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  • ASTM
    E2526-08(2013) Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
    Edition: 2013
    $103.58
    Unlimited Users per year

Description of ASTM-E2526 2013

ASTM E2526 - 08(2013)

Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells

Active Standard ASTM E2526 | Developed by Subcommittee: E56.03

Book of Standards Volume: 14.02




ASTM E2526

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. Scope

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.

ASTM Standards

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 Standard

ISO10993-5 Biological Evaluation of Medical Devices: Part 5 Tests for in vitro Cytotoxicity Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.

Keywords

cytotoxicity; hepatocytes; kidney cells; nanoparticles;


ICS Code

ICS Number Code 07.100.10 (Medical microbiology)


DOI: 10.1520/E2526

ASTM International is a member of CrossRef.

ASTM E2526

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