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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)
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:
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
Name:
Unnamed
Type:
Constituent
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 group
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.