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2088245 
Technical Report 
Redbook 2000: Guidance for industry and other stakeholders. Toxicological principles for the safety assessment of food ingredients 
U.S. Food and Drug Administration :: FDA 
2007 
U.S. Department of Health and Human Services, Food and Drug Administration 
Silver Spring, MD 
286 
English 
has individual parts 200770 Chapter IV.C.6.: Carcinogenicity studies with rodents
has individual parts 3449436 Toxicological Principles for the Safety Assessment of Food Ingredients - Chapter IV.C.9.b: Guidelines for Developmental Toxicity Studies
"Toxicological Principles for the Safety Assessment of Food Ingredients 2" ("Redbook 2000") is the new name for Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food" that was originally published in 1982 ("Redbook I") and a draft revision was published in 1993 ("Redbook II" 3). Major changes in this revised guidance are presented later in this chapter. This document provides guidance to industry and other stakeholders (e.g. academia, other regulatory groups) regarding toxicological information submitted to the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety (OFAS) regarding food ingredients. It is a guidance document that is intended to assist petitioners and notifiers in:

- determining the need for toxicity studies
- designing, conducting, and reporting the results of toxicity studies
- conducting statistical analyses of data
- the review of histological data
- the submission of this information to the FDA as part of the safety assessment of food ingredients.

The term "food ingredients", as used in this guidance, includes food additives and color additives used in food, and those substances which are classified as food contact substances (formerly known as indirect food additives), and those substances which are classified as generally recognized as safe (GRAS). The toxicity studies included in this guidance document can also be used in the safety assessment of constituent residues. 
IRIS
• Methanol (Non-Cancer)
     Ramazzini