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EC number: 228-250-8 | CAS number: 6197-30-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-MAR-30 through 1992-APR-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octocrilene
- EC Number:
- 228-250-8
- EC Name:
- Octocrilene
- Cas Number:
- 6197-30-4
- Molecular formula:
- C24H27NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyano-3,3-diphenylacrylate
- Details on test material:
- - Name of test material (as cited in study report): HR 92/600 154
- Physical state: viscous liquid
- Analytical purity: 98.5%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Mol: Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Moellegard Breeding Centre ApS, Ejby, Lille Skensved, DK
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: singly
- Diet: free access to feed pellet "Altromin 2123"
- Water: free access to water, acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 55 +/-15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required; untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- treated eyes were washed after 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: treated eyes were washed after instillation of fluorescent dye and prior to eye examination
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to table contained in OECD TG No. 405
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There was no eye reaction noted in any animal at any time.
Any other information on results incl. tables
Rabbit No. 1 |
|
1 h |
24 h F |
48 h |
72 h |
Area opacity |
|
0 |
0 |
0 |
0 |
Cornea |
|
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
Conjunctiva |
Chemosis |
0 |
0 |
0 |
0 |
Redness |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
Rabbit No. 2 |
|
1 h |
24 h F |
48 h |
72 h |
Area opacity |
|
0 |
0 |
0 |
0 |
Cornea |
|
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
Conjunctiva |
Chemosis |
0 |
0 |
0 |
0 |
Redness |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
Rabbit No. 3 |
|
1 h |
24 h F |
48 h |
72 h |
Area opacity |
|
0 |
0 |
0 |
0 |
Cornea |
|
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
Conjunctiva |
Chemosis |
0 |
0 |
0 |
0 |
Redness |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
Rabbit No. 4 |
|
1 h |
24 h F |
48 h |
72 h |
Area opacity |
|
0 |
0 |
0 |
0 |
Cornea |
|
0 |
0 |
0 |
0 |
Iris |
|
0 |
0 |
0 |
0 |
Conjunctiva |
Chemosis |
0 |
0 |
0 |
0 |
Redness |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
F= reading after instillation of fluorescent dye
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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