Table 3 Safety of topical application of SAAP-148 ointment in rabbits.

Single-dose dermal tolerance test in rabbits. Animals with intact or abraded skin were treated for 4 hours with 500 mg of vehicle or 1% (w/w) SAAP-148 ointment. As a control, untreated rabbits were included. Results are expressed as the number of animals out of the total number of animals within the group (n = 3) that showed signs of skin irritation or pathology within 72 hours after treatment.

Number of rabbits
IntactAbraded
UntreatedVehicleSAAP-148UntreatedVehicleSAAP-148
Skin irritation
  Erythema formation0/30/30/30/30/30/3
  Edema formation0/30/30/30/30/30/3
Gross pathology findings0/30/30/30/30/30/3
Histopathological findings
  Lymphohistiocytic infiltration in the dermis0/30/30/33/3*0/32/3*
  Fibrosis in the dermis0/30/30/30/32/3*0/3

*Minimal change (score 1).