title: Oral two-generation reproduction toxicity study with NM-200 synthetic amorphous silica in Wistar rats.
abstract: 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.
authors: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands. Electronic address: andre.wolterbeek@tno.nl.
authors: André
authors: A
authors: Wolterbeek
authors: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
authors: Thies
authors: T
authors: Oosterwijk
authors: BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany.
authors: Steffen
authors: S
authors: Schneider
authors: BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany.
authors: Robert
authors: R
authors: Landsiedel
authors: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
authors: Didima
authors: D
authors: de Groot
authors: TNO, P.O. Box 6235, 5600 HE Eindhoven, The Netherlands.
authors: Renz
authors: R
authors: van Ee
authors: TNO, P.O. Box 6235, 5600 HE Eindhoven, The Netherlands.
authors: Mariëlle
authors: M
authors: Wouters
authors: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
authors: Han
authors: H
authors: van de Sandt
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D030762:Estrous Cycle / Q000187:drug effects; D005260:Female; D005298:Fertility / Q000187:drug effects; D008297:Male; D049329:Nanostructures; D019055:No-Observed-Adverse-Effect Level; D011247:Pregnancy; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects*; D018570:Risk Assessment; D012741:Sexual Maturation / Q000187:drug effects; D012822:Silicon Dioxide / Q000008:administration & dosage / Q000633:toxicity*; D013094:Spermatozoa / Q000187:drug effects / Q000473:pathology; D013961:Thyroid Gland / Q000187:drug effects / Q000473:pathology
chemical_list: D012822:Silicon Dioxide
keywords: NM-200; Nanomaterials; Rat; Reproductive toxicity; Synthetic amorphous silica