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EC number: 423-270-5 | CAS number: 164462-16-2
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:
- 1 997
- Report date:
- 1997
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
Test material
Constituent 1
- 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
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