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Diss Factsheets
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EC number: 701-065-4 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- 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:
- Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
- Objective of study:
- other: deposition and clearance
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 413
- Deviations:
- yes
- Remarks:
- Special modifications as compared with standard study: Focus upon lung, respiratory tract, and regional lymph nodes. Post-exposure recovery period up to one year.
- Principles of method if other than guideline:
- Measurements of Si in lung and lymph nodes within repeated-dose toxicity study: Analytical method for silica determination (Report, part 1, p. 25):
Lung and lymph node tissue were ashed according to the temperature program up to 650 °C in a platinum crucible. Following this, the ash was dissolved in 10 % hydrogen fluoride for 30 min. at 50 °C, and a saturated boric acid solution (silicon standard solution, 1 mg/ml) was added. The Si content of the solution was determined using a Varian ASS flame atomic absorption spectrometer. - GLP compliance:
- 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:
- - Test material: SIPERNAT 22S
CAS-Name: Silica, precipitated, crystalline-free;
CAS-No.: 112926-00-8
Surface area (Ströhlein): 160 - 195 m2/g
Primary particle size: see Test Condition
- Substance type: inorganic
- Physical state: solid
- Surface area (BET): 192 m2/g (Report p. 64 Specification Certificate)
- Analytical purity: >98 % (SiO2)
- Impurities: 0.8 % Na2O, 0.2 Al2O3
- Particle size: The range of the geometric agglomerate/aggregate size distribution was 1 to about 120 µm for the amorphous silicas
with a maxima at approx. 10 µm and 100 µm (Report 1987, p. 13)
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
- Specific details on test material used for the study:
- - Test material: SIPERNAT 22S
CAS-Name: Silica, precipitated, crystalline-free;
CAS-No.: 112926-00-8
Surface area (Ströhlein): 160 - 195 m2/g
Primary particle size: see Test Condition
- Substance type: inorganic
- Physical state: solid
- Surface area (BET): 192 m2/g (Report p. 64 Specification Certificate)
- Analytical purity: >98 % (SiO2)
- Impurities: 0.8 % Na2O, 0.2 Al2O3
- Particle size: The range of the geometric agglomerate/aggregate size distribution was 1 to about 120 µm for the amorphous silicas
with a maxima at approx. 10 µm and 100 µm (Report 1987, p. 13)
- Stability under test conditions: stable
- Storage condition of test material: room temperature - Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for Breeding of Laboratory Animals TNO, Zeist/NL
- Age at study initiation: 4 weeks
- Weight at study initiation: 50 - 70 g
- Fasting period before study: no
- Housing: single during exposure
- Diet: no access during exposure
- Water: no access during exposure
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2
- Humidity (%): 50 - 70
- Air changes (per hr): 12x/h
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- inhalation
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel exposure chamber, multitiered (manufactered by Hazelton)
- Exposure chamber volume: 2.3 m3
- Method of holding animals in test chamber: single
- Exposure type: whole body
- Source and rate of air: Aerosol entrance at top of the chamber
- Method of conditioning air: no data
- System of generating particulates/aerosols: Institute´s dust generator with compressed air operating atomizer
- Temperature, humidity, pressure in air chamber: av. 21 - 23 °C, minimum 19.1, max. 25.4 °C /
65 - 75 % rel. humidity, during extreme weather occasionally up to 95.5 % or down to 48 %.
- Air flow rate: approx. 40 m3/h
- Air change rate: 40 / 2.3 = ~17/h
- Method of particle size determination: due to electrostatic charge of the particles not measured:
technical failure of the 10-stage Mercer cascade impactor and the QCM cascade (Report p. 16)
- Treatment of exhaust air: filtered before release
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically - Air samples are drawn through glass fiber filters (Sartorius)
and weighed (3 - 4 time per day)
- Samples taken from breathing zone: no data - Duration and frequency of treatment / exposure:
- 90 day(s)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
35 mg/m3 (mean analytical values)
- No. of animals per sex per dose / concentration:
- 10 each after exposure (13 weeks) and recovery period (1, 13, 29, 39, and 52 wks):
i.e. 50 m / 50 f animals per group were kept for a recovery period of at most 52 wks - Control animals:
- yes, concurrent no treatment
- Positive control reference chemical:
- no, but comparative study also including quartz
- Details on study design:
- - Dose selection rationale: see 7.5.3
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion) of SiO2
- Tissues and body fluids sampled: lung and mediastinal lymph nodes
- Time and frequency of sampling: 1, 13, 29, 39, and 52 weeks post exposure, 10 animals each
- Statistics:
- The statistical assessment of the findings for the different parameters considered was based on analysis of variance (ANOVA) and Dunnett´s test
Results and discussion
- Preliminary studies:
- No data
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- See overall remarks
- Details on distribution in tissues:
- See overall remarks
- Details on excretion:
- See overall remarks
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: ca. 7 wks (males) (from lung)
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 2nd: <7 wks (females) (from lung)
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Absolute silicon content in lung and mediastinal lymph nodes 1, 13, 29, 39, and 52 weeks post exposure
[Sipernat 22S, 35 mg/m3 (mean analytical value), 13 weeks] [Report, Tab. 59 + 61]
Lung [mg] |
Lymph nodes [mg] |
|||
Male #1 |
Female #2 |
Male |
Female |
|
Sipernat 22S |
||||
Day 98 |
0.510 ±0.024 +) (n=10)++) |
0.347 ±0.017 (n=10) |
0.037 ±0.007 (n=3) |
0.034 ±0.002 (n=5) |
Day 188 |
0.127 ±0.011 (n=10) |
0.114 ±0.006 (n=7) |
0.030 ±0.000 (n=2) |
0.050 ±0.004 (n=4) |
Day 297 |
0.049 ±0.004 (n=10) |
0.083 (n=1) |
0.027 ±0.003 (n=4) |
0.030 (n=1) |
Day 370 |
No Si detected |
No Si detected |
0.030 ±0.000 (n=2) |
No Si detected |
Day 462 |
No Si detected |
No Si detected |
0.030 (n=1) |
No Si detected |
C ontrol [untreated] |
||||
Day 188 |
0.032 (n=1) |
No Si detected |
0.030 (n=1) |
No Si detected |
+) ±SEM (Standard Error of the Mean)
++) n represents the number of animals with Si found,
the total number of animals measured was always 10 per group.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
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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