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EC number: 213-254-4
CAS number: 932-64-9
Mean recovery results obtained
on each analytical occasion during the study were within ±10% of nominal
showing the continued accuracy of the method.
The mean concentrations were
within – 15%/+10% of nominal concentrations confirming the accuracy of
formulation, with the exception of Group 4 prepared for the last week of
study that was – 18.5% of nominal. The Group 4 contingency samples were
analyzed confirming the original result and therefore this formulation
was discarded and a new Group 4 formulation prepared. The Group 4
reformulation was within limits.
Mean serum T3
Female Dams (pg/mL)
No statistically significant
difference was identified between the control group and treatment groups
using a Williams test.
Mean serum T4
The purpose of this study was to assessof the influence of
Nitrotriazolone (an industrial chemical) on embryo-fetal survival and
development when administered during the organogenesis and fetal growth
phases of pregnancy in the Sprague Dawley rat.
Three groups of 20 females receivedNitrotriazoloneat doses of 100,
300 or 1000 mg/kg/day by oral gavage administration, from Day 6 to 19
after mating. A similarly constituted Control group received the
vehicle, 1% Methylcellulose at the same volume dose as the treated
groups. Animals were killed on Day 20 after mating for reproductive
assessment and fetal examination.
Clinical observations, body weight and food consumption were
recorded. Adult females were examined macroscopically at necropsy on Day
20 after mating, blood samples were taken for thyroid hormone analysis
and the gravid uterus weight and thyroid weight were recorded.
Microscopic pathology investigations were also undertaken on the
thyroids. Ano-genital distance was measured for fetuses and all fetuses
were examined macroscopically at necropsy and subsequently by detailed
internal visceral examination or skeletal examination.
The mean concentrations were within – 15%/+10% of nominal
concentrations confirming the accuracy of formulation, with the
exception of Group 4 prepared for the last week of study that was
– 18.5% of nominal. The Group 4 contingency samples were analyzed
confirming the original result and therefore this formulation was
discarded and a new Group 4 formulation prepared. The Group 4
reformulation was within limits.
There were no premature deaths attributable to treatment.
There was no effect of treatment on maternal clinical condition in
females receiving 100 or 300 mg/kg/day where two females receiving
1000 mg/kg/day showed signs of piloerection and one of which also had
shallow breathing and was observed as underactive.
There was no effect of treatment on body weight, thyroid weight,
macropathology or histopathology of the maternal thyroid. Maternal body
weight change (adjusted for the gravid uterine) was slightly high in
females receiving 300 or 1000 mg/kg/day. In addition, food intake for
females receiving 1000 mg/kg/day was slightly low at the start of
treatment but increased towards the end of gestation and therefore was
The analysis of serum TSH, T3 and T4 concentrations performed at
scheduled termination on Day 20 of gestation revealed that serum thyroid
hormone concentrations were comparable with endogenous levels at all
dose levels when compared with the control.
Embryo-fetal survival, fetal ano-genital distance and development
were unaffected by maternal treatment. The fetal weights were slightly
low from maternal females treated at 1000 mg/kg/day. There was an
increase in incidence of short supernumerary 14thribs in the
litters of females receiving 300 or 1000 mg/kg/day and were outside the
historical control data range. These findings were considered
Oral administration of Nitrotriazolone at dose levels of 100, 300
or 1000 mg/kg/day to pregnant Sprague Dawley rats throughout
organogenesis and the fetal growth phases was well tolerated, with no
adverse findings at any dose level. Consequently, the no observed
adverse effect level (NOAEL) for maternal toxicity and embryo-fetal
survival and development was considered to be 1000 mg/kg/day.
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