Isophthaloyl dichloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 hours

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Department of Transportation, Hazardous Material Regulations, Title 49 CFR, Section 173.240(a)(1), December 31, 1973

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Isophthaloyl dichloride

EC Number:

202-774-7

EC Name:

Isophthaloyl dichloride

Cas Number:

99-63-8

Molecular formula:

C8H4Cl2O2

IUPAC Name:

benzene-1,3-dicarbonyl dichloride

Details on test material:

- Name of test material (as cited in study report): Isophthaloyl Chloride.
- Other name: Meta-phthalic acid, dichloride.
- Physical state: Crystals ground in mortar before applying.
- Analytical purity: 99+%

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: FDA-type stocks.

Test system

Type of coverage:

other: applied to skin under gauze pad.

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 grams of the test substance was applied under 1.5 by 1.5 inch (14.5 cm2), 12-ply cotton gauze pads and the trunk of each rabbit was then loosely wrapped with rubber sheeting. The overall dose that was applied equated to 34.5 mg/cm2)

Duration of treatment / exposure:

4 hours

Observation period:

4, 24, and 48 hours

Number of animals:

6

Details on study design:

Animals were placed in an FDA-type stock. The test substance was applied to the clipped skin on the animal's back and covered with cotton gauze loosely wrapped with rubber sheeting. After 4 hrs, the rabbits were removed from the stocks, the wrappings were removed and skin reactions were evaluated. The test sites were then washed. Readings were again made at 24 and 48 hours after the initial application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: all animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Remarks:

irritation read only at 24 and 48 hours

Results 2

Irritation parameter:

edema score

Basis:

other: all animals

Time point:

24/48/72 h

Remarks on result:

other: not reported

Irritant / corrosive response data:

0/6 rabbits exhibited skin corrosion.

Other effects:

N/A

Any other information on results incl. tables

0/6 of the rabbits exhibited skin corrosion after 4, 24, and 48 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was deemed not corrosive based on the requirements of the Department of Transportation, Hazardous Material Regulations, Title 49 CFR, Section 173.240(a)(1), December 31, 1973.

Executive summary:

The test substance was applied at a dosage of 34.5 mg/cm²to the shaved skin of six Albino rabbits. The test substance was applied to the clipped skin on the animal's back and covered with cotton gauze loosely wrapped with rubber sheeting. After 4 hrs, the rabbits were removed from the stocks, the wrappings were removed and skin reactions were evaluated. The test sites were then washed. Readings were again made at 24 and 48 hours after the initial application. None of the rabbits exhibited skin corrosion after 4, 24, and 48 hours.