Olib qo'yiladigan tish protezlarni tozalash uchun universal mahalliy gigiyenik vositaning o'tkir va surunkali toksikligini baholash
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Annotatsiya
The study tested the acute and subchronic (90-day) oral toxicity of a newly formulated, domestically produced Hygienic Cleansing Powder for Removable Dentures (HCPRDP, Uzbekistan) in rodents. The formulation contains sodium bicarbonate (45.18%), sodium carbonate (28.00%), citric acid (21.60%), potassium alum (2.00%), sodium lauryl sulfate (0.50%), peppermint oil (0.50%), triclosan (0.50%), and colorant E133. Acute toxicity was assessed in white outbred mice (n = 18, 18–22 g) by single oral gavage at doses of 2,000 and 5,000 mg/kg body weight using a 0.5% carboxymethylcellulose vehicle, in accordance with OECD Test Guideline 423. Animals were monitored continuously for 1 hour, then hourly on day 1, and daily thereafter for 14 days. Subchronic toxicity was evaluated in Wistar rats (n = 32, 180–220 g, with equal sex distribution) divided into four groups: a vehicle control group (distilled water) and three treatment groups receiving 120, 600, and 1,200 mg/kg/day for 90 consecutive days by oral gavage, in accordance with OECD Test Guideline 408. Blood was collected on days 15, 30, 60, and 90 for hematological (WBC, RBC, HGB, HCT, MCHC, PLT, PCT) and biochemical analyses (ALT, AST, ALP, GGT, total and direct bilirubin). Necropsy with organ weighing and H&E histopathology was performed on day 91 for the liver, kidneys, lungs, heart, and spleen. No mortality occurred in any group; the LD₅₀ exceeded 5,000 mg/kg, classifying HCPRDP as practically non-toxic according to OECD/GHS Category 5. The subchronic study demonstrated that all animals survived to scheduled necropsy without treatment-related adverse clinical signs or body weight impairment. WBC was slightly reduced in the 120 mg/kg group, without clinical significance; PCT was transiently elevated at 600 and 1,200 mg/kg on days 15–30 (p < 0.05), normalizing by day 90. Moreover, ALT showed a statistically significant but non-adverse increase from day 30 onward in all treatment groups (p < 0.05), remaining within normal reference ranges throughout. ALP was unchanged (p > 0.05), and histopathological examination confirmed the absence of hepatotoxicity or any organ damage. The value of this study lies in providing the first preclinical safety evidence for this domestic formulation, establishing a scientific basis for clinical trials and regulatory registration in Uzbekistan.
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