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    Primary Acute Toxicity Screen for Biomaterials: Rationale, In Vitro/In Vivo Relationship and Interlaboratory Performance

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    Correlation analysis of in vitro and in vivo toxic response to biomaterials, based on tests done directly on the materials and the material extracts (water, saline, polyethylene glycol-400, and cottonseed oil), demonstrated significant in vitro/in vivo correlations. In vitro tests that most strongly correlated with in vivo tests were inhibition of cell growth, hemolysis, and agar overlay tissue culture (zone index for test directly on the material). In vivo tests that most strongly correlated with in vitro tests were intradermal irritation (cottonseed oil and polyethylene glycol-400 extracts), systemic toxicity (cottonseed oil and polyethylene glycol-400 extracts of high toxicity materials), and intramuscular implantation (gross rating of the material implant). In vitro and in vivo toxicity ratings were correlated with histopathologic tissue response to material implants (necrosis [coagulative necrosis and overall degree of necrosis], inflammatory cellular infiltrates [polymorphonuclear leukocytes, macrophages, and giant cells], and fibroendothelial proliferation), although the correlations were lower than for the primary screen tests per se.

    Interlaboratory performance of the primary screen indicated a useful degree of discrimination of the toxicity of different materials; all laboratories ranking the test materials in the same order with respect to toxicity. Significant differences in the absolute toxicity ratings among laboratories indicated that laboratory performance with respect to standard reference materials will be required for meaningful comparison of toxicity ratings from different laboratories.


    biomaterials, acute toxicity, extracts, protocols, in vitro/in vivo correlations, interlaboratory performance, testing rationale

    Author Information:

    Dillingham, EO
    Associate professor and head of Cellular Toxicology, Materials Science Toxicology Laboratories, Memphis, Tenn.

    Committee/Subcommittee: F04.15

    DOI: 10.1520/STP30155S