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Toxicological information

Basic toxicokinetics

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Objective of study:
absorption
excretion
toxicokinetics
Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 417 (Toxicokinetics)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.36 (Toxicokinetics)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other:
Deviations:
no

Test material

Radiolabelling:
yes

Test animals

Species:
mouse
Strain:
C57BL
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Type:
distribution
Type:
excretion

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Key result
Test no.:
#1
Toxicokinetic parameters:
Cmax:
Key result
Test no.:
#2
Toxicokinetic parameters:
Cmax:
Key result
Test no.:
#3
Toxicokinetic parameters:
Cmax:
Key result
Test no.:
#4
Toxicokinetic parameters:
Cmax:

Metabolite characterisation studies

Metabolites identified:
not measured

Applicant's summary and conclusion