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)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

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
Details on test material:
Nature of substance: powder

Test animals / tissue source

Species:
other: New Zealand White Rabbits

Test system

Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
1.67
Max. score:
1.67
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.67
Max. score:
0.67
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0.16
Max. score:
0.16
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Remarks:
overall at 24, 48 and 72 h
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Conjunctival irritation including blisterine in all but one animal after test article administration

Applicant's summary and conclusion