Immunotoxicology—Regulatory and Risk Assessment Concepts

Abstract

Disclaimer: This article was written by Susan D. Wilson in her private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred. Address correspondence to James Blank, Pfizer Central Research (Mailbox #8014), Eastern Point Road, Groton, CT 06340, USA. E-mail: james_a_blank@groton.pfizer.com This article provides a review of presentations given at the symposium on Immunotoxicology: Regulatory and Risk Assessment Concepts held at the American College of Toxicology meeting in Orlando, Florida, in November, 1998. Immune system alterations have typically been assessed by histopathology of select lymphoid tissue, clinical pathology, clinical chemistry, plaque forming cell assay for humoral immunity, and allergic contact hypersensitivity. Advances in immunology and molecular biology have led to various activities to optimize hazard identification and risk assessment processes and strategies for immunotoxicants. With such advances, regulatory agencies have been either implementing immunotoxicology guidance as part of the safety of medical devices, evaluating environmental chemicals, or considering immunotoxicologic criteria for nonclinical assessments. Reviews of the guidance document provided by the Food and Drug Administration (FDA)/Center for Device and Radiological Health and concepts being considered by the FDA/Center for Drug Evaluation and Research are presented. In addition, a review of the process for evaluation of the murine local lymph node assay by the Interagency Coordinating Committee on the Validation of Alternative Methods and the state of risk assessment for chemical-induced autoimmunity are presented.