Registration Dossier
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EC number: 201-251-0 | CAS number: 80-10-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in Salmonella typhimurium strains: TA 98, TA 100, TA 1535, and TA 1537 (similar to OECD TG 471).
Mammalian cytogenicity (Chinese hamster lung fibroblasts V79 cell chromosome aberration assay): negative with and without metabolic activation (according to OECD TG 473).
Mammalian cell gene mutation:
No measured data are available to assess the in vitro mammalian mutagenicity potential of the registered substance, however, reliable data are available for the structural analogue substance trichloro(phenyl)silane (CAS: 98-13-5).
negative in L5178Y mouse lymphoma cells with the structural analogue substance trichloro(phenyl)silane (CAS: 98 -13 -5) (according to OECD TG 476).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30-04-1994 To 14-11-1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- the range of strains does not comply with the current guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Did not include strain to detect cross-linking mutagens.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa, uvrB and pKM101 (TA98 & TA100)
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 8-5000 µg/plate - Plate incorporation method.
31.25-1200 µg/plate - Pre-incubation method. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethylene glycol dimethylether (EGDE, dryed with a molcular sieve, 0.4 nm)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: nitrofurantoin
- Remarks:
- -S9: TA 100: 0.2 µg per plate.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- -S9: TA 1535: 10 µg per plate.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: phenylene diamine
- Remarks:
- -S9: TA1537 and TA98 : 10 and 0.5 µg per plate, respectively.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- + S9: All strains: 3 µg per plate.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation) and preincubation;
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 4
DETERMINATION OF CYTOTOXICITY
- Method: Gross appraisal of background growth on the plate, marked or dose-dependent reduction in the mutant count per plate and the titer was determined.
Metabolic activation system: It was made from the livers of at least six adult male Sprague-Dawley rats, of approximately 200 to 300 g in weight. For enzyme induction, the animals received a single intraperitoneal injection of Aroclor 1254, dissolved in corn oil, at a dose of 500 mg/kg bw, five days prior to sacrifice. The S9 mix also contained seventy mL of cofactor solution containing the following:
-MgCl2 x 6H2O (162.6 mg)
-KCl (246.0 mg)
-Glucose-6-phophate, disodium salt (179.1 mg)
NADP, disodium salt (315.0 mg)
-Phosphate buffer (100.0 mg) - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas TA 1537, at least a threefold increase should be reached. However, these guidelines may be overruled by good scientific judgement.
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >62.5 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: The salmonella/ microsome plate incorporation test, employing doses of up to 5000 µg per plate, showed diphenyldichlorosilane to produce bacterial toxic effects at 40 µg per plate and above. Therefore, 5000 µg per plate could not be used for assessment. The salmonella/ microsome test, using preincubation for 30 minutes at 37 °C and employing doses of up to 1200 µg per tube, showed diphenyldichlorosilane to produce bacterial toxic effects at 100 µg per tube and above.
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
In a bacterial mutagenicity assay according to OECD 471 and GLP, no indications of mutagenic effects of diphenyldichlorosilane was found at assessable doses of up to 1200 µg per plate in any of the Salmonella typhimurium strains used in the plate incorporation assay and in the preincubation assay. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03-05-1985 to 06-05-1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Plate incorporaton only, apparently no replicates
- Qualifier:
- according to
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- plate incorporaton only, apparently no replicates
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His operon
- Species / strain / cell type:
- E. coli WP2
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- 0.078-1.25 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine and 2-Aminofluorene
- Remarks:
- +S9: All strains: 10 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-Amino acridine, Sodium azide, Daunomycin, 4-Nitroquinoline-N-Oxide and N-Mehtyl-N-nitro-N-nitrosoquanidine
- Remarks:
- -S9: All strains: 10 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation).
DURATION
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS:1
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth. - Evaluation criteria:
- Not reported
- Statistics:
- Not reported
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1.25 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1.25 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: Concentrations of test material above 1.25 µg/plate were toxic to the tester strains.
- Conclusions:
- Interpretation of results: negative with and without metabolic activation.
