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Diss Factsheets
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EC number: 215-710-8 | CAS number: 1344-95-2
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 14 - 28 Sep. 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- The highest attainable exposure concentration was limited for technical reasons.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
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
- Details on test material:
- CAB-O-SIL M5: CAS-Name: Silica, amorphous, fumed, crystalline-free; CAS-No.: 112945-52-5, purity ca. 100 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Madison/Wisconsin
- Age at study initiation: "young" (no further data)
- Weight at study initiation: 258 - 297 g (male); 215 - 240 g (female)
- Fasting period before study: no
- Housing: single
- Diet: ad libitum except during exposure
- Water: ad libitum except during exposure
- Acclimation period: >= 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): data not included in the report
- Humidity (%): data not included in the report
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass inhalation chamber
- Exposure chamber volume: total 80 L with dimensions of the central unit of approx. 50 L
[12 inch high, 18 inch wide, 18 inch deep (approx. 30 x 46 x 46 cm)]
- Method of holding animals in test chamber: as group in the chamber cage
- Source and rate of air: from the top center of the chamber, 56 - 85 L/min
- Method of conditioning air:
- System of generating particulates/aerosols: stream of air passed through the test material
contained in a 3-L 3-necked flask equipped with a magnetic stirrer
- Method of particle size determination: using a Delron Cascade Impactor, model No. DCI-6:
Sample collected a approx. one and 3 h into the exposure
- Treatment of exhaust air: collected at the bottom and relaease to outside after dilution
- Temperature, humidity, pressure in air chamber: mean 72.3 °F (room) / mean 76.6 °F (chamber)
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric - amount of dust collected on glass fiber filter divided by air volume
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (Report Tab. 2 and 3)
- Particle size distribution: based on sample 1 and 2
16 mass% =< 0.325 µm / 0.168 µm
50 mass% =< 0.989 µm / 0.534 µm
83 mass% =< 3.007 µm / 1.698 µm
98.13 and 99.43 mass% =< 10 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD = 0.76 µm / GSD = 3.11
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: For technical limitations, the highest attainable concentration was applied. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Analytical concentration: 2.08 mg/L
(average of 10 samples with a range from 1.63 to 2.70 mg/L, one outlier with 0.45 mg/L) (Report Tab. 1)
Nominal concentration:
58.8 mg/L - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2x/d / body weight on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 2.08 mg/L air (analytical)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.08 mg/L air (analytical)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 58.8 mg/L air (nominal)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 58.8 mg/L air (nominal)
- Exp. duration:
- 4 h
- Mortality:
- no
- Clinical signs:
- other: Nasal discharge, crusty eyes, alopecia, and crusty nose
- Body weight:
- no particular findings, normal
- Gross pathology:
- Discoloration of the lung in one test rat, no other particular findings
Any other information on results incl. tables
No animals died. Nasal discharge during exposure,
crusty eyes,crusty nose and alopecia at days post-exposure.
No macroscopic organ lesions, but in one animal
discoloration of the lung.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-toxic
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