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EC number: 229-912-9 | CAS number: 6834-92-0
- 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
Disodium silicate is corrosive to skin and eyes. The degree of irritation is dependent on the concentration (and water content).
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:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: FHSA method 16 C.F.R. 1500.41 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Concentration: 10 T49-004:wt%
- Duration of treatment / exposure:
- 24 hour(s)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 5.6
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: FHSA (Federal Hazardous Substances Act) test specified in C.F.R. 1500.41 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Concentration: 6 T49-004:wt%
- Duration of treatment / exposure:
- 24 hour(s)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 8
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation / corrosion
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: DOT test, FHMTA 49 C.F.R. 173.240
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Concentration: 99 T49-004:wt%
- Duration of treatment / exposure:
- 4 hour(s)
- Interpretation of results:
- not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The method was not validated at the time the study was performed. The article is limited in detail.
- Principles of method if other than guideline:
- Method: other: Skin irritation test
- GLP compliance:
- no
- Species:
- guinea pig
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Amount / concentration applied:
- Concentration: 37 T49-004:wt%
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0.3
- Interpretation of results:
- not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The method was not validated at the time the study was performed. The article is limited in detail.
- Principles of method if other than guideline:
- Method: other: Skin irritation test
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Amount / concentration applied:
- Concentration: 37 T49-004:wt%
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 5
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 7.4
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The method was not validated at the time the study was performed. The article is limited in detail.
- Principles of method if other than guideline:
- Method: other: Skin irritation test
- GLP compliance:
- no
- Species:
- human
- Type of coverage:
- semiocclusive
- Amount / concentration applied:
- Concentration: 37 T49-004:wt%
- Duration of treatment / exposure:
- 4
- Number of animals:
- 8
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 3.6
- Conclusions:
- Classification: irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The method was not validated at the time the study was performed. The article is limited in detail.
- Principles of method if other than guideline:
- Method: other: Skin irritation test
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 8
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The method was not validated at the time the study was performed. The article is limited in detail.
- Principles of method if other than guideline:
- Method: other: Skin irritation test
- GLP compliance:
- no
- Species:
- guinea pig
- Type of coverage:
- semiocclusive
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 2.4
- Interpretation of results:
- moderately irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Inveresk Research International
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Sex: Male
- Source: Cheshire Rabbit Farms Ltd.
- Age: approx. 11 weeks
- Weight at study initiation: 2.3 - 3.0 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 5 days
- Number of animals:
- 1
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 5 days
- Score:
- 8
- Reversibility:
- not reversible
- Remarks on result:
- other: Some evidence of necrosis was observed. When the test substance was applied as dry powder, no erythema or oedema was observed.
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Inveresk Research International
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Sex: Female
- Source: Cheshire Rabbit Farms ltd.
- Age: approx. 11 weeks
- Weight at study initiation: 2.3 - 3.0 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- up to 5 days
- Number of animals:
- 1
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 5 days
- Score:
- 8
- Reversibility:
- not reversible
- Remarks on result:
- other: Severe reactions with some evidence of necrosis occured. When the test substance was applied as dry powder, no erythema and oedema was observed.
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Inveresk Research International
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Sex: Male
- Source: Cheshire Rabbit Farms ltd.
- Age: approx. 11 weeks
- Weight at study initiation: 2.3 - 3.0 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 5 days
- Number of animals:
- 1
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 5 days
- Score:
- 8
- Reversibility:
- not reversible
- Remarks:
- Effects persisted for up to 5 days after exposure
- Remarks on result:
- other: Some evidence of necrosis was observed. When the test substance was applied as dry powder, no erythema and oedema was observed.
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- no data
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- Concentration: 10%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Examination time points: 24, 48 and 72 hours
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.22
- Reversibility:
- other: The severity of erythema was reduced from 2 to 1 by day 2, but persisted. The oedema observed in 1 animal had reversed by day 2.
- Interpretation of results:
- slightly irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- no data
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- Concentration: 50 %; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Examination time points: 24, 48 and 72 hours
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3.67
- Reversibility:
- no data
- Remarks on result:
- other: Reaction extended outside application site.
- Interpretation of results:
- irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The powder was not moistened before application.
- GLP compliance:
- yes
- Remarks:
- Forsvarets Forskningsanstalt
- Species:
- rabbit
- Strain:
- other: white landrace
- Details on test animals or test system and environmental conditions:
- - Source: Dörröds Djur -och Foderservice, Veberöd
- Weight at study initiation: 2.7 kg (average) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Concentration: 57.5 T49-004:wt%; 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 7.8
- Reversibility:
- not reversible
- Other effects:
- 2 out of 3 exposed animals showed an acute skin necrosis. The third animal had a pigmented necrosis (2 cm2) on the exposed area. The necrosis andthe acute oedema outside the tissue lesion remained during the following examinations. The wound was not healed after 14 days.
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The powder was not moistened before application.
- GLP compliance:
- yes
- Remarks:
- Forsvarets|Forskningsanstalt
- Species:
- rabbit
- Strain:
- other: white landrace
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Dörröds Djur -och Foderservice, Veberöd
- Weight at study initiation: 2.7 kg (average) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Concentration: 97 T49-004:wt%; 0.5 g
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- up to 14 days
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 5.1
- Reversibility:
- not reversible
- Other effects:
- At the first examination two of the three exposed animals showed necrosis. The wounds of these two animals (1 and 3 cm2) together with a well defined oedema remained at all examinations and were not healed after the observation period of 14 days. The third animal showed four small wounds after 48 and 72 hours. The animal had fast growing fur which made it difficult to get close contact between the test substance and the exposed skin area. The wounds were healed within 14 days (observation period).
- Interpretation of results:
- corrosive
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Hazleton France
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Bancel
- Age: adult
- Weight at study initiation: 2.4-2.6 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 h
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.17
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, but no information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- Hazleton France
- Specific details on test material used for the study:
- Details on the test material are given above.
- Species:
- rabbit
- Strain:
- other: New Zealand hybrid
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Sex: male
- Source: Bancel
- Age: adult
- Weight at study initiation: 2.6 - 2.7 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- - Concentration in vehicle: 0.5 g/0.10 g purified water
- Total volume applied: 0.3 ml - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 days
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 4.67
- Reversibility:
- other: Erythema persisted for at least 14 days, while oedema, observed within 1 hour after exposure, disappeared 72 hours after exposure.
- Remarks on result:
- other: Necrosis persisted in the entire area of application for 7 days and in parts of the test area for at least 14 days.
- Interpretation of results:
- corrosive
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- see "Any other information on materials and methods"
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Sex: male
- Age: 28 days
- Weight at study initiation: 60-80 grams - Type of coverage:
- open
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.3 mL
- Duration of treatment / exposure:
- 1 hour
- Observation period:
- 1 h
- Irritation / corrosion parameter:
- other: other: electrical resistance value (kOhm. disc)
- Value:
- 0.4
- Remarks on result:
- other:
- Remarks:
- Time point: 1 h. (migrated information)
- Interpretation of results:
- corrosive
Referenceopen allclose all
RS-Freetext:
AVERAGE SCORE: Not reported
REVERSIBILITY: Not reported
OTHER EFFECTS: Not reported
RS-Freetext:
AVERAGE SCORE: not reported
REVERSIBILITY: not reported
OTHER EFFECTS: not reported
RS-Freetext:
AVERAGE SCORE: not reported
REVERSIBILITY: not reported
OTHER EFFECTS: not reported
RS-Freetext:
AVERAGE SCORE
- Erythema: Not reported.
- Edema: Not reported.
REVERSIBILITY: Not reported.
OTHER EFFECTS: PII intact skin: 0.0. PII abraded skin: 0.6.
PII: 0.3. There was tissue destruction in 0/6 intact skin
sites, and 0/6 abraded skin sites. Irritancy: negligible.
RS-Freetext:
AVERAGE SCORE
- Erythema: Not reported.
- Edema: Not reported.
REVERSIBILITY: Lesions remained for at least 96 hrs.
OTHER EFFECTS: PII intact skin: 6.8. PII abraded skin: 8.0.
PII: 7.4. There was tissue destruction in 5/5 intact skin
sites, and 5/5 abraded skin sites. Irritancy: corrosive.
RS-Freetext:
AVERAGE SCORE
- Erythema: Not reported.
- Edema: Not reported.
