Registration Dossier
Registration Dossier
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EC number: 240-005-7 | CAS number: 15876-39-8
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)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
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 2003: 49: 217–218
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- The sensitization potential of D&C Red 28 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:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- EC Number:
- 242-355-6
- EC Name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- Cas Number:
- 18472-87-2
- Molecular formula:
- C20H4Br4Cl4O5.2Na
- IUPAC Name:
- 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Details on test material:
- Name of test material (as cited in study report): D&C Red 28 also known as Phloxine B
Molecular formula (if other than submission substance): C20H4Br4Cl4O5.2Na
Molecular weight (if other than submission substance): 829.6388g/mol
Substance type: Organic
Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): D&C Red 28 also known as Phloxine B
Molecular formula: C20H4Br4Cl4O5.2Na
Molecular weight: 829.6388g/mol
Substance type: Organic
Physical state: Solid
In vivo test system
Test animals
- Species:
- human
- Strain:
- other:
- Remarks:
- not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
Challenge
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in petrolatum
- No. of animals per dose:
- 9 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.
- Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available.
Results and discussion
- Positive control results:
- No data available.
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- non sensitising
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Patch test results
Chemical |
No of patients tested |
?+ |
+ |
++ |
D&C Red 28 (1% in pet.) |
9 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The sensitization potential of test materrial was determined by performing patch tests on humans. 9 patients were tested with the dye. No sensitization reactions were reported in all patients. Hence 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one (18472-87-2) can be considered as a non- sensitizer in humans
- Executive summary:
The sensitization potential of 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one (18472-87-2) was determined by performing patch tests on humans. The test material was applied in Finn Chambers at the concentration of 2% in petrolatum and read first at 2 or (more commonly) 3 days and again at 4–7 days. 9 patients were tested with the test material.No sensitization reactions were reported in any 9 patients. Therefore 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one (18472-87-2) can be considered as a non- sensitizer in humans.
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