1-bromopropane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1st September - 15th September 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-bromopropane

EC Number:

203-445-0

EC Name:

1-bromopropane

Cas Number:

106-94-5

Molecular formula:

CH3CH2CH2Br

IUPAC Name:

1-bromopropane

Details on test material:

Purity is > 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: males = 184 ± 8 g. Females = 116 ± 3 g.
- Fasting period before study: 18 hours before dosing but with free access to water.
- Housing: The animals were housed in polycarbonate cages (48 x 27 x 30 cm) covered in a stainless steel lid.
- Diet (e.g. ad libitum): All animals had free access to AO4 pelleted diet
- Water (e.g. ad libitum): Animals had access to bottles filtered through a 0.22 micron filter.
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 50 ± 20 %
- Air changes (per hr): 13 per hour of non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 01/09/1993 To: 15/09/1993

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
N/A


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw


DOSAGE PREPARATION (if unusual): N/A

Doses:

2000 mg/kg bw. Limit test dose

No. of animals per sex per dose:

5 male and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations made at least once a day for 14 days. Body weights recorded on days 5, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination.

Statistics:

NDA

Results and discussion

Preliminary study:

NDA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female died during the observation period.

Clinical signs:

other: Clinical signs observed included sedation, lateral decubitus, dyspnoea and piloerection. All signs had disappeared by day 2.

Gross pathology:

No macroscopic abnormalities were observed.

Other findings:

N/A

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance 1-bromopropane when administered by the oral route was greater than 2000 mg/kg bw.

Executive summary:

An acute oral study (10611 TAR) was perfomed on ca. 6 week old male and female Sprague Dawley rats in a limit test with a single dosage of 2000 mg/kg. The test followed OECD guideline 401 and was performed to GLP standard.

Only one mortality was observed and therefore the LD50 of the test substance 1-bromopropane was determined to be greater than 2000 mg/kg bw.