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Diss Factsheets
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EC number: 234-858-4 | CAS number: 12037-47-7
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Dec. 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study, performed under GLP conditions. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- (100 instead of 200 metaphases were scored; unusual exposure times)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- IUPAC Name:
- dioxosilane
- Details on test material:
- - Name of test material (as cited in study report): Cab-O-Sil EH-5: CAS-Name: Silica, amorphous, fumed, cryst.-free; CAS-No.: 112945-52-5
- Substance type: inorganic
- Physical state: solid
- Analytical purity: >99%
- Lot/batch No.: 1H049
- Stability under test conditions: stable
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham´s F-12 medium without hypoxanthine with 5 % FBS, 1 % penicilin-streptomycin and 1 % L-glutamine
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
- Source: A. Hsie, Oak Ridge National Laboratories, directly received in frozen state
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9 (adult male SD rats)
- Test concentrations with justification for top dose:
- 38, 75, 150, 300 µg/mL (without S9)
250, 500, 750, 1000 µg/mL (with S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated cells
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Triethyleneamine without S9, cyclophosphamide with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; preincubation
DURATION
- Preincubation period: 16 - 24 hours at 37 +/-1 °C (5 x10^5 cell/25 ml flask in 5 +/- 1% CO2 atmosphere
- Exposure duration: 18 h (without S9); 2 h (with S9)
- Expression time (cells in growth medium): 11 h (for S9-activated cultures)
- Fixation time (start of exposure up to fixation or harvest of cells): Sum Exposure + expression time
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (addition of 0.1 µg/mL 2 h prior to sampling of metaphase cells)
STAIN (for cytogenetic assays): 5 % Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cell cycle delay
OTHER EXAMINATIONS:
- Other: chromatid-type and chromosome-type aberrations (breaks, various exchange figures)
Chromatid and isochromatid gaps were recorded, but not included in the analysis.
OTHER: Mitotic index was recorded as percentage of cells in mitosis per 500 cells counted. - Evaluation criteria:
- Dose-response with one or more concentrations elevated in relation to the solvent control (p =<0.05). A significant increase at the highest dose only with no dose-response was considered suspect. A significant increase at one dose level other than the high dose with no dose-response was considered equivocal.
Validity: The number of cells with chromosome aberrations in the negative and solvent control must be no greater than 6 %. The percentage of aberrations in the positve controls must be statistically increased (p=<0.05 Fisher´s exact test) relative to the untreated control. - Statistics:
- Fisher´s exact test for pairwise comparison of the aberrations in test and control cultures. The Cochran-Armitage test was applied for measure dose-responsiveness.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see "Additional information on results"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
none mentioned
RANGE-FINDING/SCREENING STUDIES:
9 concentration between 0.1 - 1000 µg/ml
with and without S9
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Mitotic index (MIx) and cell cycle kinetics (M1):
-S9 + S9
MIx[%] M1[%] MIx[%] M1[%]
__________________________________________________
DMSO control: 5 2 3.4 3
0.1 µg/L 3.8 2 2.6 3
10 µg/L 3.2 7 3.2 10
30 µg/L 2.6 17 2.8 7
100 µg/L 2.2 14 3.2 3
300 µg/L 1.2 27 1.0 24
__________________________________________________
Cell proliferation began to be inhibited at 30 µg/L (-S9) and 300 µg/L (+S9).
Simultaneously, the cell cycle became retarded with an accumulation of cells in the M1 phase.
Neither in the control nor in the treated cultures, cells were observed in the M3 phase (except 1 instance in the DMSO control). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary of Results
Harvest time: 18 h (-S9); 15 h (+S9)
Total metaphase cells scored: 100 each
Treatment |
S9 Activation |
Mitotic Index |
Cells with Aberrations |
Untreated |
4.8 |
2 |
|
DMSO |
No |
2.4 |
1 |
Cab-O-Sil EH-5 [µg/mL] |
|||
38 |
No |
1.7 |
1 |
75 |
No |
1.0 |
2 |
150 |
No |
0.5 |
2 |
300 |
No |
0.2 |
2 |
Triethylenemelamine, 0.5 µg/ml |
No |
1.6 |
34** |
Untreated |
Yes |
7.0 |
0 |
DMSO |
Yes |
5.7 |
2 |
Cab-O-Sil EH-5 [µg/mL] |
|||
250 |
Yes |
2.3 |
2 |
500 |
Yes |
2.7 |
3 |
750 |
Yes |
2.0 |
0 |
1000 |
Yes |
2.1 |
1 |
Cyclophosphamide, 50 µg/ml |
Yes |
4.1 |
19** |
** = statistically significant p =<0.01
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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