[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

secondary source

Title:

OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 76

Author:

SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS

Year:

2003

Bibliographic source:

COLIPA n° C8, adopted by the SCCNFP during the 23rd plenary meeting of 18 March 2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride

EC Number:

269-941-4

EC Name:

[7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride

Cas Number:

68391-30-0

Molecular formula:

C20H22ClN3O2

IUPAC Name:

7-hydroxy-8-[(2-methoxyphenyl)diazenyl]-N,N,N-trimethylnaphthalen-2-aminium chloride

Constituent 2

Reference substance name:

Basic Red 76

IUPAC Name:

Basic Red 76

Details on test material:

- Name of test material (as cited in study report):Basic Red 76- Molecular formula (if other than submission substance):C20H22N3O2 Cl- Molecular weight (if other than submission substance):371.86g/mol- Substance type:Organic

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Sex: Male and Female

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shorn intact or scarified skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 g/inch square

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

Groups of 3 male and 3 females

Details on study design:

TEST SITEArea of exposure: either shorn intact or scarified skin% coverage: no dataType of wrap if used: Basic Red 76 was applied without any vehicle at the level of 0.5 g/in2 to the backs of 3 rabbits of each sex with either shorn intact or scarified skin. The sample was occlusively covered and left in place for 24 hoursREMOVAL OF TEST SUBSTANCEWashing (if done): No dataTime after start of exposure: No dataSCORING SYSTEM: Readings were made according to Draize upon removal of the test material and daily for 14 days post administration.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 14 days

Reversibility:

no data

Remarks on result:

other: There was no sign of irritation at any observation point.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

A skin irritation study was carried out on New Zealand White rabbits to determine the irritation potency of Basic Red 76.Under the conditions of the study, Basic Red 76 was not irritating to rabbit skin

Executive summary:

A skin irritation study was carried out on New Zealand White rabbits to determine the irritation potency of Basic Red 76.

 

Basic Red 76 was applied without any vehicle at the level of 0.5 g/in2 to the backs of 3 rabbits of each sex with either shorn intact or scarified skin. The sample was occlusively covered and left in place for 24 hours. Readings were made according to Draize upon removal of the test material and daily for 14 days post administration.

There were no observable reactions to the dye. The test material was considered “not irritant” to rabbit skin.

 

Under the conditions of the study, Basic Red 76 was not irritating to rabbit skin .