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EC number: 221-264-5
CAS number: 3049-71-6
The purpose of this study was to evaluate the subchronic, reproductive, and developmental toxicity of test material when administered daily via oral gavage.
Endpoints evaluated were survival, clinical observations, body weights, food consumption measurements, neurobehavioral assessments (spontaneous locomotor activity, functional observational battery, grip strength), parturition checks, litter evaluations, clinical pathology (hematology, coagulation, serum chemistry), and anatomic pathology, including organ weights, gross observations at necropsy, and microscopic evaluation of select tissues. Blood was collected for the analysis of thyroid hormone evaluation from all F0 animals and representative pups from each litter; analysis was conducted on the F0 males and on pups at postnatal day (PND) 13. Administration of the test material at dosages of 100, 300, or 1000 mg/kg to F0 male and female rats for up to 5 weeks and 8 weeks, respectively, produced no adverse effects on body weights, food consumption, reproductive performance, FOB, grip strength, clinical pathology, thyroid hormone, or anatomic pathology parameters. A decrease in rectal temperature was observed for females at 300 and 1000 mg/kg, but the relationship to test material is unclear. Reduced locomotor activity counts were observed at all dose levels for males and for females at 100 mg/kg (rearing interval counts) and 300 mg/kg; the difference was slight and not considered to be toxicologically relevant for either sex. There were no indirect treatment-related effects on male or female F1 clinical observations, body weights, anogenital distance, and thyroid hormones, or male pup areola/nipple retention.
Therefore, the no observable adverse effect level (NOAEL) for systemic and reproductive toxicity in F0 males and females was 1000 mg/kg.
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