Registration Dossier
Registration Dossier
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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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
