In vitro and in vivo (cyto)toxicity assays using PVC and LDPE as model materials

Abstract

The choice for a biomaterial is partly based on the outcome of (cyto)toxicity assays. The rationales behind the selection of certain parameters, such as cell lines, controls, and animals, were evaluated using a positive and a negative control, and one experimental sample designed to induce intermediate toxicity. Extraction and direct contact assays were performed using human epidermal keratinocytes and mouse fibroblasts and mouse epithelial cells. Cell survival was measured with the tetrazolium salt (MTT) reduction assay. In addition, local implantation studies were performed in mice and rats. The positive control induced a high degree of toxicity in all in vitro tests performed, indicating that the toxicity observed in the direct contact assay was due to in situ extraction of toxic components. In the direct contact assay the negative control tested on the mouse fibroblasts resulted in a significant reduction of cell survival. No decrease in cell survival was found using the experimental sample. Subcutaneous implantation studies in mice showed that the positive control material induced a severe degeneration in mice. However, in rats just minimal alterations were noted. The experimental material induced moderate responses only in mice. Our results indicate that the direct contact assay provides limited additional information on the cytotoxicity of materials if certain limitations are not taken into account. For the in vivo implantation assay mice were superior to rats in detecting local toxic responses.

Biocompatibility of nanoporous alumina membranes for immunoisolation

“…The in vitro cytotoxicity test is a standard test that provides information on the interactions between cells and the surface of the material, and is often used as an initial evaluation of biocompatibility [30][31][32]. Here, the viability of cells was evaluated after a 24 hour period, and no significant difference was found between the positive control and the capsules (Figure 4).…”

Polymers with tunable toxicity: A reference scale for cytotoxicity testing of biomaterial surfaces

“…7 A further complication is that recent reports have shown that the choice of test system and material controls can significantly influence the final outcome of in vitro cytotoxicity testing. 8,9 A problem that arises during cell-material interaction testing is that interpretation of the data is often subjective and affects the final conclusion. This is because cells and tissues are rarely completely unaffected by the environmental change, i.e.…”

“…organotin-stabilized poly(vinylchloride) or even phenol (for liquid testing)) or good compatibility/ inertness (high-density or low-density polyethylene). 8,[11][12][13] Recently, a specially designed polyvinylchloride, thought to represent intermediate toxicity, was shown to be not very reliable or useful. 8 A series of materials with defined toxicity would facilitate the evaluation of responses that are in the ''moderate'' to ''mild'' region.…”

hMSC Production in Disposable Bioreactors with Regards to GMP and PAT

“…An effortless transfer of standard systems to geometrically similar disposable systems would be advantageous. Problems arise due to the lack of experience in disposable systems concerning material quality [14] or potential interactions with the products [15]. In addition, there is also an increase in costs concerning waste disposable [16].…”