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  • ASTM
    F2148-06 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
    Edition: 2006
    $93.60
    Unlimited Users per year

Description of ASTM-F2148 2006

ASTM F2148-06

Historical Standard: ASTM F2148-06 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

SUPERSEDED (see Active link, below)




ASTM F2148

1. Scope

1.1 This practice provides a methodology to use an in situ procedure for the evaluation of delayed contact hypersensitivity reactions.

1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. The guinea pig maximization test should be used for these substances.

1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation within the nodes draining the site of administration on the ears of mice.

1.4 The LLNA has been validated only for low molecular weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates.

1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.

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 and health practices and determine the applicability of regulatory limitations prior to use.

1.7 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.


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

F619 Practice for Extraction of Medical Plastics

F720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices

F750 Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

Other Document

ICCVAMNIHPublication The Murine Local Lymph Node Assay, 1999 Available from NICEATM, NIEHS, 79 Alexander Dr., Mail Drop EC-17, Research Triangle Park, NC 27709.

Keywords

biocompatibility; contact hypersensitivity; local lymph node assay; LLNA; mouse; sensitization;


ICS Code

ICS Number Code 11.100 (Laboratory medicine)


DOI: 10.1520/F2148-06

ASTM International is a member of CrossRef.


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