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Toxicological information

Skin sensitisation

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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:
2010
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:
2016
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

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
Constituent 2
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%

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).