Acute and subchronic oral toxicity studies in rats with nanoscale and pigment grade titanium dioxide particles

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
David B WarheitE M Donner

Abstract

Data generated using standardized testing protocols for toxicity studies generally provide reproducible and reliable results for establishing safe levels and formulating risk assessments. The findings of three OECD guideline-type oral toxicity studies of different duration in rats are summarized in this publication; each study evaluated different titanium dioxide (TiO2) particles of varying sizes and surface coatings. Moreover, each study finding demonstrated an absence of any TiO2 -related hazards. To briefly summarize the findings: 1) In a subchronic 90-day study (OECD TG 408), groups of young adult male and female rats were dosed with rutile-type, surface-coated pigment-grade TiO2 test particles (d50 = 145 nm - 21% nanoparticles by particle number criteria) by oral gavage for 90 days. The no-adverse-effect level (NOAEL) for both male and female rats in this study was 1000 mg/kg bw/day, the highest dose tested. The NOAEL was determined based on a lack of TiO2 particle-related adverse effects on any in-life, clinical pathology, or anatomic/microscopic pathology parameters; 2) In a 28-day repeated-dose oral toxicity study (OECD TG 407), groups of young adult male rats were administered daily doses of two rutile-type, uncoated, ...Continue Reading

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Citations

Dec 1, 2015·Regulatory Toxicology and Pharmacology : RTP·E M DonnerD B Warheit
Apr 28, 2016·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·Ismael M Urrutia-OrtegaYolanda I Chirino
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