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EC number: 200-889-7
CAS number: 75-65-0
of this study was to investigate the biotransformation of tertiary butyl
alcohol in male Fischer 344 rats following oral administration and
compare the metabolic urinary profile of rats with that of a human male
also administered [13C]-tertiary butyl alcohol by the oral route. Details
of the study in a single human male are located in Section 7.10.5 of
this submission. Based
on a comparison of NMR spectra, the metabolic profile in both species
was qualitatively similar. Conjugation
of tertiary butyl alcohol with glucuronic acid resulted in urinary
excretion of the glucuronide conjugate in both species. There
was also indirect evidence for formation of a sulfate conjugate of
tertiary butyl alcohol. Intensities of the [13C] signal in the NMR
spectra of rat urine suggest this is a major pathway of tertiary butyl
alcohol biotransformation in the rat. The
authors suggested that low recovery of the presumed tertiary butyl
alcohol sulfate in human urine was based on a low affinity of human
sulfotransferase-(s) for tertiary butyl alcohol. The
presence of 2-methyl-1,2-propanediol and 2-hydroxyisobutyrate in urine
of both species suggest further oxidative metabolism of tertiary
butyl alcohol. The
likely pathway for the formation of these metabolites involves oxidation
of tertiary butyl alcohol by cytochromes P450 to give
2-methyl-1,2-propanediol which is further oxidized to
was also reported as a minor metabolite in male rats.
metabolism study designed to investigate the biotransformation of
tertiary butyl alcohol following oral administration and compare the
urinary metabolic profile of rats and a human administered a single dose
of tertiary butyl alcohol by the oral route, rats were administered a
single dose of either [12C]- or [13C]-tertiary butyl alcohol in corn oil
by oral gavage. There
was a qualitatively similar metabolic profile in both rats and the
single human. The
major metabolites identified in the urine of both species were
2-methyl-1,2-propanediol and 2-hydroxyisobutyrate. Unconjugated
tertiary butyl alcohol and tertiary butyl alcohol glucuronide were
present as minor metabolites. Differences
were also observed. In
the rat, the presumed tertiary butyl alcohol sulfate was present as a
major metabolite while in the single human, only traces of the sulfate
were present. [13C]-Acetone
was also reported as a minor metabolite in rats while no acetone was
reported in human urine.
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