Potassium tetrafluoroborate

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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium tetrafluoroborate

EC Number:

237-340-6

EC Name:

Sodium tetrafluoroborate

Cas Number:

13755-29-8

Molecular formula:

BF4.Na

IUPAC Name:

sodium tetrafluoroborate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): sodium tetrafluoroborate
- Physical state: white crystalline solid
- Lot/batch No.: 1364A
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, UK
- Age at study initiation: ca. 5-8 weeks
- Weight at study initiation: 120-146 g (males), 120-147 g (females)
- Fasting period before study: overnight
- Housing: in groups of up to 5 by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet No. 1, Special diet Services Limited, witham, Essex, UK, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 42-68
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1/sex/dose in the dose-range finding study; 5/sex/dose in the main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily
- Frequency of weighting: individual body weights were recorded prior to dosing on day 0 and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

There were no deaths or clinical signs of toxicity in the dose-range finding study using a single dose level of 2000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the observations the LD50 of the test substance is greater than 2000 mg/kg body weight

Executive summary:

In a GLP-compliant OECD Guideline 401 study with rats, sodium tetrafluoroborate was administered to 5 male and 5 female rats (2000 mg/kg bw) by gavage. Animals were observed for 14 days and necropsied. There were no deaths or clinical signs of toxicity. All animals gained weight during the study. No pathological findings were revealed at necropsy. Based on the results of the study, the LD50 was above 2000 mg/kg bw.