Registration Dossier

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: Guideline study according OECD 405

Data source

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

Materials and methods

Principles of method if other than guideline:
100 µl (ca. 40 mg) 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:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Macrolex Blau CA 51056 = CAS 41611-76-1
pH-value: 7.0 (20 g/l H2O)

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, 72 h, 7 days
Score:
0
Max. score:
4
Reversibility:
other: score 0 = at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
2
Reversibility:
other: score 0 = at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
3
Reversibility:
other: score 0 = at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h, 7 days
Score:
0
Max. score:
4
Reversibility:
other: score 0 = at any time point
Other effects:
A slight reddening of the cornea was visible 1 hour after application of the test substance maybe caused by mechanical irritation of the test item

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 (ca. 40 mg) Macrolex Blau CA 51056 = CAS 41611-76-1 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 and chemosis score = 0. The test substance is not irritating.