Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate

EC Number:

275-177-2

EC Name:

Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate

Cas Number:

71077-34-4

Molecular formula:

C14H14N2O4S.Na

IUPAC Name:

sodium 4-[(3-amino-4-methylbenzoyl)amino]benzenesulfonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Strain: Chbb: NZW (SPF)
- Source: Chemical pharmaceutical factory Dr. K. Thomae 88400 Biberach
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: in fully air-conditioned rooms, separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (ad libitum) and hay (approx. 15 g/day)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Lighting time: 12 hours daily

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

0.5 g Aminotoluene sulfanilic acid Na salt pasted with 0.2 ml isotonic saline

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing: warm tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM:DRAIZE
Erythema and eschar formation 0 - 4
Oedema 0 - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 1 day

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 d

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.

Executive summary:

The substance was tested for skin irritation according to OECD guideline 404 with 3 female New Zealand rabbits.

Each animal was treated with 0.5 g of the substance pasted with 0.2 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semiocclusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.

One hour after removel of the patch the treated skin of one animal showed a very slight erythema. One day after removel of the patch the irritation was reversible.