Registration Dossier
Registration Dossier
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EC number: 272-939-6 | CAS number: 68921-42-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Scientific opinion on the safety and efficacy of Brilliant Blue FCF (E133) as a feed additive for cats and dogs
- Author:
- EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed)
- Year:
- 2 013
- Bibliographic source:
- European Food Safety Authority (EFSA) Journal, 2013;11(7):3288
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human Maximization Test
- Principles of method if other than guideline:
- To evalute skin sensitization potential of the test chemical in human for 12 days study period.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
- EC Number:
- 272-939-6
- EC Name:
- Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
- Cas Number:
- 68921-42-6
- Molecular formula:
- C37H36N2O9S3.xAl
- IUPAC Name:
- Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
- Test material form:
- solid
- Details on test material:
- - Name of test material : Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt
Commen name:FD&C Blue No. 1 aluminum lake
- Molecular formula:C37H36N2O9S3.xAl
- Molecular weight : 775.8764 g/mol
- Smiles notation :c1(ccccc1/C(=C/1C=C/C(=[N+](\CC)Cc2cc(ccc2)S(=O)(=O)[O-])C=C1)c1ccc(cc1)N(CC)Cc1cc(ccc1)S(=O)(=O)O)S(=O)(=O)O
- InChl 1S/C37H36N2O9S3.Al/c1-3-38(25-27-9-7-11-33(23-27)49(40,41)42)31-19-15-29(16-20-31)37(35-13-5-6-14-36(35)51(46,47)48)30-17-21-32(22-18-30)39(4-2)26-28-10-8-12-34(24-28)50(43,44)45;/h5-24H,3-4,25-26H2,1-2H3,(H2-,40,41,42,43,44,45,46,47,48);
- Substance type : Organic
-Batch No.: FG/16-17/0204
- Physical state: Solid powder (Blue)
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: no data
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous solution
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- water
- Concentration / amount:
- 5 % aqueous solution
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 207 human volunteers
- Details on study design:
- induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application
- Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 207
- Clinical observations:
- No local reactions of sensitisation was seen in 207 human volunteers
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No local reactions (irritation or sensitisation) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance was non sensitization to human skin.
- Executive summary:
The skin sensitization potential of the test chemical was evaluated on 207 human volunteers. The test chemical was used in the concentration 5% in aqueous solution. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days. No local reactions (irritation or sensitization) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance was non sensitization to human skin.
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