Cesium potassium fluoroaluminate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16 Dec 1999 to 06 March 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD 423 compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

Cesium potassium fluoroaluminate, purity 100%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Diet: Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud­ Turnhout, Belgium).
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day.

IN-LIFE DATES: From: 21 Dec 1999 To: 07 Jan 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accormplished to a visually acceptable level.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

The toxicity of the test substance was assessed by stepwise treatment of groups of 3 animals. The first group was treated at a dose level of 2000 mg/kg body weight. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were to be taken into account for determination of the time interval between the dose groups.

- Duration of observation period following administration: 14 days
- Body weight: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes. At the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: clinical signs: - Frequency of observations: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).

Results and discussion

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:

No clinical signs of systemic toxicity were noted.
One male showed alopecia and scabs in the neck before commencement of the study which persisted until day 1 (scabs) or day 11 (alopecia). These findings did not interfere with the purpose of the study and were not taken into account for interpretation of the outcome of the study.

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The oral LD50 value of Cesium potassium fluoroaluminate in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of Cesium potassium fluoroaluminate was studied according to the OECD 423 guideline, under GLP conditions. Cesium potassium fluoroaluminate was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. No clinical signs of systemic toxicity were noted.

The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

The oral LD50 value of Cesium Potassium Fluoroaluminate in Wistar rats was established to exceed 2000 mg/kg body weight. Based on this result, Cesium potassium fluoroaluminate is not harmful by ingestion according to the EC/1272/2008 CLP criteria and is not classified.