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EC number: 217-164-6 | CAS number: 1760-24-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1998-11-10 - 1998-11-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- EC Number:
- 217-164-6
- EC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- Cas Number:
- 1760-24-3
- Molecular formula:
- C8H22N2O3Si
- IUPAC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
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, other: E coli WP2 trp pKM101 (CM881)
- Species / strain / cell type:
- E. coli, other: E coli WP2 trp uvrA pKM101 (CM891)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Sponsors choice as completely miscible in water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation TA1535 5 µg/plate, TA100 3 µg/plate, CM881 and CM891 2 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 30 µg/plate
- 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 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene 2 µg/plate TA1535, 10 µg/plate CM881 and CM891
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA1537, TA98 and TA100 with metabolic activation 5 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: S9 mix contained S9 fraction 10%, MgCl, KCl, sodium orthophosphate buffer pH 7.4, glucose-6-phosphate and NADP. 0.5 ml S9 mix and 0.1ml of test solution were added to 2ml agar.
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 3 days
SELECTION AGENT (mutation assays): histidine deficient agar
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn
ACTIVATION
- Aroclor induced rat liver S9 was present at 10% in the S9 mix, which included NADP and glucolse-6-phosphate as cofactors. 0.5 ml S9 mix was added to 2 ml top agar, 0.1 ml test solution or control and 0.1 ml bacterial culture giving a final concentration of approximately 2%. - Evaluation criteria:
- A result is considered positive if there is a three-fold increase in the number of revertants in TA1535, TA1537 and TA98 over the solvent control and a two-fold increase for other strains. This should occur in both experiments and show some evidence of a dose-relationship. The positive controls must cause at least a doubling of mean revertant colony numbers over the mean of the solvent control.
- Statistics:
- None in report
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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 pKM 101
- 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, other: E. coli WP2 pKM101 (CM881)
- 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:
- S. typhimurium TA 1537
- 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:
- S. typhimurium TA 98
- 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:
- S. typhimurium 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
Any other information on results incl. tables
Average number of revertants per plate (mean of three plates)
Treatment µg/plate |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
CM 881 |
CM 891 |
|||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Solvent control |
14 |
16 |
9 |
10 |
19 |
23 |
108 |
127 |
46 |
53 |
179 |
180 |
|
50 |
14 |
19 |
7 |
6 |
22 |
27 |
110 |
133 |
56 |
67 |
201 |
190 |
|
150 |
14 |
20 |
7 |
7 |
19 |
24 |
111 |
132 |
63 |
77 |
189 |
203 |
|
500 |
14 |
16 |
7 |
8 |
24 |
24 |
109 |
113 |
46 |
56 |
193 |
203 |
|
1500 |
13 |
16 |
6 |
7 |
25 |
23 |
111 |
123 |
61 |
73 |
199 |
195 |
|
5000 |
10 |
11 |
9 |
9 |
15 |
23 |
87 |
114 |
61 |
63 |
188 |
197 |
|
Positive control |
370 |
179 |
316 |
46 |
115 |
164 |
456 |
718 |
817 |
392 |
1703 |
1799 |
|
Average Revertants per plate with and without metabolic activation – Exp 2 pre-incubation
|
|||||||||||||
Treatment µg/plate |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
CM 881 |
CM 891 |
|||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
||
Solvent control |
18 |
15 |
9 |
9 |
29 |
27 |
134 |
143 |
61 |
69 |
247 |
242 |
|
50 |
20 |
16 |
8 |
11 |
27 |
31 |
115 |
134 |
55 |
73 |
238 |
253 |
|
150 |
18 |
18 |
9 |
10 |
21 |
30 |
110 |
135 |
47 |
66 |
216 |
237 |
|
500 |
13 |
21 |
10 |
9 |
26 |
26 |
106 |
129 |
58 |
62 |
261 |
253 |
|
1500 |
18 |
18 |
7 |
8 |
21 |
28 |
113 |
114 |
54 |
80 |
230 |
235 |
|
5000 |
15 |
18 |
8 |
6 |
25 |
28 |
105 |
97 |
48 |
60 |
215 |
268 |
|
Positive control |
244 |
115 |
120 |
144 |
130 |
270 |
456 |
569 |
792 |
438 |
1569 |
758 |
|
Average Revertants per plate with and without metabolic activation – Exp 1
Applicant's summary and conclusion
- Conclusions:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria, in a study that was conducted according to the OECD TG 471 and in compliance with GLP. No evidence of test substance related increase in the number of revertants was observed with or without activation in the initial experiment using the plate incorporation method or the repeat pre-incubation assay in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, E coli WP2 trp uvrA pKM101 (CM891) and E coli WP2 trp pKM101 (CM881). The solvent used was water, and hydrolysis was likely to have occurred under test conditions, so it is assumed that exposure was to the hydrolysis product as well as the parent substance. It is not considered to invalidate the study, as it is considered that hydrolysis may occur in vivo. 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.
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