2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Irritancy of test chemical

Author:

JAMES E et.al,

Year:

1989

Bibliographic source:

J. Soc. Cosmet. Chem; 1989.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The test uses a single rabbit ear to indicate the Comedogenicity and irritancy of test chemical.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

EC Number:

227-497-9

EC Name:

Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Cas Number:

5858-81-1

Molecular formula:

C18H14N2O6S.2Na

IUPAC Name:

disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate

Test material form:

solid: particulate/powder

Details on test material:

Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylateCommon Name: D&C Red 6Molecular Formula: C18H12N2Na2O6SMolecular Weight: 430.3468 g/molInChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;Substance Type: OrganicPhysical State: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALSSource: No dataAge at study initiation: No dataWeight at study initiation: 3 kg Fasting period before study: No dataHousing: singly housed, in suspended cagesDiet (e.g. ad libitum): Purina Rabbit Chow, ad libitumWater (e.g. ad libitum): water, ad libitumAcclimation period: No dataENVIRONMENTAL CONDITIONS Temperature (°C): No data Humidity (%):No data Air changes (per hr): No data Photoperiod (hrs dark / hrs light): 12 hour light and 12 hr dark cycleIN-LIFE DATES: From: No data To: No data

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:

yes

Amount / concentration applied:

Dose of 1ml of the test material was applied once daily for five days per week for 2 weeks.

Duration of treatment / exposure:

once daily for five days per week for 2 weeks.

Observation period:

2 weeks

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: No dataREMOVAL OF TEST SUBSTANCEWashing (if done): No dataTime after start of exposure: No dataSCORING 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 vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 2 weeks

Score:

0

Max. score:

5

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema observed

Any other information on results incl. tables

Table 1: Ingredients and their Comedogenicity and Irritancy

Test chemical	Comedogenicity* [Grade 0-5]	Irritancy** [Grade 0-5]
test chemical	1	0

 

*Comedogenicity or the ability of test substance to produce follicular hyperkeratosis

** Irritancy or ability of test substance to produce surface epithelial irritation

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The test chemical falls under Grade 0 (no irritation observed).Hence it can be concluded that the test chemical was not irritating to rabbit ears.

Executive summary:

The skin irritation study of test chemical was conducted on rabbits’ ear to indicate its Comedogenicity and irritancy. The test chemical was 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 free from mites were used. Three rabbits, weighing two to three kilograms, were used for each assay. Animals were housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals were maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of the test material was 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 the chemical on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The chemical falls under Grade 0 (no irritation observed). Hence it can be concluded that the test chemical was not irritating to rabbits’ skin.