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Diss Factsheets

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:
1989-11-22 to 1990-07-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; GLP; some study details missing, range of strains differs from current guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
range of strains; full details of method not given
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichloro(methyl)(vinyl)silane
EC Number:
204-710-3
EC Name:
Dichloro(methyl)(vinyl)silane
Cas Number:
124-70-9
Molecular formula:
C3H6Cl2Si
IUPAC Name:
dichloro(methyl)vinylsilane

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat and hamster liver S9
Test concentrations with justification for top dose:
667-10000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: acetone

- Justification for choice of solvent/vehicle: none given in report
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA 98 (without activation), TA 1538 (with and without activation)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA 98, TA 100, TA 1535, TA 1537 and TA 1538 (with activation)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA 100, TA 1535 (without activation)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 3 plates per test concentration

DETERMINATION OF CYTOTOXICITY

- Method: relative total growth
Evaluation criteria:
For the test substance to be deemed positive, it must produce a dose related increase in revertants.

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA98, TA100, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: >10000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
other: >10000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: > 10000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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

Experiment B1 Average revertants per plate with and without activation (mean of 3 plates)

Strain

TA98

TA100

TA98

TA100

TA98

TA100

Activation

None

None

Rat liver

Rat liver

Hamster liver

Hamster liver

Dose

 

 

 

 

 

 

0

14

107

19

101

20

116

*

7

6

9

10

8

19

667

16

113

24

114

18

138

*

9

10

4

3

2

6

1000

19

104

23

108

24

140

*

7

7

6

1

4

5

3333

13

109

21

111

23

146

*

4

19

5

15

5

45

6667

10

24

15

94

14

105

*

3

10

5

15

3

7

10000

0

0

11

68

13

90

*

0

0

5

3

6

24

Positive control

241

508

281

418

373

510

*

31

25

73

11

28

35

Table 2 Experiment B2 Average revertants per plate without activation (mean of 3 plates)

Strain

TA98

TA100

TA1535

TA1537

TA1538

Activation

None

None

None

None

None

Dose

 

 

 

 

 

0

21

123

9

5

16

*

6

5

4

2

3

100

20

102

7

6

14

*

3

7

6

2

9

333

26

101

9

8

5

*

5

7

2

1

2

667

32

98

-

-

-

*

7

21

-

-

-

1000

19

101

9

7

8

*

6

3

2

1

1

2000

9

98

-

-

-

*

5

17

-

-

-

3333

-

-

9

2

6

*

-

-

2

2

2

10000

-

-

0

0

0

*

-

-

0

1

0

Positive control

306

463

383

356

537

*

3

35

19

37

91

Table 3 Experiment B2 Average revertants per plate with activation (mean of 3 plates)

Strain

TA1535

TA1537

TA1538

TA1535

TA1537

TA1538

Activation

Rat liver

Rat liver

Rat liver

Hamster liver

Hamster liver

Hamster liver

Dose

 

 

 

 

 

 

0

11

5

9

7

7

12

*

5

3

2

1

3

3

100

12

4

9

16

6

10

*

3

3

5

2

4

5

333

12

8

15

26

5

11

*

1

2

3

7

2

1

667

-

-

-

-

-

-

*

-

-

-

-

-

-

1000

11

7

11

27

8

12

*

2

4

3

14

4

2

2000

-

-

-

-

-

-

*

-

-

-

-

-

-

3333

12

5

10

27

5

10

*

3

4

3

4

4

4

10000

2

0

0

3

1

4

*

3

1

0

4

2

1

Positive control

182

214

1472

96

75

902

*

13

44

66

11

14

86

TAble 4 Experiment B3, B4 and B5 Average revertants per plate with and without activation (mean of 3 plates)

Strain

TA1535

TA1537

TA1538

TA1535

Expt B4
TA1538

Strain

Expt B5

TA1537

Expt B5

TA1535

Activation

None

None

None

Hamster liver

None

Activation

None

Hamster liver

Dose

 

 

 

 

 

Dose

 

 

0

11

7

5

9

5

0

9

10

*

4

4

1

4

0

*

3

3

3.3

-

-

6

-

6

1

7

-

*

-

-

3

-

0

*

3

-

10

-

-

5

-

8

3.3

4

-

*

-

-

3

-

2

*

2

-

33

15

5

6

11

6

10

7

-

*

2

2

4

1

2

*

2

-

100

12

9

4

15

5

33

5

-

*

2

2

1

7

1

*

4

-

200

-

-

6

-

6

100

5

-

*

-

-

3

-

3

*

2

-

333

9

4

-

12

333

-

18

*

3

1

-

1

*

-

1

1000

8

2

-

19

1000

-

31

*

4

1

-

11

*

-

5

2000

7

1

-

-

2000

-

32

*

3

1

-

-

*

-

2

3333

-

-

-

21

3333

-

31

*

-

-

-

10

*

-

2

Positive control

161

262

374

90

5000

-

17

*

15

96

55

6

*

-

3

 

 

 

 

 

 

Positive control

514

75

 

 

 

 

 

 

*

85

7

* = plus minus standard deviation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation strain TA 1535
negative without metabolic activation

In the definitive mutagenicity assay, the test article caused a positive response (3.9, 2.3 and 3.2 fold maximum increases) with tester strain TA1535 in the presence of hamster microsomal enzyme. The test substance is mutagenic in strain TA 1535 with metabolic activation.