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EC number: 200-889-7
CAS number: 75-65-0
STABILITY AND DOSE CONFIRMATION TESTS:
Stability: Stability was determined for the low and high dose levels.
The preliminary mixes of tertiary butyl alcohol in water were stable for
8 days when stored at room temperature and the mean % nominal values of
all samples were within ±10% of initial concentrations.
Dose Confirmation: All groups were assayed in duplicate on 3 occasions.
The % nominal values for all dose groups were within the test
laboratories SOP specified limits. The concentrations of duplicates of
the samples were within ±10% of each other, and the means of
concentration were within ±10% of nominal.
In a reproduction/developmental toxicity screening study, tertiary butyl
alcohol was administered to 12 Sprague-Dawley rats/sex/group by oral
gavage at dose levels of 0, 64, 160, 400, and 1000 mg/kg bw/day for up
to 63 days in males and from 4 weeks prior to mating through PND 21 in
females. There were no adverse effects on any reproductive parameters
including mating index, fertility index, pregnancy index, or gestation
For dams receiving 1000 mg/kg bw/day tertiary butyl alcohol through
gestation and lactation, there was a significant reduction in mean
litter size, a decrease in the number of live born per pregnancy, an
increase in the number of stillborn pups, increased pup mortality up to
PND 4, and a decrease in mean pup body weight at birth which continued
to weaning. At this dose level, mild to moderate transient systemic
toxicity was observed in both sexes in the parental generation including
reversible CNS effects such as lethargy and ataxia, and reduced feed
consumption and weight gain.
No significant toxicity was observed at any other dose level. The NOAEL
for developmental/reproductive effects was 400 mg/kg bw/day. The NOAEL
for overall toxicity was 160 mg/kg bw/day
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