Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics 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 authoritative database

Data source

Reference
Reference Type:
other: authoritative database
Title:
Skin sensitization test for CAS no:14038-43-8
Author:
HSDB
Year:
2017
Bibliographic source:
TOXNET Toxicology Data Network, 2017

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
The toxicokinitic study of Prussian blue insoluble was performed on pig
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: Prussian blue
- IUPAC 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)
Specific details on test material used for the study:
- Name of test material: Prussian blue
- IUPAC name: C.I.Pigment Blue 27
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight (if other than submission substance): 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)
Radiolabelling:
yes

Test animals

Species:
pig
Strain:
not specified
Details on species / strain selection:
No data available
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: capsule
Vehicle:
not specified
Details on exposure:
No data available
Duration and frequency of treatment / exposure:
No data available
Doses / concentrations
Dose / conc.:
40 mg/kg bw/day (nominal)
No. of animals per sex per dose:
38
Control animals:
not specified
Positive control:
No data available
Details on study design:
No data available
Details on dosing and sampling:
No data available
Statistics:
No data available

Results and discussion

Preliminary studies:
No data available
Main ADME results
Type:
excretion
Results:
99% of the administered Prussian blue dose was excreted unchanged in feces

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Test material poorly absorb
Details on distribution in tissues:
No data available
Transfer into organs
Transfer type:
other: No data available
Observation:
not determined
Details on excretion:
99% of the administered Prussian blue dose was excreted unchanged in feces
Toxicokinetic parameters
Test no.:
#1
Toxicokinetic parameters:
other: 99% excreted unchanged in feces

Metabolite characterisation studies

Metabolites identified:
not specified
Details on metabolites:
No data available

Bioaccessibility

Bioaccessibility testing results:
No data available

Applicant's summary and conclusion

Conclusions:
The toxicokinitic study of Prussian blue insoluble was performed on pig. 38 animals were used. A single dose of 40 mg labelled Prussian blue insoluble were adminstered orally. 99% of the administered Prussian blue dose was excreted unchanged in feces, therefore is likely to have low bio-accumulation potential
Executive summary:

The toxicokinitic study of Prussian blue insoluble was performed on pig. 38 animals were used. A single dose of 40 mg labelled Prussian blue insoluble were administered orally. 99% of the administered Prussian blue dose was excreted unchanged in feces,therefore is likely to have low bio-accumulation potential