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EC number: 457-310-8
CAS number: 127733-97-5
PLATINUM(2+), TETRAAMMINE-, (SP-4-1)-, DIACETATE (9CI)
potential of a solution of tetraammineplatinum dinitrate(II) to
adversely affect the fertility and reproductive parameters of CD rats
was investigated in a reproductive and developmental screening study
conducted according to OECD Test Guideline 421 and to GLP. The test
material was administered by oral gavage for at least 28 days. Males
were dosed for 14 days pre-mating and 14 days mating/post mating.
Females were dosed for 14 days pre-mating, through gestation and up to
post-partum day 3 (test day 40-47). Three dose groups (50, 250 and 1000
mg/kg bw/day) and a control group were used, each containing 12 animals
of each sex.
(F0) animals were observed for clinical signs of toxicity throughout the
study, with body weights and food consumption monitored. At necropsy,
animals were subjected to external and internal macroscopic examinations
for any abnormalities or pathological changes. Special attention was
paid to the reproductive organs. The numbers of implantation sites and
corpora lutea were recorded. Histopathological examination was performed
on the ovaries, testes and epididymides of all animals in the control
and high-dose groups, with special emphasis on the qualitative stages of
spermatogenesis and histopathology of interstitial testicular structure.
A number of reproductive indices were calculated from the collected data
(including mating, fertility and gestation indices).
clinical sign of toxicity was a significantly reduced body weight in
high-dose females at the end of the study on post-partum day 4. There
was no impact on food consumption in males or females. Thus, the NOAEL
for general toxicity was considered to be 250 mg/kg bw/day.
item-related microscopic changes were noted in the reproductive organs,
and there was no impact on fertility or on the measured reproductive
parameters at any dose level. Thus, the NOAEL for reproductive toxicity
was 1000 mg/kg bw/day, the highest dose tested.
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