Registration Dossier
Registration Dossier
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EC number: 239-263-3 | CAS number: 15206-55-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187, §1500.41, S. 27019 vom 27.09.73
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 72h observation period only (acceptable, as very mild findings only)
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl benzoylformate
- EC Number:
- 239-263-3
- EC Name:
- Methyl benzoylformate
- Cas Number:
- 15206-55-0
- Molecular formula:
- C9H8O3
- IUPAC Name:
- methyl oxo(phenyl)acetate
- Details on test material:
- - Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 3.0 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours not washed out
- Observation period (in vivo):
- 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Results:
|
|
|
|
Conjunctivae |
|
animal |
time after application |
cornea |
iris |
Redness |
Chemosis |
1 |
24 hours |
0 |
0 |
1 |
0 |
48 hours |
0 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
|
2 |
24 hours |
0 |
0 |
1 |
0 |
48 hours |
0 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
0 |
0 |
|
3 |
24 hours |
0 |
0 |
1 |
0 |
48 hours |
0 |
0 |
1 |
0 |
|
72 hours |
0 |
0 |
1 |
0 |
|
1 |
mean 24-72 h |
0.0 |
0.0 |
1.0 |
0.0 |
2 |
0.0 |
0.0 |
0.7 |
0.0 |
|
3 |
0.0 |
0.0 |
1.0 |
0.0 |
|
mean 24-72h |
0.0 |
0.0 |
0.9 |
0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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