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EC number: 212-305-8 | CAS number: 780-69-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Information is available from a reliable bacterial mutagenicity study
and a chromosome aberration assay for triethoxy(phenyl)silane (CAS
780-69-8). Reliable data are available for mammalian cell gene mutation
for the structural analogue substance trichloro(phenyl)silane (CAS
98-13-5).
Gene mutation (Bacterial reverse mutation assay / Ames test) (OECD TG
471, GLP, RL1): negative with and without activation in all strains
tested (Wacker, 2002)
Cytogenicity in mammalian cells (OECD TG 473, GLP, RL1): negative with
and without metabolic activation in V79 cells (OECD TG 473, GLP, RL1)
(BSL, 2012).
Mutagenicity in mammalian cells (CAS 98-13-5) (similar to OECD TG 476,
GLP, RL1): negative in L5178Y mouse lymphoma cells (Reconcile, 2010)
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:
- 22 Mar - 30 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- 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
- Species / strain / cell type:
- S. typhimurium TA 102
- 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:
- See table 1
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: abs. ethanol
- Justification for choice of solvent/vehicle: Solvent chosen due to solubility properties and relative nontoxicity to bacteria. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (TA 1535, TA 100); 2-nitrofluorene (TA 98); 9-aminoacridine (TA 1537); ethyl methanesulphonate (TA 102); +S9: 2-anthracene amide (TA 98, TA 102, TA 1537); cyclophosphamide (TA 100, TA 1535)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
POSITIVE CONTROLS
Plate incorporation
-S9: Sodium azide (TA 1535: 770.3 µg/plate, TA 100: 1142.3 µg/plate); 2-nitrofluorene (TA 98: 648.3 µg/plate); 9-aminoacridine (TA 1537: 527 µg/plate); ethyl methanesulphonate (TA 102: 1171 µg/plate); +S9: 2-anthracene amide (TA 98: 618.7 µg/plate, TA 102: 1200 µg/plate, TA 1537: 557.7 µg/plate); cyclophosphamide (TA 100: 1094.7 µg/plate, TA 1535:728.7 µg/plate)
Preincubation
-S9: Sodium azide (TA 1535: 808.3 µg/plate, TA 100: 1145 µg/plate); 2-nitrofluorene (TA 98: 618.7 µg/plate); 9-aminoacridine (TA 1537: 653.3 µg/plate); methyl methanesulphonate (TA 102: 789.3 µg/plate); +S9: 2-anthracene amide (TA 98: 731.7 µg/plate, TA 102: 1125.3 µg/plate, TA 1537: 793.3 µg/plate); cyclophosphamide (TA 100: 1133 µg/plate, TA 1535: 891 µg/plate)
- Evaluation criteria:
- A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both independant experiments. Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
- Statistics:
- MANN and WHITNEY and Spearman's rank correlation.
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Scarce background lawn from 100 µg. >50% reduction in revertants from 316 µg.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Scarce background lawn from 100 µg. >50% reduction in revertants from 316 µg.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Scarce background lawn from 100 µg. >50% reduction in revertants from 316 µg.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Scarce background lawn from 100 µg. >50% reduction in revertants from 316 µg.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Scarce background lawn from 100 µg. >50% reduction in revertants from 316 µg.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- See tables 1-4
COMPARISON WITH HISTORICAL CONTROL DATA: Controls were within range of historical data.
- Conclusions:
- Interpretation of results: negative
Pronounced cytotoxicity (scarce background lawn) was noted at the concentrations of 100 µg up to 5000 µg of the test substance. Reduction of the number of revertants by more than 50% was noted at concentrations of 316, 3160 and 5000 µg of the test substance.
