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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 without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12th May 1982
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-cyclohexylphenol
EC Number:
214-465-4
EC Name:
4-cyclohexylphenol
Cas Number:
1131-60-8
Molecular formula:
C12H16O
IUPAC Name:
4-cyclohexylphenol

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill, Ltd., Huntingdon, England
- Weight at study initiation: 4 - 4.8 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K Pellets, ad libitum
- Water (e.g. ad libitum): drinking water ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 mg/ rabbit
Observation period (in vivo):
7 days (1h, 24h, 48h, 72h and 7 days)
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize-grading
TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
other: score after 72h was 0, before it was 1 in one animal
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Test item is not irritating to the eye.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study was conducted according to OECD guideline 405 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the eye irritating properties of the test substance in rabbits. Scoring according to Draize resulted in mean value of 0 for cornea/iris/conjunctivae in all three tested animals and hence, the substance can be considered to be not irritating to the eye.
Executive summary:

In a primary eye irritation study (OECD guideline 405), male and female rabbits (three animals, New Zealand White) were exposed to 500 mg of test substance (undiluted). Animals then were observed for 7 days; irritation was scored by the method of Draize.

The substance has been determined to be not irritating to the eye (mean value of 0 for cornea/iris/conjunctivae in all three tested animals).