| STUDY |
A series of tests to preliminarily evaluate the cytotoxicity and mutogenicity of the degradation products released by the PCPP matrix and the PCPP-sebacic acid copolymers were conducted using the forward mutation assay of Ames et al, Mutat. Res. 31: 347-364 (1975) using mutated Salmonella typhimurium and their resistance to 8-azaguanine as a genetic marker. This mutagenicity assay also includes a test for toxicity so that the mutagenicity, if present, can be expressed quantitatively as the number of mutants per surviving cell. In this way, an independent measure of toxicity to the Salmonella bacteria could be obtained. Samples of the PCPP polymer and prepolymer were tested at 1.0 mg/ml levels both with and without the addition of mammalian metabolism enzymes. Using the techniques now uniform for this type of assay, each empirical assay was conducted in conventional format with conventional reagents and the results evaluated as described in the literature. The data reveal that both the PCPP-sebacic acid copolymers as prepared and purified, the PCPP polymeric matrix and the degradation products released by surface erosion of the PCPP matrix in physiological saline exhibited neither mutagenicity nor toxicity
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