Carcinogenicity test, current

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Jena GB, Kaul CL, Ramarao P. Regulatory requirements and ICH guidelines on carcinogenicity testing of pharmaceuticals a review on current status. Ind J Pharmacol 2005 37 209-22. 

Goodman JI. A perspective on current and future uses of alternative models for carcinogenicity testing. Toxicol Pathol 2001 29 173-6. 

The NCI Chronic Bioassay became the basis for current guidelines on carcinogenicity testing. Protocols and reports for the large-scale bioassays were standardized in order to increase scientific acceptability. 

A group of about 10 participants discussed the "battery of acceptable tests to be used in the genotoxic evaluation of a new chemical/pesticide. Considerable concern was expressed about reliability and reproducibility of various test systems and reasons for these concerns were addressed. The test methods (assays) chosen should minimize variability. It was generally agreed that good predictors of carcinogenicity are currently available in the battery of mutagenicity assays. 

A scientifically evaluated and fully referenced data bank, developed and maintained by the National Cancer Institute (NCI). It contains some 8,000 chemical records with carcinogenicity, mutagenicity, tumor promotion, and tumor inhibition test results. Data are derived from studies cited in primaiy journals, current awareness tools, NCI reports, and other special sources. Test results have been reviewed by experts in carcinogenesis and mutagenesis. 

The majority of very high concern substances will be those classified as category 1 or 2 CMRs. There are already around 850 such CMR substances based on current classifications, and it is likely that there will be another ca 500 identified from future testing. Most endocrine disrupters would require authorisation by being classified as carcinogenic or toxic for reproduction, but there is the option to add other endocrine disruptors on an ad hoc basis. 

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