Registration Dossier
Registration Dossier
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EC number: 229-872-2 | CAS number: 6798-03-4
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal.
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 mentioned below
- Principles of method if other than guideline:
- The sensitization potential of D & C Red No. 6 (CAS no: 5858-81-1) was examined to determine the allergic contact dermatitis caused by the chemical via 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:
- Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 227-497-9
- EC Name:
- Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5858-81-1
- Molecular formula:
- C18H14N2O6S.2Na
- IUPAC Name:
- disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Ldisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B
- Molecular formula (if other than submission substance): C18H14N2O6S.2Na
- Molecular weight (if other than submission substance): 432.38 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
Common Name: D & C Red No. 6
Molecular Formula: C18H12N2Na2O6S
Molecular Weight: 430.3468 g/mol
InChI: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;
Substance Type: Organic
Physical State: Solid
In vivo test system
Test animals
- Species:
- other: hunan
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 20%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
Challenge
- Route:
- other: epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 20%
- Day(s)/duration:
- 7 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 15 patients
- Details on study design:
- 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 availble
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- None of the treated patients showed allergic contact dermatitis.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- None of the treated patients showed allergic contact dermatitis.
Any other information on results incl. tables
Table 1: Patch test results
Chemical |
No of patients tested |
?+ |
+ |
++ |
D & C Red No. 6 (20% aq.) |
15 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No patients showed any signs of sensitization. Thus the chemical D & C Red No. 6 (CAS no: 5858-81-1) can be considered as non sensitizer to human skin.
- Executive summary:
The sensitization potential ofD & C Red No. 6 (CAS no: 5858-81-1)was examined to determine the allergic contact dermatitis caused by the chemical via performing patch test on human patients.
The dye was applied on15patients 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.
None of the treated patients showedany signs ofallergic contact dermatitis. Hencethe chemical D & C Red No. 6 (CAS no: 5858-81-1) can be considered as non sensitizer to human skin.
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