Registration Dossier
Registration Dossier
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EC number: 300-523-7 | CAS number: 93941-74-3
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)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data and safety assessment report
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Brilliant BLACK PN (WHO Food Additives Series 16)
- Author:
- INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY (IPCS INCHEM)
- Year:
- 1 975
- Bibliographic source:
- Joint FAO/WHO Expert Committee on Food Additives; (WHO Food Additives Series 16; IPCS INCHEM; 1975
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The skin sensitization test was conducted in guinea pigs to determine the sensitization potential of Brilliant Black 1.
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- 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
- Test material form:
- solid
- Details on test material:
- Name of test material (as cited in study report): Brilliant black 1 (2519-30-4)
- Molecular formula: C28H21N5O14S4.4Na
- Molecular weight: 867.6873 g/mole
- Substance type: Organic
- Physical state: Solid (Powder)
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Brilliant black 1 (2519-30-4)
- Molecular formula: C28-H21-N5-O14-S4.4Na
- Molecular weight: 867.6873 g/mol
- Substance type: Organic
- Physical state: Solid (Powder)
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- No data available
- Day(s)/duration:
- No data available
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- No data available
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- no data
- Details on study design:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- No data available
- No. with + reactions:
- 0
- Clinical observations:
- Not sensitizing
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No skin sensitization was observed in treated guinea pigs.
Any other information on results incl. tables
not known
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The test material Brilliant Black 1 (CAS No: 2519-30-4) was considered to be non-sensitizing to the guinea pigs skin.
- Executive summary:
The skin sensitization test of test chemical Brilliant Black 1 (CAS No: 2519-30-4) was carried out in guinea pigs to determine its sensitization efficacy.
Since the guinea pigs did not elicit any sensitizing effect, the test chemical Brilliant Black 1 (CAS No: 2519-30-4) was considered to be not sensitizing to the guinea pigs.
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