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:
2007

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 material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
1 hr, 24 hr, 48 hr, 72 hr
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
10
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
All subjects experienced redness (score 1 on a scale of 0 to 3), one experienced discharge (score 1 on a scale of 0 to 3), no sign of chemosis. No effects at 24 hours or later.

Applicant's summary and conclusion

Executive summary:

"The test material produced a maximum group mean score of 2.7 and was classified as a minimasl irritant (Class 3 on a 1 to 8 scasle) to the rabbit eye according to a modified Kay and Calandra classifgication system."