In a bacterial mutagenicity assay according to OECD 471 and GLP, the test material failed to exhibit mutagenic activity in both the activation and non-activation systems and is considered not to be mutagenic under the conditions employed. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-07-20 to 2011-12-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. certificate)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 of Wistar phenobarbital and ß-naphthoflavone-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- Pre-experiment:
with and without metabolic activation:
0.020, 0.039, 0.078, 0.156, 0.313, 0.625, 1.25, 2.5, 5 and 10 mM
Experiment I:
without metabolic activation:
0.7, 0.9 and 1.1 mM
with metabolic activation:
0.625, 1.25 and 2.5 mM
Experiment II:
without metabolic activation:
0.30, 0.45 and 0.60 mM
with metabolic activation:
1.5, 2.0 and 2.5 mM - Vehicle / solvent:
- -Vehicle (s)/solvent(s) used: cell culture medium (MEM)
- Justification for choice of solvent/vehicle: Due to the nature of the test item it was suspended in cell culture medium (MEM). The solvent was compatible with the survival of the cells and the S9 activity. - Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation Migrated to IUCLID6: 400 and 600 µg/mL
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation Migrated to IUCLID6: 0.83 µg/mL
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Experiment I with and without metabolic activation, experiment II with metabolic activation)
20 hours (Experiment II without metabolic activation)
FIXATION INTERVAL: 20 hours (Experiment I and II with and without metabolic activation)
NUMBER OF REPLICATIONS: 2 independent experiments
NUMBER OF CELLS SEEDED: 1 x 10^4 - 5 x 10^4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture),
except for concentration 2.5 mM (experiment II with metabolic activation): 112 for the 1st and 100 for the 2nd culture.
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell density - Evaluation criteria:
- There are several criteria for determining a positive result:
- a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (0.0% - 4.0% aberrant cells (with and without metabolic activation)). - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
In conclusion, it can be stated that during the described in vitro chromosomal aberration test and under the experimental conditions reported, the test item Dichloro(diphenyl)silane did not induce structural chromosomal aberrations in the V79 Chinese hamster cell line.
Therefore, the test item Dichloro(diphenyl)silane is considered to be non-clastogenic in this chromosome aberration test. - Executive summary:
To investigate the potential of Dichloro(diphenyl)silane to induce structural chromosome aberrations in Chinese hamster V79 cells, anin vitrochromosome aberration assay was carried out.
The chromosomes were prepared 20 h after start of treatment with the test item. The treatment interval was 4 h with and without metabolic activation in experiment I. In experiment II, the treatment interval was 4 h with and 20 h without metabolic activation. Duplicate cultures were treated at each concentration. 100 metaphases per culture were scored for structural chromosomal aberrations (except for concentration 2.5 mM (experiment II with metabolic activation): 112 for the 1st and 100 for the 2nd culture.)
Due to the nature of the test item it was suspended in cell culture medium (MEM). The solvent was compatible with the survival of the cells and the S9 activity.
The following concentrations were evaluated for the microscopic analysis of chromosomal aberrations:
Experiment I:
without metabolic activation: 0.7, 0.9 and 1.1 mM
with metabolic activation: 0.625, 1.25 and 2.5 mM
Experiment II:
without metabolic activation: 0.30, 0.45 and 0.60 mM
with metabolic activation: 1.5, 2.0 and 2.5 mM
In the experiments without metabolic activation no precipitation of the test item was noted after incubation with the test item at the concentrations evaluated, with metabolic activation precipitation of the test item was noted at a concentration of 2.5 mM in experiment I and 1.5 mM in experiment II.
In experiment I without metabolic activation, toxic effects of the test item were noted at a concentration of 1.1 mM, with metabolic activation at a concentration of 2.5 mM.
In experiment II without metabolic activation, toxic effects of the test item were observed at a concentration of 0.60 mM. With metabolic activation toxic effects of the test item were noted at concentrations of 2.0 mM and higher.
In experiment I and II no biologically relevant increase of the aberration rates was noted after treatment with the test item with and without metabolic activation. The aberration rates of all dose groups treated with the test item were within the historical control data of the negative control.
In both experiments with and without metabolic activation no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item as compared to the controls.
EMS (400 and 600 µg/mL) and CPA (0.83 µg/mL) were used as positive controls and induced distinct and biologically relevant increases in cells with structural chromosomal aberrations.
The positive controls induced the appropriate responses.
