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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Supplier: Fluka AG, Switzerland.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Fluka AG, Switzerland
- Purity: 99%

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dörröds Djur- och Foderservice, Veberöd (Sweden)
- Housing: Individual housing
- Diet (e.g. ad libitum): A controlled amount of feed (Ewos avelsfoder för kanin, Batch nr 3, Ewos AB, Södertälje, Sweden)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
4s, 30s, 24h
Observation period (in vivo):
1h, 24h, 48h, 72 h, 10d and 21d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with water
- Time after start of exposure: 4s, 30s, 24h

SCORING SYSTEM:
- Draize

TOOL USED TO ASSESS SCORE:
- ophthalmoscope, biomicroscope, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(24h exposure)
Basis:
mean
Remarks:
for each of 3 animals
Time point:
other: 24;48;72h
Score:
1.9
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Mean (24,48; 72h) scores of each animal: animal #1 = 1.7; animal #2 = 2; animal #3 = 2
Irritation parameter:
iris score
Remarks:
(24h exposure)
Basis:
mean
Remarks:
for each of 3 animals
Time point:
other: 24;48;72h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Remarks:
(24h exposure)
Basis:
mean
Remarks:
for each of 3 animals
Time point:
other: 24;48;72h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Remarks:
(24h exposure)
Basis:
mean
Remarks:
for each of 3 animals
Time point:
other: 24;48;72h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 10 days

Any other information on results incl. tables

As the erythema and oedema scores resulting from the 4-sec-exposure are less relevant for an assessment of the eye irritating property of the substance, the details are not reported here.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In this in vivo study on rabbits, the results indicate that the test item is irritating to the eyes of rabbits.
Executive summary:

In this GLP compliant OECD 405 study, one eye of each of 3 rabbits was treated with 0.1 mL cyclohexanol (purity 99%) for a period of 24h, 30s or 4s. Draize scoring of eye changes were performed at 24h, 48h, 72h after instillation. Regarding the 24 hour application, the mean cornea score (all animals, mean of 24 - 72 hour readings) was 1.9 (one animal with a score of 1.7 and two animals with a score of 2.0), the mean iris score was 0, the mean conjuctivae score was 2.1 (one animal with a score of 2.3 and two animals with 2.0) and the mean chemosis score was 2,3 (one animal with a score of 2,3, one with 2,7 and one with 2.0). Effects were reversible within 10 days in all animals.