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EC number: 273-761-1 | CAS number: 69012-64-2 Amorphous silicon dioxide particles from the volatilization and vaporization of furnace feed materials in the manufacture of ferrosilicon and silicon.
- 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
Test data on irritation properties of synthetic amorphous silica that have been used for read-across do not show eye or skin irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 - 19 Oct. 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White Russian
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Dose: 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The substance (0.5 g) was moistened with 0.5 ml water and placed on a skin area of approx 6.25 cm2.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Remarks:
- ID Nr. 2330
- Time point:
- other: 1 h after exposure
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Remarks:
- ID Nr. 2332
- Time point:
- other: 1 h after exposure
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Remarks:
- ID Nr. 2344
- Time point:
- other: 1 h after exposure
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #1
- Remarks:
- ID Nr. 2330
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #2
- Remarks:
- ID Nr. 2332
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #3
- Remarks:
- ID Nr. 2344
- Time point:
- 24/48/72 h
- Score:
- > 0
- Max. score:
- 0
- Reversibility:
- other: no irritation observed
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were not any irritating effects.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classification (EU and GHS)
- Executive summary:
Jahn and Berthold (1991) studied skin irritation of precipitated silica on rabbits by the OECD 404 guideline test method. No irritating effects were observed.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: other: OECD evaluation of an in vivo skin irritation study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific review by authorative international body
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- OECD evaluated the available test data on synthetic amorphous silica.
- GLP compliance:
- no
- Remarks:
- review: both yes and no status
- Species:
- rabbit
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 0 - <= 0.29
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: hydrophilic precipitated silica; slight erythemas in 4/6 animals
- Irritant / corrosive response data:
- The studies with synthetic amorphous silica presented in the OECD SIDS (2004) did not indicate that the substance is a skin irritant.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- OECD (2004) includes eight skin irritation studies, of which three were regarded as critical studies for SIDS endpoint. These three studies were conducted with hydrophilic pyrogenic or precipitated silica. None of the studies showed skin irritating effects.
- Executive summary:
In OECD (2004), hydrophilic pyrogenic or precipitated silica were tested by exposing rabbits to 0.19 g or 0.5 g of dry or moistened test item under occlusive conditions for 4 or 24 hours. These synthetic amorphous silica were not irritating to skin under experimental conditions. However, these compounds may produce skin dryness following prolonged and repeated exposure.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- No toxicological data were available for silica fume and, therefore, a read-across approach was used. The dissolution, composition and surface properties were the most important parameters considered when deciding which substances can be used for read-across.
Based on the composition, surface characteristics, and bioaccessibility data, silica fume was assumed to have toxicological properties similar to those of sparingly synthetic amorphous silicas. Therefore read-across was carried out using available toxicological studies with synthetic amorphous silica (SAS).
Details on the read-across approach are presented in Iuclid section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Weight of evidence of read-across studies
- Basis:
- other: Different parameters followed in the other studies.
- Score:
- >= 0 - <= 0.29
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No indications of skin irritation observed in studies with synthetic amorphous silica.
Referenceopen allclose all
No signs of irritation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Oct. - 05 Nov 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White Russian
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- dose: 100 mg
- Duration of treatment / exposure:
- 24 h, not rinsed
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
- Time after start of exposure: 24 h
SCORING SYSTEM: Intensities of irritation effects by using the Draize scale for grading of lesions (scores 0 - 4).
