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EC number: 200-578-6 | CAS number: 64-17-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Citet in OECD SIDS. Study with only basic documentation but carried out according to guideline.
Data source
Reference
- Reference Type:
- publication
- Title:
- OECD eye irritation tests on three alcohols.
- Author:
- Jacobs, G.A., Guido, A.
- Year:
- 1 987
- Bibliographic source:
- J. Coll. Am. Toxicol. part A, 9:56-57.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- - Analytical purity: Test substance was neat ethanol.
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: 100 other: microlitre into lower conjunctival sac. - Duration of treatment / exposure:
- single instillation of 0.1ml
- Observation period (in vivo):
- 72 hours only reported
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize method of scoring used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 0.28
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 2.4
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: average across time points 24, 48, 72 hrs
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not specified
Any other information on results incl. tables
Average Scores:
| 24 hours | 48 hours | 72 hours | |
| Conjunctivitis | 2.50 | 2.61 | 2.06 |
| Chemosis | 1.67 | 1.17 | 0.83 |
| Iritis | 0.50 | 0.33 | 0.00 |
| Corneal Opacity | 1.00 | 1.50 | 1.00 |
It is not possible to make a definitive judgement regarding classification as results from individual animals are not available. However, based on the average results across all animals, the occular lesions are not severe enough to warrant classification as an eye irritant under under directive 67/548. However, the criteria for classification under GHS are more stringent and 'significant lesions' are seen under these criteria for corneal opacity ( likely that at least 2 animals >1 based on an average of 1.2) and conjunctival redness (likely that at least 2 animals >2 based on an average of 2.4), hence a judgement that the results from this study support classification as an eye irritant (category 2) based on the immediate effects seen. There is no data on recovery rates.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: irritating
- Executive summary:
In a guideline eye irritation study results in rabbits for which only basic but key details are reported, ethanol was found to cause eye irritation. The response was not sufficiently severe to trigger classification under the criteria of directive 67/548 but, based on the available information, appears to be sufficient with respect to the corneal and conjunctival effects to trigger classification as an eye irritant (category 2) under the EU GHS regulation. The study did not include sufficient observations to be able to judge reversibility.
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