Registration Dossier
Registration Dossier
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EC number: 270-648-9 | CAS number: 68475-50-3
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:
- 1 988
- 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 substance name:
- D&C Red 33
- IUPAC Name:
- D&C Red 33
- 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
Constituent 1
Constituent 2
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 .
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