4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide

EC Number:

257-821-4

EC Name:

4-amino-2,5-dimethoxy-N-phenylbenzenesulphonamide

Cas Number:

52298-44-9

Molecular formula:

C14H16N2O4S

IUPAC Name:

4-amino-2,5-dimethoxy-N-phenylbenzene-1-sulfonamide

Details on test material:

- Name of test material (as cited in study report): Chinonbasesulfanilid TTRG 9

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: single cage
- Diet: Altromin 2123 Haltungsdiät-Kaninchen, ad libitum plus hay about 15 g/day
- Water: deionized, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

500 mg test substance mixed with 0.5 ml 0.9% NaCl-solution

Duration of treatment / exposure:

4 hours - at the end of the exposure time, remainig test substance was removed by rinsing with lukewarm tap water

Observation period:

72 hours after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: adhesive plaster with cellulose layer covered by a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm tap water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: initial slight reaction of one animal is fully reversible within 24 h. The other animals showed no signs of irritation at any time

Results 2

Irritation parameter:

edema score

Basis:

animal: # 1, 2, 3 each

Time point:

other: mean of 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Other effects:

No other effects reported.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.

Executive summary:

Chinonbasesulfanilid TTRG 9 was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol

500 mg of the test substance mixed with 0.5 ml of 0.9 % NaCl-solution were applied to the shaved skin of 3 New Zealands White rabbits. After 4 h exposure time the semiocclusive patch was removed. Residual test substance was removed with lukewarm tap water. Animals were examined for signs of skin irritation and/or corrosion at 30-60 min, 24, 48, and 72 h after patch removal. Mean scores (mean of 24, 48, and 72h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.