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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:
other: Broadly followed OECD guideline, no GLP, very limited report, but supplemented by recent laboratory communications.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Method assignment based upon recent lab communications
Principles of method if other than guideline:
Two animals were dosed with 100 microliter of test substance in the eye and observed for 7 days.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzaldehyde
EC Number:
202-860-4
EC Name:
Benzaldehyde
Cas Number:
100-52-7
Molecular formula:
C7H6O
IUPAC Name:
benzaldehyde
Details on test material:
No data given

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-4 kg

No additional data

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 microliter

No additional data
Duration of treatment / exposure:
Single application, no data on washing.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Details on study design:
None stated

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: Single page report with summary information only.
Time point:
24 h
Remarks on result:
probability of mild irritation
Remarks:
Described only as "Slightly irritating".
Irritation parameter:
iris score
Basis:
animal: 1-2
Time point:
24/48/72 h
Remarks on result:
other: No value calculated for 24/48/72h
Irritation parameter:
conjunctivae score
Basis:
animal: 1-2
Time point:
24/48/72 h
Remarks on result:
other: No value calculated for 24/48/72h
Irritation parameter:
cornea opacity score
Basis:
animal: 1-2
Time point:
24/48/72 h
Remarks on result:
other: No value calculated for 24/48/72h
Irritation parameter:
chemosis score
Basis:
animal: 1-2
Time point:
24/48/72 h
Remarks on result:
other: No value calculated for 24/48/72h
Irritant / corrosive response data:
Based upon the observation protocol employed at the time the study was run, the substance effects of slight irritation clearly do not warrant eye damage 2 classification. The data are however insufficient to exclude classification with eye damage 2.
Other effects:
Initial - moderate erythema with squealing and slight blinking.
1 hr - slight-moderate erythema of the conjunctiva, lids and nictitating membrane. Some odema of the upper palpebra conjuctiva and nictitating membrane.
24 hrs - rabbit anaemic in appearnce and smells of urine. Iris injected - cornea (anterior portion) hazy. Upper orbital and lower palpebra, nictitating membrane and anterior cornea stained.
48 hrs - only slight erythema of the conjunctiva and nictitating membrane.
Rabbit died on 6th day.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was slightly irritating to the rabbit eye in this test.
Executive summary:

Two animals were dosed with 100 microliter of test substance in the eye and observed for 7 days.

The test substance was slightly irritating to the rabbit eye in this test.