Tetrasodium 4-[[3,5-bis[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]-2,4(or 2,6)-dihydroxyphenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000, March

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Real Decree 363/1995 and Real Decree 1078/93

Principles of method if other than guideline:

Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation

GLP compliance:

no

Remarks:

Centre Certificated ISO 9001 by National Accreditation Programme (certificate N. 98 - 1101)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 4-[[3,5-bis[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]-2,4(or 2,6)-dihydroxyphenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate

EC Number:

304-762-8

EC Name:

Tetrasodium 4-[[3,5-bis[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]-2,4(or 2,6)-dihydroxyphenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate

Cas Number:

94279-16-0

Molecular formula:

C40H24N10Na4O19S4

IUPAC Name:

tetrasodium 4-[(1E)-2-{2,6-dihydroxy-3,5-bis[(1E)-2-{4-[(4-nitro-2-sulfonatophenyl)amino]phenyl}diazen-1-yl]phenyl}diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: authorized provider
- Weight: from 2.012 to 2.113 g
- Housing: inoxidable steel individual cage, Techiplast. Rabbit were maintained in cages for the total duration of the test
- Diet: daily 150 g of special fodder for experimental rabbit, by authorized provider
- Water: ad libitum, treated and filtrated
- Marking: tatoo on the upper side of ear
- Acclimatation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes: 15 prefiltered air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 regulated by timer

USED GENERAL MATERIALS:
Balance: COBOS D 6000-SX
Vinyl/latex gloves mono-used
Syringes: 1 mL of volume
Shaver: electric AESCULAP mod. Favorita II
Gauzes dressing: Melolin or equivalent authorized
Adhesive bandage
Bandage: hypoalergenic adhesive Fixomull Seretch or equivalent authorized

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
Amount applied: 0.5 g of solid substance humidified with water for assuring a good contact to the skin

Duration of treatment / exposure:

4 hours

Observation period:

Observation at: 1, 24, 48 and 72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area shaved: retro-scapular side in the area around the vertebral column (20 cm of length and 13 cm of height).
- Area of exposure: 6 cm^2
- Type of wrap if used: gauzed dressing closed by adhesive bandage, covered with adhesive hypoalergenic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: water or specific solvent

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema 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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

If reactions are not reversible until 72h, it could be necessary an observation period of a maximum 14 days

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.44

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

Observation: in rabbits 1 and 2, at 72 h lesions were fully reversible, while rabbit 3 does not show any irritating effects.

Any other information on results incl. tables

Erythema and edema

Time of observation		Rabbit 1		Rabbit 2		Rabbit 3
		Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
	1h	1	1	1	1	0	0
	24h	1	1	1	0	0	0
	48h	1	1	1	0	0	0
	72h	0	0	0	0	0	0

Media erythema: 0.44

Media edema: 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not skin irritant

Executive summary:

The susbtance was tested for skin irritation according to the Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation

All lesions observed were all completely reversible maximum in 72 hours and one animal does not show any irritating effects. The tested substance is not considered as skin irritant.