Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with GLP and appropriate OECD Guidelines

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): Iso-Propyl Bromide
- Physical state: Colourless liquid
- Analytical purity: > 99%
- Lot/batch No.: 1-302-1
- Storage condition of test material: Room temperature and protected from light

Test animals

Details on test animals or test system and environmental conditions:
Test Animals

Species, strain: rat, Sprague-Dawley ICO: OFA-SD (lOPS Caw).
Reason for this choice: rodent species commonly requested by the international regulations for this type of study.
Breeder: Iffa Credo, 69210 L'Arbresle, France.
Number and sex: one group of 10 animals (5 males and 5 females).
Age/weight: on the day of treatment, the animals were approximately 6 weeks old, and had a mean body weight of 176 ± 5 g for the males and 151 ± 5 g for the females.
Acclimatization: at least 5 days before the beginning of the study.
Identification of the animals: the animals were identified individually by earmarks or earnotches.

Environmental Conditions

During the acclimatization period and during the main test, the conditions in the animal room were as follows:
temperature : 22 ± 3°C
relative humidity: 50 ± 20%
light/dark cycle: 12 h/12 h
ventilation: about 13 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were recorded continuously and records retained.
The housing conditions (temperature, relative humidity, light/dark cycle and ventilation) were checked monthly.
The animals were housed in polycarbonate cages (48 x 27 x 20 cm) covered with a stainless steel lid . Each cage contained 4 to 7 animals of the same sex during the acclimatization period and 5 rats of the same sex during the treatment period. Each cage contained graded, dust-free sawdust (SICSA, 94142 Alfortville, France).
Bacteriological analysis of the sawdust and detection of possible contaminants (pesticides, heavy metals) are performed periodically.

Food and water

All the animals had free access to A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France). Each batch of food was analysed (composition and contaminants) by the supplier.
Drinking water filtered by a F.G. Millipore membrane (0.22 micron) was contained in bottles.
There were no contaminants in the diet, water or sawdust at levels likely to have influenced the outcome of the study.

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
2,000 mg/kg
No. of animals per sex per dose:
5 male/5 female
Control animals:
Details on study design:
The administration was performed in a single dose by oral gavage. The volume administered to each animal was adjusted according to body weight determined on the day of treatment. The single administration was performed on Day 1 and was followed by a 14-day observation period.

The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. Observation of the animals was made at least once a day for a period of 14 days, to determine whether any of the clinical
signs were reversible or not. Clinical signs were recorded for each animal individually.

The animals were checked frequently during the hours following administration of the test substance for mortality or signs of morbidity, then at least twice a day thereafter.

The animals were weighed individually just before administration of the test substance, and then on days 5, 8 and 15 for the surviving animals.
The body weight gain of the treated animals was compared to a reference curve of C.I.T. control animals with the same initial weight.

On day 15, the animals were sacrificed by CO2 inhalation in excess and a macroscopic examination was performed.

After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin. No microscopic examination was performed.

Evaluation of the innoxiousness or toxicIty of the test substance following a single oral administration in rats should include the relationship, if any, between the animals' exposure to the test substance and the incidence and severity of all abnormalities including behavioural and clinical abnormalities, macroscopic lesions, body weight changes, mortality and any other toxic effects.

Results and discussion

No deaths occurred during the observation period.
Clinical signs:
Hypoactivity (slight and marked), ataxia and piloerection were noted within 4 hours post-treatment. No clinical signs were observed thereafter.
Body weight:
The body weight gain of the animals was normal.
Gross pathology:
Macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities.

Any other information on results incl. tables

Table 1 -- Individual Clinical Signs and Mortality
Dose (mg/kg) Time Males Females Clinical Signs
2000 15 min 01-02-03-04-05 01-02-03-04-05 hypoactivity
  30 min 01-02-03-04-05 01-02-03-04-05 Sedation
  1 hr 04 02-05 Sedation, ataxia
  1 hr 01-02-03-05 01-03-04 Sedation
  2 hr 01-02-03-04-05 01-02-03-04-05 Sedation, piloerection
  4 hr 01-02-03-04-05 01-02-03-04-05 None
  Days 2 to 15 01-02-03-04-05 01-02-03-04-05  
Table 2 -- Individual Body Weight and Body Weight Change of Treated Rats (g)
Dose Sex Animal No. Days
mg/kg     1 (1) 5 (1) 8 (1) 15
2000 Male 01 184 50 234 27 261 58 319
    02 72 46 218 30 248 49 297
    03 173 52 225 28 253 62 315
    04 175 52 227 22 249 61 310
    05 175 43 218 26 244 60 304
2000 Female 01 159 43 202 13 215 27 242
    02 148 44 192 16 208 18 226
    03 148 45 193 0 193 16 209
    04 147 26 173 14 187 20 207
    05 152 57 209 7 216 10 226
(1) = Body weight gain
Table 3 - Individual Macroscopic Post-Mortem Examinations
Dose (mg/kg) Time Males Females Macroscopic Abnormalities
2000 Day 15 01-02-03-04-05 01-02-03-04-05 None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: expert judgment
Under the experimental conditions described in this study, the LDo of the test substance Iso-Propyl Bromide when administered by oral route in rats was higher than 2,000 mg/kg.
Executive summary:

In a CoR 1 acute oral toxicity study, five male and five female Sprague-Dawley rats were administered a single dose of 2,000 mg/kg bw 2 -bromopropane (>99% purity) and were observed for 14 days following exposure. No deaths occurred as the result of exposure. No lasting clinical signs were noted. Bodyweight gain was unaffected. No apparent aabnormalities to organs or tissues were noted on gross pathology.


Oral LD0 Males = > 2,000 mg/kg bw

      Females =  > 2,000 mg/kg bw

      Combined =  > 2,000 mg/kg  bw