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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

equivalent or similar to guideline

Guideline:

other: 16 CFR 1500.41, Federal Hazardous Substances Act, USA

Deviations:

no

Principles of method if other than guideline:

Dermal exposure to intact and abraded skin of rabbits under occlusive patch for 24 hours, with an observation period of 72 hours after application.

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

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

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

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded

Vehicle:

other: 25% ethanol

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 hour exposure

Observation period:

72 hours after administration of material

Number of animals:

6 each, abraded and intact skin

Details on study design:

The skin of each rabbit was prepared for treatment by prior close clipping of the hair with an electric clipper. The skin of rabbits in one of the two groups was abraded by producing shallow incisions with a scalpel blade over an area of skin measuring one inch by one inch.
The paste was applied to a rubber dental dam and placed in contact with the prepared abdominal skin of each rabbit. Adhesive tape was placed over the dental dam and the entire abdomen was wrapped with an elastic bandage to insure constant contact of the compound for a 24-hour period.
At the end of the 24 hour period of drug contact, and at 48 and 72 hours, the bandages were removed and the skin reactions were graded.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24

Score:

0

Max. score:

8

Remarks on result:

other: Duration of exposure was 24 hours.

Irritant / corrosive response data:

BTDA did not produce any irritating properties when applied to the skin of rabbits.

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 skin irritation in the intact and abraded skin of albino rabbits, under occlusive conditions, for 24 hours. The results indicate the substance is not irritating.