Trifluoro(isopropylamine)boron

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trifluoro(isopropylamine)boron

EC Number:

223-230-5

EC Name:

Trifluoro(isopropylamine)boron

Cas Number:

3776-04-3

Molecular formula:

C3H9BF3N

IUPAC Name:

boron(3+) ion propan-2-amine trifluoride

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Species Wistar rats
Source Slovak Academy of Sciences Dobrá Voda, Slovak Republic
Number and Sex of Animals 9 females
Age at First Dose 8-9 weeks; female animals were non-pregnant and nulliparous
Animal Health Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treat ment.
The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, 3 animals per cage in a room equipped with central airconditioning. The average room temperature was maintained within the range of 22.95 ± 0.46 °C, relative humidity within 54.84 ± 2.66 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard oper ation procedures.
Diet The laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at t he same time. The certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodical ly analysed and recorded; certificate of analysis is included in the raw data.
Bedding Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study co de, ID of animals and date of administration of the test item.
Justification for the Choice of Species Normally females are used for testing according to OECD TG 423 because females are typically the more sensitive gender.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted 10-12 h prior to dosing (food but not water was withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test item administration, food was withheld for further 3-4 hours.

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A dose of 300 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was observed within 30 minutes in two animals after administration of the test item. In a second step 3 females were treated at the dose of 50 mg/kg body weight. All females survived 24 hours and therefore another 3 females (third step) were treated at the same dose of 50 mg/kg body weight.

No. of animals per sex per dose:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. A dose of 300 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was observed within 30 minutes in two animals after administration of the test item. In a second step 3 females were treated at the dose of 50 mg/kg body weight. All females survived 24 hours and therefore another 3 females (third step) were treated at the same dose of 50 mg/kg body weight.

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

300 mg/kg bw

Based on:

test mat.

Mortality:

Mortality of 2/3 females at a dose of 300 mg/kg body weight was noted. All 6/6 females survived the dose of 50 mg/kg body weight.

Clinical signs:

Test item-related mortality in females treated with the test item at the dose of 300 mg/kg body weight was observed within 30 minutes after administration of the test item in animals No 1 and No 3. In animal No 2, spasm was noted one hour after administration of the test item and tremor was observed two hours after administration.
No mortality was observed in females treated with the test item at the dose of 50 mg/kg body weight. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.

Body weight:

The body weights of all survived animals increased during the study. A stagnation of the body weight in animal No 5 was observed between the first and the second week after administration.

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic findings were observed

Any other information on results incl. tables

The test item “BF3-isopropylamine-complex” administered to 3 females at the dose of 300 mg/kg body weight caused death of 2/3 animals within 30 minutes. Spasm and tremor were observed during the observation period. No signs of toxicity were observed during the first 4 hours and the 14-day observation period thereafter in females treated with the dose of 50 mg/kg body weight. The body weights of all survived animals increased during the study. A stagnation of the body weight in one animal was observed between the first and the second week after administration. During necropsy, no macroscopic findings were observed. 

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 of the test item “BF3-isopropylamine-complex” is higher than 50 mg/kg body weight and lower than 300 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 300 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “BF3-isopropylamine-complex” is according to GHS criteria classified in Category 3 with a LD50 cut off value 300 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item “BF3isopropylamine-complex” when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. 

The test item “BF3-isopropylamine-complex” administered to 3 females at a dose of 300 mg/kg body weight caused death of 2/3 animals within 30 minutes. Spasm and tremor were observed during the observation period. 

No mortality was observed in females treated with the test item at a dose of 50 mg/kg body weight. No signs of toxicity were observed during the observation period. The body weights of all survived animals increased during the study. A stagnation of the body weight in one animal was observed between the first and the second week after administration. During necropsy, no macroscopic findings were observed. 

The LD₅₀of the test item “BF3-isopropylamine-complex” is higher than 50 mg/kg body weight and lower than 300 mg/kg body weight after single oral administration to Wistar rats.

Based on Annex 2d Test Procedure with a Starting Dose of 300 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “BF3-isopropylamine-complex” is according to GHScriteria classified in Category 3 with a LD₅₀cut off value 300 mg/kg body weight, after single oral administration to Wistar rats.