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EC number: 244-617-5
CAS number: 21850-44-2
The objective of this study was todetermine
the potential toxicity of the chemical FR-720when
the material was administered to pregnant rats during the period of
Time-mated female Sprague Dawley rats were randomised into 3
treated groups and 1 control group. The study design was as follows:
No. of Animals
*The control item and vehicle for formulation was 0.5% (w/w) Carboxymethylcellulose (400-800 cps) and 0.1% (w/w) TWEEN® 80 in deionised water
Animals were dosed over Days 6-19, inclusive, of gestation (where
Day 0 of gestation was the day of detection of mating). They were
regularly monitored for clinical signs of toxicity, body weight and food
consumption, and were killed on Day 20 of gestation for examination of
pregnancies and embryo-fetal development.
There were no unscheduled deaths during the study.
At 300 or 100 mg/kg/day, increased incidences of soft/pale faeces,
erect and hunched posture were noted, when compared with controls, and
there were also incidences of decreased activity at 1000 mg/kg/day.
At 300 or 1000 mg/kg/day, reduced mean body weight gain over Days
6-20 of gestation (-7% and -12%, respectively) was noted when compared
with controls, with the reduced weight gain being most obvious over the
first approximate week of treatment (Days 6-13 of gestation). There were
no test item-related effects on body weight at 100 mg/kg/day.
At 1000 mg/kg/day, mean food consumption was approximately 20-40%
lower than controls over Days 9 to 12 of gestation, with recovery noted
from Day 13 of gestation. There were no test item-related effects on
consumption at 100 or 300 mg/kg/day.
There were no test item-related gross necropsy findings.
Uterine findings and fetal weights were comparable between control
and treated groups, and the type and distribution of major or minor
fetal abnormalities, variants and skeletal ossification parameters did
not indicate any association with treatment.
Maternal findings at 300 mg/kg/day were considered not to be
adverse due to low magnitude and no overall effect on pregnancy or fetal
development. At 1000 mg/kg/day, findings were considered to be adverse
to dams due to increased incidence and severity.
on the study results, it was, therefore, concluded that the maternal
No-Observed-Adverse-Effect-Level (NOAEL) was 300 mg/kg/day based on
increased incidences of clinical observations, reduced weight gain and
lower food consumption at 1000 mg/kg/day. The
fetal No-Observed-Adverse-Effect-Level (NOAEL) was considered to be
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