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EC number: 442-070-9 | CAS number: 329039-38-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 - 21 May 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : lack of data on test substance, no purity given
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 442-070-9
- EC Name:
- -
- Cas Number:
- 329039-38-5
- Molecular formula:
- Hill formula: C8 H16 O5 Si CAS formula: C8 H16 O5 Si
- IUPAC Name:
- (acetyloxy)(methyl)(propan-2-yloxy)silyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Experimental Acetoxysilane Derivative
- Physical state: clear, colorless liquid
- Analytical purity: 85.8 %
- Impurities (identity and concentrations): 12.9 % Acetoxydiisopropoxymethtylsilane, 1.3 % hydrolisis product (siloxane)
- Purity test date: 04.10.2001
- Lot/batch No.: AA001
- Storage condition of test material: moved from room temperature on 30. April 2001 to 2-8 °C in an airlight container under nitrogen, protected from light and moisture
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: his operon
Escherichia coli: trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa-; uvrB- (R+ for TA 98 and TA 100)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: uvrA-
- 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:
- First experiment: 2.5, 7.5, 25, 75, 200, 600, 1800 and 5000 µg/plate with and without metabolic activation
Second experiment: 75, 200, 600, 1800 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: A solubility test was conducted to select the vehicle. The test item was tested to determine the vehicle that permitted preparation of the highest soluble and workable stock concentration, up to 500 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1 µg/plate sodium azide (TA100 and 1535,-S9), 1 µg/plate 2-nitrofluorene (TA98,-S9), 75 µg/plate 9-aminoacridine (TA1537,-S9), 1 µg/plate methyl methane sulfonate (WP2 uvrA,-S9), 1 µg/plate 2-AA (TA98, 100, 1535, 1537, +S9) and 10 µg/plate 2-AA (WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: duplicates in Experiment 1 (and 1.1) and triplicates in Experiment 2
DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn - Evaluation criteria:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate were claculated and reported.
For the test item to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of the test item. Data sets for tester strains TA 1535 and TA 1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for tester strains TA 98, TA 100 and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle value. - Statistics:
- Mean and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- 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 examined
- Positive controls validity:
- valid
- 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: In the initial toxicity-mutation assay, the maximum dose tested was 5000 µg/plate. This dose was achieved using a concentration of 100 mg/mL and a 50 µL plating aliquot. Neither precipitate nor appreciable toxicity was observed in doses tested up to 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
ADDITIONAL INFORMATION:
Due to the loss of plates to contamination in Experiment 1, tester strain TA 1535 without metabolic activation was retested (Experiment 1.1). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary Ames Test Results – Experiment 1
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of triplicate) |
||||
Base-pair substitution type |
Frameshift type |
Base-pair substitution and other |
||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
WP2 uvrA |
||
- |
Vehicle control |
16±7 |
115±35 |
4±1 |
12±1 |
10±0 |
- |
2.5 |
12±9 |
139±19 |
7±5 |
8±0 |
13±1 |
- |
7.5 |
10±-- |
