Evaluation of the Extraction Method for the Cytotoxicity Testing of Latex Gloves
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초록
In this study, the cytotoxicity of medical latex gloves to cultured L-929 cells was determined using various extraction conditions. According to the extraction time and temperature, three types of extraction conditions were used: 1) 24 h at 37℃; 2) 72 h at 37℃; 3) 72 h at 50℃. Also, four different extraction vehicles were used, namely, distilled water (DW), 9g/l sodium chloride (saline) in DW, and culture media with or without serum. Under the above-mentioned conditions, the samples were extracted and then 2-fold serially diluted in the concentration range 3.13-50%. When extracted with either DW or saline for 24h or 72 h at 37℃, only 50% diluted samples showed distinct cytotoxicity to L-929 cells. Moreover, no cytotoxic potentials were observed when gloves were extracted with DW or saline at 50℃ for 72 h. Cytotoxicity was markedly greater when gloves were extracted with culture medium, irrespective of the presence of serum in the medium. These results suggest that optimal extraction conditions should be established for the cytotoxicity evaluations of biomaterials and medical devices.
Abstract
In this study, the cytotoxicity of medical latex gloves to cultured L-929 cells was determined using various extraction conditions. According to the extraction time and temperature, three types of extraction conditions were used: 1) 24 h at 37℃; 2) 72 h at 37℃; 3) 72 h at 50℃. Also, four different extraction vehicles were used, namely, distilled water (DW), 9g/l sodium chloride (saline) in DW, and culture media with or without serum. Under the above-mentioned conditions, the samples were extracted and then 2-fold serially diluted in the concentration range 3.13-50%. When extracted with either DW or saline for 24h or 72 h at 37℃, only 50% diluted samples showed distinct cytotoxicity to L-929 cells. Moreover, no cytotoxic potentials were observed when gloves were extracted with DW or saline at 50℃ for 72 h. Cytotoxicity was markedly greater when gloves were extracted with culture medium, irrespective of the presence of serum in the medium. These results suggest that optimal extraction conditions should be established for the cytotoxicity evaluations of biomaterials and medical devices.
참고문헌 (25)
- "Regulatory guidelines for biocompatibility safety testing", pp.16~43 (1997)
- "Evaluation of medical devices for biological hazards Method of test for toxicity to cells in culture of extracts from medical devices", pp.~5736 (1988)
- "Biological reactivity tests in vitro" (1990)
- "Use of 3T3 cell-neutral red uptake assay for irritants as an alternative to the rabbit", pp.473~5
- "Studies on the standardization of cytotoxicity tests and new standard reference materials useful for evaluation the safety of biomaterials", pp.138~57
- "Cytotoxicity testing. In: Shayne CG, editor. Safety evaluation of medical devices", pp.75~84 (1997), Marcel Dekker;
- "Testing biomaterials. In: Ratner BD, Hoffman AS, Schoen FJ, Lemons JE, editors. Biomaterials science: an introduction to materials in medicine.", pp.215~20 (1996), Academic Press
- "Application of a combination of neural red and amino black staining for rapid reliable cytotoxicity testing of biomaterials", 17, pp.1259~64 (1996)
- "correlation with cytotoxic potentials but not cell attachment", pp.1~8
- "Biological evaluation of medical devices-Part 12 Sample preparation and reference materials" (1996)
- "Biological evaluation of medical devices-Part 5 Tests for cytotoxicity" (1992)
- "In vitro evaluation of PEG modified polyurethanes in cellular toxicity", 2, pp.65~8 (1998)
- "Heparinized bovine pericardium as a novel cardiovascular bioprosthesis", 21, pp.2323~30 (2000)
- "Comparative studies of the toxicity of standard reference materials in various cytotoxicity tests and in vivo implantation tests", pp.153~6
- "Different cytotoxic response to gadolinium between mouse and rat alveolar macrophages", 14, pp.309~19 (2000)
- "Evaluation of the cytotoxicity of polyurethane (PU) film containing zinc diethyldithiocarbamate (ZDEC) on various cell lines", 43, pp.518~26 (2002)
- "Improved sensitivity and decreased sample size in a cytotoxicity test for biomaterials: a modified color microassay using a microplate and crystal violet staining", pp.361~7
- "Established cell lines and primary cultures on testing medical devices in vitro", 13, pp.801~10 (1999)
- "In vitro evaluation of degradation and cytotoxicity of a novel composite as a bone substitute", 67, pp.1163~9 (2003)
- "In vivo validation of a cell culture test for biocompatibility testing of urinary catheters", pp.1125~35
- "Cytotoxicity of latex urinary catheters", pp.82~7
- "Cytotoxicity assessment of latex urinary catheters on cultured human urothelial cells", 38, pp.640~3 (2000)
- "section 13, F813-83, Standard practice for direct contact cell culture evaluation of materials for medical devices", pp.~83 (1996)
- "Comparative studies by cell culture and in vivo implantation test on the toxicity of natural rubber latex materials", pp.339~56
- "In vitro evaluation of diepoxy compounds used for biomaterial modification", 29, pp.829~34 (1995)