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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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-03-25 to 1981-03-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

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 used, only 4 doses used which were not replicated.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicon tetrachloride
EC Number:
233-054-0
EC Name:
Silicon tetrachloride
Cas Number:
10026-04-7
Molecular formula:
Cl4Si
IUPAC Name:
tetrachlorosilane

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA-98, TA-100, TA-1535, TA-1537, TA-1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
0.5-500 µl/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Absolute ethanol was used for the test substance. Dimethylsulfoxide (DMSO) was used for positive control substances except sodium azide which was dissolved in water or saline.

- Justification for choice of solvent/vehicle: Previously shown to be non-mutagenic
Controlsopen allclose all
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)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA 1537 (without activation)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA 98, TA 1538 (without activation)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-anthramine
Remarks:
All strains (with activation)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation);
other: spot plate test

DURATION

- Expression time (cells in growth medium): 48 - 72 hours

NUMBER OF REPLICATIONS: 1 plate for each test concentration

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
For TA 1535, TA 1537 and TA 1538, the test substance is considered mutagenic if a positive dose response is produced over three concentrations with the lowest increase equal to twice the solvent control value.

For TA 98 and TA 100, the test substance is considered mutagenic if a positive dose response is produced over three concentrations with the highest increase equal to twice the solvent control value for TA 100, and two to three times the solvent control value for TA 98.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium: TA-98, TA-100, TA-1535, TA-1537, TA-1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 µl/plate (TA 1535 -MA / TA 1537 +MA)
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

 

Table 2a: Experiment 1 Overlay plate test, Number of revertants per plate

 

Conc.
(
µg/plate)

 

TA98

TA100

TA1535

— MA

+ MA

Cytotoxic
(yes/no)

MA

+ MA

Cytotoxic
(yes/no)

MA

+ MA

Cytotoxic
(yes/no)

0

41

36

No

225

196

No

29

30

No

0.5

31

37

No

238

186

No

26

22

No

5

34

36

No

236

134

No

31

17

No

100

33

45

No

246

218

No

23

18

No

500

38

30

No

250

160

No

12

25

Yes

Positive Control

431

>103

No

476

>103

No

311

173

No

*solvent control with Ethanol

 

Table 2b: Experiment 1 Overlay plate test, Number of revertants per plate

 

Conc.
(
µg/plate)

 

TA1537

TA 1538

— MA

+ MA

Cytotoxic
(yes/no)

— MA

+ MA

Cytotoxic
(yes/no)

0

10

17

No

24

35

No

0.5

7

11

No

23

45

No

5

9

14

No

27

41

No

100

9

8

No

20

38

No

500

9

7

Yes

20

27

No

Positive Control

121

103

No

130

>103

No

*solvent control with Ethanol

Applicant's summary and conclusion

Conclusions:
Silicon tetrachloride has been tested for mutagenicity in a reliable in vitro bacterial reverse mutation assay, conducted according to a protocol similar to OECD Test Guideline 471 and in compliance with GLP. Silicon tetrachloride did not demonstrate any genetic activity in the bacterial strains Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538, when tested in the presence and the absence of metabolic activation up to cytotoxic concentration. Appropriate solvent and positive controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity in the Salmonella typhimurium strains used under the conditions of the test .