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EC number: 945-327-8 | 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity (Oral): Based on an analogue read across approach from synthetic amorphous silicon dioxide and calcium silicate, synthetic amorphous calcium magnesium silicate is considered as acutely non-toxic.
Acute toxicity (Inhalation): Based on an analogue read across approach from synthetic amorphous silicon dioxide , acute toxicity LC0 for synthetic amorphous calcium magnesium silicate is suggested to be >691 mg/m3.
Acute toxicity (Dermal): Based on an analogue read across approach from synthetic amorphous silicon dioxide , acute toxicity LD50 for synthetic amorphous calcium magnesium silicate is suggested to be >5000 mg/kg.
Additional acute toxicity measurements are not recommended for reasons of animal welfare.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Report from year 1990.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- In the reference OECD SIDS (2004), the study was assigned realibility 1 (valid without restriction).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- other: Not specified (OECD SIDS, 2004).
- Limit test:
- yes
- Specific details on test material used for the study:
- Sident 9, >98% (SiO2), Na20 <1%, Al2O3 <0.2%, SO3 <0.8%, Fe2O3 <0.03%: CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-
8. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The dose was applied as aqueous suspension (21.5 ml/kg bw = 237 mg silica/ml
suspension) containing 1 % CMC. - Doses:
- 21.5 ml/kg bw = 237 mg silica/ml suspension. Limit test: 5110 mg/kg
- No. of animals per sex per dose:
- Five male and 5 female animals were used.
- Control animals:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- not specified
- Clinical signs:
- other: No clinical symptoms or other findings.
- Other findings:
- No clinical symptoms or other findings.
- Conclusions:
- Synthetic amorphous silicon dioxide (precipitated, CAS 112926-00-8) is considered as acutely non-toxic via oral exposure (LD50 > 5110 mg/kg bw using rat as test organism). No clinical symptoms or other findings were observed.
- Executive summary:
An acute oral toxicity study with synthetic amorphous silicon dixoide (CAS 112926 -00 -8) was carried out with male and female Wistar rats. The study was done according to OECD Guideline 401 "Acute Oral Toxicity" under GLP conditions. The dose was applied by gavage as aqueous suspension (21.5 ml/kg bw = 237 mg silica/ml
suspension) containing 1 % CMC. The LD50 was found to be > 5110 mg/kg and no clinical symtoms or other findings were observed. In conclusion, Synthetic amorphous silicon dioxide is considered as acutely non-toxic (LD50 > 5110 mg/kg bw in rat following oral exposure).
- Endpoint:
- acute toxicity: oral
- 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
- Remarks:
- According to the reference OECD SIDS (2004), the study was assigned realibility 2 (valid with restrictions; Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment).
- Principles of method if other than guideline:
- The substance was suspended (24.1 % (w/v)) in 0.85 % saline.
Observation period 7 days. - GLP compliance:
- no
- Specific details on test material used for the study:
- FDA-Compound 71-41 = Silene, calcium silicate (hydrated)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Vehicle:
- physiological saline
- Details on oral exposure:
- The substance was suspended (24.1 % (w/v)) in 0.85 % saline.
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- Not specified.
- Control animals:
- not specified
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Clinical signs:
- other: No clinical symptoms or other findings.
- Conclusions:
- Synthetic amorphous calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic via oral exposure (LD50 > 5000 mg/kg bw using rat as test organism). No clinical symptoms or other findings were observed.
- Executive summary:
An acute oral toxicity study with synthetic amorphous calcium silicate (CAS 1344 -95 -2) was carried out with male Sprague-Dawley rats. The substance was suspended (24.1 % (w/v)) in 0.85 % saline and the observation period was 7 days. The LD50 was found to be > 5000 mg/kg and no clinical symtoms or other findings were observed. In conclusion, synthetic amorphous calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic.
- Endpoint:
- acute toxicity: oral
- 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
- Principles of method if other than guideline:
- Oral administration of calcium silicate prepared as 24.1 % (w7w) suspension to male rats.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Calcium silicate (CAs 1344-95-2)
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- Single dose of 5000 mg/kg.
- No. of animals per sex per dose:
- 10 males
- Control animals:
- not specified
- Details on study design:
- Calcium silicate was prepared as a 24.1 % (w/w) suspension and administred orally to a group of 10 males rats at a single dose of 5000 mg/kg. Animals were observed during a 7-day period whereafter all animals were killed.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No detahs occured.
- Clinical signs:
- other: No signs of toxicity or abnormal behaviour were observed.
- Gross pathology:
- On necropsy, no gross findings were observed.
- Conclusions:
- Calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic following oral exposure (LD50 >5000 mg/kg using rat as test organism ).
- Executive summary:
Calcium silicate was adminsitred orally to a group of 10 male rats at a single dose of 5000 mg/kg. No signs of toxicity or abnormal behaviour were observed within a 7 -day period. No deaths occured. LD50 for calcium silicate was considered >5000 mg/kg. In conclusion, calcium silicate (CAS 1344-95-2) is considered as acutely non-toxic.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Reliabality according to OECD SIDS (2004).
- Principles of method if other than guideline:
- Nose-only exposure system. Five animals each per sex were used. Analysed chamber concentrations ranged from 650 to 725 mg/m3 (note:
Technically, the maximally achievable aerosol concentration due to substance-inherent properties resulting in sedimentation and adsorption to
the equipment.). About 45 % of the aerosol comprised particles with an aerodynamic diameter of <5 um (respirable fraction). - GLP compliance:
- yes
- Specific details on test material used for the study:
- SIPERNAT 22S >98 % (SiO2): CAS-Name: Silica, precipitated, cryst.-free; CAS-No.: 112926-00-8. Surface area: 160 - 195 m2/g.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- Maximum attainable concentration: 691 mg/m3. Analysed chamber concentrations ranged from 650 to 725 mg/m3.
- No. of animals per sex per dose:
- Five animals each per sex.
- Control animals:
- not specified
- Details on study design:
- Analysed chamber concentrations ranged from 650 to 725 mg/m3 (Technically, the maximally achievable aerosol concentration due to substance-inherent properties resulting in sedimentation and adsorption to
the equipment.). About 45 % of the aerosol comprised particles with an aerodynamic diameter of <5 um (respirable fraction). - Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 0.691 mg/L air
- Mortality:
- None
- Clinical signs:
- other: No clinical symptoms except some restlessness and eye closing.
- Body weight:
- No clinical symptoms except some restlessness and eye closing. Body weight gain was not affected in males, but females hardly gained weight
during two days after exposure, however, subsequently, showed normal development. - Gross pathology:
- No findings at autopsy after 14 d post-treatment.
- Conclusions:
- Acute inhaltation toxicity of synthetic amorphous silicon dioxide (precipitated) in rat: LC0 (4 h) >0.691 mg/L.
- Executive summary:
An acute inhaltation toxicity study with precipitated synthetic amorphous silicon dioxide was performed using rat as a test organism. Analysed chamber concentrations ranged from 650 to 725 mg/m3 (maximum attainable concentration was 691 mg/m3). No clinical symptoms except some restlessness and eye closing. Body weight gain was not affected in males, but females hardly gained weight during two days after exposure, however, subsequently, showed normal development. No findings at autopsy after 14 d post-treatment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 691 mg/m³ air
- Quality of whole database:
- LC0 >691 mg/m3
Additional information
Justification for classification or non-classification
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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