In a highly reliable test, conducted in accordance with OECD 471, under GLP, no mutagenic effect was observed for the test substance in any of the 5 test strains in two independent experiments without and with metabolic activation (plate incorporation or preincubation test). The test substance is not mutagenic in the test strains used. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and β-Naphthoflavone activated rat liver S9
- Test concentrations with justification for top dose:
- Experiment 1:
with and without metabolic activation: 0.25, 0.5, 1, 2, 4, 5, 7.5, 10 mM
Experiment 2:
with metabolic activation: 0.05, 0.1, 0.2, 0.4, 0.6, 0.8, 1.0, 1.5, 2.5, 3.5, 5.0 mM
without metabolic activation: 0.01, 0.025, 0.05, 0.1, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0 mM - Vehicle / solvent:
- - Vehicle/solvent used: acetone
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 20 hours without activation (Exp. 2), 4 hours with activation (Exp. 1+2) and without activation (Exp. 1)
- Expression time (cells in growth medium): 0 or 16 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid was added (0.2 µg/mL culture medium) to the cultures 17.5 h after the start of the treatment.
STAIN (for cytogenetic assays): Giesma
NUMBER OF REPLICATIONS: duplicate cultures per concentration
NUMBER OF CELLS EVALUATED: At least 200 well spread metaphase plate per culture were scored for cytogenetic damage on coded slides.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; other: relative well density
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: no data - Evaluation criteria:
- A test item is classified as non-clastogenic if:
- the number of induced structural chromosome aberration in all scored dose groups is in the range of the laboratory’s historical control data range.
And/or
- No significant increase of the number of structural chromosome aberration is observed.
A test item is classified as clastogenic if:
- the number of induced structural chromosome aberration is not in the range of the laboratory’s historical control data range
and
- either a concentration-related or a significant chromosome increase of the number of structural chromosome is observed. - Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.5 mM
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 2.5 mM
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the main experiment no precipitation of the test item in culture at the end of treatment was observed either in the absence or the presence of S9 mix.
RANGE-FINDING/SCREENING STUDIES:
In a range finding pre-test mitotic index and cell density were examined as an indicator for cytotoxicity after treatment with up to 10 mM under the same conditions as in the main experiment. Clear toxic effects were observed after treatment with 10 mM test substance. - Conclusions:
- Interpretation of results: negative
In conclusion, it can be stated that under the applied conditions the test item triethoxyphenylsilane did not induce structural chromosomal aberrations in the V79 cell line. Therefore, trimethoxyphenylsilane is not considered to be clastogenic in this chromosome aberration test. - 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 for cross-reference:
- read-across source
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 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
- Executive summary:
An in vitro mammalian mutagenicity study is available from the structural analogue trichloro(phenyl)silane. In this test the structural analogue did not show any genotoxic potential and thus this is also estimated for triethoxy(phenyl)silane. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in genetic toxicity that are higher than the typical experimental error of the test method.
Referenceopen allclose all
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
118 |
122 |
No |
0.316 |
108 |
136 |
No |
1 |
112 |
129 |
No |
3.16 |
127 |
100 |
No |
10 |
108 |
113 |
No |
31.6 |
120 |
112 |
No |
100# |
135 |
216 |
Yes |
316# |
105 |
0 |
Yes |
1000# |
149 |
139 |
Yes |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with Abs. ethanol
#colonies may represent pinpoint colonies rather than revertants
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
34 |
40.7 |
No |
126 |
121.7 |
No |
258 |
268.3 |
No |
3.16 |
29 |
36 |
No |
119.7 |
123.7 |
No |
238.3 |
307.7 |
No |
10 |
31.3 |
41.7 |
No |
119.7 |
112.3 |
