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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
1975
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:
2010
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

Constituent 1
Chemical structure
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)
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.