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EC number: 244-239-0 | CAS number: 21142-29-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1993
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-(triethoxysilyl)propyl methacrylate
- EC Number:
- 244-239-0
- EC Name:
- 3-(triethoxysilyl)propyl methacrylate
- Cas Number:
- 21142-29-0
- Molecular formula:
- C13H26O5Si
- IUPAC Name:
- 3-(triethoxysilyl)propyl 2-methylprop-2-enoate
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- histidine operon - Salmonella strains, tryptophan operon - E.coli strains
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- up to 5000 μg/plate
- Vehicle / solvent:
- 100% ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2, WP2 uvrA; -MA; 1000 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sterigmatocystin
- Remarks:
- WP2; +MA; 100 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; -MA; 75 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535; -MA; 1.0 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; -MA; 1.0 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 98, TA 100, TA 1535, TA 1537, WP2 uvrA; +MA; 1.0 μg/plate (10 μg/plate WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); pre-incubation
ACTIVATION:
S9 mix:
-10% S9
- 5mM glucose-6-phosphate
- 4 mM β-nicotinamide-adenine dinucleotide phosphate
- 8 mM MgCl2
- 33 mM KCl
in a 100 mM phosphate buffer at pH 7.4
0.5 ml S9 mix were added to 0.1 ml tester strain and 0.025 ml test article giving a final concentration of approximately 8% S9 during pre-incubation. 2.0 ml of top agar were added so the concentration of S9 in the plates was approximately 2%.
DURATION
- Preincubation period: 60±2 minutes at 37±2°C
- Exposure duration: 48 to 72 hours at 37±2°C
SELECTION AGENT (mutation assays): histidine or tryptophan-deficient agar plates
NUMBER OF REPLICATIONS: triplicate plates, independent repeat assays were performed. Pre-incubation was used in all assays.
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of the bacterial background lawn - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test article.
Data sets for 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 great than three times the mean vehicle control value.
Data sets for strains TA 98, TA 100, WP2 uvrA and WP" 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 control value.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed.
RANGE-FINDING/SCREENING STUDIES: Results of initial toxicity studies were used to set doses in main study.
COMPARISON WITH HISTORICAL CONTROL DATA:
Experiment B1: toxicity in control plates +S9, and excessive toxicity in TA1535 -S9 were observed, so relevant parts repeated in B2.
Experiment B2: unacceptable positive control values obtained for: TA1535 -S9; TA1537 and WP2 +S9, so relevant parts repeated in B3.
Experiment B3: unacceptable vehicle control value obtained for TA1537 +S9; unacceptable positive control value obtained for WP2 +S9; excessive toxicity in TA1537 -S9, so relevant parts repeated in B5.
Experiment B4 (confirmatory assay): unacceptable positive control value obtained for WP2 +S9; erratic toxicity in WP2 -S9, so relevant parts repeated in B6
Experiments B5 and B6: results acceptable. - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
The notation B1 -B6 in the tables indicates in which experiment the result was obtained.
