Registration Dossier

Toxicological information

Eye irritation

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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:
1989
Report Date:
1989

Materials and methods

Principles of method if other than guideline:
Macrolexgrün G was applied to the eyes of 2 rabbits. Post observation time was 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
ca. 50 mg
Duration of treatment / exposure:
7 days (eyes were not washed).
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating. Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours.
Executive summary:

Macrolexgrün G was applied to the eyes of 2 rabbits. Post observation time was 7 days. Cornea opacity, iris and chemosis score were 0 (24,48, 72 hours). The conjunctivae score was 0.2 (24, 48, 72 hours). It was fully reversible within 48 hours. Macrolexgrün G was not irritating in this test.