Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate

EC Number:

412-960-1

EC Name:

Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate

Cas Number:

148878-21-1

Molecular formula:

Hill formula: C54H31Cl2N14Na8O26S8 CAS formula: C54H38Cl2N14O26S8.xNa

IUPAC Name:

2-[(4-chloro-6-{[(3-{[4-chloro-6-({6-[2-(1,5-disulfonaphthalen-2-yl)diazen-1-yl]-5-hydroxy-1,7-disulfonaphthalen-2-yl}amino)-1,3,5-triazin-2-yl]amino}phenyl)methyl](methyl)amino}-1,3,5-triazin-2-yl)amino]-6-[2-(1,5-disulfonaphthalen-2-yl)diazen-1-yl]-5-hydroxynaphthalene-1,7-disulfonic acid octasodium hydride

Test material form:

solid: particulate/powder

Details on test material:

Tes item name in report: S156745

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield farms, UK limited
- Age at study initiation: young and adult
- Weight at study initiation: 2974-3895 g
- Housing: The rabbits were housed individually in aluminium sheet cages (65.2 cm × 68.9 cm × 45.7 cm)
- Acclimation period: 6 d prior to test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: The test substance was moistened with bi-distilled water before application.

Amount / concentration applied:

0.5 g /animal

Duration of treatment / exposure:

4 h

Observation period:

upto 4 d

Number of animals:

Three females

Details on study design:

TEST SITE
- Area of exposure: left flank of the test animals
- Type of wrap if used: treated area covered with piece of surgical quaze which was secured by two crossed strips of surgical tape. This was covered by piece of impermeable rubber sheet wrapped around the trunk of the animal and secured with adhesive impermeable polyethylene tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed with absorbant cotton swabs soaked in warm water to remove the residual amount of test susbtance.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS: 4 d
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation: The Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Any other information on results incl. tables

Pathological data:

Animal number		Histopathological finding
		Hyperkeratosis	Parakeratosis/surface debris	Acanthosis	Inflamatory cell infiltration	oedema	Hair folicle loss	Subepithelial fibrosis
4	C	0	0	0	1 F	0	0	0	DHP
4	T	0	0	1 D	2 M-F	0	0	0	DHP
5	C	0	0	1 D	1 M-F	0	0	0	SHP
5	T	0	0	1 D	2 M-F	0	0	0	SHP
6	C	0	0	0	0	0	0	0	SHP
6	T	0	0	1 D	0	0	0	0	SHP

C= control, T=test, DHP=dense hair pattern, SHP=sparse hair pattern, F= Focal, M-F=Multifocal, D=Diffuse 0=No reaction, 1=Minimal reaction, 2=Slight reaction, 3=Moderate reaction, 4=Marked reaction, 5=Sever reaction

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was not irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation potential of the substance according to a method similar to OECD Guideline 404, in compliance with GLP. The primary skin irritation potential of the test substance was investigated by topical application of 0.5 g to 2.5 cm x 2.5 cm of intact dorsal skin of three young New Zealand White rabbits. The duration of the treatment was 4 h. The scoring of skin reactions was performed at 1, 24, 48, 72 and 96 h after removal of the dressing. The scores of each animal at 24, 48 and 72 h were used in calculating the respective mean values for each type of lesion. The test substance caused red staining of the treated skin and obscured the assessment of erythema. Mean edema scores were calculated for each animal by adding together the oedema score at 1, 2 and 3 d readings and dividing the total by three which is 0.0. Mean erythema score could not be calculated, since the staining obscured the assessment of erythema. There were no other visible signs of irritation seen any animal. Histopathological examination revealed a slight inflammatory reaction in two of the test sites. Under the study conditions, the substance was not irritating to rabbit skin (Robinson, 1994).