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
Study period:
from 2007-02-15 to 2007-02-18
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2004/73/EEC
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
Batch no: EZ06-B001;

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age of animals at arrival: Young adult rabbits, 11 weeks old
Body weight at the
beginning of the study: 2699-2891 g
at the end of the study: 2782-2990 g
Acclimatisation time: 9 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
The eyes of test animals were not washed out after the test item application. Total exposure period 72 h (single dose).
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
NA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
One hour after the treatment all animals displayed some hyperaemic blood vessels (score 1). In animal No.: 5304 the discharge moistened lids and hairs just adjacent to lids (score 2). Corneal and iris alterations were not recorded throughout the study period.
24 hours after the treatment in two animals (No.: 5327, 5304) conjunctival redness did not change when compared to the previous observation (scores 1-1). The discharge from the eye was greater than normal (score 1) in two animals (No.: 5327, 5304). In animal No.: 5327 some swelling above normal were found (score 1). The animal No.: 5301 became symptom-free.
48 hours after the treatment all animals were symptom-free.
72 hours after the treatment the study was terminated, as all animals were free of symptoms of irritation.
Other effects:
General state and the behaviour of animals were normal throughout the study period. There were no significant body weight changes during the
contact and observation period.

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
AVE 5530 EVA-KET is no eye irritant.
Executive summary:

AVE 5530 EVA-KET is no eye irritant.