FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
horizontal rule

CFSAN/Office of Food Additive Safety
May 2006

horizontal rule

Guidance for Industry


Physical/chemical characterization
Water Solubility  
Dissociation Constant(s)  
Octanol/Water Partition Coefficient (Log Kow)  
Vapor Pressure or Henry's Law Constant  
Depletion mechanisms
Sorption/Desorption (Koc)  
Hydrolysis  
Aerobic Biodegradation  
Soil Biodegradation  
Photolysis  
Metabolism  
Environmental effects1
Microbial Inhibition  
Acute Toxicity  
Chronic Toxicity  

1Identify organism(s) and report results, e.g., NOEL, MIC, EC50, LC50.

(Return to Appendix A Section 7)
(Return to Appendix A Section 8)

(Return to Appendix B Section 7)
(Return to Appendix B Section 8)

(Return to Appendix C Section 7)
(Return to Appendix C Section 8)

Main Document
Table of Contents



The above guidance document supercedes the previous version dated September 2003.

 

horizontal rule
horizontal rule