Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-01-24 until 1994-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult
- Weight at study initiation: 3.67 - 4.37 kg
- Housing: single
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, CH
- Water: municipal drinking water, regularly assayed
- Acclimation period: at least 1 w eek

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
not washed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: OECD Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: iris remained normal
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: iris remained normal
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: iris remained normal
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table for details
Irritation parameter:
conjunctivae score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #1
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #2
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see table for details
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal #3
Time point:
other: 24 - 48 -72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see table for details

Any other information on results incl. tables

Animal  Reading  Opacity Iritis Redness Chemosis Symptoms
1 1 h 0 0 2 1 discharge score 3; small retractions of the eye lids
2 1 h 0 0 0 0  
3 1 h 0 0 1 0 discharge score 1
1 24 h 0 0 2 0 small retractions of the eye lids
2 24 h 0 0 0 0  
3 24 h 0 0 2 1 discharge score 1
1 48 h 0 0 2 0 small retractions of the eye lids
2 48 h 0 0 0 0  
3 48 h 0 0 2 0 discharge score 1
1 72 h 0 0 2 0 small retractions of the eye lids
2 72 h 0 0 0 0  
3 72 h 0 0 2 0 discharge score 1
1 8 d 0 0 0 0  
2 8 d 0 0 0 0  
3 8 d 0 0 0 0  
mean 24 - 72 h 0.00 0.00 1.33 0.11  

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU