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Registration Dossier
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EC number: 205-500-4 | CAS number: 141-78-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Secondary source but one that is considered highly reliable since data (generated to guideline) has undergone a peer review process before inclusion and detailed experimental results are available per animal and per timepoint. Data used in this source has been subject to a peer review process by a reputable body which mitigates the fact that the original source document for studies presented are not referenced. It should be noted that the publication is intended as a reference work of in vivo results for the development of in vitro methods.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- Study is reported to be GLP compliant but there is no information on the testing laboratory.
Test material
- Reference substance name:
- Ethyl acetate
- EC Number:
- 205-500-4
- EC Name:
- Ethyl acetate
- Cas Number:
- 141-78-6
- Molecular formula:
- C4H8O2
- IUPAC Name:
- ethyl acetate
- Details on test material:
- 99% pure, tested as pure substance, Fisher product number E-145
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- single instillation, as per guideline
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.41
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.08
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 1.25
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.58
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.17
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: average of results for 2 worst affected animals.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: average at time points 24, 48, 72hrs
- Score:
- 15
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: See notes below
- Irritant / corrosive response data:
- Overall irritation score = (Corneal Opacity+area)x5 + Irisx5 + (Conjunctival redness + chemosis + discharge)x2. Maximum possible = 110.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of these results, the substance does not warrant irritation under either the DSD or EU GHS regulation.
- Executive summary:
In a reliable secondary source, which reported the results from peer reviewed guideline studies, ethyl acetate was found to be only midly irritating to rabbit eyes, with all effects disappearing within 7 days.
Synopsis
Based on these results, this substance would not be classified as irritating under either the DSD or the EU GHS regulation.
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