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IN VIVO STUDIES FURTHER DETAILS

In Vivo Study No: 352

METHODS

Chemical	Membrane	Concentration mg/ml	Concentration mg/ml	loading (mg/cm2)	Species	Site	Area (cm2)	Occluded?	Exposure Time (h)	Analytical Method
Urea	See Notes		0.00038	Petrolatum	Rat	Back	2	2	120	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
120									6E-05	8.1		8.1

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

120

6E-05

8.1

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)
					5

NOTES

The donor concentration was 15ng/mg. 50mg were added in total. Female-Osborne Mendel Rats 3-6 months old were used. A wire mesh cover was put over the exposure site. The legs of each rat were prevented from scratching the application site by wrapping rubber tubing around the body. The rats were placed in separate metabolism cages for collection of 24hr urine samples. The values were corrected for incomplete urinary excretion, using percentages for recovery in urine after iv administration. N was between 5 and 8. I have entered 5 into the database as this is the lowest possible option.

REFERENCE

Methods For In Vitro Percutaneous Absorption Studies I. Comparison With In Vivo Studies (1982) Toxicol. Appl. Pharmacol., 62 :474-480