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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
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.
classified for STOT RE (Specific Target Organ Toxicity) systemic. No
toxicologically significant adverse effects observed.
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