Disodium 5-amino-4-hydroxy-3-(phenylazo)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:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Comedogenicity and irritancy of commonly used ingredients in skin care products

Author:

JAMES E. FULTON, JR

Year:

1989

Bibliographic source:

J. Soc. Cosmet. Chem., 40, 321-333 (November/Decembe)

Materials and methods

Principles of method if other than guideline:

The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

D&C Red 33

IUPAC Name:

D&C Red 33

Constituent 2

Reference substance name:

Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

EC Number:

222-656-9

EC Name:

Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Cas Number:

3567-66-6

Molecular formula:

C16H13N3O7S2.2Na

IUPAC Name:

disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report): D&C Red 33- Molecular formula (if other than submission substance): C16-H13-N3-O7-S2.2Na- Molecular weight (if other than submission substance): 467.3889 g/mol- Substance type: Organic- Physical state: Solid -Purity- No dtata available.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALSSource: Age at study initiation:Weight at study initiation: 3 kg Fasting period before study:Housing: singly housed, in suspended cagesDiet (e.g. ad libitum): Purina Rabbit Chow, ad libitumWater (e.g. ad libitum): water, ad libitumAcclimation period:ENVIRONMENTAL CONDITIONS Temperature (°C): Humidity (%): Air changes (per hr): Photoperiod (hrs dark / hrs light): 12 hour light and 12 hr dark cycle

Test system

Type of coverage:

other: Entire inner surface of one ear

Preparation of test site:

other: A colony of rabbits that had genetically good ears and which were free from mites were used for the assay

Vehicle:

other: The test chemical was mixed in propylene glycol at a 9 to 1 dilution for testing.

Controls:

other: Other ear acted as control.

Amount / concentration applied:

Dose of 1ml of the test material

Duration of treatment / exposure:

The test material was applied once daily for five days per week for 2 weeks.

Observation period:

No data

Number of animals:

3 rabbits

Details on study design:

TEST SITEArea of exposure: Ear% coverage: A dose of 1ml of the test chemical is applied and spread once daily to the entire inner surface of one ear five days per week for 2 weeks.Type of wrap if used:REMOVAL OF TEST SUBSTANCEWashing (if done):Time after start of exposure:SCORING SYSTEM: The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows: 0 = No irritation1 = few scales, no Erythema2 = diffuse scaling, no Erythema3 = Generalized scaling with Erythema4 = Scaling, Erythema and Edema5 = Epidermal necrosis and slough

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other:

Time point:

other: 2 weeks

Score:

2

Max. score:

5

Reversibility:

no data

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients . The irritancy produced by the test chemical was graded from 0 – 5. The test chemical falls under Grade 2 (diffuse scaling, no erythema) Hence it can be concluded that the test chemical is non-irritating to rabbit ears.

Executive summary:

The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients. Ingredients are mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated( 10% concentration)A. colony of New Zealand albino rabbits that have genetically good ears and is free from mites is used. Three rabbits, weighing two to three kilograms, are used for each assay. Animals are housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals are maintained on a 12-hourlight and 12-hour dark cycle. A dose of 1 ml of the test material is applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control.

 

The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:

 0 = No irritation

1 = few scales, no Erythema

2 = diffuse scaling, no Erythema

3 = Generalized scaling with Erythema

4 = Scaling, Erythema and Edema

5 = Epidermal necrosis and slough

 

The test chemical falls under Grade 2 (diffuse scaling, no erythema)

Hence it can be concluded that the test chemical is non-irritating to rabbit ears. Based on the above result the test chemical D&C Red 33 not classified as skin irritent.