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Toxicological information

Eye irritation

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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:
1990
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004
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

Constituent 1
Chemical structure
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 hydroxy(oxo)silanolate
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

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