Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 912-631-7 | CAS number: 12022-95-6
- 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 DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 28 Nov. - 22 Dec. 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Read-across to synthetic amorphous silica.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- Principles of method if other than guideline:
- William, G. M.: Chemical Mutagens, 4, 61-79, 1979
- GLP compliance:
- yes
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
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
Species / strain
- Species / strain / cell type:
- hepatocytes: primary culture, rat
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 10, 30, 100, 300, and 1000 µg/ml (5 concentrations tested)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO, 1 % final concentration
- Justification for choice of solvent/vehicle: No data
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated media control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS: 3
INCUBATION TIME: 18 to 20 h in the presence of silica
NUMBER OF CELLS EVALUATED: 150 (3 x50)
DETERMINATION OF CYTOTOXICITY
- LDH release
- Evaluation criteria:
- Validity: Positive control with significant increases in net nuclear grain count, and negative control with less than 15 % of the cells in repair state
and solvent control with net nuclear grain count of less than 1.
Statistical significance: increase in mean nuclear count by at least 5 counts over control ==> significant for the specific dose level.
Positive: dose-related increase and at least one dose with significant increase or
positive: significant increases at two successive doses in the absence of a dose response.
Equivocal: significant increase at one doses in the absence of a dose response.
Results and discussion
Test results
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 260 - 500 µg/ml: rel. toxicity approx. 50 %
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Primary rat hepatocytes
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No dose response was observed.
Average net grain counts per nucleus were <1 in the negative controls and ranged from <1 to 2.1 in the treated cultures.
Average net grain counts per nucleus were 30 - 32 in the positive control.
Average net grain counts per nucleus ranged from 1 to 2.1 in the treated cultures.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.