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EC number: 206-581-9
CAS number: 355-37-3
In a key
guideline (OECD 421) oral reproductive/developmental toxicity screening
test, the test material (1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane;
AsahiklinTMAC-2000) formulated in 1% aqueous carboxymethyl
cellulose with 3% Tween 80 was administered by daily oral gavage to male
and female Wistar Han rats (10/sex/dose) at dose levels of 0, 100, 300
and 1000 mg/Kg. Males were treated for 2 weeks prior to mating, during
mating, and up to the day prior to termination (for 29 days). Females
that delivered were treated for 2 weeks prior to mating, during mating,
during post-coitum, and during 13-15 days of lactation (i.e. up to the
day prior to scheduled necropsy; for 50-64 days). Two females that
failed to deliver healthy offspring were treated for 43 or 53 days.
no treatment-related changes in the in-life parameters examined in this
study up to 1000 mg/Kg (i.e. mortality, clinical appearance, body weight
and body weight gain, food consumption). Males treated at 1000 mg/Kg had
statistically significantly lower weights (absolute and relative to body
weight) of the seminal vesicles than controls. It could not be excluded
that this was related to treatment. However, as the mean value, about
20% lower compared to concurrent controls, remained within the normal
range, and reproductive performance was not affected, the lower seminal
vesicle weight at 1000 mg/kg was considered not adverse.
treatment-related changes were noted in serum thyroid hormone T4 in
males, remaining organ weights (testes, epididymides, prostate,
thyroid), or findings at macroscopic and microscopic examination
(testes, epididymides, ovaries, thyroid) up to 1000 mg/Kg.
reproduction toxicity was observed up to the highest dose level tested
treatment-related changes were noted in any of the reproductive
parameters investigated in this study (i.e. mating, fertility and
conception indices, precoital time, number of implantation sites,
estrous cycle, spermatogenic profiling, and histopathological
examination of reproductive organs).
developmental toxicity was observed up to the highest dose level tested
treatment-related changes were noted in any of the developmental
parameters investigated in this study (i.e. gestation index and
duration, post-implantation survival index, viability and lactation
indices, parturition, sex ratio, maternal care and early postnatal pup
development consisting of mortality, clinical signs, body weight,
anogenital distance (PND 1), areola/nipple retention (PND 13 males),
serum thyroid hormone T4 (PND 13-15) and macroscopy).
the results observed, the parental, reproduction and developmental
toxicity No Observed Adverse Effect Level (NOAEL) was determined to be
at least 1000 mg/Kg.
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