Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2011
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: GLP study
Deviations:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
one time exposure
Observation period (in vivo):
24, 48, 72 h and 7 and 10 days after a one time exposure
Number of animals or in vitro replicates:
6 male rabbits

Results and discussion

In vivo

Results
Irritation parameter:
other: ocular irritation score (Average Draize score)
Basis:
mean
Time point:
other: 24 h
Score:
18.17
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: two of the six animals exhibited corneal opacities that lasted until day 7, but both had returned to normal by day 10

Applicant's summary and conclusion