Validated Non-animal Alternatives
|
Methods |
Test Purpose |
Validation Authority |
OECD TG |
| In vitro micronucleus test (MNT) |
Alternative to the in vitro chromosome aberration assay for genotoxicity testing |
ECVAM |
Draft 487 |
| Bacterial Reverse Mutation Test (Ames Test) |
Genotoxicity testing - using bacterial cells |
|
471 |
| Genetic Toxicology: Saccharomyces Cerevisiae Gene Mutation Assay |
Genotoxicity testing - using bacterial cells |
|
480 |
| Genetic Toxicology: Saccharomyces Cerevisiae Mitotic Recombination Assay |
Genotoxicity testing - using bacterial cells |
|
481 |
| In Vitro Mammalian Chromosome Aberration Test |
Genotoxicity testing - using mammalian cells |
|
473 |
| In Vitro Mammalian Cell Gene Mutation Test |
Genotoxicity testing - using mammalian cells |
|
476 |
| Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells |
Genotoxicity testing - using mammalian cells |
|
479 |
| Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro |
Genotoxicity testing - using mammalian cells |
|
482 |
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) genetic toxicity page describes US regulatory activities in validating test methods and/or reviewing related Organisation for Economic Co-operation and Development (OECD) Test Guidelines (TGs). ICCVAM has not validated any methods for genotoxicity testing.
Following a weight-of-evidence retrospective validation, the European Centre for the Validation of Alterantive Methods (ECVAM) Scientific Advisory Committee (ESAC) endorsed the in vitro micronucleus test (MNT) as a scientifically valid alternative to the in vitro chromosome aberration assay for genotoxicity testing (ESAC Statement, Nov. 17, 2006; revised OECD TG 487). 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 MNT can then be considered for regulatory use as part of the tier 1 genotoxicity test battery."
The ECVAM/INVITTOX database contains seven genotoxicity testing protocols, but neither ECVAM nor ICCVAM has formally vlaidated these methods.
Although the OECD encourages the validation of test methods prior to their adoption as TGs, validation is not a prerequisite for the adoption of TGs. 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, and 482.
Additional information on in vitro methods being developed for genotoxicity testing can be found in Toxicity Endpoints & Tests: Genotoxicity.
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