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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)
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.
were 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.
No treatment-related changes were noted in serum thyroid hormone T4 in males, remaining
organ weights (testes, epididymides, prostate, thyroid),
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
(1000 mg/Kg).No 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
developmental toxicity was observed up to the highest dose level tested
(1000 mg/Kg).No 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).
on 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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