Registration Dossier
Registration Dossier
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EC number: 222-656-9 | CAS number: 3567-66-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Patch testing to FD&C and D&C dyes.
- Author:
- Guin JD.
- Year:
- 2 003
- Bibliographic source:
- Contact Dermatitis : 49: 217–218
Materials and methods
- Principles of method if other than guideline:
- The sensitization potential of D&C Red 33 was determined by performing patch test on humans.
- GLP compliance:
- not specified
- Type of study:
- patch 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-(phenylazo)naphthalene-2,7-disulphonate
- Test material form:
- other: Solid
- Details on test material:
- Name of test material (as cited in study report): D&C Red 33 [also known as Acid Red 33]Molecular 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:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- No. of animals per dose:
- 59 patients
- Details on study design:
- OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.The reactions of the patients were graded as?+. + and ++ categories
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other:
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 4
- Total no. in group:
- 59
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 4.0. Total no. in groups: 59.0.
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The sensitization potential of D&C Red 33 was determined by performing patch tests on humans.59 patients were tested with the dye. 4 patients with ‘?+ ‘results and 2 patients with ‘++ ‘ results were reported.This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.
- Executive summary:
The sensitization potential of D&C Red 33 was determined by performing patch tests on humans.
The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories
59 patients were tested with the dye.4 patients with ‘?+ ‘ results and 2 patients with ‘++ ‘ results were reported.
This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.
The CLP classification for the test chemical is ‘Not Classified’
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