Table 1 Initial experiment, without metabolic activation
Dose (µg) |
TA 98 (B1) |
TA 100 (B1) |
TA 1535 (B1) |
TA 1535 (B5) |
TA 1535 (B3) |
TA 1537 (B1) |
WP2 uvrA (B1) |
WP2 (B1) |
0.0 |
21 |
121 |
10 |
10 |
28 |
5 |
292 |
91 |
1.0 |
- |
- |
- |
9 |
- |
- |
- |
- |
3.3 |
24 |
134 |
6 |
8 |
- |
5 |
- |
- |
10 |
25 |
143 |
7 |
6 |
28 |
5 |
- |
- |
33 |
18 |
105 |
11 |
9 |
25 |
3 |
285 |
94 |
100 |
16 |
62 |
6 |
8 |
6 |
3 |
213 |
85 |
333 |
9 |
4 |
4 |
8 |
6 |
0 |
180 |
91 |
1000 |
5 |
17 |
0 |
7 |
8 |
0 |
215 |
88 |
5000 |
11 |
39 |
0 |
9 |
8 |
0 |
272 |
85 |
Positive control |
1342 |
746 |
541 |
549 |
349 |
460 |
1682 |
1550 |
Table 2 Initial experiment, with metabolic activation
Dose (µg) |
TA 98 (B2) |
TA 100 (B2) |
TA 1535 (B2) |
TA 1537 (B2) |
TA 1537 (B5) |
WP2 uvrA (B2) |
WP2 (B2) |
WP2 (B5) |
0.0 |
36 |
135 |
28 |
5 |
5 |
368 |
109 |
109 |
1.0 |
- |
- |
- |
- |
8 |
- |
- |
108 |
3.1 |
30 |
120 |
28 |
6 |
- |
- |
- |
- |
3.3 |
- |
- |
- |
- |
8 |
- |
- |
100 |
10 |
32 |
118 |
26 |
8 |
9 |
- |
- |
107 |
31 |
33 |
119 |
31 |
6 |
- |
346 |
90 |
- |
33 |
- |
- |
- |
- |
9 |
- |
- |
100 |
100 |
31 |
126 |
27 |
8 |
9 |
342 |
90 |
79 |
313 |
27 |
129 |
21 |
6 |
- |
325 |
97 |
- |
333 |
- |
- |
- |
- |
7 |
- |
- |
95 |
1000 |
30 |
117 |
18 |
5 |
3 |
323 |
84 |
102 |
5000 |
14 |
141 |
24 |
5 |
3 |
295 |
65 |
103 |
Positive control |
144 |
431 |
410 |
2451 |
21 |
2231 |
1863 |
238 |
Table 3 Confirmatory experiment without metabolic activation
Dose (µg) |
TA 98 (B4) |
TA 100 (B4) |
TA 1535 (B4) |
TA 1537 (B4) |
WP2 uvrA (B4) |
WP2 (B4) |
WP2 (B6) |
0.0 |
15 |
111 |
7 |
5 |
193 |
29 |
52 |
1.0 |
- |
- |
- |
- |
- |
- |
55 |
3.3 |
22 |
105 |
10 |
3 |
- |
- |
57 |
10 |
14 |
107 |
6 |
5 |
160 |
21 |
38 |
33 |
19 |
102 |
8 |
4 |
191 |
26 |
48 |
100 |
14 |
90 |
7 |
4 |
205 |
24 |
50 |
333 |
10 |
75 |
7 |
2 |
225 |
16 |
54 |
1000 |
11 |
105 |
6 |
4 |
227 |
14 |
49 |
5000 |
4 |
75 |
6 |
4 |
224 |
27 |
47 |
Positive control |
343 |
373 |
291 |
332 |
1679 |
798 |
1536 |
Table 4 Confirmatory experiment with metabolic activation
Dose (µg) |
TA 98 (B4) |
TA 100 (B4) |
TA 1535 (B4) |
TA 1537 (B4) |
WP2 uvrA (B4) |
WP2 (B6) |
0.0 |
30 |
134 |
9 |
7 |
277 |
65 |
1.0 |
- |
- |
- |
- |
- |
61 |
3.3 |
- |
- |
- |
- |
- |
62 |
10 |
25 |
115 |
6 |
5 |
295 |
57 |
33 |
26 |
122 |
8 |
4 |
300 |
66 |
100 |
24 |
130 |
6 |
5 |
315 |
60 |
333 |
13 |
104 |
10 |
5 |
307 |
62 |
1000 |
14 |
105 |
4 |
3 |
325 |
65 |
5000 |
15 |
111 |
12 |
4 |
241 |
67 |
Positive control |
1049 |
1040 |
110 |
151 |
911 |
140 |
Applicant's summary and conclusion
- Conclusions:
- 3-(Triethoxysilyl)propyl methacrylate has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD TG 471, compliant with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or E. coli strains WP2 or WP2 uvrA in the initial or the repeat experiments up to limit concentrations using pre-incubation. Appropriate positive and solvent controls were included and 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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