224

20

12

13

31

66

+ve control

622

398

157

533

392

380

Sterility contr

0

0

0

0

0

0

 

With metabolic activation

ug/plate

TA100

TA1535

TA1537

TA1538

TA98

WP2uvrA

0

208

14

8

19

29

70

4

212

12

11

17

31

48

20

210

13

9

13

30

54

100

209

13

10

22

33

51

500

201

12

9

18

30

57

2500

200

12

10

20

40

67

5000

208

13

10

19

31

70

2-aminoanthr

736

159

90

431

415

281

Benzo[a]pyr.

633

26

136

151

677

73

S9 mix

0

0

0

0

0

0

Sterility contr

0

0

0

0

0

0

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Methyltriglykol is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at tne dose levels investigated.
Executive summary:

In a bacterial reverse mutation (Ames) assay using the S. typhimurium strains TA 1535, TA 1537, TA1538, TA 98 and TA 100 plus the E coli strain WP2 uvrA, no mutagenic activity was observed either with our without metabolic activation up to the maximum tested dose of 10mg/plate for the substance methyl triglycol. This result can be considered representative by read across of the likely result that would be obtained with the closely related substance ethyl triglycol (2 -(2 -ethoxyethoxy)ethanol.

Categories Display