title: US FDA "Redbook II" immunotoxicity testing guidelines and research in immunotoxicity evaluations of food chemicals and new food proteins.
abstract: The rapid advances in the field of immunology and an understanding of the potential adverse effects of xenobiotics on the immune system have resulted in the development of a discipline in toxicology now referred to as immunotoxicology. This discipline has evolved steadily over the last 2 decades as a result of research in the national and international communities. Various US, European, and Japanese regulatory agencies have recognized a need to promulgate testing guidelines for immunotoxicity in support of the approval process involving toxicological testing. The US Food and Drug Administration "Redbook II" guidelines and some of the research conducted in support of the concepts and testing strategies are presented here. Concerns raised with regard to these guidelines are included, as are on-going initiatives in development of experimental approaches for assessing allergic potential and/or hypersensitivity responses to new foods and food constituents.
authors.affiliation: Biochemical and Analytical Toxicology Branch, Division of Toxicological Studies, Office of Special Research Skills, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Hinton
mesh_terms: D000818:Animals; D005260:Female; D005503:Food Additives / Q000633:toxicity*; D017408:Guidelines as Topic; D007107:Immune System / Q000187:drug effects* / Q000473:pathology; D007154:Immune System Diseases / Q000139:chemically induced*; D007166:Immunosuppressive Agents / Q000633:toxicity*; D051379:Mice; D010755:Organophosphates / Q000633:toxicity; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley; D013556:Swine, Miniature; D018675:Toxicity Tests / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005503:Food Additives; D007166:Immunosuppressive Agents; D010755:Organophosphates; C005445:triphenyl phosphate