Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Biphenol Dianhydride (BPA-DA)

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.