Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August-December 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: no guideline study; not GLP-compliant
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; deviated from Annex V (observations only at 24 hours and 7 days)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amber liquid
Details on test material:
- Test Material: C-1054
- Description: Amber liquid
- Date Received: August 7, 19B6
- Storage: Temperature - monitored room (60-85°F)
- Density: 1.2208 g/ml

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml test item was applied
Observation period (in vivo):
Observation at 24 hours and 7 days only
Number of animals or in vitro replicates:
4 animals were used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.75
Max. score:
1
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24. 48 and 72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 78 and 72 h
Score:
0.75
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item produced very mild ocular irritation. All four animals exhibited slight conjunctival irritation (redness, chemosis) and iridial changes at 24 hours. By Day 7, two animals were free of ocular irritation; two animals continued to exhibit slight conjunctival irritation.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item showed irreversible conjunctival redness in two animals after seven days.
Executive summary:

The eye irritation test was performed according to EU-testing method B.5, using 4 NZW-rabbits. Deviated from Annex V (observations only at 24 hours and 7 days after initial to administration). At 24 hours mild conjunctival redness (score 1) was observed in all animals. In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. In 2 animals conjunctival redness was still apparent at 7 days, in 1 animal accompanied by discharge. Due to the irreversible conjunctival redness observed in two animals, the test item needs to be classified "Eye dam.1, H318".