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EC number: 430-010-4 | CAS number: 12160-44-0
Toxicological information
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- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
- 1 997
- 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
- 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
Constituent 1
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:
- .
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