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 - Guideline study.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 405
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:
100mg
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Score:
1.67
Max. score:
1.67
Remarks on result:
other: Max. duration: 48h; Max.value at end of observation period:0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.67
Max. score:
0.67
Remarks on result:
other: Max. duration: 48h; Max.value at end of observation period:0
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0.16
Max. score:
0.16
Remarks on result:
other: Max. duration: 24h; Max.value at end of observation period:0
Irritation parameter:
iris score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0h; 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