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EC number: 201-645-2
CAS number: 85-98-3
test item, Ethylcentralit, was tested for prenatal developmental
toxicity using the Method B.31, Prenatal Developmental Toxicity Study,
Council Regulation (EC) No. 440/2008, Published in O.J. L. 142, 2008 and
OECD Test Guideline No. 414, Prenatal Developmental Toxicity Study,
Adopted by the Council on January 22nd 2001.
rat females (SPF quality) were used for testing. After acclimatization
the females were mated with males. The
test item was then administered to pregnant females - daily from the 5th
to the 19th day of pregnancy. The study included four groups of females
– 3 treated groups and 1 control group (vehicle only). The test item was
administered suspended in 0.5% methylcellulose in aqua pro iniectione by
stomach tube and the concentrations of suspensions at all dose levels
were adjusted to ensure the administered volume of 1 mL per 100 g of
levels which have been chosen for this study, 50, 150 and 300 mg/kg
b.w./day, were based on doses used in previous long-term toxicity
studies performed at Test Facility.
health condition, clinical status after application, body weight and
food consumption of maternal animals were monitored during the study. On
the 20th day of pregnancy, the maternal animals were euthanized, the
uterine contents were examined and the foetuses were assessed for soft
tissue and skeletal alterations.
animals toxicity and reproduction parameters
sensitivity of pregnant females to the test item treatment was found out
in the conceptus implantation period at the highest dose level.
unscheduled deaths were recorded at the highest dose level. Four females
died in short time after first application of the test item. The effect
on neurology system was observed after first application in others
females at the highest dose level - Straub phenomenon accompanied with
increased response to stimuli, body spasm and tremor were observed.
test item had a negative effect on the growth of maternal animals at the
highest dose level
food consumption was statistically significantly decreased at the 300
mg/kg b.w./day dose
level from 5th to 8th day of pregnancy.
structure of organs of pregnant females were unaffected by treatment
with the test item.
were no serious changes in reproduction parameters in treated groups.
foetuses were found sporadically at the middle and highest dose levels
(0-0-1-2). The mean number of live foetuses per litter was similar in
treated groups in comparison to the control group, the sex ratio (mean
value) was also comparable in all groups.
mean body weight of foetuses was slightly decreased at the highest dose
level without statistical significance.
necropsy of foetuses did not reveal macroscopic changes in soft tissues
or external alterations.
of foetal skull and skeleton did not revealed serious anomalies in
of vertebrae revealed higher occurrence of dumbbell ossification in
treated groups in comparison with controls with dose dependence. The
incidence of asymmetric ossification of vertebrae was slightly increased
in treated groups compared to the control group.
occurrences of dumbbell ossification and asymmetric ossification of
vertebrae are comparatively high in control foetuses in this study, so
these findings could not be considered serious anomalies. But the
highest occurrence in foetuses at the high dose level could be
associated with a decrease in the weight of the foetuses and maternal
toxicity at the highest dose level.
changes of foetus skeleton were found very sporadically and without
NOAEL (No Observed Adverse Effect Level) for toxicity in PREGNANT
FEMALES was established 150 mg/kg b.w./day. This NOAEL value is based on
no occurrence of mortality, no serious changes in health condition
status, no reproductive-related pathological findings and no changes in
reproduction parameters at the dose 150 mg/kg b.w./day.
NOAEL (No Observed Adverse Effect Level) for PRENATAL DEVELOPMENT is 300
mg/kg b.w./day. This NOAEL value is based on the no occurrence of
anomalies of foetal skull and skeleton in treated groups.
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