Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: Overall at 24,48 and 72h
Score:
0.66
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: overall at 24,28 and 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
0.33
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72h
Score:
1.6
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72h
Score:
0.66
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
0.66
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72h
Score:
1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72h
Score:
0
Other effects:
In addition to the effects scored, 2 animals showed slight conjunctival discharge during the first 24 hours post-administration. There were no eye effects noticeable by day 8.

Applicant's summary and conclusion

Interpretation of results:
other: not classified