Ethyl 2-bromobutyrate

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:

other: Performed following the OECD Guidelines for Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" and Method B1 tris Acute oral Toxicity (Oral - Acute toxic Class Method)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-bromobutyrate

EC Number:

208-574-6

EC Name:

Ethyl 2-bromobutyrate

Cas Number:

533-68-6

Molecular formula:

C6H11BrO2

IUPAC Name:

ethyl 2-bromobutanoate

Test material form:

other: Liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: 8 weeks
- Weight at study initiation: 203 - 242 g (Female), 290 - 323 g (Male)
- Fasting period before study: Overnight
- Housing: Solid-floor polypropylene cages
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Doses:

2000 mg/Kg & 200 mg/Kg

No. of animals per sex per dose:

3 female @ 2000 mg/Kg
3 female and 3 male @ 200 mg/Kg

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: ½, 1, 2 & 4 hrs and daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 - < 500 mg/kg bw

Based on:

test mat.

95% CL:

> 300 - < 500

Mortality:

2000 mg/Kg dose - all dead within 1 day
200 mg/Kg dose - all survived

Clinical signs:

Signs of systematic toxicity noted in animals treated with 2000 mg/Kg were hunched posture, lethargy, ataxia, decreased respiratory rate, laboured respiration, pilo-erection, diarrhoea and prostration.
No signs of systematic toxicity were noted in animals treated with 200 mg/Kg.

Body weight:

Body weight increase in the 200 mg/Kg dose level was as expected.

Gross pathology:

Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver, dark kidneys and sloughing of the
non-glandular epithelium of the stomach.
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:

harmful

Remarks:

Migrated information 300 - 500 mg/Kg Criteria used for interpretation of results: EU