Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: only Body weight, mortality rates and clinical signs of toxicity were recorded and histopathological examinations were conducted; therefore insufficient for assessment

Data source

Reference

Reference Type:

publication

Title:

Metabolisches Verhalten von kolloidalem Ferrihexacyanoferrat (Metabolic behaviour of Colloidal Ferrihexacyanoferrate(II))

Author:

Dvorak P., Guenther M., Zorn U. and Catsch A.

Year:

1971

Bibliographic source:

Naunyn-Schmiedebergs Arch. Pharmak. 269_ 48-56

Materials and methods

Principles of method if other than guideline:

The test material was administered at an estimated dose of ca. 2500 mg/kg bw/d to rats in the drinking water for a duration period of 12 weeks.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Colloidal Prussian Blue KFe[Fe(CN)6]

IUPAC Name:

Colloidal Prussian Blue KFe[Fe(CN)6]

Details on test material:

- Name of test material (as cited in study report): Colloidal Prussian Blue KFe[Fe(CN)6]
- Analytical purity: no data given

Test animals

Species:

rat

Strain:

other: Heiligenberg

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 weeks
- Housing: 5 animals per cage
- Diet: Altromin R pellets, ad libitum
- Water: Aqua bidest, ad libitum

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Duration of treatment / exposure:

12 weeks

Frequency of treatment:

continuous treatment

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
2 %
Basis:
nominal in water

Doses / concentrations 2

Remarks:

Doses / Concentrations:
2500 mg/kg bw/d (based on a test material concentration of 20 g/l drinking water, an average body weight of 200 g and an daily water consumption of 25 ml per animal.
Basis:
actual ingested

No. of animals per sex per dose:

10 animals per group

Control animals:

yes, concurrent vehicle

Details on study design:

The test material was administered to young male rats in the drinking water for a duration period of 12 weeks.

Examinations

Observations and examinations performed and frequency:

Body weight was recorded during the administration period.
Mortality, clinical signs of toxicity and cage side observations were checked.

Sacrifice and pathology:

After the treatment period the animals were sacrificed and the following organs were removed and histopathologically analyzed:
gastrointestinal tract, kidneys, liver and spleen.
The histological analysis was conducted as described previously by Golgner (Masson-Trichrom staining).

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

no effects observed

Details on results:

The body weight gain of all animals increased within the normal range.
No clinical signs of toxicity or any other abnormalities in behaviour were observed during the dosing period in all animals.
The histopathological examination of the gastroinestinal tract, kidneys, liver and spleen revealed no abnormalities in all animals.

Effect levels

Dose descriptor:

NOAEL

Effect level:

ca. 2 500 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

other: no effects were observed at dose level tested

Target system / organ toxicity

Critical effects observed:

not specified