Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)

Deviations:

not specified

Principles of method if other than guideline:

Irritation potency of FAT 40062/A on the rabbit skin of both sexes observed over a period of 72 hours by treating with 0.5 g of the test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate

EC Number:

274-437-2

EC Name:

Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Cas Number:

70210-40-1

Molecular formula:

C19H15BrN4O8S2.2Na

IUPAC Name:

disodium 6-amino-5-({4-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-4-hydroxynaphthalene-2-sulfonate

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): FAT 40062/A

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Huntsman/ CIBA-GEIGY Limited
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Kept separately in V2A wire cages,
- Diet: (NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

with electric clipper

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g of test substance FAT 40062/A was applied to each side.

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6 rabbits (3 males/ 3 females)

Details on study design:

Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs,were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance (0.5 g) and immediately applied to the prepared skin. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact and scarified skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

Intact and scarified skin

Basis:

mean

Remarks:

6 rabbit

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

6 rabbit

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No adverse effects were observed after treatment.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40062/A is to be considered as non-irritant to the rabbit skin.

Executive summary:

Test was performed to evaluate irritant effects after single application of FAT 40062/A on rabbit Skin by following 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). Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the Russian breed rabbits, clipped free of hair. Six rabbits (3 males/3 females) weighing 1.5 to 2 kgs,were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages. The shaven skin on the left side was slightly scarified immediately before treatment by application of 50 % Polyethylene glycol trituration (PEG 400). A gauze patch 2.5 x 2.5 cm was soaked with the test substance (0.5g) and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index along with erythema and edema to the skin of rabbits was found to be '0'. Therefore, FAT 40062/A is to be considered as non-irritant to the skin of rabbits.