Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

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:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

EC Number:

220-028-9

EC Name:

Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

Cas Number:

2610-11-9

Molecular formula:

C29H21N5O8S2.2Na

IUPAC Name:

disodium 7-benzamido-4-hydroxy-3-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Body weight: from 1.5 to 2 kg- Housing: individually in metal cage - Diet: NAFAG, Gossau SG, rat food ad libitum- Water: tap water ad libitum ENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 1- Humidity (%): 55 ± 5 %- Photoperiod (hrs dark / hrs light): 14 h light / 14 h dark

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

other: the untreated skin is used as a control.

Amount / concentration applied:

The tested substance was applied to each side, abraded and non abraded skin, in quantities of 0.5 g.

Duration of treatment / exposure:

24 h

Observation period:

up to 72 h

Number of animals:

six rabbits: 3 male and 3 female

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.

Any other information on results incl. tables

The results of the skin irritation test are summarized in Table 1.

Animal No. Sex	Skin Reaction	24 hrs after application		72 hrs after application
		intact skin	scarified skin	intact skin	scarified skin
1     m	Erythema	0	0	0	0
	Edema	0	0	0	0
2    m	Erythema	0	0	0	0
	Edema	0	0	0	0
3    m	Erythema	0	0	0	0
	Edema	0	0	0	0
4    f	Erythema	0	0	0	0
	Edema	0	0	0	0
5    f	Erythema	0	0	0	0
	Edema	0	0	0	0
6    f	Erythema	0	0	0	0
	Edema	0	0	0	0

The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those v/ith scores above 6 are considered severe irritants.

The primary irritation index of the tested item was 0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.Therefore the tested item is to be considered as non-irritant to the skin of rabbits.

Executive summary:

The primary irritation effect was assessed following the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under CLP classification.