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EC number: 215-199-1 | CAS number: 1312-76-1
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- 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
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Potassium silicate can be irritating to corrosive to the skin of rabbits, depending on the molar ratio and concentration.
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:
- supporting study
- 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:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Weight at study initiation: 3.2 kg (average) - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: deionised water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 7 T49-004:wt%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 5
- Details on study design:
- - Removal of test substance: yes
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 7 days - Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Weight at study initiation: 3.2 kg (average) - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: deionised water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 29 T49-004:wt%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 5
- Details on study design:
- - Removal of test substance: yes
- Scoring system: Primary irritation indices from 1 to 4; sum of intact and abraded scores reported
- Examination time points: 1, 24, 48 and 72 hours - Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0.25
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline, but only 1 animal tested. No information on purity of test substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal tested
- 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:
- not specified
- Amount / concentration applied:
- Concentration: 36 T49-004:wt%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 5 days
- Number of animals:
- 1
- Details on study design:
- - Removal of test substance: yes (washed away with water)
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 5 days - Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 5 days
- Score:
- 1
- Reversibility:
- other: Test sample only elicited transient erythema which was clear by day 5.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline, but only 1 animal tested.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal tested
- 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:
- Strain: New Zealand White
- 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:
- not required
- Amount / concentration applied:
- Concentration: 33 T49-004:wt%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 5 days
- Number of animals:
- 1
- Details on study design:
- - Removal of test substance: yes (washed away with water)
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 5 days - Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 5 days
- Score:
- 3
- Reversibility:
- other: The observed effects (well-defined erythema and very slight oedema) persisted for at least 5 days, the period of observation.
- Interpretation of results:
- moderately irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Weight at study initiation: 3.0 kg (average) - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: deionised water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 35 T49-004:wt%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- - Removal of test substance: yes
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 7 days - Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0.17
- Reversibility:
- other: 48 hours after treatment no effects were observed anymore.
- Other effects:
- Slight erythema after 1 hour, neglible erythema after 48 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Weight at study initiation: 3.0 kg (average) - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: deionised water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 8.8 T49-004:wt%; 0.5 mL
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- - Removal of test substance: yes
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours and 7 days - Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- Very slight erythema was observed 24 and 48 hours after treatment. None of these effects were observed thereafter. This is reported in the summary but not in the table of effects.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 18 Oct 2004 - 16 Dec 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods with acceptable restrictions; GLP
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services Inc.
- Age at study initiation: young adult
- Housing: singly in stainless steel cages
- Diet (e.g. ad libitum): pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 7 or 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 3 Nov To: 12 Nov 2004 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): assumed to be 30% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after removal of test substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 on the dorsal area and the trunk
- Type of wrap if used: 4-ply gauze pad wrapped with Micropore tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 3 min, 1 and 4 h after application
SCORING SYSTEM:
Evaluation for corrosion (PDII) and according to Draize et al., 1944 (data not presented) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.4
- Reversibility:
- fully reversible within: 72 h
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation / corrosion, 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 test specified in 16 C.F.R. 1500.41 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Concentration: 29 other: wt%
- Duration of treatment / exposure:
- 24 hour(s)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation / corrosion, 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 test specified in 16 C.F.R. 1500.41 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Concentration: 39 other: wt%
- Duration of treatment / exposure:
- 24 hour(s)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 2
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation / corrosion, 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 test specified in 16 C.F.R. 1500.41 et.seq.
- GLP compliance:
- no
- Species:
- rabbit
- Type of coverage:
- occlusive
- Amount / concentration applied:
- Concentration: 85 other: wt%
- Duration of treatment / exposure:
- 24 hour(s)
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 8
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information
Referenceopen allclose all
AVERAGE SCORE:
- Erythema: 0
- Edema: 0
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 0.25
- Edema: 0
REVERSIBILITY:
24 hours after treatment no effects were observed.
AVERAGE SCORE:
- Erythema: 1
- Edema: 0
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 2
- Edema: 1
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 0.17
- Edema: 0
No further details on "results" available.
