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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-085-3 | 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 gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov./Dec. 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- HPRT assay testing for reversion to resistance to the purine-analogue, 6-thioguanine, as result of a mutation in the X-chromosome-linked hypoxanthine-guanine phosphoribosyl transferase (HPRT).
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report) = Cab-O-Sil EH-5
Method
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:
- 10, 50, 100, 150, and 250 µg/mLNgative (without S9) and 100, 200, 300, 400, and 500 µg/mL (with S9)
- 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
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: Ethyl methanesulphonate (without S9) and benzo(a)pyrene (with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 18 - 24 hours at 37 +-1 °C, 5 x10^5 cell/25 mL flask in 5 +- 1% CO2 atmosphere
- Exposure duration: 5 h (without and with S9)
- Expression time (cells in growth medium): Post exposure: 18 - 24 h, followed by 7 - 9 days including subculturing of 2 - 3 day intervals
- Selection time (if incubation with a selection agent): In the presence of 6-thioguanine, 7 days
- Fixation time (start of exposure up to fixation or harvest of cells): 15 - 17 days
STAIN (for cytogenetic assays): 10 % Giemsa
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 2 x10^5 cells /100 mm dish (five-fold) = in total 10^6 cells per concentration
DETERMINATION OF CYTOTOXICITY
- in parallel as cloning efficiency (triplicates with each 100 cells/60 mm dish)
- Evaluation criteria:
- A response was not considered positive unless the mutant frequency exceeded 20 mutants per 10^6 clonable cells.
Significant if twice that of background and at least 11 mutants per 10^6 cells above background (solvent and untreated control).
Positive if dose-dependen increase in mutant frequency combined with significant increase at one or more test concentrations.
Suspect if no dose-response. - Statistics:
- Frequency of spontaneous mutations (if showing wide variation): C.I. (Conf. Interval) calculated by application of the one-sided student´s test from the historical background rate (upper limit of C.I.: 11 spontaneous mutants/10^6 cells).
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Not pronounced in the mutation test, while a concurrent cytotoxicity test showed considerable inhibition of the cloning efficiency over the same dose ranges.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: 9 concentrations between 0.1 and 500 µg/mL tested with and without S9, toxicity based on colony-forming efficiency
Any other information on results incl. tables
From Report Tab. 3 and 4
With S9 (all data relating to x mutants/106 cells)
negative controls: 1 and 7.2
positive control: 351
treated cells: no dose response
1 and <1 at higher dose levels (100 to 250 µg/mL) with cytotoxicity noted at 250 µg/mL.
7.3 and 10.3 at the lower dose levels (10 and 50 µg/mL, respectively).
Without S9 (all data relating to x mutants/106 cells)
negative controls: 0.8 and 8.0
positive control: 184
treated cells: no dose response
<1 to 8.2
no pronounced cytotoxcity noted at any dose level
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: 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.