Irritation index: calculated according to Draize from grades on cornea, iris and conjunctiva at the time 1, 24, 48 and 72 h,
modified according to Gilman et al. 1983
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #1
- Remarks:
- ID Nr. 2303
- Time point:
- other: 1 h after application
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #2
- Remarks:
- ID Nr. 2331
- Time point:
- other: 1 h after application
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #3
- Remarks:
- ID Nr. 2374
- Time point:
- other: 1 h after application
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #1
- Remarks:
- ID Nr. 2303
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #2
- Remarks:
- ID Nr. 2313
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #3
- Remarks:
- ID Nr. 2374
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #2
- Remarks:
- ID 2313
- Time point:
- other: 4 days
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize grades
- Remarks:
- Conjunctiva: redness, chemosis, discharge
- Basis:
- animal #2
- Remarks:
- ID Nr. 2313
- Time point:
- 7 d
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The conjuctiva reacted with diffuse redness (grade 2) in all 3 animals 1h after application. The findings had completely disappeared after 72 h to 7 days. Only at the day of application the conjuctivas were swollen (Grade 1). In addition, a slight discharge (grade 1) was observed in all 3 animals at the day of application. All effects were reversible after 48h, 72h or 7 days respectively.
It is considered that all effects were induced by the physical property (dust) of the test substance. Therefore the test substance was considered to be not irritant. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- No classification (EU and GHS)
- Executive summary:
Jahn and Berthold (1991) studied eye irritation of precipitated silica in rabbits by the OECD 405 guideline test method. There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, score 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge were very slight only 1 h after application (score 1).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: other: OECD evaluation of unpublished in vivo studies
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientific review by authorative international body
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- OECD evaluated the available test data on synthetic amorphous silica.
- GLP compliance:
- no
- Remarks:
- review: both yes and no status
- Species:
- rabbit
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: hydrophilic precipitated silica; redness 2 after 1h, and 2 and 1 after 24 h; very slight chemosis and discharge after 1h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: no data
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: hydrophilic precipitated silica
- Irritant / corrosive response data:
- The studies with synthetic amorphous silica did not cause eye irritation on rabbit.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- OECD (2004) includes six eye irritation studies with synthetic amorphous silica, of which two were regarded as critical studies for SIDS endpoint. These two studies were conducted with hydrophilic precipitated silica. None of the studies showed eye irritating effects on rabbit.
- Executive summary:
In OECD (2004), all synthetic amorphous silica products tested as a powder (0.1 g) have shown no or only weak and transient irritating effects on the conjunctivae of the eyes of rabbits with the iris and cornea not affected at all. In conclusion, synthetic amorphous silica are not irritating to eyes under experimental conditions.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- No toxicological data were available for silica fume and, therefore, a read-across approach was used. The dissolution, composition and surface properties were the most important parameters considered when deciding which substances can be used for read-across.
Based on the composition, surface characteristics, and bioaccessibility data, silica fume was assumed to have toxicological properties similar to those of sparingly synthetic amorphous silicas. Therefore read-across was carried out using available toxicological studies with synthetic amorphous silica (SAS).
Details on the read-across approach are presented in Iuclid section 13. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The studies performed with silica and Na-Al-silicate do not indicate any eye irritation.
Referenceopen allclose all
There were weakly irritating effects on the conjunctivae only: redness score 2 (of 4) in all animals after 1 h, score 2 and 1 after 24 h and reversible by 72 h. Chemosis and discharge was very slight only 1 h after application (score 1).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is data available on the irritant properties of synthetic amorphous silica. According to this data, synthetic amorphous silica and silicates are not irritating to the skin and eyes under experimental conditions. Based on the same amorphous structure and similar dissolution kinetics, silica fume is likely to resemble synthetic amorphous silica in this respect. No cases of skin or eye irritation have been reported in the literature from the ferrosilicon/silicon manufacturing industry or on the use of silica fume. Also, this supports the conclusion that silica fume can be considered to resemble synthetic amorphous silica in this respect. The dissolution of impurities from silica fume is generally low and comparable to that from synthetic amorphous silica. Therefore, they are not likely to hamper the read-across from synthetic amorphous silica in the assessment of irritancy.
Justification for classification or non-classification
Based on the weight-of-evidence and read-across from synthetic amorphous silica, silica fume is not a skin or eye irritant. No classification or further testing is proposed. Naturally, like any other dust, the dust from silica fume may also cause non-specific mechanical irritation to the eyes and respiratory tract.
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