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Diss Factsheets

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: Comparable to Guideline study. No GLP, however detailed documentation available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Batch No.: 87/70046

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler ; 6050 Offenbach/Main Germany
- Weight at study initiation: 3.16 kg (males); 2.93 kg (females)
- Housing: Single in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm X 51 cm
- Diet: KLIBA 341, 4 mm; Klingentalmuehle AG, 4303 Kaiseraugust, Switzerland about 130 g/animal/day
- Water:about 250 ml tap water/animal/day
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
Single application to the conjunctival sac of the right eyelid. the substance was not washed out.
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.6
Max. score:
1
Reversibility:
not fully reversible within: 21 d
Remarks on result:
other: in 1 out of 3 animals
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: corneal opacity: score 1, 2 and 2 on day 8, 15 and 21, respectively
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks:
15 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 15 days
Irritant / corrosive response data:
Animal number 3 lost corneal tissue, showed a contracted pupil and suppuration after 48 h. The contracted pupil was reversible after 15 days, suppuration within 8 days. However at day 8 the hair at the margins of the eyelids were lost and at day 15 there was a small retraction of the eyelid. Those symptoms persisted throughout the study.
Other effects:
Discharge could be observed in animal no 2 and 3. It was reversible in animal no 2 within 48 h while it persisted in animal no 3 throughout the study.

Applicant's summary and conclusion