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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Reference Type:
other: monograph provided by ECHA
Title:
Endpoint record:Eye irritation
Author:
ECHA
Year:
2010
Bibliographic source:
Document from ECHA

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
There is no need to add in this field.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Nature of substance:Undiluted liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Nothing to add in this field.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72hours
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
Nothing to add in this field.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Irritation parameter:
conjunctivae score
Max. score:
1
Remarks on result:
other: Max. duration: 1h; Max. value at end of observation period :0(related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: 0h; Max. value at end of observation period :0(related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 28 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period :0(related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period :0(related to all animals)
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Other effects:
Residual test material was noted around the treated eye of one animal one hour after treatment.
Minimal conjunctival redness was noted in one treated eye one hour after treatment.

Any other information on results incl. tables

All treated eyes appeared normal at the 24-hour observation. Mean scores for all ocular lesions at 24, 48 and 72 hours were 0 for all animals.The test chemical was non-irritating to the eyes of rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test chemical was non-irritating to the eyes of rabbits.
Executive summary:

According to OECD TG 405, the test material was considered not irritating to eye via acute eye irriation/corrosion study in rabbits.