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: well documented GLP Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
100 µl test substance was applied into the conjuctival sac of 3 rabbits. The treated eye was washed after 24 hours with physiological saline. Eyes were examinated after application of test substance for 7 days
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Vorprodukt Katalysator WAZ 5596 B, brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicalble - score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.56
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable - score = 0 at any time point

Any other information on results incl. tables

The test substance is not irritating to the eyes

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

100 µl Vorprodukt Katalysator WAZ 5596 B was applied into the conjuctival sac of 3 rabbits. The treated eye was washed after 24 hours with physiological saline. Eyes were examinated after application of the test substance for 7 days. Cornea, iris, conjunctiva (erythema and chemosis) were scored according to Draize at 24, 48 and 72 hours. Mean values (24, 48 and 72 h) for cornea score = 0, iris score = 0, conjuctivae score = 0.56 and chemosis score = 0. The test substance is not irritating.