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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- insufficient for a reliable tumor analysis due to low number of animals (biostatistical limitations)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 953
- Report date:
- 1953
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 956
- Report date:
- 1956
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- yes
- Remarks:
- Group size 15 m+ 15 f, histopathology with 6 m + 6 f per group, smaller than the recommended 50 (note: Sufficient biostatistical power can never be achieved for substances that have no or a very low cancerogenic potential.)
- Principles of method if other than guideline:
- see 7.5.1: Columbia 1956_Silene(CS)_oral,24 mon,rat,key,RL2
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicic acid, calcium salt
- EC Number:
- 215-710-8
- EC Name:
- Silicic acid, calcium salt
- Cas Number:
- 1344-95-2
- IUPAC Name:
- Silicic acid, Calcium salt
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: gelatine (15 g/100 mL water)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily, continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.0, 5.0, 7.5 and 10 % (w/w) in feed
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- see IUCLID section 7.5.1
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHTS: Yes (see table 51)
liver, kidneys, and spleen (both sexes, each group)
HISTOPATHOLOGY: Yes (see table 50)
Tissues from 6 m and 6 f each dose level and control preserved in formalin:
thyroid, lung, heart, liver, kidney, stomach, large and small intestine, pancreas, spleen,
adrenal, urinary bladder, gonads, bone marrow, and skeletal muscle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Result (carcinogenicity): negative; for non-neoplastic and other effects see IUCLID section 7.5.1
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 2 500 - <= 3 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- Remarks on result:
- other: corresponds to 5 % dietary level
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
No difference in survival from the control, and no gross signs of toxicity; highest dose group: growth suppression; slightly elevated pH of the urine; no tumors are observed. The NOEL is considered to be the 5% dietary level, which is estimated to correspond to about 2500 - 3200 mg/(kg bw*d), based on reduction in body-weight gain and isolated cases of calculi and brittle in kidney and urinary bladder, respectively, as well as a few cases of cholangitis-like lesions at the higher dose levels.
Applicant's summary and conclusion
- Conclusions:
- no evidence of carcinogenic potential
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.
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