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EC number: 949-147-0
CAS number: 1041263-42-6
In a Guideline (modified OECD 422) GLP study with extended treatment to Day 21 of lactation, TDP administered by gavage once daily at 0, 50, 250, 1000 mg/kg/day to parental FO CD® (SD) rats, 10/sex/group, through prebreed, mating, gestation, and Fl lactation, resulted in essentially no treatment- or dose-related adult FO parental toxicity at any dose at any time. There was no evidence of F0 parental neurotoxicity based on functional observational batteries, motor activity, auditory startle response and grip strength. Reproductive toxicity was not present in FO males or females. There was also no Fl offspring toxicity observed postnatally through the weanling necropsy. Therefore, the FO male (28 days) and female (8 -9 weeks) systemic no observable adverse effect level (NOAEL), including neurotoxicity, was at or above 1000 mg/kg/day. The NOAELs for FO reproductive toxicity were at or above 1000 mg/kg/day for males and females. The NOAELs for Fl offspring toxicity during lactation were also at or above 1000 mg/kg/day for males and females.
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