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EC number: 225-806-1 | CAS number: 5089-72-5
- 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:
- 1994-10-19 to 1994-11-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were [4 strains only. Non-standard positive controls. only 2-aminoanthracene as +S9 control]
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- yes
- Remarks:
- 4 strains only. Non-standard positive controls. only 2-aminoanthracene as +S9 control
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
- EC Number:
- 225-806-1
- EC Name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
- Cas Number:
- 5089-72-5
- Molecular formula:
- C11H28N2O3Si
- IUPAC Name:
- N-[3-(triethoxysilyl)propyl]ethylenediamine
Constituent 1
Method
- Target gene:
- His operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 33.3, 100, 333.3, 1000, 2500 and 5000 µg/pate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Untreated culture
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- Untreated culture
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 1537, TA 98 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- Untreated culture
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains (with activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: background lawn assessment - Evaluation criteria:
- A test article is considered mutagenic if in the strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537 and TA 98 at least three times higher as compared to the spontanious reversion rate. A dose dependant and reproducible increase in the number of revertants is an indication of possible existing mutagenic potential regardless of highest dose value.
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- - S9 (pre-incubation test): TA 98 and TA1537 at 5000 µg/plate, while TA 100 at 2500 µg/plate. + S9 (pre-incubation test): TA 1537 at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 2: Dose range-finding study number of revertants per plate (2 plates per strain)
|
TA 98 |
TA 100 |
||||
Concentration (μg/Plate) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
Negative control |
15 |
17 |
No |
163 |
122 |
No |
0 |
24 |
16 |
No |
147 |
129 |
No |
3.3 |
12 |
17 |
No |
150 |
128 |
No |
10 |
22 |
20 |
No |
154 |
116 |
No |
33.3 |
18 |
12 |
No |
158 |
120 |
No |
100 |
19 |
19 |
No |
155 |
119 |
No |
333.3 |
21 |
14 |
No |
87 |
107 |
No |
1000 |
23 |
16 |
No |
159 |
109 |
No |
2500 |
20 |
13 |
No |
128 |
111 |
No |
5000 |
57 |
10 |
No |
126 |
111 |
No |
Positive control |
555 |
142 |
No |
973 |
353 |
No |
*solvent control with ethanol
Table 3: Experiment 1 Mutagenicity Assay (plate incorporation) number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control |
17 |
15 |
No |
122 |
163 |
No |
13 |
13 |
No |
0 |
16 |
24 |
No |
129 |
147 |
No |
14 |
19 |
No |
33.3 |
12 |
18 |
No |
120 |
158 |
No |
15 |
16 |
No |
100 |
19 |
19 |
No |
119 |
155 |
No |
15 |
16 |
No |
333.3 |
14 |
21 |
No |
107 |
87 |
No |
13 |
15 |
No |
1000 |
16 |
23 |
No |
109 |
159 |
No |
12 |
20 |
No |
2500 |
13 |
20 |
No |
111 |
128 |
No |
11 |
19 |
No |
5000 |
10 |
57 |
No |
111 |
126 |
No |
12 |
16 |
No |
Positive control |
142 |
555 |
No |
353 |
973 |
No |
69 |
405 |
No |
*solvent control with ethanol
Table 3: Experiment 1 Mutagenicity Assay (plate incorporation ) number of revertants per plate (mean of 3 plates)
|
TA1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
Negative control |
25 |
29 |
No |
0 |
19 |
24 |
No |
33.3 |
17 |
21 |
No |
100 |
18 |
23 |
No |
333.3 |
18 |
21 |
No |
1000 |
20 |
22 |
No |
2500 |
16 |
22 |
No |
5000 |
14 |
22 |
No |
Positive control |
79 |
279 |
No |
*solvent control with ethanol
Table 4: Experiment 2 Mutagenicity Assay (pre-incubation) Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control |
27 |
39 |
No |
130 |
136 |
No |
10 |
13 |
No |
0 |
31 |
38 |
No |
103 |
122 |
No |
17 |
19 |
No |
33.3 |
27 |
36 |
No |
92 |
129 |
No |
12 |
19 |
No |
100 |
28 |
42 |
No |
105 |
126 |
No |
11 |
15 |
No |
333.3 |
29 |
32 |
No |
94 |
122 |
No |
12 |
19 |
No |
1000 |
22 |
37 |
No |
71 |
142 |
No |
15 |
20 |
No |
2500 |
18 |
31 |
No |
9 |
91 |
Yes |
10 |
13 |
No |
5000 |
0 |
31 |
Yes |
0 |
70 |
Yes |
11 |
8 |
No |
Positive control |
218 |
287 |
No |
808 |
389 |
No |
862 |
122 |
No |
*solvent control with Ethanol
Table 4: Experiment 2 Mutagenicity Assay (pre-incubation) number of revertants per plate (mean of 3 plates)
|
TA1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
Negative control |
29 |
31 |
No |
0 |
29 |
32 |
No |
33.3 |
27 |
36 |
No |
100 |
26 |
35 |
No |
333.3 |
28 |
33 |
No |
1000 |
27 |
35 |
No |
2500 |
19 |
25 |
No |
5000 |
8 |
4 |
Yes |
Positive control |
94 |
121 |
No |
*solvent control with ethanol
MA: Metabolic activation
Applicant's summary and conclusion
- Conclusions:
- negative with metabolic activation
negative without metabolic activation
Under test conditions, no mutagenic effect was observed for the test substance tested up to limit concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.
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