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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:
before 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Source is a published peer reviewed tabulation of detailed results from in house eye irritation studies performed to guideline that is intended as a reference work for the development of in vitro studies. The work is published by a reputable organisation and is therefore considered reliable.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Study indicated to be to GLP but no test laboratory named.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 100% ethanol

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Concentration: 100 % active substance
- instillation of 0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
Up to 21 days unless symptoms disappeared first.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Standard Draize grading scale for lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average over 24, 48, 72hr observations.
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average over 24, 48, 72hr observations.
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average over 24, 48, 72hr observations.
Score:
2.1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average over 24, 48, 72hr observations.
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: MMAS
Basis:
mean
Time point:
other: 24 hours
Score:
24
Max. score:
110
Irritant / corrosive response data:
Individual animal observations reported. Full reversal of all symptoms in animals occurred within 14 days. Most persistent effect was conjunctival redness, still present, grade 1, at 7 daysin 2 animals (last observation time before 14 day observation). One animal showed full recovery of all symptoms by day 4.
Other effects:
none reported.

Any other information on results incl. tables

The MMAS (modified maximum average score is calculated per animal from the 24 hour observations based corneal effects (capacity x area x 5), iris effects (x5) and conjunctival effects (redness + chemosis + discharge scores). The total possible is 80 (cornea) + iris (10) plus conjunctivae (20), ie a maximum of 110.

Average scores (all animals)

   Day 1  Day 2  Day 3
 Corneal opacity  1.33  1.33  0.66
 Iritis  0.33  0.66  0.33
 Conjunctival redness  2.66  2.00  1.66
 Chemosis  1.66  1.66  0.66

Average scores (worst two animals)

   ANIMAL #1 (average days 1,2,3)    ANIMAL #2 (average days 1,2,3)
  Corneal opacity  1.33 1.66 
   Iritis  1 0.33 
  Conjunctival redness  2.66 2.33 
  Chemosis  2 1.66 

Based on the criteria for classification, only the conjunctival redness in animal one is meets the criteria for the definition of a significant occular lesions would be regarded as significant but such a response in only one animal is not regarded as sufficient for classification as an eye irritant under directive 67/548. The average results across all 3 animals are not sufficient either. However, the criteria for classification under GHS are more stringent and a positive response is seen under these criteria for corneal opacity (2 animals >1) and conjunctival redness (2 animals >2), hence classification as an eye irritant (category 2) is required.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance clearly shows reversible eye irritant properties
Executive summary:

In a reference handbook of peer reviewed, guideline GLP eye irritation study results in rabbits, ethanol was found to cause eye irritation. All symptoms reversed within 14 days. The response was not sufficiently severe to trigger classification under the criteria of directive 67/548 but was sufficient with respect to the corneal and conjunctival effects to trigger classification as a reversible eye irritant (category 2) under the EU GHS regulation.