Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): EMI-2,4 Fluessig

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Weight at study initiation: male, 3.17 kg; females, 2.93 kg
- Housing: singly in a stainless steel cage with wire mesh walk floors (floor area: 40 x 51 cm)
- Diet (e.g. ad libitum): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-43-3 Kaiseraugst, Switserland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single application to the conjunctival sac of the right eyelid (not washed out)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
2 male, 1 female
Details on study design:
Readings: 1 hr, 24 hr, 48 hr, 72 hr after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: irritation index could not be read due to severe corneal opacity
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Other effects:
Other effects observed were contracted pupils (1, 24 h), discharge of blood (1, 24, 48 h), detachment of the cornea (1, 24 h), small retractions in the eyelids (24, 48, 72 h), suppuration (48, 72 h).
The study was discontinued after 72 h because of severe irritation.

Applicant's summary and conclusion

Interpretation of results:
other: highly irritating