potassium ferrite

Acute Toxicity: oral

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Test guideline 2

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

Test material information

Constituent 1

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:

.