ASTM E3483-25

1.1 This test method covers a procedure for evaluating the effect of a nanomaterial on phagocytic cellular function.

1.2 Phagocytes play an important role in both innate and adaptive immunity.

1.3 Testing the effect of nanomaterials on phagocytic function using phagocytic cells in vitro helps to predict the biocompatibility of drug formulations and medical devices that contain nanomaterials.

1.4 This procedure can be used to test the effect of other materials, including excipients and ions generated from the nanomaterial, on phagocytic cellular function.

1.5 This test method is intended to strengthen understanding of the potential for adverse health effects of nanomaterials on cellular phagocytic function and subsequent risk of compromising protective innate immunity on systemic administration of nanomaterials.

1.6 This test method uses an in vitro model with peripheral blood-derived human acute promyelocytic leukemia (HL-60) cells to measure zymosan A uptake via luminol chemiluminescence. HL-60 is an immortalized cell line capable of phagocytosis derived from a single donor.

1.7 This test method does not apply to nanomaterials that interfere with luminol chemiluminescence.

1.8 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.

1.9 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.