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EC number: 201-328-9
CAS number: 81-14-1
In a developmental toxicity study (32108) musk ketone was administered
to 25 female CrI:CD BR VAF/Plus (Sprague-Dawley)/dose in corn oil by
gavage at dose levels of 0, 15, 45, 150 mg/kg bw/day from days 7
through 17 of gestation.
No abortions, premature deliveries or deaths occurred during the study.
All rats survived until scheduled sacrifice. Increased incidences of
dried feces and perioral substance occurred in the 45 mg/kg bw/day
dosage group; these two adverse clinical observations, as well as
urine-stained abdominal fur, excessive salivation, dehydration, red
substance on forepaws and tremors occurred in significantly increased
numbers (p≤O.01) in the 150 mg/kg bw/day dosage group rats, and one or
two 150 mg/kg bw/day dosage group rats also had chromorhinorrhea or
chromodacryorrhea. Effects were first observed on gestation days (DGs)
13 and 7 in the 45 and 150 mg/kg bw/day dosage groups, respectively.
Urine stained abdominal fur, perioral substance, dehydration and dried
feces continued to occur in a few 150 mg/kg bw/day dosage group rats
during the postdosage period (DGs 18 to 20).
Dosage-dependent, statistically significant (p≤O.05 to p≤O.01)
reductions in weight gains and absolute Cg/day) and relative Cg/kg/day)
feed consumption values for the entire dosage period (calculated as DGs
7 to 18) occurred in the 45 and 150 mg/kg bw/day dosage groups. These
effects of the test article were most severe on DGs 7 to 10, when
signi6cant weight loss (p≤O.01) occurred in the 150 mg/kg bw/day dosage
group. These two dosage groups had significant increases (p≤O 05 to
p≤O.01) in body weight gains and absolute and relative feed consumption
values after completion of the dosage period (DGs 18 to 20), rebound
phenomena that commonly occur in these types of studies. Despite these
rebound phenomena, body weight gains and absolute and relative feed
consumption values for the entire period after initiation of dosage (DGs
7 to 20) and for the entire pregnancy (DGs 0 to 20) were reduced or
significantly reduced (p≤O.05 to p≤O 01) in the 45 and 150 mg/kg bw/day
dosage groups. Body weights were generally significantly reduced
(p≤O.05 to p≤O.01) on DGs 8 through 20 in the 45 and 150 mg/kg bw/day
Pregnancy incidences were comparable in the four dosage groups. The 150
mg/kg bw/day dosage was associated with increased postimplantation loss
[evident as significant increases (p≤O.05) in the litter averages for
total and early resorptions, a tendency for increased late resorptions
and percentage of resorbed conceptuses per litter, and increased numbers
of dams with any resorptions or with all conceptuses dead or resorbed]
and significantly reduced (p≤O.01) fetal body weight. The values for
the various parameters identifying postimplantation loss generally
exceeded the historical ranges of the Testing Facility but were not
sufficiently severe to result in statistically significant or
biologically important differences in live litter size. No
dosage-dependent, statistically significant or biologically important
differences occurred in the litter averages for corpora lutea,
implantations or percent male fetuses. Two 150 mg/kg bw/day dams had
litters consisting of only resorbed conceptuses. There were no dead
fetuses. All placentae appeared normal except those of a 150 mg/kg
bw/day dosage group dam that had peripartum bleeding, which appeared
All gross external, soft tissue and skeletal malformations and
variations in the fetuses were considered unrelated to the test article.
The maternal NOAEL is 15 mg/kg bw/day. The 45 and 150 mg/kg bw/day
dosages were toxic to the dams resulting in adverse clinical
observations and reductions in maternal body weight gains, body weights
and absolute and relative feed consumption values.
The developmental NOAEL is 45 mg/kg/day. The 150 mg/kg bw/day dosage
was associated with increased post-implantation loss (total and early
resorptions) and reduced fetal body weight. Based on these data, musk
ketone is not selectively toxic to development. Adverse effects on
embryo-fetal development (post-implantation loss and reduced fetal body
weight) occurred only at the higher of two dosages that were toxic to
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