Sodium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Details on the read across are reported in section 13. Source study has reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 049 acid

IUPAC Name:

Acid Yellow 049 acid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Spolkem chovatelů z Hradce Králové.
- Weight at study initiation: 2.5 kg.
- Housing: housed individually in metal cages.
- Diet: pelleted standard commercially manufactured compound KO-16, supplied by s.p. Velaz Prague.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: scarified and intact shaved skin

Vehicle:

water

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Application: as aqueous paste.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Three rabbits

Details on study design:

TEST SITE
- Area of exposure: a day before the application, experimental rabbits were depilated on the left and right lateral surface (area 6 × 6) of the abdominal area; the skin of the right side was scarified.
- Type of wrap if used: gauze was covered by aluminum foil and cellulose wadding. Bandage was fixed by technical tape.

OBSERVATION TIME POINTS
Dermatological skin diagnostics was perfromed focusing on the symptoms of erythema, edema at 4, 24, 48 and 72 hours. The degree of erythema was diagnosed by visual check and palpation. Additional clinical examination was carried out at 24, 48 and 72 hours.

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

Reversibility:

fully reversible within: 24 hrs

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Reversibility:

fully reversible within: 24 hrs

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Animal no.	Reaction	After 4 hrs		After 24 hrs		After 48 hrs		After 72 hrs
		Intact skin	Scarified skin	Intact skin	Scarified skin	Intact skin	Scarified skin	Intact skin	Scarified skin
22	Erythema	0	0	0	0	0	0	0	0
28	Erythema	0	1	0	0	0	0	0	0
29	Erythema	0	0	0	0	0	0	0	0
22	Oedema	0	1	0	0	0	0	0	0
28	Oedema	0	0	0	0	0	0	0	0
29	Oedema	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritating to rabbit skin.

Executive summary:

Method

The skin irritation potential of the substance was determined following OECD guideline 404. 0.5 g of test substance were placed on both intact and scarified skin, as aqueous paste. Three rabbits were used.

After 24 hours of exposure the bendage was removed and the reactions scored.

Result

The primary irritation score was 0.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema and oedema reactions (in both intact and scarified skin).