ASTM F1439-92(1996)

ASTM F1439-92(1996) - 1.1.1996

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

E2186-02a(2023)	Standard Guide for Determining DNA Single-Strand Damage in Eukaryotic Cells Using the Comet Assay (Includes all amendments and changes 12/20/2023).
E1398-91(1998)	Standard Practice for the in vivo Rat Hepatocyte DNA Repair Assay
E1397-91(1998)	Standard Practice for the in vitro Rat Hepatocyte DNA Repair Assay
E1280-97	Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
E1263-97	Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
E1262-88(2018)	Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
	National Toxicology Program General Statement of Work for the Conduct of Toxicity and Carcinogenicity Studies in Laboratory Animals Available from National Institute of Environmental Health Sciences, 111 T. W. Alexander Drive, Research Triangle Park, NC, August 1988. http://www.niehs.nih.gov/.
OECD Guidelines for Testing of Chemicals: Guideline 451, Carcinogenicity	Studies Available from Organization for Economic Cooperation and Development, 2001 L Street, N.W., Suite 650, Washington, D.C. 20036-4922. http://www.oecd.org/washington/contact.htm.
OECD Guidelines for Testing of Chemicals: Guideline 453, Combined	Chronic Toxicity/Carcinogenicity Studies
Good Laboratory Practice for Nonclinical Laboratory Studies Available from 21 CFR, Part 58, U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://www.access.gpo.gov.