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EC number: 248-363-6
CAS number: 27247-96-7
Three groups of ten male and ten female Sprague-Dawley rats received the
test item, 2-EHN (CAS No. 27247-96-7), daily, by oral (gavage)
administration, before mating and through mating and, for the females,
through gestation until day 5 post-partum, at dose-levels of 20, 100 or
500 mg/kg/day. Another group of ten males and ten females received the
vehicle, 0.5% tween 80 in purified water, alone, under the same
experimental conditions and acted as a control group. The dosing volume
was 10 mL/kg.
Clinical signs and mortality were checked daily. Body weight and food
consumption were recorded weekly until mating and then at designated
intervals. The dams were allowed to litter and rear their progeny until
day 6 post-partum. The total litter sizes and numbers of pups of each
sex were recorded after birth, pup clinical signs were recorded daily
and pup body weights were recorded on days 1 and 5 post-partum.
The males were sacrificed after completion of the mating period. The
body weight, testes and epididymides weights were recorded and a
macroscopic post-mortem examination of the principal thoracic and
abdominal organs was performed. A microscopic examination was performed,
for the control and high-dose group, on the testes and epididymides with
special emphasis on the stages of spermatogenesis and histopathology of
interstitial testicular structure.
The dams were sacrificed day 6 post-partum (or from day 25 post-coitum
for females which did not deliver) and a macroscopic examination of the
principal thoracic and abdominal organs was performed. In the females
which were apparently non-pregnant, the presence of implantation scars
on the uterus was checked using ammonium sulphide staining technique. A
examination was performed on the ovaries of the control and high-dose
The pups were sacrificed on day 6 post-partum and were carefully
examined for gross external abnormalities and a macroscopic post-mortem
examination was performed.
There were no animals prematurely sacrificed for reasons of poor
clinical condition during the study.
All animals given 500 mg/kg/day had ptyalism throughout the study which,
when measured, lasted 4-5 hours after dosing and may be related to the
taste of the test item formulations. Hypoactivity, half-closed eyes and
loud breathing were also observed sporadically in a few males and
females. One female also had emaciated appearance, round back and
piloerection for some days during the study. The majority of the females
given 100 mg/kg/day had ptyalism during the premating and gestation
periods and a few males had ptyalism during the premating period, which
may be related to the taste of the test item formulations. One female at
100 mg/kg/day had hypoactivity and half-closed eyes on day 12 of dosing.
There were no clinical signs at 20 mg/kg/day.
Male and female groups at all dose-levels gained less weight than the
controls during the premating period in a dose-related manner achieving
statistical significance at 500 mg/kg/day. Females given 500 mg/kg/day
continued to gain less weight during gestation, however all groups had
approximately comparable weight gains to the controls during lactation.
Females given 500 mg/kg/day consumed less food than the controls
throughout the study. This was not also observed in the males and there
were no effects of treatment at the other dose-levels.
All pairs mated and the mean number of days taken to mate was comparable
with the controls for all groups.
There were no effects on the numbers of corpora lutea or implantations.
The mean numbers of pups born per litter were comparable with the
controls at all dose-levels.
At 500 mg/kg/day, there was one female with one dead fetus and nine
implantation scars in the uterine horns and one female which delivered a
litter of small pups, all of which were dead by day 3 post-partum. As
pup survival was higher in the control group, a relationship to
treatment cannot be excluded.
Mean pup body weight at 500 mg/kg/day on day 1 post-partum was
non-statistically significantly lower than that of the controls. Pup
weight gain from day 1 to day 5 post-partum was non-statistically
significantly lower than the controls’ at 100 and 500 mg/kg/day in a
dose-related manner, and mean pup body weights were non-statistically
significantly lower than the controls’ on day 5 post-partum at both
There were no treatment-related pup clinical signs or necropsy findings.
There were no treatment-related findings observed at macroscopic or
microscopic examination of F0 animals and no effects on organ weights.
The test item, 2-EHN (CAS No. 27247-96-7), was administered daily by
oral gavage to male and female Sprague-Dawley rats, from before mating,
during mating, gestation and until day 5 post-partum, at dose-levels of
20, 100 or 500 mg/kg/day.
Systemic toxicity was observed at all dose-levels, as evidenced by
reduced body weight gain during, at least, the premating period (at
least 13% less weight gained than the controls during the first 2 weeks
of treatment) (statistically significant at 500 mg/kg/day). As body
weight gains which are reduced by more than 10% are considered
biologically significant, all groups had biologically significantly
reduced body weight gains. Clinical signs of hypoactivity and
half-closed eyes were also observed at 100 and 500 mg/kg/day and food
consumption was lower than controls’ for females given 500 mg/kg/day.
There were no effects of treatment on pairing but a relationship between
development of the fetuses and pups and treatment cannot be excluded
because there was one female with only implantation scars and a dead
fetus in the uterine horns and another female which delivered a litter
of small pups which consequently died on day 3 post-partum.
Mean pup body weight at 500 mg/kg/day was less than that of the controls
on day 1 post-partum and pup body weight gain was reduced at 100 and 500
Based on the experimental conditions of this study, the No Observed
Adverse Effect Level (NOAEL) for parental toxicity was considered to be
20 mg/kg/day, and the NOAEL for toxic effect on reproductive performance
and on progeny was 100 mg/kg/day.
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