Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 6, 1984 to August 13, 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

EC Number:

251-257-2

EC Name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Cas Number:

32846-21-2

Molecular formula:

C23H26N4O6S2.Na

IUPAC Name:

sodium 6-amino-5-({2-[cyclohexyl(methyl)sulfamoyl]phenyl}diazenyl)-4-hydroxynaphthalene-2-sulfonate

Test material form:

other: solid

Specific details on test material used for the study:

Test substance: FAT 20003/G
Batch No.: EN 200106.49
Purity: 80.5 %
Physical properties: Solid
Stability: stable at room temperature
Validity: guaranteed by the sponsor until June 1989
Safety precautions: gloves and face masks
Test material received: July 5, 1984

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages
- Diet: Nafag, no. 814, Gossau Switzerland; ad libitum
- Water: Fresh water; ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral flank

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg
- Concentration: Undiluted

Duration of treatment / exposure:

4 h

Observation period:

7 d

Number of animals:

3 males

Details on study design:

PROCEDURE:
-An area of about 6 cm2 was shaved on both flanks of the animals approx. 24 h before treatment. A gauze patch bearing 500 mg of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water.
-The patches were covered with an occlusive membrane and held in place for 4 h by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 h after removing the gauze patches.

SCORING SYSTEM:
Dermal irritation was graded in each animal according to the following scoring scale:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth).

- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Test substance induced intensive red staining of the skin, which impeded the erythema evaluation of the first 3 d. No erythema was observed when the staining was reduced.

Irritant / corrosive response data:

Test substance induced intensive red staining of the skin, which impeded the erythema evaluation of the first 3 d. No erythema was observed when the staining was reduced. No edema was induced by test substance.

Other effects:

not observed / nothing reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance did not induce skin irritation when applied to clipped albino rabbit skin.

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance (at ca. 80.5 % purity) in New Zealand white rabbits according to OECD Guideline 404.

 

In this study, 500 mg of the test substance was applied on a gauze patch (i.e., moistened with distilled water) which was then applied to the shaved skin of rabbits for 4 h under occlusive conditions. A control gauze patch was applied to the contra lateral flank. After the 4 h of application period, the gauze patches were removed and the application sites were assessed for oedema and erythema at 1, 24, 48, 72 h and up to 7 d.

The test substance induced intensive red staining of the skin, which impeded the erythema evaluation of the first 3 d. No erythema was observed when the staining was reduced. No edema was induced by the test substance.

 

Under the study conditions, the test substance did not induce skin irritation when applied to clipped albino rabbit skin.