Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 224-221-9 | CAS number: 4253-34-3
- 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
Data are available from reliable in vitro studies of bacterial
mutagenicity and cytogenicity to mammalian cells for methylsilanetriyl
triacetate. No further information is available for the registered
substance, however, data are available for the closely related
substances triethoxy(methyl)silane (CAS number 2031-67-6) and
trichloro(methyl)silane (CAS number 75-79-6) from in vitro assays on
mutagenicity to mammalian cells.
Gene mutation (Bacterial reverse mutation assay / Ames test): negative
with and without metabolic activation in Salmonella typhimurium strains
TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvrA (OECD TG
471) (BioReliance, 2002a).
Cytogenicity in mammalian cells: negative in CHO cells (OECD TG 473)
(BioReliance, 2002b).
Mutagenicity in mammalian cells: read-across from analogous substance
trichloro(methyl)silane (CAS 75-79-6): negative in mouse lymphoma L5178Y
cells (similar to OECD 476) (Litton Bionetics, 1978b).
Mutagenicity in mammalian cells: read-across from analogous substance
triethoxy(methyl)silane (CAS 2031-67-6): negative in mouse lymphoma
L5178Y cells (similar to OECD 476) (Litton Bionetics, 1978a).
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:
- 2001-10-24 - 2001-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 100, 333, 1000, 3333 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Sponsor's request due to compatibility with the target cells. A fresh bottle, containing less that 0.1% water, to be opened and used once for each phase of the study. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 10 µg/plate
- Remarks:
- WP2 uvrA with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 1.0 µg/plate
- Remarks:
- TA98, TA100, TA1535, TA1537 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100, TA1535 without metabolic activation 1.0 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without metabolic activation 75 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation 1000 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
ACTIVATION: S9 mix contained glucose-6 phosphate and NADP as co-factors, and 10% S9. 0.5 ml of S9 was added to 2 ml top agar, 100 µl tester strain and 50 µl of test solution giving a final concentration of 1% S9.
DURATION
- Exposure duration: 48 - 72 hours at 37±2°C
SELECTION AGENT (mutation assays): histidine-deficient agar
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Evaluation criteria:
- The mean of each positive control must exhibit at least a 3 fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three non-toxic dose levels is required to evaluate assay data. A dose level is considered toxic if one or both of the following criteria are met: (1) A >50% reduction in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction must be accompanied by an abrupt dose-dependent drop in the revertant count. (2) A reduction in the background lawn. Data sets will be judged positive if the increase in mean revertants at the peak dose response is equal to or greater than 2 times the mean negative control value.
- Statistics:
- None shown in report
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
- Conclusions:
- Methylsilanetriyl triacetate has been tested for mutagenicity to bacteria in a study which was conducted according to the OECD TG 471, and in compliance with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without metabolic activation in the initial or the repeat experiments. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 275, 550, 1100, 2200 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: information from the sponsor and compatibility with the target cells. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation 10 and 20 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation 1 and 2 mg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: none
- Exposure duration: 4 hours (with and without metabolic activation) and 20 hours (without metabolic activation)
- Expression time (cells in growth medium): 20 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 20 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): Giesma
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 200 cells were examined for chromosome aberrations
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; other: cell growth inhibition
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- A result was considered positive when there was a dose-dependent and statistically significant increase in the number of cells with aberrations.
- Statistics:
- Fischer's exact test was used to compare the percent aberrant cells of each treatment group with the solvent control.
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 15% and 2200 µg/ml
- 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: none - pH was adjusted to approximately 7.0 by addition of 1N NaOH
- Effects of osmolality: none - Conclusions:
- Methylsilanetriyl triacetate has been tested according to OECD 473 and under GLP. No increase in the number of chromosome aberrations per cell or the number of cells with aberrations was detected at any concentration with and without metabolic activation in Chinese hamster ovary cells. Solvent and positive controls gave expected results. It is considered that the test substance is negative for the induction of chromosome aberrations under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- non-activated mouse liver S9 mix used for activation; positive control toxicity expt 2 +MA was lower than required by current guideline
- Principles of method if other than guideline:
- Method: Litton Bionetics standard procedure: Screening Program for the Identification of Potential Mutagens and Carcinogens. Protocol Number : DMT 100
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mouse liver S9
- Test concentrations with justification for top dose:
- 0.01, 0.02 0.04, 0.08, 0.16, and 0.32 µL/ml, equivalent to approximately 10, 20, 40, 80, 160 and 320 µg/ml
Vehicle - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: It is assumed by the reviewer that the solvent was chosen based on solubility properties and relative non-toxicity to L5178Y cells. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- (without activation)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- Remarks:
- (with activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 10 days
- Fixation time (start of exposure up to fixation or harvest of cells): 3 days 4 hours
SELECTION AGENT (mutation assays): THMG (thymidine, hypoxanthine, methoxotrexate, glycine)
NUMBER OF REPLICATIONS: 3 plates for each test concentration, assay repeated
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A compound is considered mutagenic if:
- A dose response relationship is observed over three of the four dose levels employed
- The minimum increase at the high level of the dose response curve is at least 2.5 times greater than the solvent control value
- The solvent control data are within the normal range of spontaneous background for the TK locus. - Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 0.32 µl/ml, equivalent to 320 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test substance did not induce mutation at the thymidine kinase locus with or without activation. Because there was very little toxicity observed in the non activation tests, the study was repeated. The repeat study produced greater levels of toxicity but was still negative for inducing mutations.
