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首页> 外文期刊>Birth defects research, Part B. Developmental and reproductive toxicology >Assessment of hydroxypropyl methylcellulose, propylene glycol, polysorbate 80, and hydroxypropyl-beta-cyclodextrin for use in developmental and reproductive toxicology studies.
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Assessment of hydroxypropyl methylcellulose, propylene glycol, polysorbate 80, and hydroxypropyl-beta-cyclodextrin for use in developmental and reproductive toxicology studies.

机译：评估羟丙基甲基纤维素，丙二醇，聚山梨酯80和羟丙基-β-环糊精用于发育和生殖毒理学研究。

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BACKGROUND: A series of studies were conducted to assess Polysorbate 80 (PS80), Propylene Glycol (PG), and Hydroxypropyl-beta-Cyclodextrin (HPbetaCD), when compared with Hydroxypropyl Methylcellulose (MC) in developmental and reproductive toxicology (DART) studies. METHODS: In the rat fertility study, 20 mg/kg MC, 10 mg/kg PS80, 1,000 mg/kg PG, 500 mg/kg HPbetaCD or 1,000 mg/kg HPbetaCD were administered orally before/during mating, and on gestation Day (GD) 0-7, followed by an assessment of embryonic development on GD 14. In the rat and rabbit teratology studies, the doses of MC, PS80, PG, and HPbetaCD were the same as those in the fertility study. In these teratology studies, pregnant females were dosed during the period of organogenesis, followed by an assessment of fetal external, visceral, and skeletal development. RESULTS: In the rat fertility and rat teratology studies, PS80, PG, and HPbetaCD did not exhibit toxicity, when compared with MC. Similarly, in the rabbit teratology study, there was no PS80 or PG-related toxicity, when compared with MC. However, individual rabbits in the 500 and 1,000 mg/kg HPbetaCD groups exhibited maternal toxicity, which included stool findings, decreased food consumption, and body weight gain. Furthermore, one rabbit each in the 500 and 1,000 mg/kg HPbetaCD groups exhibited evidence of abortion, which was considered secondary to maternal toxicity. CONCLUSIONS: Although HPbetaCD was not well tolerated in rabbits at doses of 500 and 1,000 mg/kg, PS80 and PG were comparable to MC and should be considered for use in developmental and reproductive toxicology studies.
机译：背景：在发育和生殖毒理学（DART）研究中，与羟丙基甲基纤维素（MC）相比，进行了一系列研究以评估聚山梨酯80（PS80），丙二醇（PG）和羟丙基-β-环糊精（HPbetaCD）。方法：在大鼠生育力研究中，在交配之前/期间和妊娠当天口服20 mg / kg MC，10 mg / kg PS80、1,000 mg / kg PG，500 mg / kg HPbetaCD或1,000 mg / kg HPbetaCD。 GD）0-7，然后评估GD 14的胚胎发育。在大鼠和兔子畸变研究中，MC，PS80，PG和HPbetaCD的剂量与生育力研究中的剂量相同。在这些畸形学研究中，怀孕女性在器官发生期间服用，然后评估胎儿的外部，内脏和骨骼发育。结果：在大鼠生育力和大鼠畸形学研究中，与MC相比，PS80，PG和HPbetaCD没有表现出毒性。同样，在兔畸形学研究中，与MC相比，没有PS80或PG相关的毒性。但是，在500和1,000 mg / kg HPbetaCD组中的每只兔子都表现出母体毒性，包括粪便发现，食物消耗减少和体重增加。此外，在500和1,000 mg / kg HPbetaCD组中，每只兔子都有流产的证据，这被认为是继母体毒性之后的结果。结论：尽管在兔子和兔子中分别以500和1,000 mg / kg的剂量不能很好地耐受HPbetaCD，但PS80和PG与MC相当，应考虑用于发育和生殖毒理学研究。

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