Sodium 2,5-dichloro-4-[4-[[2-[(ethylphenylamino)sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate

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:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12th May, 1981

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 061 - Similar Substance 01

IUPAC Name:

Acid Yellow 061 - Similar Substance 01

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder Interfauna U.K. Ltd.
- Age at study initiation: adult, age not specified.
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: animals were maintained in individual wire cages type III.
- Diet: standard diet "ssniff K 4", ad libitum.
- Water: ad libitum.
- Health status: animals were routinely inspected for health status. The animal facilities were disinfected by Zephirol (1% in water), twice a week. About 1 day before the administration, the rabbits were examined in order to assess the suitability for use.
- Quarantine: 14 days in testing laboratories.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Relative humidity: 45 - 65 %
- Air changes: ca 10 per hr.
- Photoperiod: 12 hrs dark / hrs light.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

500 mg in water

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

Three rabbits

Details on study design:

TEST SITE
- Area of exposure: the day of the exposure, the skin rabbits was clipped on the flanks.. The shaven skin involves an area of ca 6 x 6 cm.
- Type of wrap if used: hypoallergenic gauze measuring ca 6 cm2, fixed by elastic adhesive bandage.

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

SCORING SYSTEM
Skin reacrions have been scored according to the Draize scale.

Evaluation of skin reactions
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Any other information on results incl. tables

Individual reaction

Animal N.	Effect	Reaction after
		1 h	24 hrs	48 hrs	72 hrs	7 d
T92	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
T83	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0
T75	Erythema	0	0	0	0	0
	Oedema	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

The study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines No. 404.

A single 4-hour semi-occluded application (0.5 g in water) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48, 72 hours and at 7 days after administration.

Skin reactions were recorded in none of the treated animals.

Conclusion

The mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.