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In Vivo Study No: 728

METHODS

ChemicalMembraneConcentration mg/mlConcentration mg/mlloading (mg/cm2)SpeciesSiteArea (cm2)Occluded?Exposure Time (h)Analytical Method
Progesterone0.02  95% aq. EthanolHumanVentral forearm2.5224Radiolabelled (14C)

RESULTS

Length of Study (h)% Recovery+/-Dose remaining on surface (mg)% remaining on SurfaceDose remaining in stratum corneum (mg)% remaining in stratum corneumDose remaining in the viable skin% remaining in the viable skinAmount Absorbed (mg)% Absorbed+/-% Absorbed
168963.4 82.5100   136.313
Maximal Flux (mcrg/cm2/h)Average Flux (mcrg/cm2/h)+/-Time Plasma/Blood Levels Peaked (h)Peak Blood Concentration (mg/l)nkp (cm/h)Lag Time (h)
     5  

NOTES

The applied dose was between 2 and 4 mcrg/cm2. The application site was covered with a non-occlusive, ventilated hilltop chamber. Affixed to the site with hypoallergenic adhesive tape. 24h after dosing the chamber was removed and the application site was washed with 5 cotton balls consecutively soaked in soap solution, water, soap solution, water and water. Then the site was again covered with a new chamber, after 6 days the site was washed again and after washing the stratum corneum was stripped 10 times with adhesive tape. % Absorption was determined from the amount recovered in the urine.

REFERENCE

Percutaneous Penetration And Mass Balance Accountability: Technique And Implications For Dermatology (1990) J. Toxicol.:Cutaneous Ocul. Toxicol., 8 :439-451