Registration Dossier
Registration Dossier
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EC number: 237-875-5 | CAS number: 14038-43-8
Basic toxicokinetics
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:
- 2 017
- Bibliographic source:
- TOXNET Toxicology Data Network, 2017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Prussian blue
- EC Number:
- 237-875-5
- EC Name:
- Prussian blue
- Cas Number:
- 14038-43-8
- Molecular formula:
- C6FeN6.4/3Fe
- IUPAC Name:
- iron(2+);iron(3+);octadecacyanide
- 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)
Constituent 1
- 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 or test system 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 / concentration:
- 38
- Control animals:
- not specified
- Positive control reference chemical:
- 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 (or Bioavailability)
- Bioaccessibility (or Bioavailability) 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
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