Attachment 3: Decision Tree for Identification and Qualification of a Degradation Product

A ) If considered desirable , a minimum screen ( e . g . , genotoxic potential ) , should be conducted .A study to detect point mutations and one to detect chromosomal aberrations , both in vitro , are considered an appropriate minimum screen .In general , a minimum duration of 14 days and a maximum duration of 90 days would be considered appropriate .D ) For example , do known safety data for this degradation product or its structural class preclude human exposure at the concentration present ?