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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
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
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
other: no data
Vehicle:
no data
Concentration / amount:
no data
Route:
other: no data
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
no data
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Clinical observations:
Not sensitizing
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: Not sensitizing.

not known

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin Sensitisation

Several studies for the target chemical Brilliant Black PN and Read across Acid Red 1 were reviewed to determine the skin sensitization of the test compound (CAS no 2519-30-4). The studies are summarized as below:

 

Skin sensitisation test (EFSA, 2010 and FAO/WHO Expert Committee on Food Additives, 2016 ) was conducted on guinea pig to evaluate skin sensitising potency of chemical Black PN. In vivo, non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig.

 

From ranking of hair dye substances according to Predicted sensitization potency: quantitative structure–activity relationships Predicted skin sensitization,2004, the potency of chemical Brilliant Black 1was determined by quantitative structure–activity relationships. Prediction of sensitization potency Structures identified were then imported into a molecular spreadsheet TSAR (Version 3.3, Accelrys Ltd., Cambridge, UK). Simplified Molecular Input Line Entry Specifications (SMILES,www.daylight. com), which are 1-dimensional representations of chemical structures, were generated. This list was filtered in order to remove any further duplicate structures, such as salt-containing ingredients (HCl and SO4), leaving 229 hair dye substances. Moderate sensitising effect was predicted for chemical Brilliant Black 1 determined by quantitative structure–activity relationships.

 

From Read across RED 2G (RA CAS 3734-67-6) study report (1988) indicates a sensitization test was carried out in guinea pigs to estimate the sensitizing potential of RED 2G. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted. In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs. Signs of sensitization were not observed RED 2G was found to be non sensitizing after challenge exposure.

 

From the above mentioned studies indicate that the substance is not expected to exhibit skin sensitization, though one of the study indicates the moderate skin sensitization but on the basis of majority and study performed data. It has been concluded that the substance is not expected to exhibit skin sensitization as per the CLP criteria.


Migrated from Short description of key information:
Non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig

Justification for selection of skin sensitisation endpoint:
Data is from peer review publication.

Justification for classification or non-classification