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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Jul 2010 - 18 Jan 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted in 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Országos Gyógyszerészeti Intézet, National Institute of Pharmacy, Budapest, Hungary
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- Physical state: solid
- Appearance: blue odourless powder
- Analytical purity: 93.6%
- Lot/batch No.: K73-4766
- Expiration date of the lot/batch: 20 Mar 2013
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
other: Wistar CRL:(WI)BR
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 183 - 202 g
- Fasting period before study: Animals were fasted over night before until 3 h after test substance application.
- Housing: Groups of 3 animals were housed in Type II polypropylene/polycarbonate cages with lignocell bedding.
- Diet: ssniff® SM R/M-Z+H Autoclavable complete food for rats and mice - breeding and maintenance, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 -26.1
- Humidity (%): 41 - 75
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 22 Jul 2010
To: 05 Aug 2010
From: 27 Jul 2010
To: 10 Aug 2010
From: 28 Jul 2010
To: 11 Aug 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no.: 07K05 7

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the absence of any acute toxicity data, a starting dose of 300 mg/kg bw according to OECD 423 was chosen by the study director.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw: 3 females
2000 mg/kg bw: 6 females
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 0.5, 1, 2, 3, 4 and 6 h after application of the test substance and daily thereafter. The body weight of each animal was recorded on the day before treatment, on the treatment day and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: experimental result
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14 d observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified