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EC number: 207-079-2
CAS number: 431-89-0
studies assessing the effects of 1,1,1,2,3,3,3 -heptafluoropropane on
fertility were available. However, Article 13 of REACH legislation
states that, in case no appropriate animal studies are available for
assessment, information should be generated whenever possible by means
other than vertebrate animal tests, i.e. applying alternative methods
such asin vitrotests, QSARs, grouping and read-across.
The use of analogue approach for
hydrofluorocarbons is justified and documented in the position paper
"Use of read across in the human hazard assessment of hydrofluorocarbons
(HFCs)", attached in the endpoint summary in Section 7 of the Technical
Dossier (Toxicological information).
combined fertility and developmental effects study with rats was
available on the structurally related substance, 1,1,1,3,3
-pentafluorobutane (HFC 365mfc; TNO, 2001). Groups of 28 male and female
rats were exposed to 0, 5000, 15000 and 30000 ppm of the test substance.
Males were exposed during a 10 weeks premating period, females were
exposed 2 weeks prior to mating 5 days/week, 6 h/day. Afterwards animals
were cohabited (one male and one female per cage) for maximum one week
of mating, during which they were still exposed 6 h/day. Pregnant
females were exposed until day 15 of gestation and sacrificed on day 21.
Fetus, placentas and reproductive organs were weighed and fetuses were
examined after Caesarian section. The viscera and the skeletons of all
fetuses were examined. Males were sacrificed after the mating period and
testes and epididymides, including sperm parameters, were examined.
statistically significant differences between the control group and the
exposed groups concerning the number of corpora lutea, implantation
sites, live and dead fetuses, early and late resorptions and pre-and
post-implantation losses were observed. The sex ratio of the fetuses was
comparable amongst all groups. No statistically significant differences
in gravid and empty uterus weight, ovary weight, carcass weight and net
weight change of females were observed. Also no remarkable findings of
the placenta and the mean placenta weight, as well as statistically
significant difference in mean anogenital distance were found between
the control and exposed groups. Upon fetal examination there were no
treatment-related changes in external observations or fetal soft
tissues. No statistically significant differences were observed among
the control, low-, mid- and high-concentration groups in skeletal
malformations and anomalies. Statistically significant differences found
in variations, retardation in skeletal ossification and cartilage were
considered not to be related to treatment.
on the results of the study, NOAEL for reproductive and developmental
effects was set at 30000 ppm, corresponding to the highest tested
addition, a dominant lethal assay with mice, performed according to the
protocol similar to OECD guideline 478 (ICI Central Toxicology
Laboratory, 1979) and a reproductive toxicity study with rats (Alexander
et al., 1996) on another structural analogue of 1,1,1,2,3,3,3
-heptafluoropropane, 1,1,1,2 -tetrafluoroethane (HFC 134a), were
available for assessment. No adverse effects on fertility were noted in
the dominant lethal assay in mice exposed to the test substance at
concentration levels of 0, 1000, 10000, 50000 ppm for 6 hr/days during 5
days. In the reproductive toxicity study, pregnant female rats (F0
generation) were exposed to to the test substance at concentrations of
0, 2,500, 10,000 and 50,000 ppm from day 17 to 20 of gestation. Exposure
recommenced at the same concentrations on day 1 post partum and
continued until day 21 post partum. The females were allowed to litter
and rear their young (F1 generation). On day 21, 1 male and 1 female F1
pup was retained from each of the 20 litters/group and raised to
maturity. The selected F1 rats were mated when they were approximately
84 days old and, on day 20 of pregnancy, the females were terminated to
allow the examination of their uterine contents and ovaries. The F1
males were also terminated at this time. No treatment-related effects on
reproductive performance, maturation or development of the offspring
were reported, resulting in NOAEL of 50000 ppm for effects on fertility.
Finally, gross pathology and histopathology
examinations performed in several
reproductive organs of males (testes, epididymis and prostate) and
females (uterus, ovaries and vagina) in a 90 -day inhalation study in
rats exposed up to 731690 mg/m3
HFC 227ea did not reveal any adverse effects (WIL Research Laboratories,
summary, based on the evidence from the available studies on the
structural analogues 1,1,1,2 -tetrafluoroethane and 1,1,1,3,3
-pentafluorobutane, 1,1,1,2,3,3,3 -heptafluoroethane is considered to be
not toxic for reproduction. The absence of any signs of toxicity to
reproductive organs following subchronic exposure to 731690 mg/m3
HFC 227ea further support the conclusion of no concern for possible
effects to reproduction.
The results of two developmental toxicity studies showed no maternal and developmental toxicity in rats and rabbits up to the highest concentration tested (731690 mg/m3 (105000 ppm)).
toxicity studies were available, one with rats (WIL Research
Laboratories, 1994a) and one with rabbits (WIL Research Laboratories,
Inc., 1994b), with exposure concentrations varying from ca. 137000 to
731000 mg/m3 (20000-105000
ppm). At termination, no treatment-related internal findings or organ
weight changes were observed in either of the studies up to 731690 mg/m3,
the maximum dose tested. In both the rabbit and rat studies, there were
no statistically significant differences in the intrauterine growth and
survival of foetuses after implantation between the treated and control
groups. Parameters evaluated included pre-implantation loss,
post-implantation loss, live litter size, foetal sex ratios, foetal body
weights and numbers of corpora
implantation sites. Some foetal external, soft tissue and skeletal
malformations and variations were observed; however, these observations
are commonly observed in the historical control data and appeared at a
similar incidence in the concurrent control group, or occurred
occasionally. Based on the results of the animal studies, the NOAEL for
both maternal and developmental toxicity in rabbits and in rats was
731690 mg/m3 (105000
ppm), 6 hr/day. Therefore, developmental toxicity is not considered an
endpoint of concern for the substance.
These studies support the
NOAEL of 731690 mg/m3
which will be used for DNEL derivation for repeated dose toxicity.
developmental toxicity was observed in developmental toxicity
studies with rats and rabbits up to 731.69 mg/L (105000 ppm),
classification is not warranted according to EU Directive 67/548/EEC
or EU Classification, Labelling and Packaging of Substances and
Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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