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Non-animal Methods for Toxicity Testing

Genotoxicity


Last Updated: June 20, 2011
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Validated Non-animal Alternatives

 

Methods

Test Purpose

Validation Authority

OECD TG

In vitro Mammalian Cell Micronucleus Test Alternative to the in vitro chromosome aberration assay for genotoxicity testing

ECVAM

OECD TG 487

Bacterial Reverse Mutation Test (Ames Test) Genotoxicity testing - using bacterial cells

 

OECD TG 471

Genetic Toxicology: Saccharomyces Cerevisiae Gene Mutation Assay Genotoxicity testing - using bacterial cells

 

OECD TG 480

Genetic Toxicology: Saccharomyces Cerevisiae Mitotic Recombination Assay Genotoxicity testing - using bacterial cells

 

OECD TG 481

In Vitro Mammalian Chromosome Aberration Test Genotoxicity testing - using mammalian cells

 

OECD TG 473

In Vitro Mammalian Cell Gene Mutation Test Genotoxicity testing - using mammalian cells

 

OECD TG 476

Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells Genotoxicity testing - using mammalian cells

 

OECD TG 479

Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro Genotoxicity testing - using mammalian cells

 

OECD TG 482

 


Following a weight-of-evidence retrospective validation, the ESAC endorsed the in vitro micronucleus test as a scientifically valid alternative to the in vitro chromosome aberration assay for genotoxicity testing (ESAC Statement, Nov. 17, 2006). The ESAC statement clarified their endorsement as follows: "To facilitate test guideline development and regulatory acceptance, a standardised test protocol and performance standards need to be defined. The in vitro [micronucleus test] can then be considered for regulatory use as part of the tier 1 genotoxicity test battery." The in vitro mammalian cell micronucleus test detects two types of chemical-induced changes to dividing cells: chromosome breakage (clastogens) and changes in chromosomal numbers (aneugens).

The ECVAM/INVITTOX database contains seven additional genotoxicity testing protocols, but neither ECVAM nor ICCVAM has formally validated these methods.

Although the OECD encourages the validation of test methods prior to their adoption as Test Guidelines (TGs), validation is not a prerequisite for the adoption of TGs. Except for the in vitro micronucleus test, the in vitro genotoxicity test methods incorporated into OECD TGs have not been formally validated by ECVAM or ICCVAM.

In vitro genotoxicity/mutagenicity test methods based on bacterial cells are TG 471, 480, and 481. In vitro genotoxicity/mutagenicity test methods based on mammalian cells are TG 473, 476, 479, 482, and 487.

Additional information on in vitro methods for genotoxicity testing can be found on AltTox at: Toxicity Endpoints & Tests: Genotoxicity.