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ASTM E2526-22

(Test Method)

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

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

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 and their 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.
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 represent potential target organs following systemic administration.  
1.2 This test method is part of an 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Published
Publication Date
30-Jun-2022
ICS
07.100.10 - Medical microbiology
Technical Committee
E56 - Nanotechnology
Drafting Committee
E56.03 - Environment, Health, and Safety
Current Stage
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ASTM E2526-22 - Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma CellsASTM E2526-22 - Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
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ASTM E2526-22 - Standard Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E2526 − 22
Standard Test Method for
Evaluation of Cytotoxicity of Nanoparticulate Materials in
1
Porcine Kidney Cells and Human Hepatocarcinoma Cells
This standard is issued under the fixed designation E2526; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F895TestMethodforAgarDiffusionCellCultureScreening
for Cytotoxicity
1.1 This test method provides a methodology to assess the
F1877Practice for Characterization of Particles
cytotoxicity of suspensions of nanoparticulate materials in
F1903Practice for Testing for Cellular Responses to Par-
porcine proximal tubule cells (LLC-PK1) and human hepato-
ticles in vitro
carcinoma cells (Hep G2), which represent potential target
3
organs following systemic administration. 2.2 ISO Standard:
ISO10993-5BiologicalEvaluationofMedicalDevices:Part
1.2 This test method is part of an in vitro preclinical
5 Tests for in vitro Cytotoxicity
characterization cascade.
1.3 This test method consists of a protocol utilizing two
3. Terminology
methods for estimation of cytotoxicity, 3-(4,5-
3.1 Abbreviations:
dimethylthiazolyl-2)-2,5-diphenyltetrazolium bromide (MTT)
3.1.1 APAP—acetaminophen- positive control
reduction and lactate dehydrogenase (LDH) release.
3.1.2 DMSO—dimethyl sulfoxide
1.4 The values stated in SI units are to be regarded as
3.1.3 DMEM—Dulbelcco’s modified eagles media
standard. No other units of measurement are included in this
standard.
3.1.4 FBS—fetal bovine serum
1.5 This standard does not purport to address all of the
3.1.5 Hep G2—human hepatocarcinoma cells
safety concerns, if any, associated with its use. It is the
3.1.6 LDH—lactic dehydrogenase
responsibility of the user of this standard to establish appro-
3.1.7 LLC-PK1—porcine proximal tubule cells
priate safety, health, and environmental practices and deter-
3.1.8 LPS—lipopolysacchride, bacterial endotoxin
mine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accor-
3.1.9 MTT—3-(4,5-dimethylthiazolyl-2)-2,5-diphenyltetra-
dance with internationally recognized principles on standard-
zolium bromide
ization established in the Decision on Principles for the
3.1.10 PBS—phosphate buffered saline
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
4. Summary of Test Method
Barriers to Trade (TBT) Committee.
4.1 Nanoparticulate test materials in suspension in cell
culture media and appropriate controls are added to cell
2. Referenced Documents
cultures. The release of LDH indicates membrane damage and
2
2.1 ASTM Standards:
thediminutionofMTTreductionindicateslossofcellviability.
F813Practice for Direct Contact Cell Culture Evaluation of
These are quantitative indicators of cytotoxicity. Aseptic pro-
Materials for Medical Devices
cedures are required.
5. Significance and Use
1
This test method is under the jurisdiction of ASTM Committee E56 on
Nanotechnology and is the direct responsibility of Subcommittee E56.03 on
5.1 Assessing the propensity of a nanomaterial to cause
Environment, Health, and Safety.
cytotoxicity to the cells of a target organ can assist in
CurrenteditionapprovedJuly1,2022.PublishedJuly2022.Originallyapproved
preclinical development.
in 2008. Last previous edition approved in 2013 as E2526 – 08(2013), which was
withdrawn in April 2022 and reinstated in July 2022. DOI: 10.1520/E2526-22.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2526 − 22
2+ 2+
5.2 The standard historical cytotoxicity testing of materials 6.2.13 Sterile Ca /Mg -free phosphate buffered saline
and extracts of materials has used fibroblasts and is well (PBS).
documented in Practice F813, Test Method F895, and ISO 6.2.14 Distilled or deionized water.
10993-5.Theuseofmacrophagesandmicronsizeparticleshas
6.3 Cell Lines:
also provided information on cytotoxicity and stimulation
6.3.1 LLC-PK1(porcineproximaltubulecell)(ATCCprod-
usi
...

