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Toxicological information

Skin sensitisation

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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

Constituent 1
Reference substance name:
D&C Red 33
IUPAC Name:
D&C Red 33
Constituent 2
Chemical structure
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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
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
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
water
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 .