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GUIDANCE DOCUMENT

Redbook 2000: IV. A. Introduction to Guidelines for Toxicity Studies November 2003

Final
Issued by:
Guidance Issuing Office
Human Foods Program

Toxicological Principles for the Safety Assessment of Food Ingredients

Return to Redbook 2000 table of contents

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

The Agency published its first set of guidelines for toxicity studies for food additives and color additives used in food in 1982 and the first revision in 1993. The guidelines presented in Chapter IV. of Redbook 2000 reflect current scientific knowledge relevant to the design, conduct, and reporting of toxicity studies used in the safety evaluation of food ingredients.

Information contained within Chapter IV.B. provides recommendations which generally apply to all types of toxicity studies and should be considered when designing toxicity studies. Chapter IV. B. currently includes: "General Guidelines for Designing and Conducting Toxicity Studies" (IV.B.1.), "Guidelines for Reporting the Results of Toxicity Studies" (IV.B. 2.), "Pathology Considerations in Toxicity Studies" (IV.B.3.), and "Statistical Considerations in Toxicity Studies" (IV.B.4.). Relevant information contained in the "General Guidelines for Designing and Conducting Toxicity Studies" (IV.B.1.) has also been incorporated into the specific studies (IV.C.3.-5.) in Redbook 2000, for your convenience.

Information presented within Chapter IV.C. of Redbook 2000 provides recommendations for the following specific types of toxicity studies:

  1. IV.C.1. Short-Term Tests for Genetic Toxicity
  2. IV.C.1.a. Bacterial Reverse Mutation Test
  3. IV.C.1.b. In vitro Mammalian Chromosomal Aberration Test
  4. IV.C.1.c. In vitro Mouse Lymphoma Thymidine Kinase Gene Mutation Assay
  5. IV.C.1.d. In vivo Mammalian Erythrocyte Micronucleus Test
  6. IV.C.3.a. Short-Term Toxicity Studies with Rodents
  7. IV.C.3.b. Short-Term Toxicity Studies with Non-Rodents
  8. IV.C.4.a. Subchronic Toxicity Studies with Rodents
  9. IV.C.4.b. Subchronic Toxicity Studies with Non-Rodents
  10. IV.C.5 One-Year Toxicity Studies with Non-Rodents
  11. IV.C.9.a. Guidelines for Reproduction Studies
  12. IV.C.9.b. Guidelines for Developmental Toxicity Studies
  13. IV.C.10. Neurotoxicity Studies

Other specific toxicity studies listed in the Table of Contents of Redbook 2000 will be added in the coming months. These include: acute toxicity studies and/or alternatives (Chapter IV.C.2.), carcinogenicity studies with rodents (Chapter IV.C.6.), combined chronic toxicity/carcinogenicity studies with rodents (Chapter IV.C.7.), and in utero exposure phase for addition to carcinogenicity studies (Chapter IV.C. 8.).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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