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EC number: 954-921-6
CAS number: -
The neurotoxicity of the substance when administered via the diet to female and male Han Wistar rats over a period of 13 weeks was studied under GLP to OECD TG 424. Ten female and ten male rats per dose group were exposed to plain diet (negative control) or standard rodent diet treated with the substance at nominal levels of 50, 150 or 300 ppm. The analysis of the food by a suitable ultra pressure liquid chromatography method confirmed mean concentrations within or equal to the acceptance criteria of ± 10% of their nominal concentrations. For homogeneity, the RSD of concentrations for all samples in each group was within the acceptance criteria of ≤10%. The mean achieved dosages during the 13 weeks of treatment were 3.92, 13.2 and 24.8 mg/kg/day in males and 5.49, 15.6 and 32.7 mg/kg/day in females at dietary concentrations of 50, 150 and 300 ppm, respectively. There were no signs that were attributable to treatment with SYN547407 and no animals died during the treatment period. There were no in-cage, in-hand or arena observations that were attributable to treatment and reactivity, grip strength and motor activity were also unaffected by treatment. There were no treatment-related ophthalmic findings. Body weight gain slightly was high at 50 ppm in males and at 150, 500 ppm in both sexes but there was no relationship to increasing dietary concentration, and there was no corresponding effect upon food consumption. There was no effect of treatment on brain weight and there were no treatment-related macroscopic or neurohistopathological findings.
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