Genotoxicity

Conventional
test method

Alternative Test Method

Last Reviewed
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
No specific conventional test method is superseded Bacterial Reverse Mutation Test (Ames test)
Description and references
No information OECD: TG 471 (1997) US: Approved for the safety testing of food by US FDA (2000) Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
Saccharomyces cerevisiae Gene Mutation Assay
Description and references
No information OECD: TG 480 (1986) Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
Saccharomyces cerevisiae Mitotic Recombination Assay
Description and references
No information OECD: TG 481 (1986) Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
In Vitro Mammalian Chromosome Aberration Test
Description and references
No information OECD: TG 473 (1997) US: EPA Health Effects Test Guideline POOTS 870.5375 (1998); and approved for the safety testing of food by US FDA (2003)  Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
In Vitro Mammalian Cell Gene Mutation Test
Description and references
No information OECD: TG 476 (1997) US: EPA Health Effects Test Guideline OPPTS 870.5300 (1996) Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
In Vitro Sister Chromatid Exchange (SCE) Test
(Non-lethal Mouse Model for Botulinum Toxin Potency Testing)
Description and references
No information OECD: TG 479 (1986) Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
In Vitro Unscheduled DNA Synthesis (UDS) in Mammalian Cells Test
Description and references
No information OECD: TG 482 (1986) Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
In Vitro Mammalian Chromosome Aberration Test (OECD TG 473) In Vitro Micronucleus Test (MNT)
Description and references
EU: Endorsed as valid by ESAC (2006) OECD: OECD TG 487 (2010)

EU: Approved for use as part of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) (2006)

Under consideration for revised ICH guidelines
Reduction
(part of a tiered testing strategy that results in use of  fewer animals)
May 2012
No specific conventional test method is superseded In Vitro Comet Assay (Single-Cell Gel Electrophoresis [SCGE] Technique)
Description and references
Japan: JaCVAM presently conducting validation  OECD: new Test Guideline proposed Reduction
(part of a tiered testing strategy that results in use of fewer animals)
May 2012

 

List of Abbreviations

Test Methods Categories

Toxicity
Dermal Tests
Vaccines