Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate

EC Number:

289-550-2

EC Name:

Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate

Cas Number:

89923-62-6

Molecular formula:

C23H19N3O6S.Na

IUPAC Name:

sodium 1-amino-9,10-dioxo-4-[(3-propanamidophenyl)amino]-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Code No.: FAT 20242/E
Batch No.: EN 1500.52
Contents of active ingredients: 100%
Validity: April 1991
Description: Solid/powder; Solubility in water: Approx. (10 g/L at 20°C, pH 7.3)
Safety precautions : Golve and face masks.
Test article received: June 2, 1986.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation:approx. 12-14 weeks old
- Weight at study initiation: 2220 to 2360 g
- Housing:The animals were housed individually in metal cages, identified with individually numbered ear tags.
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod:12 hours light cycle day.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

Distilled

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 male rabbits

Details on study design:

An area of at least 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (20cm²) bearing 0.5g 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 loosely covered with an aluminium foil (36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

- The animals were checked daily for systemic symptoms and mortality.
- The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
- The body weight was recorded at start and on days 3, 7 and 14 of the test.

SCORING SYSTEM:

Erythema and eschar formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score 4

Edema formation
- No edema 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Blue - staining (substance related)

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No edema formation was observed during an observation period of 14 days.

Other effects:

The application area was stained blue (substance-related) up to the end of the observation period. Therefore the evaluation of a possible slight erythema formation was impeded. However, a marked erythema formation was not noted and on the unstained marginal zone of the application area no erythema was recorded.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20242/E can be classified as non-irritant in albino rabbits.

Executive summary:

The test was performed on 3 male rabbits to determine the irritation or corrosive potency of FAT 20242/E. This test was concucted as per OECD Guideline 404.

A gauze patch (20 cm2) bearing 0.5 g of the test substance was applied to shaved area on the flank.

No edema formation was observed during an observation period of 14 days. The application area was stained blue (substance-related) up to the end of the observation period. Therefore the evaluation of a possible slight erythema formation was impeded. However, a marked erythema formation was not noted and on the unstained marginal zone of the application area no erythema was recorded.

Hence it can be concluded that under the experimental conditions, FAT 20242/E did not induce skin irritation when applied to the shaved albino rabbit skin.