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EC number: 473-390-7
CAS number: -
OBJECTIVE: This study evaluated the potential reproduction and/or
development effects following treatment with FC-770 (colorless liquid,
purity 100%, lot 040031) in Sprague Dawley rats.
METHODS: This study was performed in compliance with OECD GLP. The test
method was based on OECD 421. FC-770 was diluted in a vehicle composed
of 0.5% Natrosol 250HX and 0.1% Tween 80 in Water for Irrigation. Rats
(10/sex/group) received vehicle, 100, 500, or 1000 mg/kg-day MTDID 7145
via oral gavage. Males were dosed once daily for 4 weeks overall,
commencing 2 weeks prior to mating. Females were dosed once daily from 2
weeks prior to mating and then continued until at least Day 4 of
lactation. Females were euthanized with their litters between Days 5 and
6 of lactation. Parameters evaluated: Clinical observations (daily);
body weights (weekly and Days 0, 7, 14, 16, 20 of gestation and Days 1
and 4 of lactation for females); food consumption (weekly and Days 0-4
of lactation for females); litter live/dead evaluation (Day 0 of
lactation); necropsy; ovary and testis weights; histopathology of ovary,
epididymis, and testis of control and 1000 mg/kg-day animals.
Reproductive indices were calculated. Pups were examined for external
abnormalities. Externally normal pups were discarded at necropsy.
Externally abnormal pups were fixed in formalin for possible future
RESULTS: In treated females prior to mating, there was a slight
reduction in group mean body weight gains and food consumption over the
first two weeks of treatment, compared with control; these reductions
achieved statistical significance in animals treated at 500 and 1000
mg/kg-day. However, absolute body weights and food consumption of the
females was also slightly lower than control prior to the treatment
period, and therefore this slight reduction that persisted from
commencement of treatment was not likely attributed to treatment. Group
mean body weight gains and food consumption in the males throughout the
study, and for females during gestation and lactation were similar to
control. Mating performance, fertility, duration of gestation, litter
size and survival, and litter and pup weights did not indicate any
obvious effect of treatment at any of the dose levels tested.
CONCLUSION: Based on the results of this study, the no observed effect
level (NOEL) for adults and for reproductive parameters was considered
to be 1000 mg/kg-day.
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