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In a GLP compliant study conducted in accordance with standardised guidelines OECD 407, EU Method B.7., EPA OPPTS 870.3050 and appropriate Japanese guidelines, the repeat oral toxicity of the test substance was determined.
The test substance was administered by oral gavage to three groups consisting of five male and five female rats for twenty-eight consecutive days at dose levels of 30, 300 or 1000 mg/kg bw/day. A control group of five males and five females was dosed with the vehicle alone. Two recovery groups (each of five males and five females) were also treated with either 1000 mg/kg bw/day or to the vehicle alone for twenty-eight consecutive days and were then maintained without treatment for an additional fourteen days.
Clinical signs, body weight changes, food and water consumption were monitored during the study. Haematology, blood chemistry and urinanalysis were evaluated for all non-recovery group animals at the end of the treatment period and for all recovery group animals at the end of the treatment-free period.
There were no unscheduled deaths observed or clinical signs of toxicity detected during the study. No treatment-related changes were observed in any of the parameters measured during the study.
Under the conditions of the test, the NOAEL for systemic toxicity was determined to be 1000 mg/kg bw/day.
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