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Registration Dossier
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EC number: 205-746-2 | CAS number: 149-74-6
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:
- 04.03.2002 - 04.09.2002
- 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:
- Dichloro(methyl)(phenyl)silane
- EC Number:
- 205-746-2
- EC Name:
- Dichloro(methyl)(phenyl)silane
- Cas Number:
- 149-74-6
- Molecular formula:
- C7H8Cl2Si
- IUPAC Name:
- dichloro(methyl)(phenyl)silane
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1537, TA 102, TA 98, TA 1535, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment 1: 10 - 1000 µg/plate; Experiment 2: 1 - 100 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Abs. ethylene glycol dimethylether
- Justification for choice of solvent/vehicle: Solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
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 conc 10 µg/plate
- 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 conc 10 µg/plate
- 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 conc 1300 µg/plate
- 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 conc 100 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthracene amide 2 µg/plate
- Remarks:
- TA 98, TA 102, 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 1500 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): Histidine deficient agar
NUMBER OF REPLICATIONS: Triplicate plates: independent repeat experiment
DETERMINATION OF CYTOTOXICITY
- Method: other: Inhibition of background lawn and greater than 50% reduction in the number of revertants - Evaluation criteria:
- A chemical is considered positive if it shows a statistically significant dose dependent and reproducible increase in the number of revertants relative to the solvent control.
- Statistics:
- Mann and Whitney U-test and Spearman's rank correlation coefficient
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA1536, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH:
- Effects of osmolality:
- Evaporation from medium:
- Water solubility:
- Precipitation: None
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: The results for solvent and positive controls fall within the range of the historical controls
Any other information on results incl. tables
Plate incorporation test
Treatment µg/plate |
TA 98
|
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
|
0 |
34.0 |
44.3 |
142.0 |
160.3 |
262.0 |
279.3 |
13.7 |
13.3 |
4.3 |
4.0 |
10 |
37.7 |
44.0 |
145.3 |
137.3 |
262.0 |
276.3 |
12.0 |
12.7 |
3.0 |
3.7 |
31.6 |
34.7 |
44.3 |
130.0 |
131.3 |
264.0 |
282.3 |
13.7 |
12.3 |
3.3 |
2.7 |
100 |
42.7 |
40.3 |
133.0 |
137.3 |
273.0 |
289.3 |
11.7 |
12.0 |
3.0 |
4.3 |
316 |
41.7 |
36.3 |
136.3 |
126.0 |
258.0 |
280.3 |
13.0 |
12.7 |
3.0 |
3.0 |
1000 |
39.7 |
47.7 |
151.0# |
155.3 |
294.3 |
289.7 |
13.0 |
12.7 |
3.3 |
3.3 |
Pos con |
1031.0 |
1032.7 |
1359.3 |
1345.7 |
1364.3 |
1363.3 |
620.3 |
995.7 |
1072.3 |
1072 |
Pre-incubation test
Treatment µg/plate |
TA 98
|
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
|
0 |
42.7 |
53.3 |
160.7 |
172.0 |
275.7 |
299.3 |
13.3 |
15.0 |
6.0 |
6.3 |
1 |
34.3 |
41.3 |
174.7 |
157.7 |
261.0 |
281.0 |
14.3 |
13.0 |
7.0 |
7.7 |
3.16 |
54.7 |
39.3 |
168.7 |
168.3 |
284.7 |
271.7 |
14.0 |
14.3 |
6.3 |
6.7 |
10 |
30.3 |
42.3 |
169.7 |
146.7 |
267.7 |
256.0 |
12.0 |
16.3 |
6.3 |
7.3 |
31.6 |
36.3 |
50.3 |
181.7 |
155.0 |
278.0 |
272.7 |
13.7 |
12.7 |
7.0 |
6.3 |
100 |
26.0# |
0.0# |
153.3# |
177.7# |
269.0# |
298.0 |
14.7# |
13.7# |
5.0# |
8.0# |
Pos con |
758.7 |
969.7 |
1284.3 |
1324.0 |
1267.0 |
1236.3 |
327.3 |
347.7 |
353.3 |
350.7 |
# = scarce background lawn
Applicant's summary and conclusion
- Conclusions:
- Dichloro(methyl)(phenyl)silane has been tested in a reliable bacterial mutagenicity assay according to OECD TG 471 and under GLP. The test substance did not induce an increase in the number of revertants in either the initial plate incorporation assay or the repeat pre-incubation assay. Solvent and positive controls gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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