Disodium 4-[(2-amino-4-hydroxyphenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate, mono[(p-nitrophenyl)azo] mono[(2-hydroxy-3,5-dinitrophenyl)azo] derivative

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:

March, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

study conducted on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.

Justification for type of information:

The read across justification is detailed in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: REAL DECRETO 363/1995, 10 march

Version / remarks:

1995

GLP compliance:

not specified

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: authorised supplier
- Weight at study initiation: 2033-2113 g
- Housing: Stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water: filtered tap water (5 µm) , ad libitum
- Acclimation period: 7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature: 21± 2 °C
- Humidity: 55 ± 25 %
- Air changes: 15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied:0.5 g

Duration of treatment / exposure:

4 hours of treatment

Observation period:

1, 24, 48 ,72 hours and 7 and 14 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal column area near the spine, forming a rectangle 20 cm x 13 cm
- area / coverage: 6 x 6 cm
- Type of wrap if used: simple bandage and covered in turn with a light hypoallergenic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing : yes

SCORING SYSTEM: erithema and edema (equivalent to OECD 404)

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

Edema formation
0 - No edema
1 - Very slight edema (barely perceptible)
2 - Slight edema (edges of area well defined by definite raising)
3 - Moderate edema (raised approximately 1 mm)
4 - Severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

 Table 1: erythema and oedema scores

Animal	Time	Erythema	Oedema
animal #1	1 hour	2	0
	24 hours	2	0
	48 hours	2	0
	72 hours	1	0
animal #2	1 hour	1	0
	24 hours	1	0
	48 hours	1	0
	72 hours	0	0
animal #3	1 hour	1	0
	24 hours	1	0
	48 hours	1	0
	72 hours	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No. 1272/2008

Conclusions:

The test item was found to be not irritating to rabbit skin.

Executive summary:

The skin irritation potential of the test item was evaluated in an in vivo experimental study, according to a method similar to the OECD Guideline 404. The test item was applied to the shaved dorsal region of 3 male New Zealand White rabbits for a duration of 4 hours with an occlusive bandage, after which the bandage was removed and skin was evaluated for erythema and oedema after 1, 24, 48 and 72 hours, and 7 and 14 days.

The mean (24/48/72 hours) erythema scores for each animal were 1.67 (animal #1) and 0.67 (animals #2 and #3); the mean (24/48/72 hours) oedema scores were were 0 in all animals. The effects observed were fully reversible within 7 days.