Sodium 6-amino-4-hydroxy-5-[[2-(phenylsulphonyl)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:

1979

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations" Title 16 , Sections 1500.41"

Principles of method if other than guideline:

0.5 g of the test item were applied to clipped and abraded skin of 6 rabbits. The duration of the application was 24 hours and the readings were performed after 1 and 48 hours and 7 days.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acid Red 042

IUPAC Name:

Acid Red 042

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Weight at study initiation: between 2 .5 kg and 3 .5 kg
-Housing: individual cages measuring 540 X 360 X 315 mm or in restraining devices which allow the back of the animal to be treated.
-Diet: 200 g of food is provided per animal per day in the form of granules (Granulés Lapin "entretien" SANDERS)
-Water: ad libitum

ENVIRONMENTAL CONDITIONS
-Temperature: 22 °C ± 2 °C
-Humidity: 55 % ± 20 %
-Air changes: 12 change per hour

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount: 0.5 g per area and animal

Duration of treatment / exposure:

24 hours

Observation period:

1, 48 hours and 7 days

Number of animals:

Six male rabbits

Details on study design:

TEST SITE
- Area of exposure:
clipped: 14 cm x 14 cm
abraded: the right flank is scarified with a sterile scalpel blade, making three parallel superficial incisions 2 cm long and 0.5 cm apart .
- % coverage: 2 cm²
- Type of wrap if used: gauze pad consisting of sterile, hydrophilic gauze of four layers. The material to be tested and the gauze pads are kept in contact with the skin by a patch (NEODERMOTEST ROC) consisting of a central, circular disc of 22 mm diameter with a surrounding, adhesive, hypoallergenic, perforated plaster 10 mm wide. An adhesive tape 6 cm wide is wound around the animal to complete the fixing of the patches .

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
yes, surplus material which had not penetrated the skin was removed with a sterile gauze soaked in warm water.
- Time after start of exposure: 24 hours

SCORING SYSTEM
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
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

Basis:

animal: #1, #3, #4, #5

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: clipped skin

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: clipped skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: clipped skin

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5 ,#6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: clipped skin

Other effects:

The purple colour of the test substance made the macroscopic examination of the erythema inaccurate. Reading was made 1 hour later, after removing the surplus material, but remains more or less imprecise.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The substance was found to be not irritating for rabbit skin.

Executive summary:

The skin irritation test was performed to rabbit skin according to the Code of Federal Regulations" Title 16, Sections 1500.41". 0.5 g of the test item were applied to clipped and abraded skin of 6 rabbits. The duration of the application was 24 hours and the readings were performed after 1 and 48 hours and 7 days.

The purple colour of the test substance made the macroscopic examination of the erythema inaccurate at 1 hour-observation. The erythema and the oedema scores were calculated following the mean values after 24/48/72 h. For the scores at 48 h the greater value observed during the test was considered, as no observation was performed at this time-point. The erythema scores (mean values 24/48/72 hours) were 0.67 in four animals (animals #1,#3, #4 and #5), 1.33 in animal #2 and 0 in animal #6. The oedema scores (mean values 24/48/72 hours) were 0 in all animals.