Registration Dossier
Registration Dossier
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EC number: 203-299-8 | CAS number: 105-45-3
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: study performed in accordance with the corresponding OECD-/EU-testing guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl acetoacetate
- EC Number:
- 203-299-8
- EC Name:
- Methyl acetoacetate
- Cas Number:
- 105-45-3
- Molecular formula:
- C5H8O3
- IUPAC Name:
- methyl 3-oxobutanoate
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Molecular formula: C5H8O3
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: in the dark at room temperature (20°C)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- number of animals: 3
- Weight at study initiation: 2200-2600 mg/kg
- Housing: single housing
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- Duration of treatment was 24 hours
- Observation period (in vivo):
- Obervations were done at 1, 24, 48 and 72 hours and 7, 14 and 21 days after application
- Number of animals or in vitro replicates:
- 3 animals were used in this study
- Details on study design:
- The treated eyes were rinsed 24 hours after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 2.3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: cornea opacity with vascularization
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 2.7
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 2.3
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- The test item showed severe irritating effects in this test. The effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 21 days after treatment. The cornea opacity incl. vascularization observed in one animal persisted in one animal until the end of the observation period and was therefore not reversible.
- Other effects:
- Strong clear or slimy secretion was noted in the treated eyes of all animals up to 72 hours after application. The animal with irreversible opacity of thecornea showed also vascularization from day 7 until the end of the observation period of 21 days.
Any other information on results incl. tables
See table above.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is severely irritating and caused irreversible effects on the cornea. Therefore, it has to be classified as Category 1 eye-irritant.
- Executive summary:
The study was performed in 1983 under GLP according to OECD 405. Three albino rabbits were treated; 0.1 ml test item was applied into the conjunctival sac of the eye. Observation times were 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment .
The test item showed severe irritating effects in this test. The effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 21 days after treatment. The cornea opacity incl. vascularization observed in one animal persisted in one animal until the end of the observation period and was therefore not reversible. In conclusion, MAA needs to be classified as Category 1 eye-irritant.
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