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Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
EU Method B.3 (Acute Toxicity (Dermal))
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
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

Details on test animals or test system and environmental conditions:
- Source: Harlan U.K. Ltd, Bicester, Oxon, England
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 228 grams
- Housing: metal cages with wire mesh floors
- Diet : standard laboratory rodent diet (RM 1 (E) SQC) available ad libitum
- Water: drinking water available ad libitum
- Acclimation period: 11 days prior to start study

- Temperature (°C): 18.5 - 22
- Humidity (%): 37-59
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
corn oil
Details on dermal exposure:
TEST SUBSTANCE PREPARATION: Potassium ferrite was formulated at the maximum practical concentration of 83.33% w/v in corn oil and administered at a dose volume of 2.4 mL/kg bodyweight. The test material was prepared on the day of dosing. The absorption of the test substance was not determined.
ADMINISTRATION OF THE TEST SUBSTANCE: Due to the irritant nature of the test material only one female rat was treated (at 2000 mg/kg bodyweight). One day prior to treatment, hair was removed from the dorso-lumbar region of the rat with electric clippers taking care to avoid damaging the skin, exposing an area equivalent to approximately 10% of the total body surface area. The test substance was applied by spreading it evenly over the prepared skin. The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal. Treatment in this manner was performed on Day 1 (day of dosing) of the study only. At the end of the 24 hours exposure period the dressing was carefully removed and the treated area of skin was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Duration of exposure:
24 hours
2000 mg/kg bw
No. of animals per sex per dose:
1 female
Control animals:
Details on study design:
Due to the irritant nature of the test material only one female rat was treated (at 2000 mg/kg bodyweight)
- Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- Mortality: The rat was checked at least twice daily for mortality.
- Clinical signs: After dosing and at frequent intervals for the remainder of Day 1. On subsequent days the animal was observed once in the moming and again at the end of the experimental day (with the exception of Day 15 - moming only). Consideration was given each day as to whether continuation of the study was justified. The latter observation each day was at approximately 16.30 hours on week days or 11.30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation.
- Dermal responses: Local dermal irritation at the treatment site was assessed.
- Bodyweights: The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Weekly bodyweight changes were calculated.
- Macroscopic pathology: The animal was subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The cranial cavity was not examined as observations did not indicate neurotoxic activity. The macroscopic appearance of all tissues was recorded and any macroscopic abnormalities were preserved.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
There was no death following a single dermal application of Potassium ferrite to one female rat at a dosage of 2000 mg/kg bodyweight.
Clinical signs:
other: There were no signs of systemic response in the animal throughout the study.
Gross pathology:
No macroscopic abnormalities were observed for the animal killed on Day 15.
Other findings:
A severe dermal response, characterised by necrosis/whitening of the epidermis and moderate oedema, was evident following removal of the dressings. A similar level of dermal response was persistent through the study, with some slight recovery evident by day 13.

Applicant's summary and conclusion