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Registration Dossier
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 7 to October 22, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Details on test material:
- - Physical state: white solid
- Analytical purity: 99%
- Lot/batch No.: 08-018
- Expiration date of the lot/batch: July 26, 2013
- Storage condition of test material: room temperature (permissible range: 10-30°C, actual values: 18.1-25.3°C ) in light-shielded and air-tight container)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Body weight at administration: 194-214g (all within ±20% of the mean value)
- Fasting period before study: 18 hours
- Housing: Autoclave-sterilized polycarbonate cages (W265*D426*H200)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4-23.5
- Humidity (%): 46.3-69.0
- Air changes (per hr): 6-20 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Tween80 and CMC-Na
- Details on oral exposure:
- VEHICLE
-Preparation: 0.5 w/v% CMC-Na and 0.1 w/v% Tween 80 dissolved in purified water (stored in refrigerator and used within 4 days)
- Concentration in vehicle: 30 and 200mg/mL
- Amount of vehicle (if gavage): 10mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: There was no information on toxicity of the test substance or related substances. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations: before dosing and 10 and 30 minutes and 1, 3 and 6 hours after the dosing on the day of the administration and once daily for 14 days thereafter
-Measurement of body weight: on days 1(just before the administration) , 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and body weight gain
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no dead animals.
- Clinical signs:
- No abnormal clinical signs were noted.
- Body weight:
- No abnormal body weight change were noted.
- Gross pathology:
- There were no abnormal change in gross pathology.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of the test substance after single oral administration to rats was > 2000 mg/kg
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