Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test was performed according to internationally accepted testing guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

EC Number:

274-434-6

EC Name:

Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

Cas Number:

70210-37-6

Molecular formula:

C30H21N3O9S2.2Na

IUPAC Name:

disodium (E)-5-benzamido-4-hydroxy-3-((2-(otolyloxy)phenyl)diazenyl)naphthalene-2,7-disulfonate

Test animals

Species:

rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: from 1.4 to 2.3 kg
- Housing: metal cages
- Diet and water: fed with standard diet of Nafag and drinking water ad libitum
- Acclimation period: the animals were acclimatized to the environment in laboratories for at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount of 0.5 g of test substance were applied

Duration of treatment / exposure:

The gauze patches were removed 24 hours after application

Observation period:

The reaction of the skin was appraised upon removal during an observation period of 8 days

Number of animals:

6 (3 males and 3 females) rabbits

Details on study design:

TEST SITE
- Area of exposure: shaved one day before treatment. The shaved skin area on the left side was slightly scarified immediately before treatment. A gauze patch of 2.5x2.5 cm laden with the test substance was immediately applied to the prepared skin.
- Type of wrap if used: the patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adesive tape.

SCORING SYSTEM: The reaction of the skin was appraised upon removal during an observation period of 8 days.

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
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No skin reaction observed

Remarks on result:

other: The complete table of results is attached below

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No skin reaction observed

Remarks on result:

other: The complete table of results is attached below

Irritant / corrosive response data:

The test substance was found to be non irritant when applied to intact or abraded rabbit skin, after an observation period of 8 days. The mean score for each animal is zero.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU

Conclusions:

The test substance was found to be non irritant when applied to intact or abraded rabbit skin.

Executive summary:

METHOD

The skin irritation test was performed to rabbit skin using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

RESULT/CONCLUSION

The criteria for the evaluation of the skin irritation potential followed in the test are different from those reported into the OECD guideline. Nevertheless, the scoring system used for the erythema and eschar formation and for oedema formation are the same of that reported into the OECD. Since the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC n. 1272/2008).

The test substance was found to be non irritant when applied to intact or abraded rabbit skin.

Therefore, the test substance can be classified as NON IRRITATING, according to the CLP Regulation (EC n. 1272/2008).