Registration Dossier
Registration Dossier
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EC number: 402-400-4 | CAS number: 54660-00-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- yes
- Remarks:
- Research & Consulting Company AG, Itingen / Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Physical state: solid
- Analytical purity: commercial grade
- Stability under test conditions: stable for at least 2 hours
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: KFM-Han, Wistar (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: males: 228 - 247 g, females: 176 - 191 g
- Fasting period before study: 12 to 18 hours
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 ± 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 ml at 5000 mg/kg
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1, daily durinq days 2-15; weighing: Test days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occured during study
- Clinical signs:
- other: Sedation, rales, dyspnea, curved body position, ruffled fur, extremities: red discolored (test article). All rats had recovered within 3 observation days.
- Gross pathology:
- No macroscopic organ changes mere observed.
Applicant's summary and conclusion
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