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Registration Dossier
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Eye irritation
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:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- 1982
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- other: aqueous solution
Constituent 1
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
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