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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 d
Score:
0
Max. score:
4
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.