Benzophenone-3,3':4,4'-tetracarboxylic dianhydride

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: guideline study; precedes establishment of GLP. Documentation is limited.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42, Federal Hazardous Substances Act, USA

Principles of method if other than guideline:

Test material is placed in one eye of six albino rabbits, and the eyes are examined and graded for ocular irritation 24, 48 and 72 hours after administration.

GLP compliance:

no

Remarks:

preceeds establishment of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Benzophenone-3,3':4,4'-tetracarboxylic dianhydride

EC Number:

219-348-1

EC Name:

Benzophenone-3,3':4,4'-tetracarboxylic dianhydride

Cas Number:

2421-28-5

Molecular formula:

C17H6O7

IUPAC Name:

5-(1,3-dioxo-1,3-dihydro-2-benzofuran-5-carbonyl)-1,3-dihydro-2-benzofuran-1,3-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

male and female.
Individually housed in metal cages suspended above the droppings.
Food and water were available ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

3 mg applied to one eye.

Duration of treatment / exposure:

7 days.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

The untreated eye of each rabbit served as the control. Prior to application of the compound and again at the termination of the 7-day observation period, the eyes of each animal were examined with the use of 2% sodium fluorescein and a small-window ultraviolet, quartz, mercury pencil lamp. Other observations for eye irritation were made frequently on the day of application and again at 24, 48 and 72 hours, and at 4 and 7 days thereafter. Eye irritation was graded and recorded according the method of Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", 1959.
The treated eye was not washed.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h and later

Score:

0.1

Max. score:

8

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

One rabbit showed mild irritation of the exposed eye one hour after instillation of the test material. This reaction appeared normal within 24 hours.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

1,3-Isobenzofurandione, 5,5'-carbonylbis- (BTDA) was tested for eye irritation in albino rabbits, and evaluated for up to 7 days. The results indicate the substance is not irritating.