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EC number: 234-919-5 | CAS number: 12040-43-6
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The host organism is inoculated by intraperitoneal injection with a common indicator microorganism/tester strain before treatment with the test substance. After "incubation" in the host organism, the tester strain is withdrawn from the ascites and tested for mutation on minimal agar plate., e.g. accroding to Ames.
- GLP compliance:
- not specified
- Type of assay:
- other: host mediated assy
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Molecular formula:
- AlNaO6Si2
- IUPAC Name:
- aluminium(3+) sodium bis(oxosilanebis(olate))
- Details on test material:
- Other Test Substance
SIPERNAT 820A, sodium aluminium silicate (Degussa) [CAS No. 1344-00-9]
Chemical formula: 1.2Na2O x Al2O3 x 13.4SiO2
Degree of Purity: ~99 %
Water solubility: 48 mg/L
Constituent 1
- Specific details on test material used for the study:
- FDA-Compound 71-45, "sodium silicoaluminate",
synthetic silica
Lot no. SR-1621
Test animals
- Species:
- mouse
- Strain:
- ICL-ICR
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Type: Salmonella typhimurium reverse mutation assay
Method: The test substance was administered orally to 10 host animals per dose. In the acute study the bacteria (Salmonella typhimurium TA 1530 and his G-46)were inocculated i.p. after the administration of the test substance. In the subacute study the bacteria were injected after the last administration of the test substance. Negative (0.85 % saline) and positive (100 mg/kg dimethylnitrosamine) controls were run in parallel. The animals were sacrificed three hours after administration and the bacteria were removed from the peritoneal cavity. The induction of reverse mutation was quantified on agar plates. - Duration of treatment / exposure:
- single administration ("acute") and repeated administration (5 times, "subacute")
- Frequency of treatment:
- 1x and 5x (1x/d)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4.25 mg/kg bw/day (nominal)
- Remarks:
- suspended in 0.85 % saline, administered 1x/d (Test I)
- Dose / conc.:
- 42.5 mg/kg bw/day (nominal)
- Remarks:
- suspended in 0.85 % saline, administered 1x/d (Test I)
- Dose / conc.:
- 425 mg/kg bw/day (nominal)
- Remarks:
- suspended in 0.85 % saline, administered 1x/d (Test I)
- Dose / conc.:
- 5 000 mg/kg bw (total dose)
- Remarks:
- suspended in 0.85 % saline (Test II)
- No. of animals per sex per dose:
- 10 (males only)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes, treated with 100 mg/kg bw Dimethylnitrosamine (DMN)
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- There was a high increase in mutants following oral treatment with Dimethylnitrosamine (DMN), but no significant increases in mutation rates at any dose and dose regimen.
Applicant's summary and conclusion
- Conclusions:
- There was a high increase in mutants following oral treatment with DMN, but no significant increases in mutation rates at any dose and dose regimen.
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