Tetraethylammonium tetrafluoroborate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 July - 21 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EC No 440/2008 Part B. Acute Oral Toxicity, Acute Toxic Class Method

Version / remarks:

May 2008

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)

Version / remarks:

November 2000, including the most recent revisions

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

tetraethylammonium tetrafluoroborate

Cas Number:

429-06-1

Molecular formula:

C8H20BF4N

IUPAC Name:

tetraethylammonium tetrafluoroborate

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

other: Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Number of Animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
- Age at the Initiation of Dosing: Young adult animals (approximately 11 weeks old).
- Weight at the Initiation of Dosing: 146 to 203 g.
- Housing: in groups of 3 in polycarbonate cages (Makrolon MIV type; height 18 cm.).
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study.
- Water (e.g. ad libitum): Municipal tap-water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Ten or greater air changes per hour
- Photoperiod (hrs dark / hrs light): A 12 hour light / 12 hour dark cycle was maintained.

IN-LIFE DATES: From: To: from 21 August 2018 to 20 September 2018

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Identification: Water (Elix)
- Supplier: Millipore S.A.S., Molsheim, France
- Specific gravity: 1.0
- Justification for choice of vehicle: Trial preparations were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure. Trial preparation formulations were not used for dosing and were discarded after the assessment is complete.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. Animals were weighed individually on Day 1 (predose), 8 and 15. A fasted weight was recorded on the day of dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination.

Statistics:

No statistical analysis was performed.

Results and discussion

Preliminary study:

NDA

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal was found dead on Day 1. No further mortality occurred.

Clinical signs:

other: Lethargy, hunched posture, uncoordinated movements, flat gait, piloerection, salivation and/or ptosis were noted on Days 1 and/or 2. On Days 6 and/or 7, hunched posture and/or piloerection reoccurred for two animals.

Gross pathology:

Beginning autolysis was found in the animal that died during the study, at macroscopic post mortem examination. No test item related abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

NDA

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The oral LD50 value of Tetraethylammonium tetrafluoroborate in Wistar Han rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The objective of this study was to determine the potential toxicity of Tetraethylammonium tetrafluoroborate, when given by oral gavage at a single dose to rats of a single sex at one or more defined doses to evaluate the potential reversibility of any findings.

Tetraethylammonium tetrafluoroborate was administered by oral gavage to two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. 

The oral LD50 value of Tetraethylammonium tetrafluoroborate in Wistar Han rats was established to exceed 2000 mg/kg body weight.

According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight.

Based on these results:

• according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments), Tetraethylammonium tetrafluoroborate should be classified as: may be harmful if swallowed (Category 5) for acute toxicity by the oral route.
• according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Tetraethylammonium tetrafluoroborate does not have to be classified and has no obligatory labelling requirement for oral toxicity.