Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 group
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 .