Trisodium 4-[[4-chloro-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[[1-(2,5-dichloro-4-sulphonatophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]benzenesulphonate

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:

Comedogenicity and irritancy of commonly used ingredients in skin care products

Author:

Fulton Jr, J. E

Year:

1989

Bibliographic source:

J. Soc. Cosmet. Chem. 40, 321-333,1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the comedogenicity and irritancy potential of FD & C Red NO. 40 in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

EC Number:

247-368-0

EC Name:

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

Cas Number:

25956-17-6

Molecular formula:

C18H16N2O8S2.2Na

IUPAC Name:

disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): FD & C Red NO. 40 or Allura Red AC
- IUPAC name: disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Molecular formula : C18H16N2O8S2.2Na
- Molecular weight: 496.4266 g/mole
- Substance type: Organic
- Physical State: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): FD & C Red NO. 40 or Allura Red AC
- IUPAC name: disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Molecular formula : C18H16N2O8S2.2Na
- Molecular weight: 496.4266 g/mole
- Substance type: Organic
- Physical State: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: No data
Age at study initiation: No data
Weight at study initiation: 3 kg
Fasting period before study: No data
Housing: singly housed, in suspended cages
Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
Water (e.g. ad libitum): water, ad libitum
Acclimation period: No data

ENVIRONMENTAL 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 cycle

IN-LIFE DATES: From: No data To: No data

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

other: propylene glycol

Controls:

other: The untreated ear served as control.

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:

2 weeks

Observation period:

2 weeks

Number of animals:

3 animals

Details on study design:

TEST SITE
Area 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 data

REMOVAL OF TEST SUBSTANCE
Washing (if done): No data
Time after start of exposure: No data

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 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

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 2 weeks

Score:

2

Max. score:

5

Reversibility:

no data

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Grade 2 indicates diffuse scaling, no Erythema

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]
D & C RED NO 40	2	2

 

*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:

FD&C Red 40 falls under Grade 2 (diffuse scaling and no erythema). Hence it can be concluded that FD&C Red 40 was not 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-hour light and 12-hour dark cycle. A dose of 1 ml of FD&C Red 40 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 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

and 5 = Epidermal necrosis and slough.

FD&C Red 40 falls under Grade 2 (diffuse scaling and no erythema). Hence it can be concluded that FD&C Red 40 was not irritating to rabbit ears.