Registration Dossier
Registration Dossier
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: 246-467-6 | CAS number: 24801-88-5
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-03-11 to 1999-08-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- guideline not mentioned.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triethoxy(3-isocyanatopropyl)silane
- EC Number:
- 246-467-6
- EC Name:
- Triethoxy(3-isocyanatopropyl)silane
- Cas Number:
- 24801-88-5
- Molecular formula:
- C10H21NO4Si
- IUPAC Name:
- triethoxy(3-isocyanatopropyl)silane
Constituent 1
Method
Species / strainopen allclose all
- 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 induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-experiment with and without metabolic activation:
6.7, 10, 33, 67, 100, 333, 667, 1000, 3333, 5000 µg/plate
Main experiment:
with metabolic activation:
25, 75, 200, 600, 1800, 5000 µg/plate
without metabolic activation:
7.5, 25, 75, 200, 600, 1800 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All salmonella strains + WP2 uvrA (with activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without activation)
- 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 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA
- Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 - 72 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, revertant colony counts
METABOLIC ACTIVATION: S9 was prepared from male Sprague Dawley rates induced with a single ip dose of Aroclor 1254, 500 mg/kg bw, 5 days before sacrifice. Each preparation of S9 was assayed for ability to metabolise 2-aminoanthracene and 7,12-dimethylbenz(a)anthracene to forms mutagenic to TA 100. S9 mix contained 10% S9, 5mM glucose-6-phosphate, 4 mM NADP, 8 mM MgCl2, 33 mM KCl. 0.5 ml was added to 100 microlitre vehicle or test article and (after pre-incubation) 2.0 ml top agar. The final concentration of S9 was therefore approximately 2%.- Evaluation criteria:
- Cytotoxicity is defined as a reduction in the number of colonies by >50% compared with the solvent control and/or at least a moderate reduction in
the background lawn (background code 3,4 or 5).
The mean of each positive control must exhibit at least a three-fold increase in the number of revertants over the mean value of the respective vehicle control.
A minimum of three non-toxic dose levels are required to evaluate assay data.
A dose level is considered toxic if one or both of the following are met: (1) A >50 % reduction in the mean number of revertants per plate as
compared to the mean vehicle control. This reduction must be accompanied by an abrupt dose-dependant drop in the revertant count. (2) A reduction in the background lawn.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 1800 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1800 - 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 1800 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1800 - 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 1800 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1800 - 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 1800 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 5000 μg/plate
- 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:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1800 - 5000 μg/plate
- 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
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 600 - 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (2 plates per strain)
TA 100 |
WP2 uvrA |
|||||
Concentration (μg/Plate) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
0 |
133 |
98 |
No |
16 |
23 |
No |
6.7 |
128 |
110 |
No |
13 |
8 |
No |
10 |
123 |
95 |
No |
28 |
17 |
No |
33 |
134 |
98 |
No |
13 |
9 |
No |
67 |
150 |
84 |
No |
19 |
19 |
No |
100 |
147 |
111 |
No |
17 |
15 |
No |
333 |
146 |
107 |
No |
11 |
20 |
No |
667 |
134 |
104 |
No |
22 |
26 |
No |
1000 |
148 |
123 |
No |
32 |
16 |
No |
3333 |
146 |
116 |
No |
15 |
18 |
No |
5000 |
168 |
113 |
No |
24 |
16 |
No |
*solvent control with DMSO
Table 3: Experiment 1 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
16 |
27 |
No |
134 |
161 |
No |
11 |
12 |
No |
100 |
21 |
30 |
No |
131 |
156 |
No |
11 |
11 |
No |
333 |
11 |
24 |
No |
134 |
163 |
No |
10 |
14 |
No |
1000 |
20 |
24 |
No |
129 |
164 |
No |
12 |
13 |
No |
3333 |
20 |
32 |
No |
141 |
167 |
No |
9 |
11 |
No |
5000 |
15 |
28 |
No |
126 |
172 |
No |
10 |
15 |
No |
Positive control |
367 |
873 |
No |
720 |
1035 |
No |
637 |
129 |
No |
*solvent control with DMSO
Table 3: Experiment 1 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
5 |
12 |
No |
17 |
19 |
No |
100 |
4 |
8 |
No |
14 |
18 |
No |
333 |
6 |
8 |
No |
17 |
13 |
No |
1000 |
4 |
9 |
No |
10 |
16 |
No |
3333 |
6 |
8 |
Yes |
16 |
15 |
No |
5000 |
6 |
6 |
Yes |
17 |
14 |
No |
Positive control |
1070 |
119 |
No |
292 |
108 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
26 |
44 |
No |
106 |
129 |
No |
10 |
12 |
No |
33 |
26 |
39 |
No |
121 |
131 |
No |
11 |
11 |
No |
100 |
24 |
46 |
No |
136 |
153 |
No |
9 |
16 |
No |
333 |
26 |
35 |
No |
117 |
142 |
No |
11 |
14 |
No |
1000 |
25 |
39 |
No |
119 |
166 |
No |
11 |
11 |
No |
5000 |
19 |
38 |
No |
138 |
167 |
No |
11 |
10 |
No |
Positive control |
292 |
901 |
No |
534 |
945 |
No |
446 |
106 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2 uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
6 |
5 |
No |
21 |
14 |
No |
33 |
5 |
6 |
No |
16 |
14 |
No |
100 |
5 |
7 |
No |
21 |
15 |
No |
333 |
4 |
6 |
No |
18 |
15 |
No |
1000 |
5 |
9 |
No |
19 |
18 |
No |
5000 |
3 |
7 |
Yes |
22 |
15 |
No |
Positive control |
598 |
97 |
No |
430 |
118 |
No |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Triethoxy(3-isocyanatopropyl)silane has been tested according to a protocol that is similar to OECD 471 and in compliance with GLP in Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E. coli WP2 uvrA. No test substance induced increase in the number of revertants was observed in the presence or absence of metabolic activation when tested up to cytotoxic concentrations. Appropriate solvent and positive 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.
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.
