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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-04-08 to 2008-04-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001-12-17
Deviations:
yes
Remarks:
rationale for the selection of the starting dose is missing; control group is used (not foreseen by the guideline)
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2007-02-15
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Imidazole hydrobromide
Cas Number:
101023-55-6
Molecular formula:
C3H5BrN2
IUPAC Name:
Imidazole hydrobromide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Imidazolhydrobromid
- State of aggregation: white powder
- Stability in water: 3 months
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: 190 to 210 g
- Fasting period before study: day before treatment food was removed and restored 4 hours after test item administration
- Housing: three rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; bedding: sawdust
- Diet (ad libitum)
- Water (ad libitum): drinking water (tap-water from public distribution system)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 °C - 23 °C
- Relative humidity: 42 % - 56 %
- Air exchanges: at least ten changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Batch no.: 100284201

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw (control group: 2 mL/kg bw)

DOSAGE PREPARATION:
The test item was freshly prepared in distilled water.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Treatment group: 6 female rats (3 females/step)
Control group: 6 female rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: during the acclimatisation period the animals were observed once a day. Furthermore, observations were carried out 30 minutes as well as 1, 3, and 4 hours after test item administration followed by daily administration.
The animals were weighed just before administeration of the test item (day 0) then on days 2, 7, and 14. Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes, macroscopic examinations were carried out. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
Statistics:
not applicable

Results and discussion

Preliminary study:
not applicable
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs were observed during the acclimatisation period.
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the treated and control animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the treated animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.

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