Biological evaluation of polymers I. Poly(methyl methacylate)

Abstract

A series of poly(methyl methacrylate) formulations differing widely in chemical and physical properties was employed for the evaluation of primary screening methods for the assessment of acute toxicity. Materials and USP extracts of materials were tested in parallel. Tissue culture, hemolysis, intradermal irritation, systemic toxicity, muscle implant and histopathologic responses were determined for each of 27 formulations. A determination of the nonvolatile methanol extractable components was carried out on each formulation. The formulations varied with respect to percent, w/w, methyl methacrylate, N,N‐dimethyl‐p‐toluidine, stannous octoate, 3,4‐diamino‐toluene and, also, with respect to curing conditions. Volatile components, primarily methyl methacrylate, of three selected formulations were determined quantitatively by vacuum distillation and mass spectrographic analysis. Statistical analysis of the primary data indicated a significant correlation of residue weight (methanol extractable) with hemolytic activity (r = 0.93) and with the cumulative biological response (r = 0.9). Multiple linear regression analysis of residue weights with hemolysis and intradermal irriation responses gave the highest overall correlation (r = 0.96). Hemolytic activity and tissue culture responses were significantly correlated (r = 0.87). It was concluded that the observed variation of biological test results reflected significant differences in the toxicity of the test materials. The poly(methyl methacrylate) series examined was relatively low in toxicity and the biological tests examined, particularly the in vitro tests, were found to be responsive to formulation and curing conditions which indicated their suitability for primary toxicity screening.