Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-899-1 | CAS number: 75-76-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-06 to 2002-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetramethylsilane
- EC Number:
- 200-899-1
- EC Name:
- Tetramethylsilane
- Cas Number:
- 75-76-3
- Molecular formula:
- C4H12Si
- IUPAC Name:
- tetramethylsilane
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 102, TA 1535, TA1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 100-5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- 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:
- sodium azide
- Remarks:
- TA 1535, TA 100 without metabolic 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 without metabolic 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 metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 102 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthracene amide
- Remarks:
- TA 98, TA102, TA 1537 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- TA 100, TA 1535 with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: Aroclor induced rat liver S9; NADP and glucose-6-phosphate as cofactors; S9 mix contained 5% S9; 0.5 ml S9 mix added to 2.2 ml agar/cell suspension/test material
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT (mutation assays): minimal agar
NUMBER OF REPLICATIONS: 3 plates per concentration; 2 independent experiments, the first plate incorporation, the second pre-incubation
NUMBER OF CELLS EVALUATED: 10 E07 to 10 E08 cells
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of bacterial lawn - Evaluation criteria:
- A chemical is considered positive if there is a reproducible dose-related statistically significant increase in the number of revertants compared with solvent control to at least 2 fold (strains TA 98, TA100 and TA 102) or 3-fold (strains TA 1535 and TA 1537). In addition, the histidine independence of the revertants has to be confirmed.
- Statistics:
- Statistically significant: p
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 3160 µg/plate (pre-incubation experiment only)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate (pre-incubation experiment only)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate (Pre-incubation experiment only)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate (pre-incubation experiment only)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5000 µg/plate (pre-incubation experiment only)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table 1 Experiment 1 Plate incorporation: Number of revertants per plate (mean of 3 plates)
Concentration µg/plate |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
5000 |
35.7 |
41.0 |
132.3 |
128.3 |
269.3 |
310.3 |
11.7 |
12.0 |
8.0 |
7.0 |
3160 |
31.3 |
38.0 |
128.7 |
136.7 |
259.3 |
302.7 |
12.3 |
11.3 |
6.3 |
7.3 |
1000 |
34.7 |
36.0 |
117.0 |
125.0 |
258.7 |
300.0 |
11.7 |
11.0 |
5.7 |
7.7 |
316 |
31.7 |
37.3 |
116.7 |
126.0 |
310.7 |
307.3 |
11.0 |
11.7 |
5.3 |
6.3 |
100 |
25.0 |
39.7 |
134.3 |
144.0 |
276.7 |
280.7 |
11.3 |
12.7 |
4.0 |
5.0 |
0** |
36.0 |
42.0 |
127.0 |
122.7 |
265.0 |
298.3 |
12.3 |
11.3 |
5.7 |
6.3 |
Positive control |
986.3 |
990.3 |
1206.3 |
1196.7 |
1005.0 |
1135.0 |
213.3 |
207.0 |
207.7 |
208.7 |
** Solvent control with DMSO
Table 2 Experiment 2 Pre-incubation: Number of revertants per plate (mean of 3 plates)
Concentration µg/plate |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
5000 |
33.7* |
0.0* |
122.3* |
118.0* |
261.0* |
281.3* |
12.3* |
15.0* |
3.3* |
0.0* |
3160 |
38.3* |
27.7* |
143.3 |
122.0 |
274.7 |
278.7 |
11.7 |
14.7 |
3.0 |
4.0 |
1000 |
39.7 |
36.3 |
148.0 |
151.7 |
250.3 |
265.0 |
10.7 |
15.3 |
2.7 |
2.7 |
316 |
50.7 |
30.0 |
141.0 |
154.3 |
282.0 |
287.3 |
12.0 |
13.3 |
3.0 |
3.3 |
100 |
38.0 |
31.0 |
145.7 |
159.0 |
284.7 |
285.3 |
13.0 |
16.7 |
3.3 |
3.0 |
0** |
29.0 |
40.0 |
121.7 |
137.7 |
290.0 |
287.0 |
13.3 |
15.7 |
3.0 |
3.7 |
Positive control |
1164.0 |
1139.3 |
1181.3 |
1189.0 |
1179.7 |
1188.0 |
674.0 |
671.7 |
696.0 |
700.3 |
* Scarce background lawn
** Solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Negative with and without metabolic activation
Tetramethylsilane was tested in a valid study according to OECD 471 and under GLP. No increase in the number of revertants was observed in the plate incorporation assay with and without metabolic activation. These results were confirmed in the repeat pre-incubation experiment, also with and without metabolic activation. Vehicle and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
