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: GLP-study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye of the rabbits remained untreated and served as a control
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
control eye
Time point:
other: 24 -72 hrs. (mean)
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness/chemosis
Basis:
animal #1
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
treated eye
Time point:
other: 24-72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness/chemosis
Basis:
animal #2
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
control eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: redness animal #3 control eye - score 0; max. score 0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
treated eye
Time point:
other: 24 - 72 hrs (mean)
Score:
0
Max. score:
0
Remarks on result:
other: chemosis animal #3 control eye - score 0; max. score 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Because the mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, the TS can be classified as non-irritant.