Aluminate(1-), tetrafluoro-, cesium (1:1), (T-4)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-01-13 to 2017-03-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 2001
*Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris
*EPA Health Effects Test Guidelines (OPPTS 870.1100), United States, EPA 712-C-98-190 (1998)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

June 2015

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Caesium tetrafluoroaluminate

EC Number:

630-337-4

Cas Number:

39211-00-2

Molecular formula:

Al F4 . Cs

IUPAC Name:

Caesium tetrafluoroaluminate

Test material form:

solid: crystalline

Details on test material:

- Name of test material: Cesium tetrafluoroaluminate
- Chemical name: Cesium tetrafluoroaluminate
- Molecular formula: CsAlF4
- Physical state: White powder
- Analytical purity: Treated as 100%
- Purity: ≥ 96.0% CsAlF4
- Purity test date: 24/11/2016
- Lot/batch No.: BWF20627
- Storage condition of test material: Controlled Room Temperature 15-25°C, below 70% Relative Humidity (RH%), protected from humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 214 – 237 g
- Fasting period before study: On the night before treatment, the animals were fasted. The food but not water was withheld during an overnight period. The food was made available again at about 3 hours after the treatment.
- Housing: standard housing conditions ; 3 animals / cage, Type II polypropylene/polycarbonate cages, “Lignocel 3/4-S Hygienic Animal Bedding” and “Arbocel crinklets natural” nest building material produced by J. Rettenmaier & Söhne GmbH & Co.KG (D-73494 Rosenberg, Germany) were available to animals during the study.
- Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Diet: ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany (Batch number: 141 8884, expiry date: 31 January 2017 and Batch number:
484 14771, expiry date: 30 June 2017), ad libitum
- Water: tap water from the municipal supply, as for human consumption from 500 ml bottles, ad libitum
- Acclimation period: At least 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 25.8°C
- Humidity (%): 26 - 66%
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 am to 6.00 pm

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: The selection of the vehicle was made during trial formulations with the test item.
- Lot/batch no.: 2H22012N32
- Purity: 1% methylcellulose

CLASS METHOD
- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Clinical Observations
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

- Body Weight Measurement
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0), Day 7 and Day 14.
 
- Necropsy
All animals were subjected to a necropsy and a macroscopic examination. The animals were exsanguinated after verification of narcosis following an injection of pentobarbital sodium (Release; Lot No.: 106075, expiry date: July 2018, produced by: Wirtschaftsgenossenschaft deutscher Tierärzte eG, Siemensstr. 14, 30827 Garbsen, Germany). After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross macroscopic changes were recorded for each animal.

Statistics:

No statistics were performed.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Test item did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical signs:

No treatment-related observations were recorded at a dose level of 2000 mg/kg bw. All animals were symptom-free during the study.

Body weight:

There was no indication of a test item-related effect on body weight or body weight gain during the study.

Gross pathology:

There was no evidence of the macroscopic changes at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item Cesium tetrafluoroaluminate was found to be above 2000 mg/kg bw in female CRL:(WI) rats.

Executive summary:

The single-dose oral toxicity of cesium tetrafluoroaluminate was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris) in CRL:(WI) rats and GLP conditions.

Two groups of three females were treated at the dose level of 2000 mg/kg bw resulting in no mortality. All animals were symptom-free during the 14 -day observation period at a dose level of 2000 mg/kg bw. There were no effects on body weights or body weight gain that could be attributed to treatment with cesium tetrafluoroaluminate. There was no evidence of macroscopic observations in animals dosed at 2000 mg/kg bw and terminated on Day 14. Under the conditions of the study, the acute oral LD50 value of the test item cesium tetrafluoroaluminate was found to be above 2000 mg/kg bw.