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Prenatal toxicity of synthetic amorphous silica nanomaterial in rats
Affiliation:1. BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany;2. TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands;1. The Hamner Institutes for Health Sciences, Six Davis Drive, PO Box 12137, Research Triangle Park, NC 27709, USA;2. Toxicology Consulting Services, 26881 Wedgewood Dr., Bonita Springs, FL 34134, USA;3. Exponent Inc., 1910 St. Andrews St., Midland, MI 48640, USA;1. TBS Associates, 7500 Rainwater Road, Raleigh, NC 27615, USA;2. Toxicology Consulting Services, 26881 Wedgewood Dr, Bonita Springs, FL 34134, USA;1. Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, US FDA, Jefferson, AR, United States;2. Toxicology Excellence for Risk Assessment, Cincinnati, OH, United States;3. Toxicology Consulting Services, Bonita Springs, FL, United States;4. Exponent, Midland, MI, United States;1. Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, USFDA, Jefferson, AR, United States;2. Toxicological Excellence for Risk Assessment, Cincinnati, OH, United States;3. Center for Toxicology and Mechanistic Biology, Exponent Inc., Midland, MI, United States;4. Toxicology Consulting Services, Bonita Springs, FL, United States;5. IIT Research Institute, Chicago, IL, United States;1. Department of Neurochemistry, Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland;2. University of Warsaw, Faculty of Chemistry, Biological and Chemical Research Centre, Warsaw, Poland
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 1000 mg/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 1000 mg/kg bw/d.
Keywords:Nanomaterials  Synthetic amorphous silica  NM-200  Prenatal toxicity  Rat  SAS"  },{"  #name"  :"  keyword"  ,"  $"  :{"  id"  :"  kw0035"  },"  $$"  :[{"  #name"  :"  text"  ,"  _"  :"  synthetic amorphous silica
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