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EC number: 449-160-7 | CAS number: -
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Oct - 08 Nov 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian chromosome aberration test (migrated information)
Test material
- Reference substance name:
- -
- EC Number:
- 449-160-7
- EC Name:
- -
- Cas Number:
- 116912-64-2
- Molecular formula:
- C7H18N2O4Si C8H20N2O4Si C9H22N2O4Si C10H24N2O4Si
- IUPAC Name:
- [3-(ethoxydimethoxysilyl)propyl]urea; [3-(trimethoxysilyl)propyl]urea; {3-[diethoxy(methoxy)silyl]propyl}urea
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Details on mammalian cell type (if applicable):
- Peripheral lymphocytes from healthy human males were cultured within 4 h after blood sampling. The cells were cultured in Ham´s F10 without thymidine and hypoxanthine supplemented with fetal calf serum, L-glutamine, P/S, sodium bicarbonate and heparin.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from livers of Aroclor 1254 induced male Wistar rats
- Test concentrations with justification for top dose:
- Without S9-mix: 100, 180, 333, 420, 560 µg/ml
With S9-mix: 333, 560, 1000, 1300, 1800 µg/ml - Vehicle / solvent:
- Dimethylsulphoxide (final concentration 0.9%)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: Cyclophosphamide, 15 µg/ml; -S9: Mitomycin C, 0.5, 0.2 and 0.1 µg/ml for 3, 24 and 48 h treatment, respectively.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Exposure duration: 3 h
- Fixation time (start of exposure up to fixation or harvest of cells): 24 h
SPINDLE INHIBITOR (cytogenetic assays): Colchicine (0.5 µg/ml) was added 3 h before fixation of cells.
STAIN (for cytogenetic assays): Giemsa (5% in tap water)
NUMBER OF REPLICATIONS: duplicate
NUMBER OF CELLS EVALUATED: 100 metaphase chromosome spreads per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index (metaphases per 1000 cells)
OTHER EXAMINATIONS:
- Determination of polyploidy: no data
- Determination of endoreplication: no data
- Range finding test: cells were treated for 3 (fixation at 24 h, ± S9), 24 (fixation at 24 h, -S9), and 48 h (fixation at 48 h, -S9) for determination of mitotic index. - Evaluation criteria:
- A test substance was considered positive (clastogenic) if:
- induction of a dose-related statistically significant increase in the number of cells with chromosomal aberrations.
- a statistically significant increase in the frequencies of the number of cells with chromosome aberrations as observed in the absence of a clear dose-response relationship. - Statistics:
- - induction of a dose-related statistically significant increase in the number of cells with chromosomal aberrations: Chi-square test, p<0.05
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Mitotic index < 50% at the highest concentration ± S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: pH 7.54 was measured at the highest concentration of 5000 µg/ml (pH 7.67 in the solvent control)
- Effects of osmolality: 385 mOsm/kg was measured at the highest concentration of 5000 µg/ml (428 mOsm/kg in the solvent control)
RANGE-FINDING/SCREENING STUDIES: for details see table 1
COMPARISON WITH HISTORICAL CONTROL DATA: Solvent control data were within the historical control data
Any other information on results incl. tables
Table 1: Results determined in the range-finder assay:
Test item |
Concentration |
Mitotic Index |
|
in µg/ml |
in % |
Exposure period 3 h, fixation time 24 h, without S9 mix |
||
Test substance |
100 |
93 |
333 |
66 |
|
1000 |
7 |
|
3333 |
0 |
|
5000 |
0 |
|
Exposure period 24 h, fixation time 24 h, without S9 mix |
||
Test substance |
100 |
110 |
333 |
28 |
|
1000 |
0 |
|
3333 |
0 |
|
5000 |
0 |
|
Exposure period 48 h, fixation time 48 h, without S9 mix |
||
Test substance |
100 |
79 |
333 |
15 |
|
1000 |
0 |
|
3333 |
0 |
|
5000 |
0 |
|
Exposure period 3 h, fixation time 24 h, with S9 mix |
||
Test substance |
100 |
120 |
333 |
104 |
|
1000 |
56 |
|
3333 |
0 |
|
5000 |
0 |
Table 2: Results of the cytogenicity assay:
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
in µg/ml |
in % |
with gaps |
without gaps |
Exposure period 3 h, fixation time 24 h, without S9 mix |
||||
DMSO |
0.9% (v/v) |
100 |
1 |
1 |
MMC |
0.5 |
113 |
9 |
8 |
Test substance |
180 |
101 |
7 |
6 |
333 |
69 |
16 |
13 |
|
420 |
39 |
18 |
15 |
|
Exposure period 3 h, fixation time 24 h, with S9 mix |
||||
DMSO |
0.9% (v/v) |
100 |
1 |
1 |
CP |
15 |
31 |
32 |
32 |
Test substance |
333 |
99 |
2 |
2 |
560 |
84 |
4 |
3 |
|
1000 |
48 |
19 |
15 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positive
In a chromosomal aberration assay according to OECD 473 and GLP, a genotoxic effect was observed for the test substance tested in a 3 h treatment in two independent experiments without and with metabolic activation. Appropriate solvent and positive controls were included and gave expected results. The test substance is genotoxic under the test conditions applied.
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