4-Pyrimidinecarboxamide, 2-(1-amino-1-methylethyl)-N-[(4-fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-6-oxo-

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:

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

Test material information

Constituent 1

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

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