Registration Dossier
Registration Dossier
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EC number: 611-832-4 | CAS number: 59468-73-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12/06/2008-28/07/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, OPPTS 870.1000 "Acute toxicity testing background"
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Methanone, [2-[5-(aminomethyl)-2-methyl-1H-imidazol-1-yl]-5-chlorophenyl](2-fluorophenyl)-, dihydrochloride
- EC Number:
- 611-832-4
- Cas Number:
- 59468-73-4
- Molecular formula:
- C18H17Cl3FN3O
- IUPAC Name:
- Methanone, [2-[5-(aminomethyl)-2-methyl-1H-imidazol-1-yl]-5-chlorophenyl](2-fluorophenyl)-, dihydrochloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
- Weight at study initiation: step 1: 160-174 g, step 2: 154-165 g, step 3: 152-159g
- Fasting period before study:
- Housing: barrier maintained (semi-barrier) in an air conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55+/- 10%
- Air changes (per hr): 10x/ hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: due to it's non-toxic charachteristics
- Lot/batch no. (if required): Lot 15608D
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 1.step - item was given at the dose of 2000 mg/kg bw
2.step was performed at a dose of 300 mg/kg bw
3. step was performed at a dose of 300 mg/kg bw - No. of animals per sex per dose:
- 3 females per step
- Control animals:
- yes
- Details on study design:
- The surviving animals were observed for 14 days after dosing.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- step 1 - compound -related mortality was found in all three animals of step
step 2 - compound-related mortality was found in 1 animal of step 2
step 3- no compound-related mortality was found in any animal of step 3 - Clinical signs:
- Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observation of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Body weight:
- Throughout the 14-days observation period no weigh loss was recorded in any surviving animal. The weigh gain was within the expected range.
- Gross pathology:
- At the end of the observation period the surviving animals were sacrificed by an overdosage of pentobarbital. All animals were subjected to gross necropsy.
Beside acute injection of blood vessekls in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were found in any animal of any step. - Other findings:
- Step 1 - in all animals the stomach contained remains of the test item.
step 2 - animal N.3 - the stomach and the small intestine contained yellow coloured remains of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Considering the reported data of this toxicity test it can be stated that the test item A0800290 showed acute orally toxic characteristics. According to GHS the test item A0800290 was classified into Category 4.
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