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IN VIVO STUDIES FURTHER DETAILS


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In Vivo Study No: 312

METHODS

ChemicalMembraneConcentration mg/mlConcentration mg/mlloading (mg/cm2)SpeciesSiteArea (cm2)Occluded?Exposure Time (h)Analytical Method
Lindane0.010.5080.004EthanolHuman skin grafted mouseAbdomen, Breast or Face1.27224Radiolabelled (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
 6550.0021943.2  4.06E-050.80.0010821.2 21.2
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)
     3  

NOTES

Athymic Nude Mice were used. For successful grafting a portion of the dermis was removed with a dermatome. The final thickness of the grafted skin was about 0.7mm. The graft was positioned laterally towards the anterior end of the mouse and 6 weeks were allowed for the graft to heal before the start of the experiment. A non-occlusive patch was used to protect the application site.% absorption was calculated by adding together the amounts found in the faeces + urine and carcass - skin. Measurements were taken until excreted amounts reached background levels.

REFERENCE

Evaluation Of Animal Models For Predicting Skin Penetration in Man (1984) Fundam. Appl. Toxicol., 4 :224-230