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EC number: 244-007-9 | CAS number: 20749-68-2
The Macrolex Rot EG was administered once daily by gavage to male and female Wistar rats in daily doses of 100, 300 and 1000 mg/kg bw/day suspended in polyethylene glycol 400. The administration volume was 5 ml/kg bw. The animals were observed for mortality and clinical signs, determination of hematology and clinical chemistry data. After termination of treatment animals were subjected to gross and histopathological examination.
For general toxicity see the respective section for repeated dose toxicity.
At necropsy there was no evidence at any gross finding that had to be attributed to dosing with the test compound.
Histopathology revealed minimally or slightly reduced secretion in the seminal vesicles in 3 out of 5 males at 1000 mg/kg which was not associated with degeneration. Changes in other male genital organs (testes, epididymides, prostate or coagulation glands) could not be found up to and including 1000 mg/kg. Thus, reduced secretion is regarded as unspecific and possibly stress—related. An adverse effect is not assumed. Therefore, an overall NOAEL (reproductive organs) = 1000 mg/kg bw/day was established.
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