Registration Dossier
Registration Dossier
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EC number: 850-248-6 | CAS number: 2374784-45-7
Endpoint summary
Administrative data
Description of key information
No data on intermediate 1-(5,7-dihydro-4H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine triflate. The available information is for the free base.
Oral-dose studies in mice, rats, and dogs over durations of 28 days, 6 and 9 months, respectively are available.
In mice, the substance (≤100 mg/kg/day) was generally well tolerated except for limited mortality in females. In rats and dogs, there were clinical observations consistent with CNS activity including dilated pupils (dogs only), increased or decreased activity, impaired coordination, hypersensitivity to touch, salivation, vocalization, lacrimation, and tremor. Convulsions were sporadically noted at >60 mg/kg/day in rats and at 15 mg/kg/day as single instance of self-limiting intermittent convulsions in a female dog.
In rats, low body weight gains were noted throughout the dosing period.
In dogs, an increased incidence and severity of clinical observations consistent with CNS activity occurred at ≥2.5 mg/kg/day.
The NOAELs were 100 and 50 mg/kg/day in male and female mice, 15 mg/kg/day in rats, and 10 mg/kg/day in dogs.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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