Registration Dossier
Registration Dossier
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EC number: 219-746-5 | CAS number: 2519-30-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Scientific Opinion on the re-evaluation of Brilliant Black BN (E 151) as a food additive
- Author:
- EFSA
- Year:
- 2 010
- Bibliographic source:
- EFSA Journal 2010;8(4):1540
- Reference Type:
- review article or handbook
- Title:
- BRILLIANT BLACK PN-acute oral toxicity
- Author:
- Joint FAO/WHO Expert Committee on Food Additives
- Year:
- 2 016
- Bibliographic source:
- JECFA - Monographs & Evaluations,499. Brilliant BLACK PN (WHO Food Additives Series 16),2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Skin sensitisation of Brilliant Black BN is reported
- GLP compliance:
- not specified
- Type of study:
- not specified
Test material
- Reference substance name:
- Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
- EC Number:
- 219-746-5
- EC Name:
- Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate
- Cas Number:
- 2519-30-4
- Molecular formula:
- C28H21N5O14S4.4Na
- IUPAC Name:
- tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate
- Reference substance name:
- Brilliant Black BN
- IUPAC Name:
- Brilliant Black BN
- Details on test material:
- Name of test material (as cited in study report): Brilliant black 1 (2519-30-4)- Molecular formula (if other than submission substance): Not applicable- Molecular weight (if other than submission substance): Not applicable- Substance type: Organic- Physical state: Solid (Powder)- Purity: 83.6%
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- no data
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- no data
- No. of animals per dose:
- no data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- Not sensitizing
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Clinical observations: Not sensitizing.
Any other information on results incl. tables
not known
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig.
- Executive summary:
Skin sensitisation test was conducted on guinea pig to evaluate skin sensitising potency of chemical Black PN.
Non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig(Bar & Griepentrog, 1960).
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