Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)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:

1974

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

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:

yes

Remarks:

Compared to today's guidelines apprasive and occlusive testing conditions have been used representing elevated testing conditions

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

274-436-7

EC Name:

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

Cas Number:

70210-39-8

Molecular formula:

C20H17BrN4O8S2.2Na

IUPAC Name:

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

Test material form:

other: Solid

Details on test material:

FAT 40063/A

Test animals

Species:

rabbit

Strain:

other: Russian Breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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:

abraded

Vehicle:

other: polyethylene glycol

Remarks:

PEG 400

Controls:

not required

Amount / concentration applied:

Before application a 50 % polyethylene glycol trituration (PEG 400) was made. FAT 40063/A was applied to each side in quantities of 0.5 g.

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

Number of animals:

6 rabbits (3 males/3 females)

Details on study design:

TEST SITE
- Area of exposure: left side of the body of rabbit
- Type of wrap if used: Gauze patch and covered with plastic film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 72 h

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact and scarified skin

Basis:

mean

Remarks:

6 animal

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 skin

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

scarified skin

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Remarks:

Scarified skin

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

edema score

Remarks:

scarified skin

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

edema score

Remarks:

scarified skin

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: within 72 h

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

edema score

Remarks:

scarified skin

Basis:

animal #5

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 13

Irritation parameter:

edema score

Remarks:

Scarified skin

Basis:

animal #6

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

positive indication of irritation

Results 14

Irritation parameter:

edema score

Remarks:

Intact and scarified skin

Basis:

mean

Remarks:

6 animal

Time point:

48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 15

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 16

Irritation parameter:

edema score

Remarks:

Scarified skin

Basis:

mean

Remarks:

6 animal

Time point:

72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The primary irritation index of FAT 40063/A was 0.7

Any other information on results incl. tables

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 h 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 with scores above 6 are considered severe irritants.

 

Individual Animal Score: Erythema

Animal Number	Intact Skin		Scarified skin
	24 h	72 h	24 h	72 h
1	0	0	0	0
2	0	0	0	0
3	0	0	0	0
4	0	0	0	0
5	0	0	0	0
6	0	0	0	0

 

Individual Animal Score: Edema

Animal Number	Intact Skin		Scarified skin
	24 h	72 h	24 h	72 h
1	1	0	2	0
2	0	0	1	0
3	1	0	2	0
4	0	0	1	0
5	1	0	2	0
6	2	0	3	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40063/A is to be considered as a mild irritant to the skin of rabbits. According to the classification and labelling according to GHS system no classification and labelling is required.

Executive summary:

The study was carried out to determine the primary-irritation index with the test substance (FAT 40063/A) on the skin of the rabbits. 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). 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 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. FAT 40063/A was applied to each side in quantities of 0.5 g. Before application, a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the evaluation scheme. 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 h on the intact and slightly scarified skin. The primary irritation index was found to be 0.7, therefore, FAT 40063/A is to be considered as a mild irritant to the skin of rabbits.