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4.1 Single-use systems (SUSs) used for biopharmaceutical manufacturing must maintain sterility and product quality of the fluid inside. Such articles or systems should therefore be validated as providing an effective barrier against microbial ingress. The microbial barrier properties of a SUS may be demonstrated using deterministic physical tests that have been correlated to microbial integrity. Such physical test methods are described in Test Method E3336. Two microbial test methods (aerosol exposure and immersion exposure) are described in this test method that can be used to demonstrate microbial integrity of a SUS or determine the MALL, the maximum defect size that does not allow microbial ingress, into a SUS.  
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1.1 The microbial test method outlined in this test method applies to microbial ingress risk assessment of a single-use system (SUS) or its individual components that require integrity testing either by the assembly supplier or the end user of the assembly based on a potential risk of a breach to the product or manufacturing process.  
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5.1 In-vitro osteoblast differentiation assays are one approach to screen progenitor stem cells for their capability to become osteoblasts. The extent of calcium deposits or mineralized matrix that form in vitro may be an indicator of differentiation to a functional osteoblast; however, expression of osteogenic genes or proteins is another important measurement to use in conjunction with this assay to determine the presence of an osteoblast.  
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5.1 This guide should be used by producers and potential producers of non-culture tests to determine the accuracy, selectivity, specificity, and precision of the tests, as defined in Practice E691. Results of such studies should identify the limitations and indicate the utility or applicability of the non-culture test, or both, for use on different types of samples. Guide E1488 recommends other statistical tools for evaluating the suitability and applicability of proposed new test methods.  
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1.1 The purpose of this guide is to assist users and producers of non-culture microbiological tests in determining the applicability of the test for processing different types of samples and evaluating the accuracy of the results. Culture test procedures such as the Heterotrophic (Standard) Plate Count, the Most Probable Number (MPN) method and the Spread Plate Count are widely cited and accepted for the enumeration of microorganisms. However, these methods have their limitations, such as performance time. Moreover, any given culture test method typically recovers only a portion of the total viable microbes present in a sample. It is these limitations that have recently led to the marketing of a variety of non-culture procedures, test kits and instruments.  
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4.1 This practice is useful for assessing cytotoxic potential both when evaluating new materials or formulations for possible use in medical applications, and as part of a quality control program for established medical materials and medical devices.  
4.2 This practice assumes that assessment of cytotoxicity potential provides one method for predicting the potential for cytotoxic or necrotic reactions to medical materials and devices during clinical applications to humans. In general, cell culture testing methods have shown good correlation with animal assays when only chemical toxicities are being considered.
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1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.  
1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared.  
1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.  
1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748.  
1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.  
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4.1 The primary use of these test methods is testing to determine the specified mechanical properties of steel, stainless steel, and related alloy products for the evaluation of conformance of such products to a material specification under the jurisdiction of ASTM Committee A01 and its subcommittees as designated by a purchaser in a purchase order or contract.  
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Brinell  
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Rockwell  
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Portable  
19  
Impact  
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Keywords  
32  
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Annex  
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Annex A1  
Tubular Products  
Annex A2  
Fasteners  
Annex A3  
Round Wire Products  
Annex A4  
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Annex A5  
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Annex A6    
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Annex A7  
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Annex A8  
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Annex A9  
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Annex A10  
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4.1 Using the procedures and apparatus in Sections 8 and 9 and the manufacturer's instructions, pressure-tight joints as strong as the pipe itself can be made between manufacturer-recommended combinations of pipe and fittings. See Specification F1055 for performance requirements of polyethylene electrofusion fittings.
SCOPE
1.1 This practice describes procedures for making joints suitable for pressure service with polyethylene (PE) pipe and fittings by means of electrofusion joining techniques in, but not limited to, a field environment. Other suitable electrofusion joining procedures are available from various sources including fitting manufacturers. This standard does not purport to address all possible electrofusion joining procedures, or to preclude the use of qualified procedures developed by other parties that have been proven to produce reliable electrofusion joints. (Note 1)
Note 1: Reference to the manufacturer in this practice refers to the electrofusion fitting manufacturer.  
1.2 The parameters and procedure are applicable only to joining polyethylene pipe and fittings (Note 2) which are intended for PE fuel gas pipe per Specification D2513 and PE potable water, sewer and industrial pipe manufactured per Specification F714, Specification D3035, Specification F2619, and AWWA C901 and C906.
Note 2: Commercially available materials classified with a thermoplastic pipe material designation code beginning with PE 14, PE 23, PE 24, PE 27, PE 33, PE 34, PE 36, and PE 46, and PE 47 in accordance with Specification D3350 and Terminology F412 are generally acceptable for electrofusion joining using this practice. Consult with the pipe or fitting manufacturer for specific compatibility information.  
1.3 Parts that are within the dimensional tolerances given in present ASTM specifications are required to produce sound joints between polyethylene pipe and fittings when using the joining techniques described in this practice.  
1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.5 The text of this practice references notes, footnotes, and appendices which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the practice.  
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM D5141-23(Test Method)
Standard Test Method for Determining Filtering Efficiency and Flow Rate of the Filtration Component of a Sediment Retention Device

