Toxicological testing guidelines

GENETIC TOXICOLOGY, TESTING GUIDELINES AND REGULATIONS, AND NOVEL ASSAYS... 

EFSA is currently in the process of revising its toxicology testing guidelines for FCS, the draft is expected for December 2013. 

The 3R concept lies behind efforts to improve ethical standards for the use of experimental animals throughout the scientific community, including toxicity testing. A number of in vitro methods for genetic toxicology testing have been established as guideline methods for many years, e.g., the bacterial reverse mutation test, more popularly known as the Ames test. 

In the hazard assessment, it is important to evaluate the toxicological database with regard to its adequacy. The adequacy of a study includes its validity and its relevance. The relevance refers to what has been studied in relation to what is needed for the hazard and risk assessment, and the validity refers to how the study was performed, e.g., conforming with a particular test guideline. The validity and the relevance of a study, or a whole database, has to be considered in relation to the reliability and thus the confidence. The data for hazard assessment are described in detail in Chapter 3. 

Toxicology and Environmental Health Information Program Transcutaneous Electrical Resistance Test Guideline... 

Hinton, D.M. (2000) US FDA Redbook II immimotoxicity testing guidelines and research in immunotoxicity evaluations of food chemicals and new food proteins. Toxicologic Pathology, 28, 467-478. 

H., Miyamae, Y, Rojas, E. et al. (2000) Single cell gel/comet assay guidelines for in vitro and in vivo genetic toxicology testing. Environmental and Molecular Mutagenesis, 35, 206-221. 

EMEA (1997) Note for guidance on preclini-cal pharmacological and toxicological testing of vaccines. CPMP/SWP/465/95. http //www. ema.europa.eu/docs/en GB/document library/Scientific guideline/2 00 9/09/ WC500003102.pdf. Accessed 16 Sept 2011... 

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