There was no evidence of test item induced over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5375; OECD 473 for in vitro cytogenetic mutagenicity data.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose:
- read-across source
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 900 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative with and without activation
The structural analogue substance trichloro(phenyl)silane (CAS: 98-13-5) was tested in a reliable study according to OECD TG 476 and under GLP. No increase in mutant frequency was observed at any concentration with and without activation (4 hours treatment) and without activation (24 hours treatment). Expected results were obtained with positive and negative controls. It is concluded that trichloro(phenyl)silane and thus dichloro(diphenyl)silane are negative for the induction of mutations in L5178Y cells under the conditions of the test.
Referenceopen allclose all
Table 1. Summary of mean values without S9 mix.
Groups | Strain | |||
TA 1535 | TA 100 | TA 1537 | TA 98 | |
Plate incorporation method (µg/plate) |
|
|
|
|
0 | 25 | 120 | 12 | 23 |
8 | 26 | 116 | 9 | 24 |
40 | 27 | 117 | 11 | 24 |
20 | 31 | 104 | 9 | 23 |
1000 | 30 | 105 | 8 | 29 |
5000 | - | - | - | - |
Na-azide | 926 |
|
|
|
NF |
| 378 |
|
|
4-NPDA |
|
| 101 | 118 |
Pre-incubation method- µg/plate |
|
|
|
|
0 | 22 | 143 | 13 | 31 |
31.25 | 29 | 146 | 13 | 31 |
62.5 | 36 | 157 | 14 | 31 |
125 | 30 | 166 | 15 | 28 |
250 | 43 | 134 | 8 | 27 |
500 | 38 | 144 | 6 | 22 |
1000 | 32 | 117 | 6 | 17 |
Na-azide | 897 |
|
|
|
NF |
| 531 |
|
|
4-NPDA |
|
| 83 | 60 |
Table 2. Summary of mean values with S9 mix.
Groups | Strain | |||
TA 1535 | TA 100 | TA 1537 | TA 98 | |
Plate incorporation method (µg/plate) |
|
|
|
|
0 | 21 | 150 | 16 | 42 |
8 | 19 | 146 | 12 | 44 |
40 | 18 | 142 | 14 | 42 |
20 | 17 | 119 | 12 | 39 |
1000 | 16 | 119 | 12 | 34 |
5000 | - | - | - | - |
2-AA | 211 | 1476 | 117 | 891 |
Pre-incubation method (µg/plate) |
|
|
|
|
0 | 17 | 141 | 10 | 40 |
31.25 | 17 | 151 | 12 | 38 |
62.5 | 17 | 148 | 13 | 46 |
125 | 22 | 166 | 11 | 45 |
250 | 19 | 154 | 11 | 48 |
500 | 21 | 168 | 11 | 41 |
1000 | 19 | 119 | 7 | 36 |
2-AA | 213 | 1268 | 126 | 1107 |
Plate incorporation method:
There was no indication of a bacterial toxic effect of diphenylchlorosilane at 8 µg per plate. The total bacterial counts consistently produced results comparable to the negative controls, or differed only insignificantly. No inhibition of growth was noted as well. None of the four strains concerned showed a dose- related and biologically relevant increase in mutant counts over those of the negative controls. This applied both to the tests with and without S9-mix.
Pre-incubation method:
There was no indication of a bacterial toxic effect of diphenylchlorosilane at doses of up to and including 62.5 µg per tube. The total bacteria counts consistently produced results comparable to the negative controls, or differed only insignificantly. No inhibition of growth was noted as well. One of the four strains concerned revealed an increase in mutant counts to double those of negative controls. Strains TA 1535 were affected. This increase did, however, not correlate with dose and could not be confirmed. Therefore, it was considered to be of no relevance.
