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EC number: 457-310-8 | CAS number: -
The 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.
Parental (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).
The only 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.
No test 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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