title: Prenatal toxicity of synthetic amorphous silica nanomaterial in rats.
abstract: Synthetic amorphous silica is a nanostructured material, which is produced and used in a wide variety of technological applications and consumer products. No regulatory prenatal toxicity studies with this substance were reported yet. Therefore, synthetic amorphous silica was tested for prenatal toxicity, according to OECD guideline 414 in Wistar rats following oral (gavage) administration at the dose levels 0, 100, 300, or 1000mg/kg bw/d from gestation day 6-19. At gestation day 20, all pregnant animals were examined by cesarean section. Numbers of corpora lutea, implantations, resorptions, live and dead fetuses were counted. Fetal and placental weights were determined. Fetuses were examined for external, visceral and skeletal abnormalities. No maternal toxicity was observed at any dose level. Likewise, administration of the test compound did not alter cesarean section parameters and did not influence fetal or placental weights. No compound-related increase in the incidence of malformations or variations was observed in the fetuses. The no observed adverse effect level (NOAEL) was 1000mg/kg bw/d.
authors.affiliation: BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany. Electronic address: Thomas.b.hofmann@basf.com.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hofmann
authors.affiliation: BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.affiliation: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
authors.forename: André
authors.initials: A
authors.lastname: Wolterbeek
authors.affiliation: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
authors.forename: Han
authors.initials: H
authors.lastname: van de Sandt
authors.affiliation: BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Landsiedel
authors.affiliation: BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany.
authors.forename: Bennard
authors.initials: B
authors.lastname: van Ravenzwaay
mesh_terms: D000284:Administration, Oral; D000818:Animals; D005260:Female; D005313:Fetal Death; D020567:Fetal Weight / Q000187:drug effects; D005333:Fetus / Q000187:drug effects / Q000473:pathology; D005865:Gestational Age; D008297:Male; D049329:Nanostructures; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010920:Placenta / Q000187:drug effects / Q000473:pathology; D011247:Pregnancy; D017208:Rats, Wistar; D018570:Risk Assessment; D012822:Silicon Dioxide / Q000008:administration & dosage / Q000633:toxicity*; D013997:Time Factors
chemical_list: D012822:Silicon Dioxide
keywords: NM-200; Nanomaterials; Prenatal toxicity; Rat; Synthetic amorphous silica