N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 21 September, 1993 to 24 September, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

EC Number:

201-369-2

EC Name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Cas Number:

81-68-5

Molecular formula:

C22H18N2O5S

IUPAC Name:

N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 36034/E
- Substance type: Dye
- Physical state: Solid; dark violet powder
- Analytical purity: Approx. 93%
- Lot/batch No.: 9300102

Specific details on test material used for the study:

Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2310 to 2350 g
- Housing: The animals were housed individually in metal cages.
- Diet: Standard rabbit pellet – Nafag No. 814, Gossau, Switzerland (ad libitum)
- Water: Fresh water (ad libitum)
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C.
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

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 (volume or weight with unit): 500 mg
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 males

Details on study design:

PROCEDURE:
- An area of at least 36 cm² was shaved on both flanks of the animals approx. 24 h before treatment.
- A gauze patch (approx. 12-16 cm²) bearing 500 mg of the test substance was applied to the right flank of each animal. The skin area exposed directly to the test substance was approx. 6 cm². A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.
- The patches were loosely covered with an aluminium foil (approx. 36 cm²) 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 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure).

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

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No skin reactions were observed in any of the tested animals.

Any other information on results incl. tables

Body weights (g):

Animal no.	1	2	3
At start of test	2310	2330	2350
After 3 d (end)	2440	2440	2420

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance did not induce skin irritation.

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance (of ca. 93 % purity) in rabbits according to OECD Guideline 404 and EU method B4 in compliance with GLP. 500 mg of test substance was applied on a gauze patch (moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80) 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. No skin reaction was induced by the test substance. Under the study conditions, the test substance did not induce skin irritation in albino rabbit.