Alternative Test Methods: Validation and Regulatory Status

Conventional test method Alternative Test Method Infor- mation Last Updated
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Genotoxicity
No specific conventional test method is superseded Bacterial Reverse Mutation Test (Ames test)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)

 April 2009
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)		 April 2009
Saacharomyces 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)		 April 2009
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)

 April 2009
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)		 April 2009
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)		 April 2009
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)		 April 2009
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: Draft TG 487 (2007)

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)

 April 2009
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)

 April 2009

List of Abbreviations