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Genotoxicology Testing

Genotoxicology (mutagenicity) tests evaluate the ability of a material to cause mutation or gross chromosomal damage. Any materials intended for implantation or long-term exposure should be evaluated for mutagenic properties. Unpolymerized materials, additives, trace monomers or oligomers and biodegradative products can all be potential mutagens.

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These tests are performed according to ISO 10993-3 using OECD test method 471.
Mammalian cells are exposed to the test material or extract in the presence and absence of metabolic activation and blocked in metaphase using a spindle poison.
Mouse lymphoma cells are used to determine whether a test material has the capacity to induce either point mutations or clastogenic (chromosomal breakage) events in a cultured mammalian cell line.
This assay is used to evaluate the potential of the test article to induce micronuclei formation in immature polychromatic erythrocytes.
Mammalian cells are exposed to the test material or extract in the presence and absence of metabolic activation and blocked in metaphase using a spindle poison.
This assay is used to evaluate the potential of the test article to induce micronuclei formation in immature polychromatic erythrocytes.

MHLW Testing

The purpose of this study is to evaluate the mutagenic potential of the test article (or its metabolites) by measuring its ability to induce back mutations at selected loci of four strains of Salmonella typhimurium and one strain of Escherichia coli in the presence and absence of microsomal enzymes.
Mouse lymphoma cells are used to determine whether a test material has the capacity to induce either point mutations or clastogenic (chromosomal breakage) events in cultured mammalian cell lines.
Mammalian cells are exposed to the test material or extract in the presence and absence of metabolic activation and blocked in metaphase using a spindle poison.
This assay is used to evaluate the potential of the test article to induce micronuclei formation in immature polychromatic erythrocytes.