Table 3.

In vivo genetic toxicology assays.

OECD Test Guideline	Name	Endpoint	Comments
474 (OECD, 2016d)	Mammalian erythrocyte micronucleus test	Clastogenicity / aneugenicity	Kinetochore staining or MN sizing required to differentiate clastogens and aneugens
475 (OECD, 2016e)	Mammalian bone marrow chromosome aberration test	Clastogenicity
478 (OECD, 2016g)	Genetic toxicology: Rodent dominant lethal test	Chromosome aberration by clastogenicity/aneugenicity (gene mutations)	Germ cell assay
483 (OECD, 2016h)	Mammalian spermatagonial chromosome aberration test	Clastogenicity	Germ cell assay
485 (OECD, 1986e)	Genetic toxicology: Mouse heritable translocation assay	Clastogenicity / aneugenicity	Not updated in 2014–16 revisions
486 (OECD, 1997b)	Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo	Unscheduled DNA synthesis	Not updated in 2014–16 revisions
488 (OECD, 2013)	Transgenic rodent somatic and germ cell gene mutation assays	Gene mutation	Somatic and male germ cell assays. Many data reported before adoption of the OECD test guideline so critical data review essential
489 (OECD, 2016j)	In vivo mammalian alkaline comet assay	DNA damage	Many data reported before adoption of the OECD test guideline so critical data review essential
484 (OECD, 1986d)	Genetic toxicology: Mouse spot test	Gene mutation	Deleted by OECD
	Pig-a	Gene mutation	No guideline adopted by the OECD but is under review for inclusion (Gollapudi et al., 2015). This assay may be considered as having high relevance in the pharmaceutical sector due to the inclusion in the ICH M7 Note 3 as a follow-up assay to a positive bacterial mutagenicity result