Wolterbeek André, Oosterwijk Thies, Schneider Steffen, Landsiedel Robert, de Groot Didima, van Ee Renz, Wouters Mariëlle, van de Sandt Han
TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
Reprod Toxicol. 2015 Aug 15;56:147-54. doi: 10.1016/j.reprotox.2015.03.006. Epub 2015 Mar 25.
Synthetic amorphous silica (SAS) like NM-200 is used in a wide variety of technological applications and consumer products. Although SAS has been widely investigated the available reproductive toxicity studies are old and do not cover all requirements of current OECD Guidelines. As part of a CEFIC-LRI project, NM-200 was tested in a two-generation reproduction toxicity study according to OECD guideline 416. Male and female rats were treated by oral gavage with NM-200 at dose levels of 0, 100, 300 and 1000mg/kg bw/day for two generations. Body weight and food consumption were measured throughout the study. Reproductive and developmental parameters were measured and at sacrifice (reproductive) organs and tissues were sampled for histopathological analysis. Oral administration of NM-200 up to 1000mg/kg bw/day had no adverse effects on the reproductive performance of rats or on the growth and development of the offspring into adulthood for two consecutive generations. The NOAEL was 1000mg/kg body weight per day.
像NM - 200这样的合成无定形二氧化硅（SAS）被广泛应用于各种技术应用和消费品中。尽管对SAS已进行了广泛研究，但现有的生殖毒性研究年代久远，并未涵盖当前经合组织指南的所有要求。作为欧洲化学工业理事会 - 生命科学倡议组织（CEFIC - LRI）项目的一部分，根据经合组织指南416，对NM - 200进行了两代生殖毒性研究。雄性和雌性大鼠连续两代经口灌胃给予剂量水平为0、100、300和1000mg/kg体重/天的NM - 200。在整个研究过程中测量体重和食物摄入量。测量生殖和发育参数，并在处死时采集（生殖）器官和组织进行组织病理学分析。连续两代经口给予高达1000mg/kg体重/天的NM - 200对大鼠的生殖性能或后代成长至成年期的生长和发育均无不良影响。无观察到有害作用水平（NOAEL）为每天1000mg/kg体重。
