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Registration Dossier
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EC number: 253-781-7 | CAS number: 38103-06-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride
- EC Number:
- 253-781-7
- EC Name:
- 4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride
- Cas Number:
- 38103-06-9
- Molecular formula:
- C31H20O8
- IUPAC Name:
- 5,5'-[propane-2,2-diylbis(4,1-phenyleneoxy)]bis(2-benzofuran-1,3-dione)
- Details on test material:
- Biphenol Dianhydride (BPA-DA)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male and female New Zealand White rabbits, approximately 12 to 18 weeks of age, weighing 2.0 to 3.0 kg were obtained from Hazleton-Dutchland, Inc. The animals were acclimated for at least five days and individually housed in cages with wire floors. They were maintained on rabbit diet and provided water (municipal) ad libitum. Room temperature ranged from 67 °F to 70 °F and the relative humidity ranged between 48-56%. Room lights were on a 12-hour cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Six rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. The test material was placed in the conjunctival sac of the eye and the lids were held together for one second. One eye was dosed, per rabbit, with test material, while the other eye served as a control.
- Observation period (in vivo):
- Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose. Fluorescein staining was included at one day and subsequent days.
- Number of animals or in vitro replicates:
- Six
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Treatment with BPA-DA resulted in no corneal injury in any of the 6 rabbit eyes. Two rabbits developed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.
- Other effects:
- One animal was found dead on Day 6, this was not considered to be treatment-related.
Any other information on results incl. tables
Rabbit No. |
87-33761 |
87-33762 |
87-33763 |
87-33780 |
87-33781 |
87-33782 |
Mean |
|
Score/Effects at 1 Hour |
||||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
1 |
0 |
0 |
1 |
0 |
0.3 |
Conjunct: |
Redness |
1 |
1 |
1 |
1 |
1 |
1 |
1.0 |
Chemosis |
1 |
1 |
1 |
1 |
1 |
0 |
0.8 |
|
Discharge |
3 |
2 |
2 |
1 |
1 |
1 |
1.7 |
|
Score/Effects at 24 Hours |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Score/Effects at 48 Hours |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Score/Effects at 72 Hours |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Score/Effects at 7 Days |
Mean |
|||||||
Cornea: |
Opacity |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
Area |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Iris: |
Inflam. |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
Conjunct: |
Redness |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
Chemosis |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Discharge |
0 |
0 |
0 |
- |
0 |
0 |
0.0 |
|
Other Effects: Rabbit 33780 found dead on Day 6 from unknown causes (probably not dose-related). |
||||||||
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the test material caused minor ocular irritancy overall and requires no classification in accordance with EU criteria.
- Executive summary:
The eye irritation potential of the test material was investigated in accordance with the US EPA TSCA Health Effects Test Guidelines under GLP conditions (Bushy Run Research Center, 1988).
Six New Zealand White rabbits were dosed with 0.1 mL (equivalent to 60 mg) of test material per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours and at 7 days post-dose.
Treatment resulted in no corneal injury in any of the 6 rabbit eyes. At the 1 hour observation two rabbits displayed iritis in the treated eye and all six rabbits displayed minor conjunctival irritation, with minor to moderate discharge. All six treated eyes were healed after 24 hours.
Under the conditions of this study, the test material is considered to be a non-irritant.
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