Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1995
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
one time treatment
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
2 m and 2 f

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72 h
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 72 h
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 72 h
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 72 h
Score:
>= 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #1
Time point:
other: 1 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #2
Time point:
other: 1 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #3
Time point:
other: 1 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #4
Time point:
other: 1 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
1 h post administrations , only a slight redness of the conjunctiva was seen in all four rabbits. It was no longer evident 24 h post administration. Mean maximal score for conjunctival redness was 1.0.
No other findings were recorded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
No special labelling is necessary in accordance with German regulations regarding eye irritation.