Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report

Data source

Reference
Reference Type:
secondary source
Title:
IUCLID Dataset - Tetrasodium Hexacyanoferrate
Author:
European Chemicals Bureau (ECB)
Year:
2000
Bibliographic source:
IUCLID Dataset - Tetrasodium Hexacyanoferrate, European Chemicals Bureau (ECB), 2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Magnusson–Kligman
Principles of method if other than guideline:
To evaluate skin sensitization potential of Tetrasodium hexacyanoferrate on guinea pig by Magnusson–Kligman methode
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
IUPAC name: Tetrasodium hexacyanoferrate
common name:Sodium ferrocyanide
Molecular formula:C6FeN6Na4
Molecular weight: 303.913 g/mol
Physical state: solid
InChI:1S/6CN.Fe.4Na/c6*1-2;;;;;/q;;;;;;-4;4*+1
Smiles:[Fe-4](C#N)(C#N)(C#N)(C#N)(C#N)C#N.[Na+].[Na+].[Na+].[Na+]
Specific details on test material used for the study:
IUPAC name: Tetrasodium hexacyanoferrate
common name:Sodium ferrocyanide
Molecular formula:C6FeN6Na4
Molecular weight: 303.913 g/mol
Physical state: solid
InChI:1S/6CN.Fe.4Na/c6*1-2;;;;;/q;;;;;;-4;4*+1
Smiles:[Fe-4](C#N)(C#N)(C#N)(C#N)(C#N)C#N.[Na+].[Na+].[Na+].[Na+]

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
Not specified
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
Not specified
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Not specified
Details on study design:
Not specified
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
0
Group:
test group
Dose level:
Not specified
Clinical observations:
No skin allergic reactions observed
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No skin allergic reactions observed

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
Tetrasodium hexacyanoferrate when evaluated for its skin sensitization potential on guinea pig produced no skin allergic reactions . Hence Tetrasodium hexacyanoferrate was considered to be not sensitizing to guinea pig skin.
Executive summary:

Tetrasodium hexacyanoferrate was used as a test material to evaluate skin sensitization potential on guinea pig .Tetrasodium hexacyanoferrate when evaluated for its skin sensitization potential on guinea pig produced no skin allergic reactions . Hence Tetrasodium hexacyanoferrate was considered to be not sensitizing to guinea pig skin.