Repeated-dose 90-day oral toxicity study of GST in Sprague-Dawley rats

Abstract

TiO₂ have been studied on inhalation and skin exposure due to the properties of the materials’ use (cosmetics, paints and other products) and the additional safety information on other intake routes for the potential risk assessment is limited. Therefore, the aim of this study was to obtain safety data for new TiO₂ powder, GST produced through sludge recycling of the sewage treatment plant through repeated-dose toxicity in Sprague-Dawley (SD) rats in according to the OECD test guideline (TG 408). Based on the results of the dose-range finding study (28-day repeated toxicity), GST was orally administered to rats at doses of 0, 500, 1000, and 2000 mg/kg B.W/day for 90-day and reversibility of effects of 2000 mg/kg bw/day was assessed after 4 weeks. In clinical signs, compound-colored stool was observed in all animals of treatment group (low: day 14 or 15, middle: day 8, high: day 8) and continuously observed up to the end of administration or day 1 of recovery period (high dose group). Also, the test substance retention in gastro-intestinal tract was observed in all animals of treatment group in gross finding at necropsy and foreign materials in lumen of these organs (stomach, duodenum, ileum, cecum, colon, rectum) likely indicative for the presence of test material in histopathological examination. In addition, no test substance-related adverse effects were noted in the detailed clinical observations, sensory reactivity/ functional assessments, body weight, food consumption, urinary analysis, ophthalmological examination, hematological / biochemical parameters, organ weights, histopathological findings. Therefore, the present results show that the NOAEL (no observed adverse effect level) of new TiO₂ powder, GST was considered to be 2000 mg/kg B.W/day in rats after repeated oral administration for 90-day under the present study conditions and no target organs were identified.