The positive controls sodium azide, nitrofurantonin, 4-nitro-1,2-phenyl diamine and 2-aminoanthracene increased mutant counts well over those of the negative controls, and thus demonstrated the system’s sensitivity and the activity of the S9 mix
Table 1. Overlay plate test results:
Test | Revertants per plate | ||||
TA-1535 | TA-1537 | TA-98 | TA-100 | WP2 | |
Non-Activation (-S9) |
|
|
|
|
|
Solvent control | 29 | 9 | 22 | 94 | 36 |
Positive control* | 125 | 152 | 169 | 532 | 124 |
Test Material (µg/plate) |
|
|
|
|
|
0.078 | 23 | 10 | 19 | 98 | 42 |
0.156 | 22 | 7 | 18 | 126 | 37 |
0.312 | 17 | 6 | 16 | 84 | 37 |
0.625 | 11 | 8 | 22 | 120 | 28 |
1.250 | 14 | 9 | 24 | 132 | 24 |
Activation (+S9) |
|
|
|
|
|
Solvent control | 17 | 8 | 58 | 100 | 17 |
Positive control** | 171 | 168 | 1074 | 1045 | 251 |
Test Material (µg/plate) |
|
|
|
|
|
0.078 | 13 | 12 | 49 | 98 | 18 |
0.156 | 15 | 8 | 58 | 94 | 17 |
0.312 | 16 | 12 | 51 | 114 | 19 |
0.625 | 12 | 12 | 50 | 121 | 17 |
1.250 | 13 | 14 | 43 | 88 | 20 |
*TA-1535: AZ (10 µg/plate) ** TA-1535:ANTH (10 µg/plate)
*TA1537: NQNO (10 µg/plate) ** TA1537:AF(10 µg/plate)
*TA98: D (10 µg/plate) ** TA98:AF (10 µg/plate)
*TA-100: AZ (10 µg/plate) **TA-100:AF (10 µg/plate)
*WP2:MNNG (10 µg/plate) **WP2:ANTH (10 µg/plate)
Solvent: Dimethylsulfoxide (50 µg/plate)
| Results of chromosome analysis | |||||||||||||||
| without metabolic activation | |||||||||||||||
| Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly-ploidy | mean % aberrant cells | |||||||||
| Scored cells | gaps | breaks | inter-changes | other | gaps | breaks | inter-changes | other | incl. Gaps | excl. Gaps | |||||
| Experiment I | |||||||||||||||
| negative control | 200 | - | 2 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 100 | 100 | 0 | 2.5 | 1.5 |
| 0.25 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 122 | n.d. | n.d. | n.d. | n.d. |
| 0.5 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 106 | n.d. | n.d. | n.d. | n.d. |
| 0.7 mM | 200 | no | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 104 | 93 | 1 | 2.0 | 0.5 |
| 0.9 mM | 200 | no | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 73 | 75 | 0 | 1.5 | 0.5 |
| 1.1 mM | 200 | yes | 6 | 2 | 0 | 1 | 0 | 0 | 1 | 0 | 47 | 66 | 1 | 4.0 | 1.5 |
| 1.3 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 0 | n.d. | n.d. | n.d. | n.d. |
| 1.5 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 0 | n.d. | n.d. | n.d. | n.d. |
| EMS (600 mg/mL) | 200 | - | 5 | 11 | 5 | 3 | 0 | 0 | 1 | 0 | 101 | 91 | 0 | 11.0 | 9.0 |
| Experiment II | |||||||||||||||
| negative control | 200 | - | 1 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 100 | 100 | 0 | 1.5 | 1.0 |
| 0.10 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 97 | n.d. | n.d. | n.d. | n.d. |
| 0.30 mM | 200 | no | 2 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 83 | 98 | 1 | 3.0 | 1.5 |
| 0.45 mM | 200 | no | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 71 | 98 | 0 | 2.0 | 1.0 |
| 0.60 mM | 200 | yes | 0 | 2 | 0 | 1 | 1 | 0 | 1 | 0 | 44 | 85 | 1 | 2.5 | 2.0 |
| 0.75 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 0 | n.d. | n.d. | n.d. | n.d. |
| EMS (400 µg/mL) | 200 | - | 0 | 12 | 5 | 0 | 1 | 0 | 1 | 1 | 54 | 98 | 1 | 8.5 | 8.0 |
| Results of chromosome analysis | |||||||||||||||
| with metabolic activation | |||||||||||||||
| Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly-ploidy | mean % aberrant cells | |||||||||
| Scored cells | gaps | breaks | inter-changes | other | gaps | breaks | inter-changes | other | incl. Gaps | excl. Gaps | |||||
| Experiment I | |||||||||||||||
| negative control | 200 | - | 6 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 5 | 4.5 | 1.5 |
| 0.156 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 96 | n.d. | n.d. | n.d. | n.d. |
| 0.313 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 92 | n.d. | n.d. | n.d. | n.d. |
| 0.625 mM | 200 | no | 4 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 92 | 109 | 0 | 3.5 | 1.0 |
| 1.25 mM | 200 | no | 1 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 104 | 94 | 0 | 2.5 | 1.5 |
| 2.5 mM | 200 | yes | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 47 | 97 | 1 | 3.0 | 2.0 |
