Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- Test material contained approximately 31.1% water so the dosing preparations were corrected for water content.
- Lot/batch No.: Bx2712/2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zeneca
- Age at study initiation: young adults
- Weight at study initiation: male=303-329g female=208-236g
- Fasting period before study: No
- Housing: Suspended cages (32.5cm x 37.5cm x 23cm) stainless steel
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 °C
- Humidity (%): 40-70%
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: hydroxypropylmethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage): 10ml/kg - Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days post dose
- Frequency of observations and weighing: daily observations, weighing days -1, 1, 2, 3, 4, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, post mortem examination
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None of the animals died
- Clinical signs:
- other: There were no signs of toxicity in any animal at any time during the study
- Gross pathology:
- No treatment related macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was >2000 mg/kg to rats.
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