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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity is > 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
Clinical signs observed included sedation, lateral decubitus, dyspnoea and piloerection. All signs had disappeared by day 2.
Body weight:
The body weight gains of the surviving animals was reported to be normal.
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.