Genotoxicity testing
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- The data are discussed relative to whether genotoxicity testing is a valuable exercise when assessing potentially toxic liabilities of biotechnology-derived compounds.
- At present genotoxicity testing is time consuming and thus highly expensive.
- EPA agrees that no additional genotoxicity testing is needed based on the adequate data submitted for 3,3'-thiodipropionic acid didodecyl ester and 3,3'-thiodipropionic acid dioctadecyl ester.
- FDA bases its toxicology standards on determining the levels in the diet and has indicated that genotoxicity testing is needed for substances with an exposure level above 0.
- Because the basic mechanism of cancer involves genetic changes in somatic cells, genotoxicity testing is currently used as a screening procedure for potential carcinogenic effects.
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