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Toxicological information

Skin irritation / corrosion

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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:
other: Department of Transportation, Hazardous Material Regulations, Title 49 CFR, Section 173.240(a)(1), December 31, 1973
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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.