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IN VIVO STUDIES FURTHER DETAILS

In Vivo Study No: 697

METHODS

Chemical	Membrane	Concentration mg/ml	Concentration mg/ml	loading (mg/cm2)	Species	Site	Area (cm2)	Occluded?	Exposure Time (h)	Analytical Method
2-Nitro-4-Phenylenediamine	0.1	4.81	0.0481	50% aq. Hair colourant base	Rat	Back	10	1	48	Radiolabelled (14C)

RESULTS

Length of Study (h)	% Recovery	+/-	Dose remaining on surface (mg)	% remaining on Surface	Dose remaining in stratum corneum (mg)	% remaining in stratum corneum	Dose remaining in the viable skin	% remaining in the viable skin	Amount Absorbed (mg)	% Absorbed	+/-	% Absorbed
48	90.1	4.5	0.01	2.1			0.105	21.83	0.339	70.48	8.32	70.48

Maximal Flux (mcrg/cm2/h)	Average Flux (mcrg/cm2/h)	+/-	Time Plasma/Blood Levels Peaked (h)	Peak Blood Concentration (mg/l)	n	kp (cm/h)	Lag Time (h)
					3

NOTES

Female Colworth Wistar Rats were used. After the application to the skin, the area was lightly massaged with a rounded glass rod for 1 min to produce a lather and then the skin was covered with an occlusive protective patch. The rats were kept in metabolism cages and the excreta was collected. There is no mention that the skin was washed so the dose left in the skin may in fact include that left on the surface. % absorption includes the amounts recovered in the excreta and that recovered from the carcass excluding the application site. The dose left at the surface is that recovered from the protective patch.

REFERENCE

Percutaneous Absorption Of 2-nitro-p-phenylenediamine (1983) Int. J. Cosm. Sci., 5 :215-226