No |
252.7 |
290.3 |
No |
31.6 |
30.7 |
38.3 |
No |
133.3 |
113.3 |
No |
255.3 |
282.3 |
No |
100 |
30 |
32.7 |
No |
110 |
109.3 |
No |
254.3 |
269.7 |
No |
316 |
33.7 |
37.7 |
No |
127.7 |
127.3 |
Yes |
254.7 |
304 |
No |
Positive control |
618.7 |
618.7 |
No |
1142.3 |
1094.7 |
No |
789.3 |
1200 |
No |
*solvent control with Abs. ethanol
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
15.7 |
15.3 |
No |
10.7 |
10.3 |
No |
3.16 |
18.7 |
11.3 |
No |
6.7 |
9 |
No |
10 |
17.7 |
15.3 |
No |
7 |
11.7 |
No |
31.6 |
16 |
16 |
No |
8.3 |
10.3 |
No |
100 |
15.7 |
21.7 |
No |
7.7 |
10 |
No |
316 |
12.7 |
12.7 |
Yes |
9.7 |
11.3 |
Yes |
Positive control |
808.3 |
728.7 |
No |
527 |
557.7 |
No |
*solvent control with Abs. ethanol
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
28.7 |
36 |
No |
122.7 |
131 |
No |
268 |
251.3 |
No |
3.16 |
31 |
34 |
No |
123.3 |
128 |
No |
259.7 |
277.3 |
No |
10 |
27.7 |
28.3 |
No |
122 |
134.7 |
No |
247.7 |
248 |
No |
31.6 |
26.3 |
39 |
No |
121 |
136.7 |
No |
247.3 |
317.7 |
No |
100 |
25 |
0 |
Yes |
145.3 |
139.3 |
Yes |
207.3 |
277.3 |
Yes |
316 |
26 |
0 |
Yes |
0 |
0 |
Yes |
258 |
253.7 |
Yes |
Positive control |
648.3 |
731.7 |
No |
1145 |
1133 |
No |
1171 |
1125.3 |
No |
*solvent control with Abs. ethanol
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
15 |
14.3 |
No |
11.7 |
13 |
No |
3.16 |
11.3 |
13.7 |
No |
12 |
12.3 |
No |
10 |
12 |
12 |
No |
16.7 |
12.7 |
No |
31.6 |
9.7 |
14.7 |
No |
11 |
14.3 |
No |
100 |
0 |
0 |
Yes |
0 |
0 |
Yes |
316 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
770.3 |
891 |
No |
653.3 |
793.3 |
No |
*solvent control with Abs. ethanol
Table 1. Summary of results of the chromosome aberration study with triethoxyphenylsilane.
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
[mM] |
in % |
with gaps |
without gaps |
Exposure period 4 h, fixation time 20 h, with S9 mix |
||||
Solvent (0.25%) |
|
100 |
2.5 |
1.0 |
CPA (0.83 µg/l) |
|
88 |
11.0 |
8.0 |
Test substance |
1.5 |
63 |
2.5 |
1.5 |
2.5 |
47 |
2.5 |
1.5 |
|
3.5 |
41 |
1.0 |
1.0 |
|
Negative control |
|
103 |
4.5 |
2.0 |
|
|
|
|
|
Exposure period 20 h, fixation time 20 h, without S9 mix |
||||
Solvent (0.25%) |
|
100 |
1.5 |
1.0 |
EMS (400 µg/l) |
|
85 |
12.0 |
10.5 |
Test substance |
0.1 |
108 |
2.5 |
0.5 |
0.25 |
93 |
3.0 |
2.0 |
|
0.5 |
44 |
4.5 |
3.0 |
|
Negative control |
|
90 |
4.5 |
2.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
In a reliable test with triethoxy(phenyl)silane (CAS 780-69-8), conducted in accordance with OECD 471, under GLP, no mutagenic effect was observed for the test substance in any of the 5 test strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102) in two independent experiments without and with metabolic activation (plate incorporation or preincubation test). The test substance was not mutagenic under the conditions of the test. However, pronounced cytotoxicity (scarce background lawn) was noted at the concentrations of 100 µg up to 5000 µg of the test substance. Reduction of the number of revertants by more than 50% was noted at concentrations of 316, 3160 and 5000 µg of the test substance.
Trichloro(phenyl)silane (CAS 98-13-5) has been tested in a reliable study according to OECD TG 476 and under GLP. No increase in mutant frequency was observed at any concentration from 300 to 1000 µg/ml without activation (4 hours treatment), from 200 to 900 µg/ml with 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 is negative for the induction of mutations in L5178Y cells under the conditions of the test.
In a key in vitro chromosome aberration (chinese hamster cell line) test conducted according to OECD 473 and GLP no effects on chromosome aberration were observed in the absence and presence of metabolic activation. Therefore, triethoxy(phenyl)silane is not considered to be clastogenic in this chromosome aberration assay.
In conclusion, based on the negative results in in vitro genotoxicity tests, triethoxyphenylsilane is considered to be not genotoxic, and therefore no classification is warranted. No in vivo data are available for triethoxy(phenyl)silane.
Justification for classification or non-classification
The available data on genetic toxicity of the registered substance do not meet the criteria for classification according to Regulation 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
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