Registration Dossier
Registration Dossier
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EC number: 243-654-4 | CAS number: 20262-76-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 E133 as a feed additive for cats and dogs
- Author:
- EFSA
- Year:
- 2 013
- Bibliographic source:
- EFSA Journal, 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of the test chemical on 207 human volunteers
- 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 (as cited in study report):Brilliant Blue FCF aluminum lake- 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- Molecular formula:C37H36N2O9S3.xAl- Molecular weight:775.8764 g/mol- Substance type:Organic- Physical state:Solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 207 human volunteers were used
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: Not specified
- Vehicle:
- water
- Concentration / amount:
- 5 % aqueous solution
- Day(s)/duration:
- 3 week
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: Not specified
- 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:
- RANGE FINDING TESTS: MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 9 - Exposure period: Not specified - Test groups: 207 human volunteers - Control group: Not specified - Site: Not specified - Frequency of applications: three times per week for three weeks - Duration: 3 weeks - Concentrations: 5% aqueous solution B. CHALLENGE EXPOSURE - No. of exposures: Not specified - Day(s) of challenge: Not specified - Exposure period: Not specified - Test groups: 207 human volunteers - Control group: Not specified - Site: Not specified - Concentrations: 5% aqueous solution - Evaluation (hr after challenge): Not specified OTHER: challenge treatment was followed after 12 days of induction treatment
- Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 5% aqueous solution
- No. with + reactions:
- 0
- Total no. in group:
- 207
- Clinical observations:
- No skin irritation or reaction was observed
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No skin irritation or reaction was observed
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 was considered that test substance was not sensitizing to human skin.
- Executive summary:
A skin sensitization study was performed to evaluate the skin sensitization potential of the test chemical on 207 human volunteers.
5% aqueous solution pf the test chemical was applied during induction and challenge process. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days. No local reactions of sensitisation was seen in 207 human volunteers
Thus it was considered that test substance was non sensitization to human skin.
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