Registration Dossier
Registration Dossier
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EC number: 213-995-3 | CAS number: 1071-76-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Fate of n-Butanol in Rats after Oral Administration and its uptake by dogs after inhalation or skin application
- Author:
- DiVincenzo GD, Hamilton ML
- Year:
- 1 979
- Bibliographic source:
- Toxicology and Applied Pharmacology 48: 317-325
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- n-[1-14C]Butanol was mixed with corn oil and administered by gavage to male Charles River CD (SD) rats in doses of 4.5, 45, or 450 mg/kg bw. The excretion of the n-[1-14C]Butanol was examined.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Butan-1-ol
- EC Number:
- 200-751-6
- EC Name:
- Butan-1-ol
- Cas Number:
- 71-36-3
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-1-ol
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- C14
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
Doses / concentrationsopen allclose all
- Dose / conc.:
- 4.5 mg/kg bw (total dose)
- Dose / conc.:
- 45 mg/kg bw (total dose)
- Dose / conc.:
- 450 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- not specified.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- distribution
- Results:
- highest concentrations: liver 3.88 % at 8 h, blood 0.74 % at 8 h, kidney 0.24 % at 4 h, other tissue < 0.12 %
- Type:
- excretion
- Results:
- Elimination of administered dose 450 mg/kg bw: > 44 % within 4 h, 69.3 % at 8 h, 83.3 % at 24 h
- Type:
- other: remaining radioactivity in carcass
- Results:
- at 4 h: 42.2 %; at 8 h: 27.2 %; at 24 h: 12.3 %
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- About 75 % of the radioactivity was detected as 1-butanol, presumably both as an O-sulfate (44.4 %) and as an O-glucuronide (30.7 %). Urea accounted for the remainder of the radioactivity.
Applicant's summary and conclusion
- Conclusions:
- no bioaccumulation potential based on study results
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