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EC number: 700-340-6 | CAS number: 76524-94-2
- 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:
- 21 Sep - 12 Oct 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Kanpoan No. 287 - EPA; Eisei No. 127 - Ministry of Health & Welfare; Heisei 09/10/31 Kikyoku No.2 - Ministry of Intern. Trade & Industry
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Landwirtschaft und Forsten, Mainzer Straße 80, D-65189 Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]formamide
- EC Number:
- 700-340-6
- Cas Number:
- 76524-94-2
- Molecular formula:
- C10H23NO4Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]formamide
- Details on test material:
- - Name of test material (as cited in study report): Y-15864
- Analytical purity: 97.5 - 99.5%
- Lot/batch No.: TER00010-68-31
- Expiration date of the lot/batch: December 09, 2012
- Storage condition of test material: at room temperature
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 phenobarbital/β-naphthoflavone.
- Test concentrations with justification for top dose:
- Pre-Experiment and first experiment: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without S9 mix
Second Experiment: 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without S9 mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- culture media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 10 µg/plate sodium azide (TA100 and 1535, -S9), 10 µg/plate 4-nitro-o-phenylen-diamine (TA98 and 1537, -S9), 3 µL/plate methyl methane sulfonate (WP2, -S9), 2.5 µg/plate 2-aminoanthracene (2-AA) (TA98, 100, 1535, 1537, +S9), 10 µg/plate 2-AA (WP2, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment I: plate incorporation; Experiment II: preincubation
EXPERIMENTAL PERFORMANCE
The following materials were mixed in a test tube and poured onto the minimal agar plates:
100 µL Test solution at each dose level, solvent (negative control) or reference mutagen
solution (positive control),
500 µL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test
without metabolic activation),
100 µL Bacteria suspension (cf. test system, pre-culture of the strains),
2000 µL Overlay agar
DURATION
- Preincubation period: 60 min
- Selection time (if incubation with a selection agent): 48 hours
SELECTION AGENT (mutation assays): minimal agar
NUMBER OF REPLICATIONS: triplicates in each of two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth / regular background growth / spontaneous reversion rates in the negative and solvent control - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - 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:
- valid
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Yes
- 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 – Pre-Experiment and 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 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
||
- |
Negative control |
18±5 |
144±13 |
12±3 |
41±2 |
45±6 |
- |
Vehicle control |
15±4 |
139±3 |
11±3 |
32±3 |
43±4 |
- |
3 |
16±4 |
138±12 |
13±5 |
30±5 |
42±7 |
- |
10 |
15±5 |
127±7 |
12±2 |
32±8 |
43±4 |
- |
33 |
13±3 |
134±10 |
14±4 |
31±8 |
36±6 |
- |
100 |
17±5 |
141±10 |
11±4 |
35±5 |
41±7 |
- |
333 |
13±3 |
147±5 |
14±4 |
36±5 |
43±11 |
- |
1000 |
10±2 |
145±8 |
11±1 |
35±5 |
41±1 |
- |
2500 |
11±5 |
147±7 |
12±4 |
31±10 |
38±3 |
- |
5000 |
11±1 |
122±10 |
9±2 |
38±4 |
33±4 |
Positive controls - S9 |
Name |
NaN3 |
NaN3 |
4-NOPD |
4-NOPD |
MMS |
Concentrations (μg/plate) |
10 |
10 |
50 |
10 |
3.0 µL |
|
Number of colonies/plate |
1726±40 |
1998±64 |
84±7 |
385±32 |
1043±98 |
|
|
TA 1535 |
TA 100 |
TA1537 |
TA98 |
WP2 uvrA |
|
+ |
Negative control |
17±5 |
127±11 |
16±4 |
41±2 |
62±13 |
+ |
Vehicle control |
21±5 |
133±10 |
17±4 |
41±11 |
52±3 |
+ |
3 |
19±2 |
119±9 |
16±1 |
45±2 |
50±6 |
+ |
10 |
23±3 |
124±5 |
16±3 |
41±6 |
48±7 |
+ |
33 |
21±3 |
129±17 |
16±4 |
40±5 |
47±3 |
+ |
100 |
16±1 |
129±20 |
16±3 |
35±6 |
48±2 |
+ |
333 |
19±3 |
128±8 |
19±6 |
44±3 |
48±8 |
+ |
1000 |
16±1 |
119±9 |
18±3 |
38±3 |
51±6 |
+ |
2500 |
18±3 |
143±28 |
15±5 |
42±7 |
44±7 |
+ |
5000 |
20±4 |
142±20 |
13±3 |
39±5 |
50±8 |
Positive controls + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
10.0 |
|
Number of colonies/plate |
329±14 |
1316±2 |
184±14 |
1458±56 |
198±19 |
Table 2: 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 |
TA100 |
TA1537 |
TA98 |
WP2 uvrA |
||
- |
Negative control |
9±3 |
124±11 |
19±6 |
35±8 |
41±7 |
- |
Vehicle control |
9±1 |
102±8 |
11±2 |
27±10 |
48±3 |
- |
33 |
11±3 |
109±6 |
11±1 |
28±8 |
43±1 |
- |
100 |
12±2 |
101±12 |
11±5 |
23±3 |
49±5 |
- |
333 |
9±2 |
98±4 |
12±2 |
26±3 |
42±6 |
- |
1000 |
11±3 |
91±11 |
11±3 |
31±4 |
45±4 |
- |
2500 |
11±2 |
91±8 |
13±3 |
27±8 |
48±6 |
- |
5000 |
10±1 |
66±6 |
11±3 |
22±6 |
41±3 |
Positive controls - S9 |
Name |
NaN3 |
NaN3 |
4-NOPD |
4-NOPD |
MMS |
Concentrations (μg/plate) |
10 |
10 |
50 |
10 |
3.0 µL |
|
Number of colonies/plate |
1633±7 |
1672±50 |
78±12 |
339±21 |
443±64 |
|
|
TA 1535 |
TA 100 |
TA1537 |
TA98 |
WP2 uvrA |
|
+ |
Negative control |
16±5 |
144±15 |
22±6 |
38±4 |
62±8 |
+ |
Vehicle control |
16±4 |
110±9 |
15±6 |
39±4 |
48±9 |
+ |
33 |
15±5 |
114±13 |
18±3 |
43±2 |
51±5 |
+ |
100 |
19±4 |
123±12 |
18±3 |
41±1 |
51±11 |
+ |
333 |
16±2 |
114±8 |
16±3 |
38±8 |
49±3 |
+ |
1000 |
15±4 |
107±6 |
13±3 |
41±3 |
49±9 |
+ |
2500 |
17±6 |
126±4 |
16±2 |
35±4 |
47±4 |
+ |
5000 |
19±6 |
117±11 |
17±5 |
43±2 |
51±9 |
Positive controls + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
10.0 |
|
Number of colonies/plate |
260±9 |
1510±152 |
185±0 |
1382±7 |
312±9 |
NaN3 = sodium azide
2-AA = 2-aminoanthracene
4-NOPD = 4 -nitro-o-phenylene-diamine
MMS = methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
N-[3-(Triethoxysilyl)propyl]formamide 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 the 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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