Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov/Dec 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1980

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

274-675-7

EC Name:

Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

70571-81-2

Molecular formula:

C22H17N3O6S.Na

IUPAC Name:

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

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill Ltd, Huntingdon, UK
- Age at study initiation: no data
- Weight at study initiation: 2.8 to 3.1 kg
- Housing: single
- Diet (e.g. ad libitum): ssniff K ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours; 7 and 14 days

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- % coverage: full
- Type of wrap if used: covered with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

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:

no indication of irritation

Remarks:

Due to the staining of the test material detection of reddening was temporarily difficult; at 1 h no erythema value was derived in all animals, at 24 h in one animal. However, as the other two animals did not show any reddening, this was assumed to also be true for the third animal

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 irritation

Other effects:

reversible staining of the skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.

Executive summary:

A sample of the test item was tested in three female New Zealand White rabbits for acute dermal irritating properties according to OECD guideline 404. The dermal exposure period was 4 hours under semi-occlusive conditions. The test item did not cause any skin effects. Thus, under the conditions of this study, the test item can be considered as non-irritating.