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EC number: 482-020-3
CAS number: -
purpose of this study was to evaluate the maternal and developmental
toxicity of 1,3- and 1,4-cyclohexanedicarboxaldehyde in Crl:CD(SD) rats
following repeated gavage administration.Groups of 24 time-mated female
rats were administered 1,3- and 1,4 -cyclohexanedicarboxaldehyde by
gavage in corn oil on gestation day (GD) 6 through 20 at dose levels of
0, 25, 75 and 225 mg/kg/day. These dose levels were selected based upon
a treatment-related ulceration of the stomach in a single dam at 250
mg/kg/day along withgastric hyperkeratosis and hyperplasia in three of
five damsin a preceeding developmental toxicity probe study. The stomach
ulceration observed at 250 mg/kg/day in the developmental toxicity probe
study showed that this dose level exceeded an acceptable high dose level
for the full developmental toxicity study. In-life maternal study
parameters included clinical observations, body weight, body weight gain
and feed consumption. On GD 21, all rats were euthanized and examined
for gross pathologic alterations. Liver, kidneys and gravid uterine
weights were recorded, along with the number of corpora lutea, uterine
implantations, resorptions and live/dead fetuses. Histopathological
examination of the stomachs from all pregnant dams was conducted. All
fetuses were weighed, sexed and examined for external
alterations. Approximately one half of the fetuses were examined for
visceral alterations while skeletal examinations were conducted on the
administration of1,3- and 1,4-cyclohexanedicarboxaldehyderesulted in no
treatment-related effects on clinical observations, body weight, body
weight gain, feed consumption, organ weights, or gross pathology in dams
in any treated groups.
examination of dams revealed treatment-related very slight or slight
hyperkeratosis and hyperplasia of the non-glandular mucosa of the
stomach at the limiting ridge with associated chronic active
inflammation of the underlying sub-mucosa at dose levels of 75 and 225 mg/kg/day. In
addition to hyperkeratosis and hyperplasia, a single animal given 225 mg/kg/day,
1,3- and 1,4 –cyclohexanedicarboxaldehydehad
focal moderate ulceration of the non-glandular mucosa at the limiting
ridge and moderate focal chronic-active inflammation within associated
of 1,3- and 1,4-cyclohexanedicarboxaldehyde via gavage at dose levels up
to and including 225 mg/kg/day produced no indications of embryo/fetal
toxicity or teratogenicity.
to point of contact irritation resulting in hyperkeratosis and
hyperplasia in the stomach at dose levels ≥75 mg/kg/day, the
no-observed-effect level (NOEL) for maternal toxicity was 25
mg/kg/day. Based on the absence of systemic effects up to and including
225 mg/kg/day, the NOEL for systemic maternal toxicity was 225
mg/kg/day. The embryo/fetal no-observed-effect level (NOEL) was 225
mg/kg/day, the highest dose level tested.
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