Registration Dossier

Administrative data

Description of key information

Skin sensitization:

The skin sensitization study for the target chemical Prussian blue was not available.  Thus on the basis of available studies for the strcturally similar read across substances , Tetrasodium hexacyanoferrate (13601-19-9) and Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-) (25869-00-5) and applying the weight of evidence approach Prussian blue can be considered not irritating to skin and can be classified under the category “Not classified” as per CLP regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence based on structurally similar substances
Justification for type of information:
Weight of evidence based on structurally similar substances
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
other: Weight of evidence based on structurally similar substances
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based on strutural and functional similarity to assess the dermal sensitization potential of Prussian Blue
GLP compliance:
not specified
Type of study:
other: Weight of eveidance
Justification for non-LLNA method:
not specified
Specific details on test material used for the study:
- Name of test material: Prussian blue
- IUPAC name: iron(2+);iron(3+);octadecacyanide
- Common name: C.I. Pigment Blue 27
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight: 859.23 g/mol
- Smiles : [CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-] (#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[Fe+3].[Fe+3].[Fe+3].[Fe+3]
- InChI : 1S/18CN.7Fe/c18*1-2;;;;;;;/q18*-1;3*+2;4*+3
- Substance type: Inorganic
- Physical state: Solid powder (dark blue)
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data available
Route:
other: not specified
Vehicle:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: not specified
Vehicle:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
no data available
Details on study design:
The study is based on weight of eveiance approach from the read across values
Challenge controls:
no data available
Positive control substance(s):
not specified
Other effects / acceptance of results:
no data available
Reading:
1st reading
Group:
test group
Clinical observations:
no dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
On the basis of available studies for the functionally similar read across substances, the weight of evidence approach is applied to assess the skin sensitization potential for target substance. Prussian blue was estimated to be not sensitizing to guinea pig skin.
Executive summary:

On the basis of available studies for the functionally similar read across substances , Tetrasodium hexacyanoferrate (13601-19-9) and Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-) (25869-00-5) the weight of evidence approach is applied to assess the skin sensitization potential for Prussian blue[CAS: 14038 -43 -8].

Skin sensitization potential was evaluated for the functionally similar read across substance Tetrasodium hexacyanoferrate (13601-19-9) (summarized in IUCLID Dataset by European Chemicals Bureau (ECB) 2000) Tetrasodium Hexacyanoferrate.

Tetrasodium hexacyanoferrate was applied on the skin of guinea pig and it did not produce any allergic dermal reactions . Hence Tetrasodium hexacyanoferrate was considered to be not sensitizing to guinea pig skin.

The above experimental data was further supported by experimental study summarized in IUCLID Dataset of functionally similar read across substance Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-) (25869-00-5)  available at European Chemicals Bureau (ECB) .

Ammonium iron(3+) hexakis(cyano–C)ferrate(4–) was applied on guinea pig skin in concentration 30% in water for induction and challenge treatment.

No skin sensitization reaction was observed. Hence, Ammonium iron(3+) hexakis(cyano–C)ferrate(4–) was considered as not sensitizing to guinea pig skin.

Based on the available data for the functionally similar read across substances and applying the weight of evidence approach, it can be concluded that Prussian blue will also be have in similar manner that of the read across substances and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

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

Skin Sensitization:

On the basis of available studies for the functionally similar read across substances , Tetrasodium hexacyanoferrate (13601-19-9) and Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-) (25869-00-5) the weight of evidence approach is applied to assess the skin sensitization potential for Prussian blue[CAS: 14038 -43 -8].

Skin sensitization potential was evaluated for the functionally similar read across substance Tetrasodium hexacyanoferrate (13601-19-9) (summarized in IUCLID Dataset by European Chemicals Bureau (ECB) 2000) Tetrasodium Hexacyanoferrate.

Tetrasodium hexacyanoferrate was applied on the skin of guinea pig and it did not produce any allergic dermal reactions . Hence Tetrasodium hexacyanoferrate was considered to be not sensitizing to guinea pig skin.

The above experimental data was further supported by experimental study summarized in IUCLID Dataset of functionally similar read across substance Ammonium Iron(3+) Hexakis(Cyano-C)Ferrate(4-) (25869-00-5)  available at European Chemicals Bureau (ECB) .

Ammonium iron(3+) hexakis(cyano–C)ferrate(4–) was applied on guinea pig skin in concentration 30% in water for induction and challenge treatment.

No skin sensitization reaction was observed. Hence, Ammonium iron(3+) hexakis(cyano–C)ferrate(4–) was considered as not sensitizing to guinea pig skin.

Based on the available data for the functionally similar read across substances and applying the weight of evidence approach, it can be concluded that Prussian blue will also behave in similar manner that of the read across substances and was estimated to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for the functionally similar read across substances;and applying the weight of evidence approach, it can be concluded that Prussian blue was not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.