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Toxicological information

Basic toxicokinetics

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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:
1979
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
Name:
Unnamed
Type:
Constituent
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:
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