Principles of Toxicology by Phillip L. Williams & ROBERT C. JAMES

Author:Phillip L. Williams & ROBERT C. JAMES [Williams, Phillip L. && JAMES, ROBERT C.]
Language: eng
Format: epub
ISBN: 9781118982518
Publisher: Wiley
Published: 2014-12-12T00:00:00+00:00

Guidelines for performing the in vitro mammalian gene mutation assays can be found in OECD TG 476 and the FDA CFSAN Redbook. Because the MLA Expert Workgroup of the International Workshop for Genotoxicity Testing (IWGT) has reached consensus on a number of parameters for assay acceptance and for evaluating the data as positive or negative, a separate OECD guideline for the MLA is currently under development to include these new recommendations. This resulted in the need to revise OECD TG 476, to include only the Hprt assay. When finalized, both of the OECD TGs dealing with in vitro gene mutation assays will include new recommendations for determining the acceptability of individual experiments and the interpretation of data.

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