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EC number: - | CAS number: -
An oral repeated dose toxicity study in rats incorporating reproductive toxicity screening conducted according to OECD 422 in which no adverse effect was seen in any of the toxicological parameters examined at any dose.
A key toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on Diurea 8 in a base grease via oral gavage administration. Diurea 8 was administered by daily oral gavage at dose levels of 0, 375, 750 and 1500 mg/kg bw/day nominal in MOL WO M46 Medicinal white oil, equating to 64.8, 130 and 259 mg/kg bw/day Active Ingredient. There were no treatment-related effects at any dose level on any of the toxicological parameters evaluated in this study. Based on these data, the NOAEL for repeated dose toxicity was 1500 mg/kg bw/day (259 mg/kg bw/day Active Ingredient).
As a carrier was required for administration of the test substance in this study, and given that the chemical constituents of Diurea 8 exist solely in base oil, a separate batch of Diurea 8 used was prepared in medicinal white oil, a standard carrier for this test at a concentration of 17.29 %. As this concentration is slightly higher than the current maximum used in commercial greases of 16 %, the results of the OECD 422 study are considered to provide worst-case scenarios for the repeated dose toxicity of Diurea 8.
Not classified for STOT RE (Specific Target Organ Toxicity) systemic. No toxicologically significant adverse effects observed.
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