Registration Dossier
Registration Dossier
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EC number: 215-687-4 | CAS number: 1344-09-8
Skin irritation / corrosion
Administrative data
- 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.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Forsvarets Forskningsanstalt
Test material
- Reference substance name:
- Silicic acid, sodium salt
- EC Number:
- 215-687-4
- EC Name:
- Silicic acid, sodium salt
- Cas Number:
- 1344-09-8
- Molecular formula:
- Na2O x (SiO2)n with Molar Ratio (MR) (SiO2/Na2O): 1.5 – 4
- IUPAC Name:
- sodium hydroxy(oxo)silanolate
- Details on test material:
- SOURCE: EKA AB
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 53.5 wt% Sodium Silicate in water. Molecular weight 158, pH 12.8, liquid, molar ratio 1.6. Classification "corrosive" according to Swedish standards
Constituent 1
Test animals
- 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)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g/mL applied
Concentration: 53.5 wt% in water - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- One week for animals with no lesions and 14 days for animals with wounds.
- Number of animals:
- 3
- Details on study design:
- - Removal of test substance with water after 4 hrs exposure
- Scoring system: skin irritation index, according to OECD 404.
- Examination time points: 1, 24, 48 and 72 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 24, 48, 72 h
- Score:
- 8
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- observation for 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- observation for 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- observation for 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- observation for 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- observation for 14 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- observation for 14 d
- Remarks on result:
- probability of severe irritation
- Other effects:
- All exposed animals showed an acute necrosis. The necrosis and an acute oedema outside the wound remained during the following examinations.
Any other information on results incl. tables
AVERAGE SCORE:
- Erythema: 4
- Edema: 4
No further details on "results" available.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
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