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EC number: 275-702-5
CAS number: 71617-10-2
Mortality of dams
= During the study, no animal died in the control, the low, and the
intermediate dose group (0.25 and 0.75 ml/kg/d) and the positive control
group. In the group with the highest dose of isopentyl
p-methoxycinnamate, 2 of 21
sperm-positive and treated animals died (10%). These animals died on day
11 p.c. and day 13 p.c., respectively. Necropsy findings revealed that
in both cases, misdosing can be excluded as the cause of death. The
probable cause of death is substance-related erosion of the epithelium
of the gastro-intestinal tract wich led to gastro-intestinal bleedings.
= The group with the highest dose of isopentyl
p-methoxycinnamate showed a decrease
in body weight during treatment. During the course of treatment,
significant differences with respect to the control group and the other
treatment groups were observed from the 2nd day of treatment on. After
termination of treatment, the body weight increased. These effects can
be regarded as a sign of a general toxic effect at high dosages (2.25
Drinking water consumption and feed
consumption = From the
start of treatment on, the animals of the highest dose group (2.25
ml/kg/d) showed a significant increase in drinking water consumption
when compared to the other groups. This increase remained at a
significant level until the end of gestation. In the second half of the
treatment period, significantly increased water consumption could also
be observed in the low (0.25 ml/kg/d) and intermediate dose group (0.75
ml/kd/d) in comparison to the control. After termination of the
treatment the consumed water amount was only slightly increased in these
groups as against the control and did not reach a significantly
deviating level. At no time did the positive control show a significant
deviation in water consumption from that of the control.
During the first half of the treatment
period, feed consumption in the intermediate (0.75 ml/kg/d) and high
dose group (2.25 ml/kg/d) was significantly lower than that of the
control group. During the second half of the treatment period, only the
animals of the high dose group (2.25 ml/kg/d) showed significantly
reduced feed consumption. After termination of treatment, no significant
differences could be observed. The observed effects on water and feed
consumption are most probably due to substance-related local irritations
of the gastro-intestinal tract.
= Changes in the coat including a localized loss of hair are almost
regularly observed and happen also spontaneously in the Wistar strain
employed. The increasing frequency in the intermediate and high dose
group could be considered to be a first sign of a test substance effect
that, before anything else, becomes evident in a site of predilection.
= Necropsy findings revealed no macroscopic abnormalities.
The Institute of Pharmacology and
Toxicology of the University of Münster designed and conducted a study
in Wistar rats in compliance with the regulations of OECD/EC. This study
was geared to determining teratogenicity and embryotoxicity of isopentyl
p-methoxycinnamate after oral administration of the doses 0.25
mL/kg/d, 0.75 mL/kg/d, and 2.25 mL/kg/d; Tretinoin was used as a
positive control. The study showed that, under the conditions described,
the test substance has no teratogenic properties at any of the dosages
tested. Embryotoxicity observed at the highest dose (2.25 mg/kg/d) is
due to a general toxic effect on the dam (maternal toxicity).
On the basis of the
above-mentioned results, a dosage of 0.25 mL/kg/d after oral
administration under the experimental conditions in the rat can be
regarded as a safe "no observed effect level", if strict standards
concerning general toxicity are applied. Even at an (oral) dose of 2.25
mL/kg/day, no teratogenic effects could be observed; the ascertained
embryotoxic effect can be explained by intoxication of the maternal
organism (maternal toxicity after oral administration). In accordance
with the conventional standards of assessment acknowledged by FDA and
other national authorities - among others the Federal Health Office in
Berlin - as well as other international administrative bodies, the
intermediate test substance dosage (0.75 mL/kg/d) can be regarded as
NOAEL . The increased loss of hair observed in this treatment group as
deviating from the control group is no serious finding in the evaluation
and assessment of the total result.
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