Registration Dossier
Registration Dossier
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EC number: 215-199-1 | CAS number: 1312-76-1
Eye irritation
Administrative data
- 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.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- 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 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Pharmatox Beratung und Forschung GmbH
Test material
- Reference substance name:
- Silicic acid, potassium salt
- EC Number:
- 215-199-1
- EC Name:
- Silicic acid, potassium salt
- Cas Number:
- 1312-76-1
- Molecular formula:
- K2O x (SiO2)n with Molar Ratio (MR) (SiO2/K2O): 0.5 – 5 (with exception of MR = 1)
- IUPAC Name:
- potassium hydroxysilanoylolate
- Details on test material:
- SOURCE: Woellner Werke GmbH
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 29 wt% Potassium Silicate. Molar ratio 3.9
Constituent 1
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
No further details on "results" available.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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