- Conclusions:
- Trichloro(methyl)silane was tested for mutagenicity in mammalian cells in a reliable and reproducible assay according to a protocol that is similar to OECD 476. Appropriate concurrent negative and positive controls were included and the expected responses were observed, though the cytotoxicity observed with the positive controls in the with activation experiments was high (2.8% and 5.8%). No test-substance related increase in mutant frequency was observed. It is concluded that trichloro(methyl)silane is negative for the induction of mutation in mammalian cells under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The restrictions are that the experiment did not include replicate culture, and mouse liver S9 was used for metabolic activation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- Insufficient test concentrations / no duplicates
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase operon
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- mouse liver S9
- Test concentrations with justification for top dose:
- +/- MA 0.1, 0.2, 0.4, 0.8, 1.6 µl/ml
- 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:
- ethylmethanesulphonate
- Remarks:
- (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Dimethylnitrosamine
- Remarks:
- (with activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: none
- Exposure duration: four hours
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): 10 days
SELECTION AGENT (mutation assays): medium containing thymidine kinase, hypoxanthine, methotrexate and glycine
NUMBER OF REPLICATIONS: single doses, triplicate counts
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A compound is considered mutagenic if there is an increase in the mutant frequency relative to the control, showing a dose response relationship over three of the doses employed, with a minimum increase at the highest dose at least 2.5 times greater than the solvent control value, which should be within the normal range for the TK locus.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- 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
- Conclusions:
- Triethoxy(methyl)silane has been tested according to a protocol that is similar to OECD 476, without replication. No increase in mutant frequency was observed at any concentration with or without metabolic activation. The solvent and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity in mouse lymphoma L5178Y cells under the conditions of the test.
Referenceopen allclose all
Experiment 1 Plate incorporation - Number of revertants per plate (mean of three plates)
Treatment µg/plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0* |
15 |
18 |
154 |
181 |
14 |
12 |
4 |
7 |
11 |
11 |
100 |
11 |
21 |
170 |
161 |
13 |
10 |
3 |
5 |
10 |
8 |
333 |
11 |
16 |
155 |
196 |
9 |
13 |
4 |
6 |
9 |
6 |
1000 |
11 |
17 |
140 |
178 |
13 |
11 |
3 |
5 |
9 |
8 |
3333 |
15 |
18 |
166 |
152 |
21 |
8 |
6 |
4 |
10 |
12 |
5000 |
20 |
21 |
149 |
159 |
20 |
14 |
5 |
5 |
10 |
8 |
Positive control |
92 |
365 |
479 |
584 |
215 |
102 |
633 |
58 |
71 |
296 |
*solvent control with DMSO
Experiment 2 Plate incorporation - Number of revertants per plate (mean of three plates)
Treatment µg/plate |
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0 * |
16 |
20 |
134 |
154 |
19 |
12 |
8 |
7 |
12 |
12 |
100 |
10 |
19 |
138 |
165 |
21 |
15 |
5 |
10 |
14 |
13 |
333 |
15 |
23 |
152 |
163 |
17 |
19 |
5 |
10 |
12 |
17 |
1000 |
15 |
28 |
137 |
181 |
19 |
14 |
13 |
9 |
12 |
16 |
3333 |
15 |
25 |
136 |
145 |
21 |
16 |
9 |
6 |
10 |
14 |
5000 |
13 |
22 |
124 |
151 |
18 |
16 |
7 |
4 |
10 |
13 |
Positive control |
67 |
495 |
441 |
690 |
203 |
124 |
352 |
137 |
84 |
291 |
*solvent control with DMSO
Summary of results
Treatment time (hours) |
Recovery time (hours) |
Harvest time (hours) |
Metabolic activation |
Toxicity at highest dose scored (µg/ml) |
Mitotic reduction |
Structural abnormalities observed |
Numerical abnormalities observed |
4 |
16 |
20 |
- |
None |
None |
None |
None |
20 |
0 |
20 |
- |
None |
None |
None |
None |
4 |
16 |
20 |
+ |
None |
13% |
None |
None |
Table 2 :Results of Mammalian Mutagenicity assay (Test 1) with L5178Y/TK+/- Mouse Lymphoma cells
Concentration µg/ml |
Mutant* Frequency |
Mutant* Frequency |
%Relative Growth. |
%Relative Growth. |
Cytotoxicity |
- MA |
+ MA |
- MA |
+ MA |
- |
|
Solvent control |
10.6 |
12.2 |
100 |
100 |
- |
Negative control |
12.2 |
10.3 |
123 |
64.1 |
- |
Positive control |
511.0 |
368.1 |
18.5 |
5.8 |
yes |
0.1 |
8.0 |
- |
134.2 |
- |
no |
0.02 |
10.8 |
23.1 |
140 |
