Registration Dossier
Registration Dossier
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EC number: 205-516-1 | CAS number: 141-97-9
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:
- guideline study
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
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Molecular formula: C6H10O3
- Physical state: liquid
- Storage condition of test material: in the dark at room temperature (20°C)
- Stability under test conditions: stable
Constituent 1
- Specific details on test material used for the study:
- - Batch-no.: 15.07.83
- Storage: at room temperature in the dark
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: 3200-3500 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:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: scores observed one hour after treatment
- Irritant / corrosive response data:
- The test item showed irritating effects in this test. All effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 48 or 72 hours after treatment.
- Other effects:
- Slight secretion was noted in the treated eye of one animal one hour after application.
Any other information on results incl. tables
See table above.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is slightly irritating to the rabbit eye; however classification/labelling according GHS-criteria is not necessary.
- 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 days after treatment . The test item showed slight irritating effects in this test. The effects on conjunctiva (chemosis and redness) and on iris were found to be reversible within 48 and 72 hours after treatment.
In conclusion, EAA needs not to be classified as eye-irritant.
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