Registration Dossier
Registration Dossier
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EC number: 241-409-6 | CAS number: 17372-87-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
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: Patch test
- Principles of method if other than guideline:
- Patch test was performed to determine the allergic contact dermatitis caused by the chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 241-409-6
- EC Name:
- Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 17372-87-1
- Molecular formula:
- C20H6Br4Na2O5
- IUPAC Name:
- disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Eosine
- Molecular formula (if other than submission substance): C20H8Br4O5.2Na
- Molecular weight (if other than submission substance): 691.858 g/mol
- Smiles notation (if other than submission substance): c1(c2c(oc3c1cc(Br)c(c3Br)[O-])c(c(=O)c(c2)Br)Br)c1c(cccc1)C(=O)[O-].[Na+].[Na+]
- InChl (if other than submission substance): 1S/C20H8Br4O5.2Na/c21-11-5-9-13(7-3-1-2-4-8(7)20(27)28)10-6-12(22)17(26)15(24)19(10)29-18(9)14(23)16(11)25;;/h1-6,25H,(H,27,28);;/q;2*+1/p-2
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% in petrolatum
- Day(s)/duration:
- 2-3 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% in petrolatum
- Day(s)/duration:
- 2-3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 9 patients
- Details on study design:
- 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. - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no dermal reactions observed
- 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 |
?+ |
+ |
++ |
17372 -87 -1 (50% petrolatum.) |
9 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- 9 patients were tested with the dye.No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.
- Executive summary:
The sensitization potential of the test chemical was determined by performing patch tests on humans. 9 patients were tested with the test chemical.
50% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories
No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.
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