72.5 |
no |
0.04 |
7.3 |
10.5 |
134.1 |
99.1 |
no |
0.08 |
11.3 |
14.1 |
118.1 |
101.2 |
no |
0.16 |
18.1 |
17.6 |
112.4 |
94.1 |
no |
0.32 |
- |
12.9 |
- |
45.7 |
yes |
*Per 106surviving cells
Solvent control with Ethanol
Table 3 : Results of Mammalian Mutagenicity assay (Test 2) with L5178Y/TK+/- Mouse Lymphoma cells
Concentration µg/ml |
Mutant* Frequency |
Mutant* Frequency |
%Relative Growth. |
%Relative Growth. |
Cytotoxicity |
|
— MA |
+ MA |
— MA |
+ MA |
- |
Solvent Control |
14 |
17 |
100 |
100 |
No |
Negative Control |
25.3 |
15.8 |
83.1 |
89.2 |
No |
Positive Control |
385 |
514 |
27 |
2.8** |
No |
0.04 |
- |
15.4 |
- |
87.8 |
No |
0.08 |
26.9 |
22.1 |
65.7 |
75.6 |
No |
0.16 |
27.5 |
16.5 |
60.1 |
48 |
Yes |
0.24 |
16.5 |
- |
58.6 |
- |
No |
0.32 |
26.6 |
58 |
0.2 |
0.1 |
Yes |
*Per 106surviving cells
Solvent control with Ethanol
**It is noted that this level of toxicity is lower than acceptable under current guidelines.
Table 1 Mutagenicity in L5178Y cells (mutant frequencies are the mean of three counts)
Concentration µl/ml |
-MA |
+MA |
||
Mutant frequency |
% growth |
Mutant frequency |
% growth |
|
Solvent control* |
3.3 |
100 |
6.5 |
100 |
Negative control |
4.2 |
80.3 |
3.0 |
84.4 |
0.1 |
10.9 |
103.7 |
12.1 |
75.0 |
0.2 |
15.5 |
71.1 |
8.3 |
64.7 |
0.4 |
6.4 |
58.5 |
13.6 |
68.1 |
0.8 |
3.9 |
80.2 |
14.4 |
89.6 |
1.6 |
4.9 |
51.5 |
7.5 |
50.7 |
Positive control |
485.6 |
12.9 |
643.9 |
2.9 |
* Solvent control with ethanol
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data are available from reliable in vitro studies of bacterial mutagenicity and cytogenicity to mammalian cells for methylsilanetriyl triacetate. No further information is available for the registered substance, however, data are available for the closely related substances triethoxy(methyl)silane (CAS number 2031-67-6) and trichloro(methyl)silane (CAS number 75-79-6) from in vitro assays on mutagenicity to mammalian cells.
Methylsilanetriyl triacetate has been tested for mutagenicity to bacteria in a study which was conducted according to the OECD TG 471, and in compliance with GLP (BioReliance, 2002a). No evidence of a test substance related increase in the number of revertants was observed with or without metabolic activation in the initial or the repeat experiments. Appropriate positive and solvent controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Methylsilanetriyl triacetate has been tested according to OECD 473 and under GLP (BioReliance, 2002b). No increase in the number of chromosome aberrations per cell or the number of cells with aberrations was detected at any concentration with and without metabolic activation in Chinese hamster ovary cells. Solvent and positive controls gave expected results. It is considered that the test substance is negative for the induction of chromosome aberrations under the conditions of the test.
The structural analogue triethoxy(methyl)silane has been tested according to a protocol that is similar to OECD 476, but without replication (Litton Bionetics, 1978a). No increase in mutant frequency was observed at any concentration with or without metabolic activation. The solvent and positive controls gave expected results. It is concluded that the test substance is negative for mutagenicity in mouse lymphoma L5178Y cells under the conditions of the test.
A second structural analogue, trichloro(methyl)silane, was tested for mutagenicity in mammalian cells in a reliable and reproducible assay according to a protocol that is similar to OECD 476 (Litton Bionetics, 1978b). Appropriate concurrent negative and positive controls were included and the expected responses were observed, though the cytotoxicity observed with the positive controls in the experiments with activation was high (2.8% and 5.8%). It is noted by the reviewer that the toxicity of the positive control in the experiments with activation was greater than is acceptable under current guidelines. No test-substance related increase in mutant frequency was observed. It is concluded that trichloro(methyl)silane is negative for the induction of mutation in mammalian cells under the conditions of the test.
No evidence for genetic toxicity was observed in the in vitro studies, so it is considered that in vivo testing is not required.
Justification for classification or non-classification
Based on the available in vitro genotoxicity data, methylsilanetriyl triacetate is not classified for mutagenicity according to Regulation (EC) No 1272/2008.
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.