Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- 3 male rabbits used – 1 treated group
- Age/Bodyweight at start: 2 to 4 month-old; 3.0 +/-0.1kg
- Temperature: 18+/-3°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 1 rabbit/cage
- Food and water ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg/animal
Duration of treatment / exposure:
- Application directly in the conjunctival sac of 1 eye
- No rinsing after application
- The controlateral eye served as control.
Observation period (in vivo):
eye examination at 1, 24, 48, 72 hours after the treatment
Number of animals or in vitro replicates:
3
Details on study design:
Control animals
not required (the contro-lateral eye served as control)

At each time of examination, individual scoring for conjunctival reactions, iritis and corneal opacification

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: chemosis
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: chemosis
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: chemosis
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: conjunctiva redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: conjunctiva redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: conjunctiva redness
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Remarks on result:
other: iris
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Remarks on result:
other: iris
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Remarks on result:
other: iris
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: corneal opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: corneal opacity
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: corneal opacity
Other effects:
Observation: Whitish purulent discharge in 1 animal on day 2. Fully reversible.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information fully reversible Criteria used for interpretation of results: EU
Conclusions:
Classification is not required.