Registration Dossier
Registration Dossier
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EC number: 850-774-6 | CAS number: 873697-71-3
Endpoint summary
Administrative data
Description of key information
Omecamtiv mecarbil was tested in a 13 week oral gavage study in rats and dogs and in a 26 week and 39 week oral study in rats and dog
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1.5 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- dog
- Organ:
- adrenal glands
- heart
- liver
Additional information
Justification for classification or non-classification
In a 13 week oral gavage study the NOAEL with rats was 5 mg/kg/day and the NOEL with dogs was 1.5 mg/Kg/day.
In a 26 week and 39 week oral study in rats and dogs, respectively, the NOAEL was 5 mg/kg/day.
Adverse effects occured in the heart and kidney in repeat-dose studies, and effects were also observed in the adrenals which may have been secondary to stress.
Target organs: heart, liver and adrenal gland.
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