Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" - US Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

EC Number:

222-111-5

EC Name:

Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

Cas Number:

3351-05-1

Molecular formula:

C32H23N5O6S2.2Na

IUPAC Name:

disodium 8-(phenylamino)-5-[(1E)-2-{4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]naphthalen-1-yl}diazen-1-yl]naphthalene-1-sulfonate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (± 1°) and a relative humidityof 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

water

Controls:

other: intact skin was used as control

Amount / concentration applied:

Test solution: 10 g of the test compound in 10 ml of water0.75 ml of the test solution was applied to each test site on a 2.5 square cm gauze pad.

Duration of treatment / exposure:

24 h

Observation period:

up to 14 days

Number of animals:

6 (3 males; 3 females)

Details on study design:

Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% ofthe total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before theapplication of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions weresufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.10g. of the test compound was mixed with 10 ml of water to make solution of 15 ml., 0.75 ml of which was applied to each testsite on a 2.5 cm. square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Cohan" self adhesive bandage in order to retain the test substance in close contace with the skin.After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema.A further assessment was made at 72 hours and for any further period considered necessary up to 14 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact

Basis:

mean

Time point:

other: 24h

Score:

ca. 1.17

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Remarks:

Abraded

Basis:

mean

Time point:

other: 24 h

Score:

ca. 1.5

Reversibility:

other: 3 fully reversible within 72 hours

Results 3

Irritation parameter:

edema score

Remarks:

Intact

Basis:

mean

Time point:

other: 24 h

Score:

ca. 2.67

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Remarks:

Abraded

Basis:

mean

Time point:

other: 24

Score:

ca. 3

Reversibility:

other: 4 fully reversible within 72 hours

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Results 7

Irritation parameter:

erythema score

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 2.29.

Any other information on results incl. tables

Erythema formation

No/sex	Intact		Abraded
	24 hours	72 hours	24 hours	72 hours
11 male	1	0	1	0
13	1	0	2	0
15	1	0	2	1
12 female	2	0	2	0
14	1	0	1	1
16	1	0	1	0
Mean	1.17	0	1.5	0.33

Edema Formation

No/sex	Intact		Abraded
	24 hours	72 hours	24 hours	72 hours
11 male	3	0	3	0
13	3	0	3	0
15	2	0	3	2
12 female	3	0	3	0
14	3	0	3	1
16	2	0	3	0
Mean	2.67	0	3	0.5

Total: 9.17

Primary irritation index: 2.29

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

non-irritant to the skin

Executive summary:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 1.17 for Erythema and 2.67 for Edema based on US Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

Therefore the tested item is to be considered as non-irritant to the skin of rabbits.