Abstract # F-07

Methapyrilene, a Human Antihistamine and a Rat Liver Carcinogen, Is an Agent that Decreases Phenotypic Expression of Transformed Cells and Reduces Their Tumorigenic Potential in Nude Mice. B.S. Hass, L. Wu, T.R. Fincher, J.J. Chen, B.D. Lyn-Cook, N.A. Littlefield. FDA, NCTR, Jefferson AR 72079

Methapyrilene (MP) is an antihistamine that was used in sleep aid and allergy medications until it was shown to be a rat liver carcinogen. It was removed from the marketplace, but not until a substantial population had been exposed. The present report describes the opposite actions that MP exerts on non-transformed and transformed rat liver epithelial (RLE) cells. While mitogenically stimulating non-transformed RLEs, MP inhibits growth of transformed RLE cells, suppresses their anchorage independent growth in soft agar, and depresses tumor indices when MP-treated cells are injected into nude mice. This reversion of transformation is induced at MP concentrations as low as 1 and 10µM, which are not toxic; thus, the mechanism of antitransformational action of MP on transformed cells involves a cytostatic effect that is transient and decreases rapidly as MP is removed. This transient, non-genotoxic response implies a reduced risk attributable to MP than might have been implicated on the basis of the original assertion of MP's tumorigenic potential.