4-[(4-ethoxyphenyl)amino]-N,N-dimethyl-3-nitrobenzenesulphonamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted on a similar substance. The complete justification for the read across is attached at section 13.

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01

IUPAC Name:

Similar substance 01

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: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3 °C
- Humidity (%): 30-70
- Air changes (per hr): 12 hours light/day
- Photoperiod (hrs dark / hrs light): approximately 15 air changes/h

Test system

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 6 sq. cm

SCORING SYSTEM: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme (DRAIZE),

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 19, 21

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal: 19, 21

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal: 20

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

edema score

Basis:

animal: 20

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 24 h

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation

Conclusions:

The substance showed to be not irritant and not corrosive .

Executive summary:

The skin irritation study was conducted in rabbits according to OECD guideline 404.

Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm, by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape. The substance was water moistened before application. Exposure duration was 4 hours. After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme (Draize scoring system).

Under the conditions of the present experiment the substance was found to be not irritating when applied to the rabbit skin according to the CLP Regulation (EC n. 1272/2008).