Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 417 (Toxicokinetics)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics)

Test material

Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Main ADME results
Type:
absorption

Toxicokinetic / pharmacokinetic studies

Transfer into organs
Test no.:
#1
Transfer type:
other:
Observation:
other:
Toxicokinetic parameters
Test no.:
#1
Toxicokinetic parameters:
other:

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion