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EC number: 221-660-8 | CAS number: 3179-76-8
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998-10-20 to 1998-12-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The original study was considered reliability 1. Read-across to the registered substance is considered scientifically justified and is reliability 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 3-aminopropyltriethoxysilane
- EC Number:
- 213-048-4
- EC Name:
- 3-aminopropyltriethoxysilane
- Cas Number:
- 919-30-2
- IUPAC Name:
- 3-(triethoxysilyl)propan-1-amine
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and Beta-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 200, 600, 1800, 3000, 5000 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: culture medium
- Justification for choice of solvent/vehicle: homogeneous (as determined by visual inspection)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ham's F12 medium with 2 mM Glutamine, 100 IU/ml Penicillin, and 100 µg/ml Streptomycin
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without activation
Migrated to IUCLID6: 300 µg/ml
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ham's F12 medium with 2 mM Glutamine, 100 IU/ml Penicillin, and 100 µg/ml Streptomycin
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- with activation
Migrated to IUCLID6: 10 µg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
DURATION
- Exposure duration: 4 hours (with and without activation)
- Expression time (cells in growth medium): 9 days
- Selection time (if incubation with a selection agent): 9 days
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays): H 10 medium
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
NUMBER OF CELLS EVALUATED: approx 5x10 E05
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
ACTIVATION: S9 mix contained 3% S9 and glucose-6-phosphate and NADP as cofactors. - Evaluation criteria:
- A test compound is considered positive in this assay if it causes a statistically significant, dose related increase in mutant frequency at concentrations of test substance resulting in >20% survival, at a level which is significantly above the maximum spontaneous mutant frequency.
- Statistics:
- t-test
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- >5000 µg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: CHO K-1
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Cytotoxicity test: Concentrations in the range of 50-5000 µg/ml were tested for induction of cytotoxicity. There was no effect of the test substance on cloning efficiency of the CHO cells in the presence or absence of metabolic activation at any concentration tested.
The frequency of mutations was low in all groups. In the absence of metabolic activation mutant frequencies of test substance treated cells were within the range of historical negative controls (i.e., 0-21 mutants per 10 E06 viable cells. The test substance did not produce significant mutant frequency at any concentration tested in the absence of metabolic activation. In the presence of metabolic activation, the test substance did induce significant increases of the mutant frequencies at the concentration of 600 µg/ml. The observed mutant frequencies were within the range of the historical negative control (0- 23 mutants per 10 E+06 viable cells) and did not show a dose response relationship, the statistical significance is the result of normal assay variation rather than indicative of a mutagenic effect of the test substance.
Table 1 Mutant frequency (x10E-06) (mean of 5 flasks)
Concentration µg/ml |
Experiment 1 |
Experiment 2 |
||||
- MA |
+ MA |
cytotoxicity |
- MA |
+ MA |
cytotoxicity |
|
0 * |
3 |
1 |
no |
4 |
3 |
no |
200 |
2 |
1 |
no |
5 |
3 |
no |
600 |
2 |
5*** |
no |
0 |
8**** |
no |
1800 |
0 |
0 |
no |
0 |
5 |
no |
3000 |
1 |
1 |
no |
5 |
3 |
no |
5000 |
0 |
3 |
no |
1 |
2 |
no |
Positive control |
265** |
290** |
no |
342** |
230** |
no |
* Solvent control with culture medium
** Highly significant, no statistical evaluation
*** Statistically significant, P<0.001 but within the range of the historical negative control
**** Statistically significant 0.1<P<0.05but within the range of the historical negative control
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without activation
3-aminopropyltriethoxysilane has been tested in a reliable assay according to OECD TG 476 and under GLP. Expected results were obtained from medium and positive controls. The results from the repeat experiment were consistent with those from the initial test. No increase in the mutant frequency was observed in Chinese hamster Ovary (CHO) cells in the absence of activation. In the presence of activation, a statistically significant increase was observed at a single concentration. As this result was within the range of the mutant frequencies of the historical negative controls, and no dose response relationship was observed, the increases are a result of normal assay variation rather than a mutagenic effect of the test substance. It is the opinion of the reviewer that although the test substance hydrolyses in water, and so the use of aqueous cell culture medium may have led to exposure of the test organisms to the products of hydrolysis rather than the test substance itself, this does not invalidate the test, as hydrolysis would occur in exposed organisms. It is concluded that the test substance in not mutagenic to mammalian cells under the conditions of the test.
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