Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
430-010-4
EC Name:
-
Cas Number:
12160-44-0
Molecular formula:
K2Fe22O34
IUPAC Name:
hydrate iron potassium hydride
Details on test material:
- Name of test material (as cited in study report):Potassium ferrite
- Physical state: Reddish brown powder
- Composition of test material, percentage of components: K2Fe22O34; 83,8%, K2Fe10O16; 6.2%, K2CO3 1.5H2O; 10.0%
- Lot/batch No.: 23388-17 CG20X 407448A
- Expiration date of the lot/batch: 6 August 1997
- Storage condition of test material: Room temperature, dark, desiccated

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan U.K. Ltd, Bicester, Oxon, England
- Age at study initiation: male and female; 4-7 weeks
- Weight at study initiation: males 83-91 grams; females 89-97 grams
- Fasting period before study: 1 night before dosing and 4 hours after dosing
- Housing: metal cages with wire mesh floors; in groups of up to 5 rats of the same sex
- Diet : standard Iaboratory rodent diet (SDS LAD I) available ad libitum
- Water: drinking water available ad libitum
- Acclimation period: 5 days prior to start study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 22
- Humidity (%): 31-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Potassium ferrite was prepared at a concentration of 20% w/v in corn oil and administered at a volume of 10 mL/kg bodyweight in the main study
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- Mortality: Cages of rats were checked at least twice daily for any mortalities.
- Clinical signs: After dosing and at frequent intervals for the remainder of Day 1 (a period of four hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturdays, Sundays and public holidays.
- Bodyweights: The bodyweight of each rat was recorded on Days 1 (prior to dosing), 2, 3, 4, 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Macroscopic pathology: All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.

Results and discussion

Preliminary study:
One female rat was treated at 500 and 2000 mg/kg bodyweight to establish a dosing regime for the main study. The results indicated the acute lethal oral dose of Potassium ferrite to female rats to be greater than 2000 mg/kg bodyweight.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
other: Piloerection was observed in all rats within five minutes of dosing, accompanied in all rats later on Day 1 by hunched posture and additionally in all females by soft to liquid faeces. There were no other clinical signs and recovery was complete by either
Gross pathology:
Macroscopic examination of animals killed on day 15 revealed no abnormalities.

Applicant's summary and conclusion

Executive summary:
.