REVERSIBILITY: Lesions disappeared after unknown time
period.
OTHER EFFECTS: PII intact skin: 3.0. PII abraded skin: 4.2.
PII: 3.6. There was tissue destruction in 0/8 intact skin
sites, and 1/8 abraded skin sites. Irritancy: severe. A
single subject developed a severe erythematous and vesicular
reaction on intact skin. The lesion was not permanent.
RS-Freetext:
AVERAGE SCORE
- Erythema: Not reported.
- Edema: Not reported.
REVERSIBILITY: Lesions remained for at least 96 hrs.
OTHER EFFECTS: PII intact skin: 8.0. PII abraded skin: 8.0.
PII: 8.0. There was tissue destruction in 6/6 intact skin
sites, and 6/6 abraded skin sites. Irritancy: corrosive.
RS-Freetext:
AVERAGE SCORE
- Erythema: Not reported.
- Edema: Not reported.
REVERSIBILITY: Lesions remained less than 96 hrs.
OTHER EFFECTS: PII intact skin: 1.7. PII abraded skin: 3.2.
PII: 2.4. There was tissue destruction in 0/6 intact skin
sites, and 3/6 abraded skin sites. Irritancy: moderate.
AVERAGE SCORE:
- Erythema: 4
- Edema: 4
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 4
- Edema: 4
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 4
- Edema: 4
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 1.11
- Edema: 0.11
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 2.33
- Edema: 1.33
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 4
- Edema: 3.8
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 2.8
- Edema: 2.3
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 0.22
- Oedema: 0.11
REVERSIBILITY: Erythema and oedema observed within 1 hour
after exposure in one of three animals disappeared 72 hours
after exposure.
OTHER EFFECTS: Only one animal developed a well defined
erythema and a barely perceptible oedema within 1 hour after
exposure; the other two animals did not reveal erythema or
oedema at any time.
AVERAGE SCORE:
- Erythema: 4
- Edema: 0.67
No further details on "results" available.
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: FHSA (Federal Hazardous Substances Act) specified in C.F.R. 1500.42 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Amount / concentration applied:
- Concentration: 10 other: wt%
- Interpretation of results:
- irritating
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: FHSA (Federal Hazardous Substances Act) specified in C.F.R. 1500.42 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Amount / concentration applied:
- Concentration: 6 other: wt%
- Interpretation of results:
- irritating
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: FHSA (Federal Hazardous Substances Act) specified in C.F.R. 1500.42 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Amount / concentration applied:
- Concentration: 5 other: wt%
- Interpretation of results:
- irritating
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available (review).
- Principles of method if other than guideline:
- Method: other: FHSA (Federal Hazardous Substances Act) specified in C.F.R. 1500.42 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Amount / concentration applied:
- Concentration: 3 other: wt%
- Interpretation of results:
- irritating
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Method not validated and only secondary literature available.
- Principles of method if other than guideline:
- Method: other: Esophageal test
- GLP compliance:
- no
- Species:
- rabbit
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- other justification
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- the study need not be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5)
- other:
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- the study need not be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5)
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The method is well-documented, but not validated. There are no guidelines for this kind of study, but the protocol is in use as an alternative to in vivo eye irritation studies for substances which are shown to be skin irritating/corrosive in in vivo studies.
- Principles of method if other than guideline:
- In vitro rabbit eye irritation study according to York et al., 1994; York et al., 1982; Burton et al., 1981.
- GLP compliance:
- yes
- Remarks:
- Environmental safety laboratory, Unilever Research, Bedford UK.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: Huntingdon Research centre (HRC) ltd. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted ; 50 mg
- Duration of treatment / exposure:
- 0.17 minute(s)
- Irritation parameter:
- other: opacity score
- Basis:
- mean
- Time point:
- other: 30 minutes, 1, 2, 3 and 4 hours after treatment
- Score:
- > 0
- Interpretation of results:
- corrosive
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The method is well-documented, but not validated. There are no guidelines for this kind of study, but the protocol is in use as an alternative to in vivo eye irritation studies for substances which are shown to be skin irritating/corrosive in in vivo studies.
- Principles of method if other than guideline:
- In vitro rabbit eye irritation study discribed by York et al., 1982; Burton et al., 1981.