SIGNIFICANCE AND USE
5.1 This test method is used to determine the filtering efficiency and flow rate of the filtration component of a sediment retention device, such as a silt fence, a silt barrier, or a silt curtain, for specific soil tested.  
5.2 This test method may be used for the design of the filtration component of a sediment retention device to meet requirements of regulatory agencies in filtering efficiency or flow rate for the specific soil tested.  
5.2.1 The designer can use this test method to determine the spacing between sediment retention devices.  
5.3 This test method is intended for performance evaluation, as the results will depend on the specific soil evaluated. Unless testing with the default soil is desired, it is recommended that the user or representative perform the test to pre-approve products, as sediment retention device manufacturers are not typically equipped to handle or test soil requirements.  
5.4 This test method provides a means of evaluating the filtration component of sediment retention devices with different soils under various conditions that simulate the conditions that exist in a sediment retention device installation. This test method may be used to simulate several storm events on the same sediment retention device specimen. Therefore, the number of times this test is repeated per specimen is dependent upon the user and the site conditions.
SCOPE
1.1 This test method is used to determine the filtering efficiency and the flow rate of the filtration component of a sediment retention device, such as a silt fence, silt barrier, or inlet protector.  
1.1.1 The results are shown as a percentage for filtering efficiency and cubic metres per square metre per minute (m3/m2/min) or gallons per square foot per minute (gal/ft2/min) for flow rate.  
1.1.2 The filtering efficiency indicates the percent of sediment removed from sediment-laden water.  
1.1.3 The flow rate is the average rate of passage of the sediment-laden water through the filtration component of a sediment retention device.  
1.2 This test method requires several specialized pieces of equipment, such as an integrated water sampler and an analytical balance, or a vacuum filtration system. At the client’s discretion, the test soil is either a site-specific soil or a soil that is representative of a target default gradation.  
1.3 The values stated in SI units are the standard, while the inch-pound units are provided for information. The values expressed in each system may not be exact equivalents; therefore, each system must be used independently of the other, without combining values in any way.  
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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  • Standard
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    English language
    sale 15% off