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Toxicological information

Eye irritation

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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:
1987
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

Constituent 1
Chemical structure
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.

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.