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IN VITRO STUDIES FURTHER DETAILS

In Vitro Study No: 815

METHODS

Chemical

Conc. (mg/ml)

Volume (ml)

Loading (mg/cm2)

Vehicle

Species

Membrane

Site

Area (cm2)

Cell Type

Receptor Fluid

Temp. (oC)

Temp. Measured

Exposure Time (h)

Study Length (h)

Occluded

Analytical Method

MbOCA

See Notes

Ethanol

Human

Full Thickness Skin

Dorsal

0.32

Flow-through

HHBSS & 0.5% gentamycin

Skin

Radiolabelled (14C)

RESULTS

% Recovery	+/-	% In Stratum Corneum	+/-	% in Viable Skin	+/-	% Penetrated	+/-	% Absorbed	+/-	s-s-flux (mcrg/cm2/h)	+/-	kp (cm/h)	n	Lag Time (h)
			16.5	42.2		48.1		5.9	3.6				15	10

% Recovery

+/-

% In Stratum Corneum

+/-

% in Viable Skin

+/-

% Penetrated

+/-

% Absorbed

+/-

s-s-flux (mcrg/cm2/h)

+/-

kp (cm/h)

Lag Time (h)

16.5

42.2

48.1

5.9

3.6

NOTES

Healthy human breast skin was obtained from surgical resection. The cells were occluded with Teflon caps 2.9cm above the skin surface. The dose applied was between 5 and 10 mcl. Dosing levels ranged from 14.3-62.5 mcg/cm2. % Penetrated has been calculated by adding together the amount found in the receptor fluid and the amount found in the skin.

REFERENCE

Percutaneous Absorption Of 4,4'Methylene-Bis-(2-Chloroaniline) And 4,4'Methylenedianiline Through Rat And Human Skin In Vitro (1993) Toxicol. Vitro, 7 :141-148