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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Objective of study:
absorption
excretion
Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 417 (Toxicokinetics)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Results:
incomplete absorption of 17-33 % of the dose applied
Type:
excretion
Results:
rapid urinary excretion half-life of 3-6 h

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Single oral administration
500 mg/kg bw:
- Average dose: about 465.2 mg/kg bw (nominal).
- Bioavailability: 20.94 % of the administered substance
- Mean residence time: 10.2 h

25 mg/kg bw:
- Average dose: about 24.1 mg/kg bw (nominal).
- Bioavailability: 16.98 % of the administered substance
- Mean residence time: 4 h

Repeated oral administration (500 mg/kg bw):
- Average dose: about 475.8 mg/kg bw/day (nominal).
- Bioavailability: 32.94 % of the administered substance
- Mean residence time: 17.5 h



Details on distribution in tissues:
During the 7 days administration period, the body weight of the animals decreased continously which indicates systemic availability of the test item. It increased again during the 72 h observation period following the last administration.
Details on excretion:
Single oral administration
500 mg/kg bw:
- Excretion half-life: 6.1 h (urinary excretion)
- Details of excretion: 20.94 % of the administered substance was urinary excreted within 72 h; 80 % thereof within the first 12 h post application


25 mg/kg bw:
- Excretion half-life: 2.5 h (urinary excretion)
- Details of excretion: 16.98 % of the administered substance was urinary excreted within 72 h; 100 % thereof within the first 12 h post application


Repeated oral administration (500 mg/kg bw):
- Excretion half-life: 6.3 h (urinary excretion)
- Details of excretion: 32.94 % of the administered substance was urinary excreted within the treatment period and up to 72 h after the last administration

Metabolite characterisation studies

Metabolites identified:
not measured

Applicant's summary and conclusion