Reaction mass of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine and N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-1-amine

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 journal and authoritative database

Data source

Reference

Reference 1

Reference Type:

publication

Title:

WHO Food Additives

Author:

Joint FAO/WHO Expert Committee on Food Additives

Year:

1980

Bibliographic source:

Joint FAO/WHO Expert Committee on Food Additives, 2004

Reference 2

Reference Type:

other: Authoritative data base

Title:

HSDB (Hazardous Substances Data Bank)

Author:

U.S National Library of Medicine

Year:

2011

Bibliographic source:

HSDB (Hazardous Substances Data Bank), U.S National Library of Medicine ; 2011

Reference 3

Reference Type:

secondary source

Title:

REPORTS of the Scientific Committee on Cosmetology (seventh series)

Author:

Published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation

Year:

1988

Bibliographic source:

Scientific Committee on Cosmetology (seventh series),1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To evaluate skin irritation potential of test chemical on 200 human subjects

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): disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
(ALLURA RED AC)
- Substance type: Organic
- Physical state: solid

Test animals

Species:

other: Human

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data available

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

neat or as a 25% aqueous solution to the skin

Duration of treatment / exposure:

72 hours, and this was followed by a 24-hour application 10 to 14 days later

Observation period:

10 to 14 days later

Number of animals:

200 human subjects

Details on study design:

no data availble

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None of the subjects exhibited compound induced irritation.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

None of the subjects exhibited compound induced irritation . Hence,the test chemical was considered to be not irritating to human skin.

Executive summary:

A prophetic patch test was conducted on 200 human volunteers to assess the dermal irritation potential of the test chemical.

The test chemical was applied on the human skin in the concentration 25% neat or in aqueous solution for 72 hours followed by one 48 hours application 10-14 days later. None of the subjects exhibited compound induced irritation . Hence, the test chemical was considered to be not irritating to human skin.