Tris[5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)]dialuminium

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

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

Principles of method if other than guideline:

To determine the skin sensitizing potential of D&C Red 33

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

D&C Red 33

IUPAC Name:

D&C Red 33

Constituent 2

Reference substance name:

Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

EC Number:

222-656-9

EC Name:

Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate

Cas Number:

3567-66-6

Molecular formula:

C16H13N3O7S2.2Na

IUPAC Name:

disodium 5-amino-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate

Test material form:

not specified

Details on test material:

Name of test material (as cited in study report): D&C Red 33Molecular formula (if other than submission substance): C16-H13-N3-O7-S2.2NaMolecular weight (if other than submission substance): 467.3889 g/mol Substance type: OrganicPhysical state: Solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Induction exposure: 5% Aqueous Solution through Intradermal Injection and 10% aqueous solution through topical applicationChallenge Exposure: topical application of 5 and 10% aqueous solution

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

water

Challenge 2

Concentration / amount:

Induction exposure: 5% Aqueous Solution through Intradermal Injection and 10% aqueous solution through topical applicationChallenge Exposure: topical application of 5 and 10% aqueous solution

No. of animals per dose:

No data available.

Details on study design:

MAIN STUDYA. INDUCTION EXPOSURENo. of exposures: single exposureExposure period: No dataTest groups: No dataControl group: No dataSite: No dataFrequency of applications: singleDuration: No dataConcentrations: 5% Aqueous Solution through Intradermal Injection and 10% aqueous solution through topical applicationB. CHALLENGE EXPOSURENo. of exposures: singleDay(s) of challenge: 14 days Exposure period: No dataTest groups: No dataControl group: No dataSite: No dataConcentrations: topical application of 5 and 10% aqueous solutionEvaluation (hr after challenge): No data

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Group:

test chemical

Clinical observations:

No sensitization observed

Remarks on result:

other: Group: test group. Clinical observations: No sensitization observed.

Any other information on results incl. tables

not known

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

A sensitization test was carried out in guinea pigs to estimate the sensitizing potential of D & C Red 33. D & C Red 33 was found to be non sensitizing after challenge exposure.

Executive summary:

A maximization test in guinea pigs was carried out with an induction treatment by intradermal injection of 5% aqueous solution of the test chemical and by topical application of 10% aqueous solution. The challenge was made by topical application of 10% and 5% aqueous solution 2 weeks later. There were no positive reactions.

It was concluded that 10% aqueous solution of the test substance was not sensitizing to guinea pig skin. based on the above result the test chemical was concluded to be non sensitizing .