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EC number: 208-760-7
CAS number: 540-88-5
Based on stability analyses from test substance storage containers and
inhalation vapor generation reservoirs, the test substance was found to
be stable when stored at room temperature in the sponsor-supplied drums
over the duration of the study and was stable for at least 7 days when
stored at room temperature in the inhalation atmosphere generator
In a subchronic toxicity study, tertiary butyl acetate was administered
to 30 CD-1 mice/sex/group via whole-body inhalation at target exposure
concentrations of 0, 100, 400 and 1600 ppm (actual concentrations were
0, 101, 400 and 1698 ppm) for 6 hr/day, 7 days/wk for 90 days. Test
substance-related effects were limited to transient clinical
observations in the 400 and 1600 ppm groups (hyperactivity and excessive
grooming at post-exposure observations and impaired equilibrium and
labored respiration [1600 ppm only] at the exposure midpoint) and slight
liver enlargement in both sexes at 1600 ppm (as evidenced by higher
liver weights) associated with minimal centrilobular hypertrophy in a
single female and a marginally higher PCNA labeling index in 1600 ppm
females only. Liver weight effects were more pronounced in female
mice. In addition, lower statistically significant mean T4 levels were
found in 1600 ppm group males.
In a 2-week inhalation toxicity study used to establish exposure levels
for the 13-week study, higher liver weights were found for females and
minimal centrilobular hypertrophy was observed in 2 of 5 males and 5 of
5 females exposed to 1500 ppm. The pattern of these liver findings,
including the higher incidence of centrilobular hypertrophy in animals
exposed to a similar concentration for a shorter duration, appears to
represent metabolizing enzyme induction. Findings related to liver
enzyme induction have been reported to be typically less pronounced
following long-term repeated exposure than following short-term repeated
The NOAEC for acute effects in the 13-week study is considered to be 100
ppm based on transient clinical findings that were observed in the mid-
and high-exposure groups during and following exposures while the NOAEC
for systemic target organ effects was considered to be 400 ppm for male
and female CD-1 mice based on minimal effects on the liver.
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