p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

other: Authoritative data base

Title:

HSDB (Hazardous Substances Data Bank) for allura red acid dye AC.

Author:

U.S National Library of Medicine

Year:

2011

Bibliographic source:

HSDB (Hazardous Substances Data Bank)for allura red acid dye AC.U.S National Library of Medicine ; 2011

Reference 2

Reference Type:

review article or handbook

Title:

Allura red AC (WHO Food Additives Series 15)

Author:

IPCS INCHEM

Year:

1981

Bibliographic source:

Allura red AC (WHO Food Additives Series 15); IPCS INCHEM; 1981.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The Prophetic patch test was performed on 200 human subjects for screening the primary irritation caused by the chemical Allura Red AC dye (CAS No: 25956-17-6).

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

Remarks:

migrated information: 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

Specific details on test material used for the study:

-IUPAC name :Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
-Commen name-1-(2-methoxy-5-methyl-4-sulfophenyl-1-azo)-6 sulfo-2-hydroxynapthalene,
disodium salt ( ALLURA RED AC)
Molecular formula:C18H16N2O8S2.2Na
Molecular weight:496.4266 g/mol
- Substance type: Organic
- Physical state: solid
-InChI:1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
Smiles:c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]

Test animals

Species:

other: human

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: undiluted or aqueous solution

Controls:

not specified

Amount / concentration applied:

neat or as a 25% aqueous solution to the skin

Duration of treatment / exposure:

14 days

Observation period:

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

Number of animals:

200 human subjects

Details on study design:

No data available

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

no data

Remarks on result:

other: None of the subjects exhibited compound induced 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 skin irritation. Hence the chemical Allura Red AC dye (CAS No: 25956-17-6) was considered to be not irritating to the skin of 200 human subjects in a prophetic patch test.

Executive summary:

Prophetic patch test was performed on 200 human subject s for screening the primary irritation caused by the chemical Allura Red AC dye . The chemical Allura Red was applied either as a neat or as a 25% aqueous solution to the skin of 200 human subjects. The initial exposure to the compound was for 72 hours, and this was followed by a 24-hour application 10 to 14 days later. None of the subjects exhibited compound induced irritation. Hence the chemical Allura Red AC dye was considered to be not irritating to the skin of 200 human subjects in a prophetic patch test.