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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guidelineopen allclose all
Qualifier:
no guideline available
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The method as described by Dr. Draize in “Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", published by the Association of Food and Drug Officials of the United States, was used, which later on formed the basis for development of an in vivo OECD protocol for eye irritation. 3 animals (albino rabbits) were treated with 0.1 mL of the test sample instilled into the right eye with no further treatment. The untreated left eye of each animal served as its own control. Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day.
The scorings recorded were made according to the Draize scale for scoring ocular lesions.
GLP compliance:
no
Remarks:
pre-dates GLP development

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenylpropan-1-ol
EC Number:
214-379-7
EC Name:
2-phenylpropan-1-ol
Cas Number:
1123-85-9
Molecular formula:
C9H12O
IUPAC Name:
2-phenylpropan-1-ol
Test material form:
liquid
Specific details on test material used for the study:
The concentration tested was 0.625% hydratropic alcohol in water; 0.1 mL were instilled in the right eye of albino rabbit.

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Instillation of test substance, which was not removed; animals were observed daily for four days and then agin on day 7 following treatment
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
5 animals were used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
not fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 7
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 4 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No effects on cornea and iris were observed in this in vivo study with rabbits. However, redness and chemosis was observed, but both effects were fully reversible within 7 days and the criteria according to GHS/CLP (conjunctival redness ≥2 and chemosis ≥2 in at least 2 of 3 treated animals, calculated as mean scores of grading 24, 48 and 72 hours) were not fulfilled.
Executive summary:

When tested in vivo in a study similar in design to OECD 405, which was developed much later, the test substance was found to show no effects on cornea and iris. However, redness and chemosis was observed, but both effects were fully reversible within 7 days.