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EC number: 231-545-4 | CAS number: 7631-86-9
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented study report which meets basic scientific principles [see time-related elimination in the following entry (Sipernat 22S)]
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented study report which meets basic scientific principles
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- other: deposition and clearance
- 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
- Radiolabelling:
- no
- 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 - 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)
- 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
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: ca. 7 wks (males) (from lung, see Table below)
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 2nd: <7 wks (females) (from lung, see Table below)
- Metabolites identified:
- not measured
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
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] |
Lymphnodes [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.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Exposure: 20 Jul. 1984 - 19 Oct. 1984 / end observation: 15 Oct. 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented study report which meets basic scientific principles [see time-related elimination in the following entry (Sipernat 22S)]
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- other: deposition and clearance of SiO2 from lung
- 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
- Radiolabelling:
- no
- 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 - Route of administration:
- inhalation: aerosol
- Vehicle:
- unchanged (no vehicle)
- 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)
- Remarks:
- Doses / Concentrations:
1.3, 5.9 or 31 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 7.5.2
- 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
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: rapid from lung of male rats: not determinable by means of and at selected intervals (see Table below).
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 2nd: rapid from lung of female rats: not determinable by means of and at selected intervals (see Table below).
- Metabolites identified:
- not measured
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
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 of SiO2 from lung
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
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- CAS-Name: Silica, amorphous, fumed, cryst.-free; CAS-No.: 112945-52-5
Constituent 1
- 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:
1.3, 5.9 or 31 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
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: rapid from lung of male rats: not determinable by means of and at selected intervals (see Table below).
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 2nd: rapid from lung of female rats: not determinable by means of and at selected intervals (see Table below).
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Absolute silicon content in lung and mediastinal lymph nodes 1 week after exposure termination (98 days) [Report, Tab. 59 + 61]
Lung [mg] |
Lymphnodes [mg] |
|||
Aerosil 200 [mg/m3, nominal] |
Male #1 |
Female #2 |
Male |
Female |
1 |
0.263 ±0.216+) (n=3) |
0.051 ±0.005 (n=3) |
0.080 ±0.040*) (n=2) |
No Si detected |
6 |
0.114 ±0.004 (n=10) |
0.058 ±0.006 (n=7) |
No Si detected |
No Si detected |
30 |
0.256 ±0.012 (n=10) |
0.212 ±0.019 (n=10) |
0.030 (n=1) |
0.020 (n=1) |
0 |
0.032 (n=1) |
No Si detected |
0.030 (n=1) |
No Si detected |
*) One male animal showed a too high value for reasons that could not be clarified.
+) ±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.
Note: No Si was detected at the other time points of 13, 29, 39, and 52 weeks post exposure.
13 weeks as the second time point post was too long as to estimate the elimination half-life.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
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