Registration Dossier
Registration Dossier
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EC number: 465-070-0 | CAS number: 518048-03-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- November 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- The 3 hour systemic observations were inadvertantly not recorded. This did not effect the outcome of the study since the animals were normal at the 2 hour and 4 hour observation periods
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- -
- EC Number:
- 465-070-0
- EC Name:
- -
- Cas Number:
- 518048-03-8
- Molecular formula:
- C16H19FN403
- IUPAC Name:
- 2-(2-aminopropan-2-yl)-N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
- Details on test material:
- L-000900405-000M004
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methyl cellulose 1%
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females
Results and discussion
- Mortality:
- All six animals survived the 2000 mg/kg oral dose in good health.
- Clinical signs:
- other: There were no abnormal physical signs noted during the observation period.
- Gross pathology:
- Necropsy Findings : necropsy results were normal
Applicant's summary and conclusion
- Interpretation of results:
- other: practically non-toxic if swallowed
- Remarks:
- Criteria used for interpretation of results: EU
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