Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-11-09 to 1982-11-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

EC Number:

273-402-9

EC Name:

Sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

Cas Number:

68959-19-3

Molecular formula:

C17H16Cl2N4O5S2.Na

IUPAC Name:

sodium 2-[[[2,5-dichloro-4-[(2-methyl-1H-indol-3-yl)azo]phenyl]sulphonyl]amino]ethanesulphonate

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: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: average: 2.5 kg
- Housing: individually in cages
- Diet (e.g. ad libitum): diet “mümmel z" (ssniff / Soest); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

test item moistened with water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg

Duration of treatment / exposure:

4 hours

Observation period:

8 days, irritation scores were obtained 1, 24, 48, 72 hours and 8 days after treatment

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm² (2.5 x 2.5 cm)
- Type of wrap if used: Surgical gauze covered with test item were fixed with band-aid (Leukoflex), covered with a surrounding of a thin sheet of cellulose and afterwards the whole trunk were wrapped with an elastique bandage (Eloflex).

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

OBSERVATION TIME POINTS
- 1, 24, 48, 72 hours and after 8 days

SCORING SYSTEM:
- Method of calculation: Draize (see Table 1 in box "Any other information on materials and methods incl. tables")

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Max. score:

4

Remarks on result:

not determinable

Remarks:

Erythema could not be assessed as the skin was stained by the test material

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation were observed. The erythema score could not be determined due to test material related colouring of the skin. For individual results please refer to Table 2 in box "Any other information on results incl. tables".

Other effects:

No skin irritation/erythema observed under the staining layer on the skin.

Any other information on results incl. tables

Table 2: Individual Skin Irritation Scores

	24 hours		48 hours		72 hours		Mean
Animal no.	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	*	0	*	0	*	0	-	0
2	*	0	*	0	*	0	-	0
3	*	0	*	0	*	0	-	0

* not determinable due to substance-induced staining of skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this acute dermal irritation/corrosion study, conducted according to OECD 404, the test item can be considered as non-irritating to the skin.

Executive summary:

In a primary dermal irritation study (OECD 404), three New Zealand White rabbits were dermally exposed to 0.5 g of the test item for 4 hours to an area of exposure of 2.5 x 2.5 cm under semi-occlusive conditions. Animals then were observed for 8 days. Irritation was scored by the method of Draize. No signs of irritation have been recorded at any of the observation points (1, 24, 48 and 72 h and 8 days). Based on the results, the test item can be considered as not dermal irritating.