| 5 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| 10 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
| CPA (0.83 µg/mL) | 200 | - | 7 | 10 | 3 | 4 | 0 | 0 | 0 | 0 | 82 | 87 | 1 | 11.5 | 8.5 |
| Experiment II | |||||||||||||||
| negative control | 200 | - | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 1 | 3.0 | 1.0 |
| 0.75 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 95 | n.d. | n.d. | n.d. | n.d. |
| 1.0 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 91 | n.d. | n.d. | n.d. | n.d. |
| 1.5 mM | 200 | no | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 87 | 110 | 1 | 2.0 | 0.5 |
| 2.0 mM | 200 | yes | 2 | 3 | 0 | 0 | 0 | 0 | 1 | 0 | 41 | 111 | 2 | 3.0 | 2.0 |
| 2.5 mM | 212 | yes | 3 | 4 | 0 | 2 | 0 | 0 | 0 | 0 | 32 | 45 | 1 | 4.2 | 2.8 |
| 3.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 10 | n.d. | n.d. | n.d. | n.d. |
| 3.5 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 15 | n.d. | n.d. | n.d. | n.d. |
| 4.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 0 | n.d. | n.d. | n.d. | n.d. |
| 5.0 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 0 | n.d. | n.d. | n.d. | n.d. |
| CPA (0.83 µg/mL) | 200 | - | 12 | 13 | 5 | 1 | 0 | 0 | 0 | 0 | 88 | 104 | 1 | 11.5 | 8.0 |
n.d. not determined
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key bacterial reverse mutation assay according to OECD TG 471 and GLP is available for dichloro(diphenyl)silane. No evidence for a test-substance related increase in the number of revertants was observed in Salmonella typhimurium strains: TA 98, TA 100, TA 1535, and TA 1537. The strains were treated with doses of up to 1200 µg/plate with and without metabolic activation system. Appropriate positive and solvent controls were included and gave expected results. Under the conditions of this study, dichloro(diphenyl)silane was concluded to be non-mutagenic in the Salmonella typhimurium strains tested (Herbold, B.1994). An additional key bacterial reverse mutation assay with the registered substance is also available. In that study, there was no evidence for a test-substance related increase in the number of revertants was observed in Salmonella typhimurium: TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli WP2 strains. The strains were treated with doses of 0.078 to 1.25 µg/plate with and without metabolic activation system. Appropriate positive and solvent controls were included and gave expected results ( Dow Corning Corporation, 1985). The results of both studies are in agreement and give evidence that the test substance is non-mutagenic in the bacterial reverse mutation assay under the applied test conditions.
The key in vitro cytogenicity study on dichloro(diphenyl)silane was conducted according to OECD TG 473 and to GLP. In the presence and absence of metabolic activation no biologically relevant increase in the frequencies of polyploidy cells was found after treatment with the test item in Chinese Hamster V79 cells as compared to the controls. Appropriate positive and solvent controls were included and gave expected results. The test substance was therefore considered to be non-clastogenic in Chinese Hamster V79 cells (Oppong-Nketiah, M. 2012).
The key in vitro mammalian cell gene mutation study on the structural analogue substance trichlorophenylsilane (CAS: 98-13-5) was conducted according to OECD TG 476 and to GLP. No increase in mutant frequency was observed at any concentration with and without metabolic activation after 4 hours of treatment and without metabolic activation after 24 hours of treatment. Expected results were obtained with positive and negative controls. It was concluded that the structural analogue substance, trichlorophenylsilane is negative for the induction of mutations in L5178Y cells under the conditions of the test (Flanders, L.2010).
In vivo testing is not required as no evidence for genetic toxicity was found in the in vitro studies.
Justification for classification or non-classification
Based on the available in vitro data on mutagenicity of the registered substance and the structural analogue substance, trichloro(phenyl)silane (CAS: 98-13-5, dichloro(diphenyl)silane is not classified for mutagenicity according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.
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