Registration Dossier
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EC number: 412-830-4 | CAS number: 1823-59-2 ODPA
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-oxydiphthalic anhydride
- EC Number:
- 412-830-4
- EC Name:
- 4,4'-oxydiphthalic anhydride
- Cas Number:
- 1823-59-2
- Molecular formula:
- C16H6O7
- IUPAC Name:
- 5-[(1,3-dioxo-1,3-dihydro-2-benzofuran-5-yl)oxy]-1,3-dihydro-2-benzofuran-1,3-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Nature of substance: powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 100 mg
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.6
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.6
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- The following observations were made after 1h in one or more animals:
- Conjunctival redness (score of 1 or 2)
- Chemosis (score of 1)
- Iris effects (score of 1)
The following observations were made after 24 and 48h in one or more animals:
- Discharge
All effects were fully reversible within 3 days.
Any other information on results incl. tables
In the second test, maximum scores of 1 were recorded for conjunctival redness and other eye effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not classifed.
- Executive summary:
In a test according to EU Method B.5, the test item was found to cause some eye irritation effects that were visible at the inspection 1h after administration. These effects were fully reversible after 1 day. During the observations at 24h and 48h, discharge was observed. All effects were fully reversible within 3 days.
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