Triethylmethylammonium Tetrafluoroborate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-03-29 to 2006-04-27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001-12-17

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed November 2005

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

tetrafluoroboranuide; triethyl(methyl)azanium

Cas Number:

69444-47-9

Molecular formula:

C7H18BF4N

IUPAC Name:

tetrafluoroboranuide; triethyl(methyl)azanium

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Triethylmethylammonium tetrafluoroborate
- Physical state: Colourless crystals solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5°C), light protected, in a desiccator and under N2.
- Stability of test item: Stable under storage conditions

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS - (Rats were SPF)
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf/Switzerland
- Age at study initiation: 12 weeks
- Weight at study initiation: 166.1 g - 193.5 g
- Fasting period before study: Animals were fasted for apporximately 17 to 18 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (ad libitum except for fasting period, see above): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 001/06 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland)
- Water (ad libitum): Community tap water from Füllinsdorf
- Acclimation period: 7 days
Music during the daytime light period.

ENVIRONMENTAL CONDITIONS - air-conditioned
- Temperature: 22 ± 3°C
- Relative humidity: 30 - 70%
- Air changes: 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
Purified water was found to be a suitable vehicle.
Purified water prepared at RCC Ltd (deionised water which was processed and treated by the PURELAB Option-R unit. This latter links four purification technologies: reverse osmosis, adsorption, ion-exchange and photo oxidation).

APPLICATION VOLUME: 10 mg/kg body weight

DOSAGE PREPARATION (if unusual): The dose formulations were made shortly before each dosing occasion using a magnetic stirrer as homogenizer.
The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The glass beaker was wrapped with aluminium foil to protect the test item solution against light.
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.

Doses:

2000 mg/kg body weight
300 mg/kg body weight

No. of animals per sex per dose:

2000 mg/kg bw: 3 females
300 mg/kg bw: 6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 -15.
Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2 - 15.
- Necropsy of survivors performed: Yes
Macroscopic examination was performed on animals found dead or killed. Animals sacrificed for ethical reasons were killed by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 mL/kg body weight (equivalent to at lesat 324 mg sodium pentobarbitone/kg body weight).
All surviving animals were killed at the end of the observation period by Carbon dioxide asphyxiation.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One 2000 m/kg treated animal died spontaneously approximately 1 hour after treatment and the two remaining animals treated at the same dose were killed in extremis for ethical reasons approximately 2 hours after treatment. All animals treated at 300 mg/kg survived until the end of the study period.

Clinical signs:

other: Slightly ruffled fur with slight to moderate sedation was noted in all 2000 mg/kg treated animals at the 30-minute reading and persisted until death occurred just after the 1-hour or 2-hour reading. Moderate poor coordination was noted in all animals kill

Gross pathology:

Liquid contents in the stomach were noted in all 2000 mg/kg treated animals at the unscheduled necropsy. No macroscopic findings were recorded at necropsy of all 300 mg/kg treated animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

300 mg/kg body weight < LD50 (female rat) < 2000 mg/kg body weight (LD50 cut off value: 500)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is acutely toxic via the oral route (Category 4).