Registration Dossier
Registration Dossier
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EC number: 473-870-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 96/54/EC, Method B1.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test animals
- Species:
- other: Rat, Wistar strain.
Administration / exposure
- Vehicle:
- other: Arachis oil BP.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 500 mg/kg bw; Number of animals: 2; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 2; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
Preliminary Study:
There were no deaths or clinical signs of toxicity at dose
levels of 500 and 2000 mg/kg bodyweight.
Based on this information a dose level of 2000 mg/kg
bodyweight was selected for the main study.
Main study:
There were no deaths.
No clinical signs of toxicity were noted during the study.
All animals showed expected gains in bodyweight over the
14-day study period. - Gross pathology:
- Effects on organs:
Main Study:
No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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