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EC number: 201-188-9
CAS number: 79-24-3
objective of this study was to provide data on the possible effects of
the test material nitromethane on pregnant female rats (Wistar Han IGS),
and on the development of the embryo and fetus. The test material was
administered by inhalation (via whole body exposure) to groups of 24
mated females from gestation day (GD) 6 up to and including GD 20. The
overall average actual concentrations of the test material in the test
atmospheres as determined by total carbon analysis were 303 (± 3.3), 601
(± 12.4) and 1178 (± 43.9) ppm for the low-, mid- and high
concentration, respectively and close to the respective target
concentrations of 0, 300, 600 or 1200 ppm. At gestation day 21 caesarean
section was performed, dams were examined macroscopically and
reproductive organs, liver and kidney were weighed. Fetuses and
placentas were weighed and fetuses were examined externally. Half of the
fetuses of each litter were subjected to visceral examination, the other
half to skeletal examination.
whole body exposure (6 hours per day) to nitromethane from gestation day
6 up to and including gestation day 20 at concentrations of 0, 300, 600
and 1200 ppm resulted in:
treatment related clinical signs or macroscopic changes in the dams;
food consumption at the onset of treatment and at the end of gestation
in the 1200 ppm group;
body weight and body weight gain at the end of gestation in the 1200 ppm
mean uterus weight in the 1200 ppm group, which was related to the
increased post-implantation loss;
kidney was identified as the target organ, as evidenced by a slight
increase in kidney weight in all treatment groups. In view of the
limited increase, this was not considered an adverse effect;
effects on the mean number of corpora lutea or the mean number of
marked, statistically significant, increase in post-implantation loss in
the 1200 ppm group, due to a statistically significant increase in late
resorptions and the complete litter loss of 5 females;
significantly decreased mean fetus weight in the 1200 ppm group.
ossification in the fetuses in the 1200 ppm group. In addition, the
visceral observations and skeletal observations in the 1200 ppm group,
were indicative for fetal toxicity or considered secondary to the fetal
toxicity observed in this group.
effects on fetal weight, visceral observations and skeletal observations
were observed in the 300 and 600 ppm groups.
the lower body weight and body weight gain at the end of gestation and
the lower feed intake at the start of exposure and the end of gestation
in the high concentration group, the No Observed Adverse Effect
Concentration (NOAEC) for maternal toxicity was considered to be 600
ppm. Based on the effects on post-implantation loss (as evidenced by an
increase in late resorptions), fetus weight, the delay in ossification
and skeletal and visceral observations in the high concentration group,
the NOAEC for developmental toxicity was considered to be 600 ppm.
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