[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Principles of method if other than guideline:

In order to evaluate the primary skin irritation of the substance, a single dose was tested on the skin of six rabbits. 0.5 g of test substance was applied to intact and wound skin of each animal using a 25 cm^2 sticking plaster. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of diazotised Sodium Picramate coupled with Resorcinol, subsequently coupled with diazotised 4'-Amino-4-Nitrodiphenylamin-2-Sulfonic Acid, at the end metallized with Iron (II) sulphate heptahydrate, sodium and ammonium salts

EC Number:

946-788-8

Molecular formula:

not available being an UVCB substance

IUPAC Name:

Reaction products of diazotised Sodium Picramate coupled with Resorcinol, subsequently coupled with diazotised 4'-Amino-4-Nitrodiphenylamin-2-Sulfonic Acid, at the end metallized with Iron (II) sulphate heptahydrate, sodium and ammonium salts

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5 g

Observation period:

24 and 72 h

Number of animals:

6

Details on study design:

TEST SYSTEM
-Test site: intact and wound skin
-Type of wrap: 25 cm^2 sticking plaster

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all animals (6/6)

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal: all animals (6/6)

Time point:

24/48/72 h

Score:

0

Any other information on results incl. tables

As the observations time were only at 24 and 72 h, for mean calculations of 24/48/72 h it was used the worst case approach using the higher score at 48 h.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

The test substance was found to be non irritant when applied to intact rabbit skin.

Executive summary:

The skin irritation test was performed to rabbit skin according to an internal method: a single dose was tested on the skin of six rabbits. 0.5 g of test substance was applied to intact and wound skin of each animal using a 25 cm² sticking plaster. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours. The erythema and the oedema scores were calculated following the mean values after 24/48/72 h. For the scores at 48 h the greater value observed during the test was considered, as no observation was performed at this time-point. The erythema and oedema scores (mean values 24/48/72 hours) were 0 in all animals.