AVERAGE SCORE:
- Erythema: 0
- Edema: 0
REVERSIBILITY:
48 hours after treatment the effects were no longer present.
No further details on "results" available.
All animals did not show signs of systemic toxicity. Very slight erythema was observed one hour after removal of the test patch in 3/3 animals. Within 72 h all animals were free of dermal irritation.
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
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 Draize method specified in 16 C.F.R. 1500.42
- GLP compliance:
- no
- Species:
- rabbit
- Amount / concentration applied:
- Concentration: 80 other: wt%
- Reversibility:
- not specified
- Remarks on result:
- other: highly irritating
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0 - 3.2 kg - Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- Concentration: 29 T49-004:wt%
Amount applied: 0.1 ml - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: not rinsed
- Postexposure period: scoring done at 1, 2, 4, 8 hours and 1-7 days daily
- Ophtalmoscopic examination: cornea, iris, conjunctiva
- Scoring system: according to OECD Guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 1.5
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0.7
- Reversibility:
- fully reversible within: 2 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Weight at study initiation: 3.0 -3.2 kg - Vehicle:
- other: deionised water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 7 T49-004:wt%
Amount applied: 0.1 ml - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: not rinsed
- Post-exposure period scoring at: 1, 2, 4, 8 hours and day 1-7 daily
- Ophtalmoscopic examination: cornea, iris, conjunctivae
- Scoring system: according to OECD Guideline 405' - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and day 1-7 daily
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and day 1-7 daily
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and day 1-7 daily
- Score:
- 0.7
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and day 1-7 daily
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0 -3.2 kg - Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 35 T49-004:wt%
Amount applied: 0.1 ml - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
- Postexposure period: scoring done at 1, 2, 4, 8 hours and 1-7 days daily
- Ophtalmoscopic examination: cornea, iris, conjuntiva
- Scoring system: according to OECD Guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 1.2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 1.4
- Reversibility:
- not reversible
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Pharmatox Beratung und Forschung GmbH
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.0 - 3.2 kg - Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 8.8 T49-004:wt%
Amount applied: 0.1 ml - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: not rinsed
- Postexposure period: scoring done at 1, 2, 4, 8 hours and 1-7 days daily
- Ophtalmoscopic examination: cornea, iris, conjunctiva
- Scoring system: according to OECD Guideline 405 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0.7
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1, 2, 4, 8 hours and 1-7 days daily
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods with acceptable restrictions; GLP
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Product Safety Laboratories
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services Inc.
- Age at study initiation: young adult
- Housing: singly in stainless steel cages
- Diet (e.g. ad libitum): pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): filtered tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 Nov To: 17 Nov 2004 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): assumed to be 30% - Duration of treatment / exposure:
- The test substance remained in the eye.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
According to Draize et al. 1944
TOOL USED TO ASSESS SCORE: high-intenstity white light and fluorescein dye evaluation after 24 h - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.7
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 4 days
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
Referenceopen allclose all
RS-Freetext:
AVERAGE SCORE: Not reported
DESCRIPTION OF LESIONS: Not reported
REVERSIBILITY: Not reported
OTHER EFFECTS: Not reported
No further details on "results" available.
No further details on "results" available.
AVERAGE SCORE:
- Cornea: 0/0/0
- Iris: 0/0/0
- Conjunctivae (redness): 1.0/1.3/1.3
- Conjunctivae (chemosis): 1.5/1.3/1.5
REVERSIBILITY:
The effects observed persisted for at least 6
to 7 days after treatment (period of observation).
No further details on "results" available.
Additional information
As observed with sodium silicates, potassium silicates of comparable concentrations and different molar ratios show an inverse correlation to irritancy. Molar ratios of 2.0 - 3.0 and 30 - 36% were irritating to the skin, whereas molar ratios of 3.4 and 3.9 (29- 35%) caused no irritation.
At concentrations up to 35% potassium silicates with molar ratio of 2.47, 3.4 and 3.9 were only slightly or not irritating to the eyes of rabbits.
Justification for classification or non-classification
DSD: Irritating to corrosive depending on the molar ratio/specific concentration limit.
CLP:
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