Comparison of in vitro bacterial bioluminescence and tissue culture bioassays and in vivo tests for evaluating acute toxicity of biomaterials

Abstract
The sensitivity of a bacterial bioluminescent acute toxicity test was compared to the sensitivity of the USP mouse safety, rabbit intramuscular implantation, rabbit intracutaneous, mouse systemic injection, and the MEM elution tissue culture tests. A variety of industrial plastics were used to evaluate the comparative sensitivities. Additional tests were conducted on lowdensity polyethylene containing a range of dibutyltin dichloride or trans‐cinnamic acid concentrations. The bacterial bioluminescent test was more sensitive than any of the in vivo acute toxicity tests. The luminescent bacteria test was generally more sensitive than the tissue culture acute toxicity assay. The bacterial bioluminescent test offers a sensitive, rapid, uncomplicated, and inexpensive means for preliminary compatibility evaluation of biomaterials.