Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Gavage administration of methyl polyhydroxymethyl stearate, at dose levels up to and including the limit dose of 1000 mg/kg/day produced no indication of reproductive toxicity at any dose level. There were no effects on prenatal/early neonatal growth and survival of the offspring. Based on these results, the NOEL for reproductive and neurological effects was 1000 mg/kg/day, the highest dose level tested.
Short description of key information:
Test substance (Methyl Polyhydroxymethyl Stearate) was evaluated in a repeated oral gavage study according to OECD TG 422. CD rats were administered 100, 500 or 1000 mg/kg/day. Females were dosed once daily for two weeks prior to breeding, through breeding (two weeks), gestation (three weeks), and through postpartum day 4 or 5. Females were necropsied on postpartum day 5 or 6. Males were dosed two weeks prior to breeding and continuing through breeding (two weeks) until necropsy (test day 34). Effects on reproductive and neurological function as well as general toxicity were evaluated. In addition, postmortem examinations included a gross necropsy of the adults with collection of organ weights and histopathologic examination of tissues. Litter size, pup survival, sex, body weight, and the presence of gross external abnormalities were also assessed.
Effects on developmental toxicity
Additional information
Gavage administration of methyl polyhydroxymethyl stearate, at dose levels up to and including the limit dose of 1000 mg/kg/day produced no indication of developmental toxicity at any dose level. There were no effects on prenatal/early neonatal growth, appearance and survival of the offspring. Based on these results, the NOEL for developmental effects was 1000 mg/kg/day, the highest dose level tested.
Justification for classification or non-classification
As there were no effects to suggest reproductive or developmental toxicity, this test substance does not merit classification.
Additional information
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