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EC number: 471-480-0
CAS number: 1645-83-6
In this study, groups of 28 CD
rats/sex/group were exposed to the test substance by inhalation to 0
(sham control), 2,000 ppm, 5,000 ppm and 20,000 ppm for two generations.
There were no effects on reproductive indexes, food consumption,
clinical observations, organ weights or histopathological observations
in the parental animals. There were no effects on development, sexual
maturation, litter size, litter survival, litter sex ratio, clinical
observations, organ weights or macroscopic findings in the pups from
either generation. At 20,000 ppm, there were 7 F0 generation female
decedents during late lactation (between Day 11 to 21), and 2 F1
generation female decedents during late lactation (Day 14 and 15). Three
of the F0 generation decedents were sacrificed following hindlimb
paralysis. Brain lesions were established as the cause of death in one
F0 generation female. The cause of death for the remaining females was
not determined. Due to the fact that mortality was only observed in the
high exposure level group, this was considered to be related to the
exposure to the test article. The NOEL for paternal (systemic) toxicity
was therefore considered to be 5,000 ppm. The NOEL for fertility and
development was 20,000 ppm because no adverse effects on fertility
parameters or offspring were observed.
In the 2 -Generation reproductive toxicity
study groups of 28 CD rats/sex/group were exposed by inhalation to 0
(sham control), 2000, 5000 and 20000 ppm (respectively 9320, 23200 and
93200 mg/m3) for two generations. There were no effects on reproductive
indexes, food consumption, clinical observations, organ weights or
histopathological observations in parental animals. Additionally, there
were no effects on development, sexual maturation, litter size, litter
survival, litter sex ratio, clinical observations, organ weights or
macroscopic findings in the pups from either generation. At 20000 ppm
there were some decedents, but as mortality was only observed in the
high exposure level groups this was considered to be related to exposure
to the test article. Therefore, the NOEL for parental toxicity
(systemic) was considered to be 5000 ppm, while the NOEC for fertility
and development was 20000 as no adverse effects on fertility parameters
or offspring were observed.
Short description of key information:
No adverse effects on fertility were
observed in the inhalation 2-Generation reproductive toxicity study up
to exposure levels of 93200 mg/m3 (20000 ppm). Additionally, no adverse
effects on reproduction or development were observed in rat or rabbit
developmental toxicity studies or following histological examination of
reproductive organs following 90 days of repeated inhalation exposure in
any of the exposure groups.
In the developmental toxicity studies no
maternal or fetal toxicity was observed in rats or rabbits exposed by
inhalation to concentrations up to 15000 ppm (69900 mg/m3) during
gestation. Furthermore, in the 2-generation study with rats, no
developmental effects were observed up to concentrations of 20000 ppm
In the rat and rabbit teratology studies, no
maternal or developmental toxicity was observed after exposure up to
15000 ppm (69900 mg/m3) HFO-1234ze. Furthermore, no adverse effects were
observed following histological examination of the gonads in male and
female rats following 90 days of exposure to 15000 ppm (69900 mg/m3)
HFO-1234ze. This was confirmed in the 2 -generation reproductive
toxicity study as no developmental effects were observed after exposure
up to 20000 ppm (93200 mg/m3) (including histology).
No effects related to
either developmental or reproductive toxicity were observed in the
available studies (several developmental toxicity studies and a 2
-generation reproductive toxicity study), this up to concentratration of
respectively 15000 (69900 mg/m3) and 20000 ppm (93200 mg/m3).
Consequently classification for this endpoint is not deemed necessary.
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