139±6 |
5±1 |
12±0 |
12±2 |
- |
25 |
11±3 |
114±43 |
7±4 |
10±1 |
10±0 |
- |
75 |
-- |
97±21 |
8±4 |
9±4 |
10±2 |
- |
200 |
5±-- |
115±11 |
8±4 |
12±6 |
9±3 |
- |
600 |
5±1 |
128±8 |
5±3 |
11±1 |
7±3 |
- |
1800 |
5±1 |
107±15 |
4±3 |
8±4 |
8±0 |
- |
5000 |
10±1 |
70±6 |
3±2 |
15±9 |
8±1 |
Positive controls - S9 |
Name |
NaN3 |
NaN3 |
9-AA |
2-NF |
MMS |
Concentrations (μg/plate) |
1.0 |
1.0 |
75 |
1.0 |
10. |
|
Number of colonies/plate |
344±18 |
481±66 |
250±9 |
113±19 |
65±10 |
|
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
WP2 uvrA |
|
+ |
Vehicle control |
9±2 |
140±20 |
5±0 |
13±4 |
11±1 |
+ |
2.5 |
13±5 |
130±37 |
7±2 |
10±3 |
11±4 |
+ |
7.5 |
7±3 |
133±18 |
5±1 |
12±6 |
10±1 |
+ |
25 |
11±1 |
135±16 |
6±1 |
16±3 |
9±3 |
+ |
75 |
11±5 |
122±5 |
6±3 |
15±4 |
10±1 |
+ |
200 |
9±1 |
113±13 |
6±1 |
16±3 |
9±1 |
+ |
600 |
14±6 |
145±12 |
7±1 |
15±4 |
10±1 |
+ |
1800 |
13±4 |
118±7 |
5±2 |
12±7 |
11±2 |
+ |
5000 |
11±6 |
126±1 |
5±1 |
12±1 |
9±0 |
Positive controls + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
1.0 |
1.0 |
1.0 |
1.0 |
10 |
|
Number of colonies/plate |
134±10 |
1099±644 |
91±9 |
578±255 |
110±8 |
Table 2: Summary Ames Test Results - Experiment 1.1
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of triplicate) |
||||
Base-pair substitution type |
Frameshift type |
Base-pair substitution and other |
||||
TA 1535 |
|
|
|
|
||
- |
Vehicle control |
10±6 |
|
|
|
|
- |
2.5 |
11±1 |
|
|
|
|
- |
7.5 |
13±1 |
|
|
|
|
- |
25 |
13±4 |
|
|
|
|
- |
75 |
16±7 |
|
|
|
|
- |
200 |
12±4 |
|
|
|
|
- |
600 |
17±1 |
|
|
|
|
- |
1800 |
16±2 |
|
|
|
|
- |
5000 |
18±4 |
|
|
|
|
Positive controls - S9 |
Name |
NaN3 |
|
|
|
|
Concentrations (μg/plate) |
1.0 |
|
|
|
|
|
Number of colonies/plate |
300±9 |
|
|
|
|
Table 3: Summary Ames Test Results - Experiment 2
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of triplicate) |
||||
Base-pair substitution type |
Frameshift type |
Base-pair substitution and other |
||||
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
WP2 uvrA |
||
- |
Vehicle control |
12±3 |
197±13 |
7±2 |
12±3 |
13±3 |
- |
75 |
16±4 |
171±13 |
10±2 |
12±1 |
9±1 |
- |
200 |
14±7 |
220±11 |
11±5 |
15±3 |
15±3 |
- |
600 |
18±3 |
145±24 |
8±1 |
15±4 |
10±2 |
- |
1800 |
14±3 |
142±6 |
8±4 |
15±4 |
9±4 |
- |
5000 |
15±4 |
209±42 |
10±3 |
14±2 |
11±2 |
Positive controls - S9 |
Name |
NaN3 |
NaN3 |
9-AA |
2-NF |
MMS |
Concentrations (μg/plate) |
1.0 |
1.0 |
75 |
1.0 |
10. |
|
Number of colonies/plate |
365±4 |
592±3 |
935±19 |
185±36 |
81±12 |
|
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
WP2 uvrA |
|
+ |
Vehicle control |
8±2 |
201±11 |
9±5 |
15±3 |
11±3 |
+ |
75 |
10±2 |
197±10 |
7±0 |
16±3 |
11±3 |
+ |
200 |
13±2 |
260±9 |
11±1 |
16±3 |
12±1 |
+ |
600 |
12±2 |
228±22 |
6±2 |
12±2 |
9±2 |
+ |
1800 |
12±4 |
181±22 |
8±2 |
14±4 |
14±2 |
+ |
5000 |
10±3 |
185±20 |
11±1 |
13±6 |
11±3 |
Positive controls + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
1.0 |
1.0 |
1.0 |
1.0 |
10 |
|
Number of colonies/plate |
246±31 |
1745±208 |
370±51 |
1465±127 |
80±11 |
NaN3 = sodium azide
2-AA = 2-aminoanthracene
9-AA = 9-aminoacridine
2-NF = 2-nitrofluorene
MMS = methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
Methyldiacetoxyisopropoxy silane was tested in an Ames test using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100 and the Escherichia coli strain WP2 uvrA . The substance was tested up to 5000 µg/plate with and without metabolic activation. No toxic effects occurred in all test groups, with and without S9 mix. Under the experimental conditions the test item did not induce mutations by base pair changes or frameshifts in the genome of the strains used.
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