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EC number: 203-838-7
CAS number: 111-14-8
Dryness around the mouth
Reddish vaginal discharge and Blood in the bedding
Body weight and body weight changes:
Body weight change
Days 6 - 29p.c.
Days 6 - 9p.c.
Days 9 - 12p.c.
Days 24 - 29p.c.
significance: *: p<0.05; **: p<0.01; in brackets and italic: differences
from controls (%).
Days 15 - 19p.c.
significance: *: p<0.05, #: p<0.001; in brackets and italic: differences
from controls (%).
Colored deposit (brownish)
Colored area(s) (often reddish and depressed)
Colored focus (i)
Total number of animals with at least one finding in stomach:
Translucent contents in the gallbladder
Liver: whitish colored focus
Liver: colored nodule
Liver: irregular color
Absent left kidney/ureter
Dilated brachiocephalic trunk
Absent aortic arch
Dilated left pulmonary artery
Dilated aortic arch
Statistically different from controls: *:
p<0.05; a: one same fetus; b: one same fetus; HCD: Historical Control
Data 2008-2013 [litter incidences], except liver: colored nodule:
2006-2010; -: not in HCD.
The objective of this prenatal
developmental toxicity study was to evaluate the potential toxic effects
of the test item on the pregnant female and on embryonic and fetal
development following daily oral administration (gavage) to pregnant
female rabbits from implantation to the day prior to the scheduled
hysterectomy (Day 6 to Day 28 post-coitum (p.c.)
inclusive) at dose levels of 100, 300 or 1000 mg/kg/day..
On Day 29 p.c.,
females were sacrificed and submitted to a macroscopic post-mortem examination.
Hysterectomy was performed and the numbers of corpora lutea,
implantations, early and late resorptions, and live and dead fetuses
were recorded. The fetuses were weighed, sexed and examined for
external, soft tissue and skeletal/cartilage abnormalities.
changes were observed:
There were no unscheduled deaths
except at 1000 mg/kg/day where two pregnant females were found dead
around mid-gestation; this was considered to be related to the test item
The most relevant test item
treatment-related clinical sign was dryness around the mouth at 300 and
1000 mg/kg/day. Loud breathing was also recorded in a few females
treated at 300 and 1000 mg/kg/day, included the dead females.
At 300 and 1000 mg/kg/day, there were
slightly mean body weight losses at the beginning (1000 mg/kg/day) and
at the end (both doses) of the dosing period. Mean food consumption was
reduced at treatment initiation and towards mid-gestation (p<0.05) at
1000 mg/kg/day but mainly at the end of the treatment at 300 and 1000
At necropsy, the high incidence of
findings in the stomach (i.e. reddish mucosa, reddish area on the
mucosa, thickened mucosa, reddish foci on the mucosa) in all test
item-treated groups was considered to be due to the corrosive properties
of the test item.
There were no test item
treatment-related external, soft tissue or skeletal malformations or
The test item was administered by
gavage daily from Day 6 to Day 28 p.c .to inseminated
female New Zealand White rabbits at 100, 300 and 1000 mg/kg/day.
On the basis of the results obtained
in this study:
No Observed Adverse Effect Level (NOAEL) for maternal parameters was
considered to be 300 mg/kg/day, based mainly on the 2 dead dams at 1000
NOAEL for embryo-fetal development was considered to be 1000 mg/kg/day,
based on the absence of adverse effects in the fetuses.
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