Policy document
June 29th 2020

Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays

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OECD
OECD
https://www.oecd.org Flag of igo IGO

The Organisation for Economic Co-operation and Development is an intergovernmental organization with 38 member countries, founded in 1961 to stimulate economic progress and world trade. It is a forum the members of which are countries describing themselves as committed to democracy and the market economy, providing a platform to compare policy experiences, seek answers to common problems, identify good practices and coordinate domestic and international policies of its members. The majority of OECD members are high-income economies with a very high Human Development Index (HDI) and are regarded as developed countries.

This Test Guideline describes an in vivo assay that detects chemicals that may induce gene mutations in somatic and germ cells. In this assay, transgenic rats or mice that contain multiple copies of chromosomally integrated plasmid or phage shuttle vectors are used. The transgenes contain reporter genes for the detection of various types of mutations induced by test chemicals. A negative control group and a minimum of 3 treatment groups of transgenic animals are treated for 28 consecutive days. Administration is followed by a period of time, prior to sacrifice, during which the agent is not administered and during which unrepaired DNA lesions are fixed into stable mutations. At the end of this period (usually 3 or 28 days depending on the cell type and requirements), the animals are sacrificed, genomic DNA is isolated from the tissue(s) of interest and purified. Mutations that have arisen during treatment are scored by recovering the transgene and analysing the phenotype of the reporter gene in a bacterial...

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oecddiscovery-85799dc89554b4c59dcfedbdf0c1c46c

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Cited by 53 other policy documents (41 of them are from other policy sources)