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 study, conducted according to EPA FIFRA Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
1982
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Ohio, USA
- Age at study initiation: young adult
- Weight at study initiation: 2.634-3.104 kg

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL


Duration of treatment / exposure:
single application
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes of 3 rabbits were rinsed for about 1 min, the eyes of the remaining 6 rabbits were not washed out
- Time after start of exposure: 30 seconds

SCORING SYSTEM:
Conjunctiva redness and cornea values were scored on the scale 0-3, chemosis and iris findings were evaluated according to a 5 graded scale (0-4) and a 3 graded scale (0-2).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
2.27
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
2.83
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
(mean of 6 animals, eyes were not washed out after treatment)
Time point:
other: 24 / 48 / 72 h
Score:
1.1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
The findings were not reversible within the 21-days observation period.

Applicant's summary and conclusion

Interpretation of results:
other: severe eye damage
Remarks:
Criteria used for interpretation of results: EU