Document Detail

US FDA "Redbook II" immunotoxicity testing guidelines and research in immunotoxicity evaluations of food chemicals and new food proteins.
MedLine Citation:
PMID:  10862567     Owner:  NLM     Status:  MEDLINE    
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.
D M Hinton
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Toxicologic pathology     Volume:  28     ISSN:  0192-6233     ISO Abbreviation:  Toxicol Pathol     Publication Date:    2000 May-Jun
Date Detail:
Created Date:  2000-10-05     Completed Date:  2000-10-05     Revised Date:  2009-07-01    
Medline Journal Info:
Nlm Unique ID:  7905907     Medline TA:  Toxicol Pathol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  467-78     Citation Subset:  IM    
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.
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MeSH Terms
Food Additives / toxicity*
Guidelines as Topic*
Immune System / drug effects*,  pathology
Immune System Diseases / chemically induced*
Immunosuppressive Agents / toxicity*
Phosphoric Acid Esters / toxicity
Rats, Sprague-Dawley
Swine, Miniature
Toxicity Tests / standards*
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Food Additives; 0/Immunosuppressive Agents; 0/Phosphoric Acid Esters; 115-86-6/triphenyl phosphate

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