Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study completion date - 14 August 1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

EC Number:

264-129-6

EC Name:

Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

Cas Number:

63405-85-6

Molecular formula:

C20H18N4O5S.Na

IUPAC Name:

sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Name: FAT 20004/D
Purity: 61 %

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG Gossau SG
- Water: water ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1°C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hours light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

Up to 7 d

Number of animals:

six animals (Three males and three females)

Details on study design:

TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

Score for skin irritation in rabbits
Erythema and eschar formation
No erythema............................................................ 0
Very slight erythema (barely perceptible).................... 1
Well defined erythema.............................................. 2
Moderate to severe erythema.................................... 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ........4
Total possible erythema score 4

Edema formation
No edema................................................................ 0
Very slight edema (barely perceptible)........................ 1
Slight edema (edges of area well defined by definite raising)..... 2
Moderate edema (raised approximately 1 mm)........................ 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) ........4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal:

Remarks:

mean of six animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

animal:

Remarks:

mean of six animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal:

Remarks:

mean of six animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

animal:

Remarks:

mean of six animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Calculation of the primary skin irritation index:

The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.

 

Time after exposure h	mean reaction score of 6 rabbits
	erythema		edema
	intact skin	abraded skin	intact skin	abraded skin
24	0	0	0	0
72	0	0	0	0
subtotal	0	0	0	0
total	0        +       0      +        0      +          0    =     0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.

Executive summary:

A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24-hours exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.