Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
Results are from an in-vivo study performed in 1976, i.e. before the in vitro eye irritation requirement.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Federal Hazardous Substances Labelling Act.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Product name: Ceraphyl 31

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: corn oil
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
7 days
Observation period (in vivo):
Every 24 hours for foour days and on the seventh day.
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
hyperemia
Basis:
animal #3
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48h - day 7
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
hyperemia
Basis:
animal #5
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 48 h - day 7
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: all
Score:
0
Max. score:
0
Other effects:
Not recorded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Installation of 0.1 ml of the test material into the eyes of six rabbits produced a primary irritation index of 0.1. Hence, the substance was not irritant for the rabbit's eye. Thus, not sufficient for classification.