Registration Dossier
Registration Dossier
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EC number: 850-249-1 | CAS number: 2374784-46-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Justification for classification or non-classification
No data on intermediate 1-[(7S)-4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl]-N-methylmethanamine (2R). The available information is for the free base.
No adverse effects in reproductive parameters at ≤50 mg/kg/day (NOAEL).
In rats, dose-dependent reductions in maternal body weight gain food consumption were noted
at ≤100 mg/kg/day. Lower fetal body weight observed at 100 mg/kg/day correlated with
increased incidence of visceral and skeletal variations; NOAEL was 50 mg/kg/day. Likewise,
for rabbits, the NOAEL was 50 mg/kg/day. At ≥100 mg/kg/day, maternal toxicity, postimplantation
losses, and lower mean fetal body weights were noted. At 200 mg/kg/day, a
higher mean litter proportion of fetal malformations was observed (open eyelids, spinal cord
defect, pulmonary tract narrowing, skeletal and aorta defects).
Additional information
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