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Toxicological information

Repeated dose toxicity: oral

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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

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 / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
2 %
Basis:
nominal in water
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

Applicant's summary and conclusion

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