1. Scope

1.1 This guide is intended to assist the biomaterials testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for new materials to evoke a neoplastic response. The procedure is generally reserved only for those materials which have not previously been used for human implantation for a significant period of time.

1.2 Assessment of tumorigenicity is one of several procedures employed in determining the biological response to a material as recommended in Practice F748. It is assumed that the investigator has already determined that this type of testing is necessary for a particular material before consulting this guide. The recommendations of Practice F748 should be considered before a study is commenced.

1.3 Whenever possible, it is recommended that a battery of genotoxicity procedures be initiated and proposed as an alternative to an in-vivo tumorigenicity bioassay. Genotoxicity assays may also be considered as initial screening procedures due to the sensitivity of the assays, the significant reduction in time to gain valuable data, and the desire to reduce the use of animals for testing. Genotoxicity assays that may be considered are outlined in Guides E1262 and E1280 and Practices E1397 and E1398. Additionally, other genotoxicity testing which might be considered (but which do not yet have ASTM test methods) include Salmonella/ Mammalian-Microsomal Plate Incorporation Mutagenicity Assay, In Vivo Cytogenetics Bone Marrow Chromosomal Damage Assay, BALB/3T3 Morphological Transformation of Mouse Embryo Cells, and the Mouse Micronucleus Assay. The investigator is advised to consider carefully the appropriateness of a particular method for his application after a review of the published literature.

1.4 This standard does not purport to address all of the safety problems, 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

E1262 Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

E1263 Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes

E1280 Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity

E1397 Practice for In Vitro Rat Hepatocyte DNA Repair Assay

E1398 Practice for In Vivo Rat Hepatocyte DNA Repair Assay

E2186 Guide for Determining DNA Single-Strand Damage in Eukaryotic Cells Using the Comet Assay

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

Other Documents

Keywords

biocompatibility; carcinogenicity testing; tumorigenicity testing; Biocompatibility; Biomedical materials/applications; Neoplastic response; Performance--surgical materials/applications; Rats; Test animals; Tumoreigenic potential

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F1439-92R96

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