Registration Dossier
Registration Dossier
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EC number: 202-860-4 | CAS number: 100-52-7
Eye irritation
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:
- 1 979
- 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
- 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
Constituent 1
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.
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