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Significance and Use
5.1 Assessing the propensity of a nanomaterial to cause cytotoxicity to the cells of a target organ can assist in preclinical development.
5.2 The standard historical cytotoxicity testing of materials and extracts of materials has used fibroblasts and is well documented in Practice F813, Test Method F895, and ISO 10993-5. The use of macrophages and micron size particles has also provided information on cytotoxicity and stimulation using Practice F1903.
5.3 This test method adds to the cytotoxicity test protocols by using target organ cells. Two quantitative assays measuring LDH leakage and MTT reduction are used to estimate cytotoxicity.
5.4 This test method may not be predictive of events occurring in all types of nanomaterial applications and the user is cautioned to consider the appropriateness of the test for various types of nanomaterial applications. This procedure should only be used to compare the cytoxicity of a series of related nanomaterials. Meaningful comparison of unrelated nanomaterials is not possible without additional characterization of physicochemical properties of each individual nanomaterial in the assay matrix.
1.1 This test method provides a methodology to assess the cytotoxicity of suspensions of nanoparticulate materials in porcine proximal tubule cells (LLC-PK1) and human hepatocarcinoma cells (Hep G2) which represents potential target organs following systemic administration
1.2 This test method is part of the in vitro preclinical characterization cascade.
1.3 This test method consists of a protocol utilizing two methods for estimation of cytotoxicity, 3-(4,5-Dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide (MTT) reduction and lactate dehydrogenase (LDH) release.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F813 Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
F1877 Practice for Characterization of Particles
F1903 Practice for Testing For Biological Responses to Particles In Vitro
ISO StandardISO10993-5 Biological Evaluation of Medical Devices: Part 5 Tests for in vitro Cytotoxicity
ICS Number Code 07.100.10 (Medical microbiology)