Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: White russians
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG
- Age at study initiation: males 9 months; females 9 months
- Weight at study initiation: males 2.63 and 2.89 kg; female 2.9 kg
- Housing: individually in stainless steel cages with grating
- Diet: standard diet ssniff K ("special diet for rabbits") approx. 120 gram/day /animal
- Water: drinking water ad libitum
- Acclimation period: one day under test conditions before start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24.5
- Humidity (%): 30 - 50
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.023 gram (representing a volume of about 0.1 ml)
Duration of treatment / exposure:
the treated eye was not rinsed
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
According to Draize scores were calculated with the individual grades on cornea, iris, and conjunctiva recorded at examination times 1, 24, 48 and 72 hours. The irritation index is given by the sum of scores.
A corresponding gradation was allocated to this index by the following scheme.

Index Ranges Gradation
0 - 10 non-irritant
11 - 25 slightly irritant
26 - 56 moderatly irritant
57 - 110 severely irritant

TOOL USED TO ASSESS SCORE:
Cliptrix pencil light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Area of cornea involved
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Area of cornea involved
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
Area of cornea involved
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
under the conditions of the study the test material was not irritating for the eyes