1-bromo-3,4,5-trifluorobenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

02-1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-bromo-3,4,5-trifluorobenzene

EC Number:

418-480-9

EC Name:

1-bromo-3,4,5-trifluorobenzene

Cas Number:

138526-69-9

Molecular formula:

Hill formula: C6H2BrF3 CAS formula: C6H2BrF3

IUPAC Name:

5-bromo-1,2,3-trifluorobenzene

Test material form:

liquid

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 Ltd., Manston, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 145 – 162 g
- Fasting period before study: overnight before dosing and 2 hours after treatment
- Housing: groups of 5 by sex in solid-floor PP cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24
- Humidity (%): 40 – 66
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regimen

IN-LIFE DATES: From days 1 to 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Dose volume: 1.13 mL/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 m / 5 f

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 7, 14 or at death
- Necropsy of survivors performed: yes (gross pathology)

Statistics:

Standard statistical methods have been applied for data processing.

Results and discussion

Preliminary study:

Yes: Range-finding with dose levels of 1000 or 2000 mg/kg, 1 m / 1 f for each dose level

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1/5 m, 0/5 f

Clinical signs:

other: The dosing caused common signs of lethargy. Additional signs of toxicity noted in females were hunched posture, decreased respiratory rate and red/brown stains around eyes and snout. An isolated incident of ataxia was also noted in one female. Surviving m

Gross pathology:

Abnormalities noted at necropsy of the male that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

For regulatory purposes, the median lethal dose (LD50) can be declared as > 2000 mg/kg.

Executive summary:

The undiluted test item was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401. The surviving animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

One male was found dead one day after dosing. Lethargy was commonly noted. Additional signs of toxicity noted in females were hunched posture, decreased respiratory rate and red/brown stains around eyes and snout. An isolated incident of ataxia was also noted in one female. Surviving males appeared normal one day after dosing while females appeared normal two to five days after dosing.

Surviving animals showed expected gain in bodyweight during the study.

Abnormalities noted at necropsy of the male that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals killed at the end of the study.

For regulatory purposes, the median lethal dose (LD50) can be declared as > 2000 mg/kg.