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Diss Factsheets
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EC number: 310-060-2 | CAS number: 102110-59-8
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles. Comparable to guideline study. Read-across to silicates.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Calcium silicate
- EC Number:
- 233-250-6
- EC Name:
- Calcium silicate
- Cas Number:
- 10101-39-0
- IUPAC Name:
- calcium oxosilanediolate
- Details on test material:
- - Name of test material (as cited in study report): FDA-Compound 71-41 = Silene, calcium silicate (hydrated)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Flow laboratories
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 300-350 g
- Fasting period before study: no data
- Housing: 1-5 rats / cage
- Diet (e.g. ad libitum): commercial 4% fat diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.85% saline
- Duration of treatment / exposure:
- Single administration (acute) and repeated (5 days) administration (subacute)
- Frequency of treatment:
- Once per day
- Post exposure period:
- Observations 6, 24 and 48 hours, resp. after administration (acute study) and 6 hours after last administration (subacute study).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15, 150, 1500 and 5000 mg/kg bw
Basis:
actual ingested
gavage
- No. of animals per sex per dose:
- 15, 150 and 1500 mg/kg: 15 animals
5000 mg/kg: acute test 5 animals, subacute 15 animals
negative control: 9 animals - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 0.3 mg/kg triethylene melamine
Examinations
- Tissues and cell types examined:
- Bone-marrow cell preparations were made and 50 cells per animal were counted in metaphase for aberrations. Mitotic indices were obtained by counting at least 500 cells.
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION: The cells were collected nd centrifuged and fixed with 3:1 absolute methanol:glacial acetic acid. After being resuspended a small amount of the suspension was pipetted on a slide. The slides were stained using Giemsa solution (5%), rinsed with solvents and mounted using Permount and coverglasses
METHOD OF ANALYSIS: The slides were examined microscopically. - Evaluation criteria:
- The chromosomes of each cell were counted and only diploid cells were analyzed. They were scored for chromatid gaps and breaks, chromosome gaps and breaks, reunions, cells with >10 aberrations, polyploidy, pulverization, and any other chromosomal aberrations. The outcome were expressed as percentages.
50 metaphase spreads were scored per animal. The mitotic index was expressed as the ratio of number of cells in mitosis / the number of cells observed. At least 500 cells were counted.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No significant bone marrow metaphase chromosomal aberrations were observed in any of the exposure groups.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Calcium silicate was negative in an oral cytogenetic rat bone marrow test. - Executive summary:
The ability of calcium silicate to induce chromosomal aberrations was studied in male rats (Litton 1974). The rats were given doses of 15 -5000 mg/kg calcium silicate by gavage either as a single acute dose, or subacutely with one dose on five consecutive days. The induction of bone marrow metaphase chromosomal aberrations was measured, and the results showed that the outcome was at the same level as in the saline controls.
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