Registration Dossier
Registration Dossier
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EC number: 606-269-6 | CAS number: 192314-93-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
NOAEL for 28-day study rat <10 mg / kg / day, modest evidence of systemic changes at higher doses.The reported no-effect doses are significantly higher than the potentially effective dose for clinical effect (1- 3 mg / kg).
In humans: well tolerated in doses up to 2 mg / kg on male volunteers intravenously. Good tolerability for the highest dose of 150 mg diluted in a saline solution at a concentration of 1 mg / ml.
The overall NOEL of rat studies with repeated oral administration was 30 mg iclaprim base / kg / DA.
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