4-bromo-3,3,4,4-tetrafluorobut-1-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 March 2020 - 09 April 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-bromo-3,3,4,4-tetrafluorobut-1-ene

EC Number:

242-440-8

EC Name:

4-bromo-3,3,4,4-tetrafluorobut-1-ene

Cas Number:

18599-22-9

Molecular formula:

C4H3BrF4

IUPAC Name:

4-bromo-3,3,4,4-tetrafluorobut-1-ene

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD(SD)

Sex:

male

Details on test animals or test system and environmental conditions:

- Source: Charles River Raleigh, Raleigh, NC
- Age at study initiation: 8 weeks old
- Weight at study initiation: 244 to 302 g
- Fasting period before study: Animals were fasted the day before dosing.
- Housing: Group housing (up to 3 animals per cage) in polycarbonate cages, containing appropriate bedding material and an automatic watering valve. Animals were socially housed for psychological/environmental enrichment and were provided with items such as a chewing object. Edible enrichment treats were also offered throughout the study.
- Diet: Ad libitum (except during designated procedures), Pelleted Lab Diet Certified CR Rodent Diet 5CR4. (Based on analysis provided by the supplier it is considered that there were no known contaminants in the feed that interfered with the objectives of the study)
- Water: Ad libitum (except during designated procedures), Municipal tap water, treated by reverse osmosis and ultraviolet irradiation (Based on periodic analysis of the water it is considered that there were no known contaminants in the water that interfered with the outcome of the study.)
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 (targeted conditions)
- Humidity (%): 30-70 (targeted conditions)
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 March 2020 - 09 April 2020

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
No vehicle was used, the substance was administered as received.

DOSE VOLUME APPLIED:
2000 mg/kg bodyweight
The dose volume (1.29 mL/kg) did not exceed 20 mL/kg for aqueous preparations.

CLASS METHOD
Rationale for the selection of the starting dose: Because the test substance was thought to be of low toxicity, a limit test was conducted at a single high-dose level (e.g., 2000 mg/kg).

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

2 groups of 3 males/dose

Control animals:

no

Details on study design:

The test substance was administered using a syringe attached to a gavage cannula. Individual doses were calculated based on the animal’s fasted (Day 0) body weight. The dose formulations were inverted 5 times prior to dosing. Animals were returned to ad libitum feeding after dosing.

Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- Mortality/Viability: twice daily;
- Body weights: on the day of dosing (fasted weight) and on day 0 (pre-administration), 7 and 14;
- Clinical signs: at periodic intervals on the day of dosing (day 0) and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

The LD50 cut-off value was established based on OECD guideline 423. No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

There were no test substance-related clinical observations.

Body weight:

There were no test substance-related effects on body weight. All dosed animals gained weight from Day 0 to Day 14.

Gross pathology:

There were no test substance-related macroscopic pathology findings. Dark discoloration of the thymus (left lobe) in one animal was observed.This macroscopic pathology finding is a common incidental finding in toxicity studies for this age and strain of rat.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on an acute toxicity study performed according to OECD TG 423 and in accordance with GLP principles the acute oral LD50 of BTFB was determined to be > 2000 mg/kg in the male rat.