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Diss Factsheets

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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
According to FDA methos at the time.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde
EC Number:
250-078-7
EC Name:
4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde
Cas Number:
30168-23-1
Molecular formula:
C14H20O
IUPAC Name:
4-[(8Z)-tricyclo[5.2.1.0^{2,6}]decan-8-ylidene]butanal
Test material form:
liquid
Specific details on test material used for the study:
Dupical: U 05481
A clear yellowish liquid.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Acclimatisation: 3 days.
Individually housed.
Temperature: 23 +/0 1'C.
Relative humidity: 50 +10%.
12 hour light and dark cycle.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100%
Duration of treatment / exposure:
No eye washing conducted.
Observation period (in vivo):
7 days observation (24, 48 and 72 hours and 7 days).
Number of animals or in vitro replicates:
Test 1: 6 animals.
Test 2: 6 animals.
Test 3: 6 animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.055
Max. score:
2
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 1
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 1
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
4
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
4
Reversibility:
other: Study did not go to 21 days but expected to be reversible
Remarks on result:
other: Test 2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.61
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritant / corrosive response data:
Since the results obtained from the first and the second test were still inconclusive, a third test was performed. In the third experiment the test-material caused moderate redness and slight swelling of the conjunctivae in one animal and slight redness and/or swelling of the conjunctivae in all other animals. After seven days slight conjunctivitis wasstill noticeable in two animals. Overall it may be said that Dupical is not an eye irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the present results it is concluded that according to FDA standards Dupical is not considered to be an eye irritant.
Although a low level of eye irritation was observed in the 3 tests carried out, the severity does not fulfill the current GHS or EU classification criteria.
Executive summary:

The product Dupical was examined for eye irritation and phototoxicity. New Zealand White albino rabbits were used as the experimental animals. According to FDA standards, Dupical is not considered to be an eye irritant. A 10% dilution of Dupical in absolute ethanol was not found to be phototoxic.