The method is not validated yet, but is in use as an alternative to in vivo eye irritation studies, providing the test substance is shown to be skin irritating/corrosive. - GLP compliance:
- yes
- Remarks:
- no data
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted ; 50 mg
- Duration of treatment / exposure:
- 0.17 minute(s)
- Irritation parameter:
- other: opacity score
- Basis:
- mean
- Time point:
- other: 30 minutes, 1, 2, 3 and 4 hours after treamtent
- Score:
- > 0
- Max. score:
- 4
- Interpretation of results:
- corrosive
Referenceopen allclose all
RS-Freetext:
AVERAGE SCORE: Not reported
REVERSIBILITY: Not reported
OTHER EFFECTS: Not reported
RS-Freetext:
AVERAGE SCORE: not reported
DESCRIPTION OF LESIONS: not reported
REVERSIBILITY: not reported
OTHER EFFECTS: not reported
RS-Freetext:
AVERAGE SCORE: not reported
DESCRIPTION OF LESIONS: not reported
REVERSIBILITY: not reported
OTHER EFFECTS: not reported
RS-Freetext:
AVERAGE SCORE: not reported
DESCRIPTION OF LESIONS: not reported
REVERSIBILITY: not reported
OTHER EFFECTS: not reported
RS-Freetext:
MORTALITY: Not reported
CLINICAL SIGNS: Not reported
NECROPSY FINDINGS: Corrosive effects in the esophagus
POTENTIAL TARGET ORGANS: Not reported
SEX-SPECIFIC DIFFERENCES: Not reported
R
M-Freetext:
Schleyer et al. (1982) reports on a series of esophageal
tests (oral, rabbit) conducted under the auspicies of the
Consumer Product Safety Commission.
Microscopic examination of the esophagus was used as the
primary criterion for categorizing results as either
"corrosive" or "negative". The data is given below.
SiO2/Na2O Concentration Results
weight ratio
1.0 10% w/v +,+
AVERAGE SCORE:
- Maximum macroscopic and microscopic opacity score: 4
(complete corneal opacity, iris not discernible)
- Mean maximum corneal swelling: 41.30% (increase in thickness)
- Fluorescein staining: extreme (intense staining of very
badly damaged cornea, appears yellow/orange as opposed to
the bright green in previous grades).
- Loss of corneal cell layers: 3-6 (a normal cornea has ca. 8 layers)
REVERSIBILITY: Not applicable
OTHER EFFECTS: The overall result was severe irritation
(moderate/severe opacity and/or >35% swelling and/or 7-8
cell layers of the cornea lost)
AVERAGE SCORE:
- Maximum macroscopic and microscopic opacity score: 4
(complete corneal opacity, iris not discernible)
- Mean maximum corneal swelling: 43.18% (increase in thickness)
- Fluorescein staining: extreme (intense staining of very
badly damaged cornea, appears yellow/orange as opposed to the bright
green in previous grades).
- Loss of corneal cell layers: 2-4 (a normal cornea has ca. 8 layers)
REVERSIBILITY: Not applicable
OTHER EFFECTS: The overall result was severe irritation
(moderate/severe opacity and/or >35% swelling and/or 7-8 cell
layers of the cornea
Additional information
Disodium metasilicate is irritating as a 10% and corrosive as a 50% aqueous solution. When tested as an anhydrous powder, it was not irritating to the skin, when moistened with water it was found to be corrosive. Taking into account the results of the studies, the degree of irritation is dependent on the concentration (and therefore water content): lower concentrations exhibit lower irritancy compared to higher concentrations of the same molar ratio.
Due to animal welfare, in vivo studies were not conducted since the substance is skin irritating/corrosive and at the same time a strong base (pH > 11.5). Results from non-validated in vitro assays (in vitro rabbit eye test) indicate corrosiveness of disodium metasilicate, either administered as a powder or as granules with a molar ratio of 1.0.
Justification for classification or non-classification
DSD:Causes burns. Irritating to the respiratory system. According to Annex I the substance is classified as C; R34 and Xi; R37.
CLP:Causes severe skin burns and eye damage. May cause respiratory irritation. According to Annex VI disodium metasilicate is classified as Skin corr 1B, H314 and STOT SE 3, H335.
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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