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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:
2004

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

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
465-070-0
EC Name:
-
Cas Number:
518048-03-8
Molecular formula:
C16H19FN403
IUPAC Name:
2-(1-amino-1-methylethyl)-N-(4-fluorobenzyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
Details on test material:
L-000900405-000M004

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:
There were no abnormal physical signs noted during the observation period.
Body weight:
Body weight changes were normal.
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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