Mammalian erythrocyte micronucleus test

Mammalian Erythrocyte Micronucleus Test (Updated Guideline, adopted 21 July 1997)... 

B.ll Mutagenicity - In vivo mammalian bone-marrow chromosome aberration test B.12 Mutagenicity mammalian erythrocyte micronucleus test B.20 Sex-Unked recessive lethal test in Drosophila melanogaster B.22 Rodent dominant lethal test... 

Developmental rats, rabbits Prenatal and postnatal development none Genetic toxicology Ames test, in vitro mammalian chromosome aberration test in V79 Chinese hamster cells, and in vivo mammalian erythrocyte micronucleus test in rats... 

OECD (1997c). Mammalian erythrocyte micronucleus test. OECD Guideline for Testing of Chemicals 474, 1-10. 

Mammalian erythrocyte micronucleus test Mammalian erythrocyte Structural and numerical chromosome aherrations in somatic cells B12/TG474... 

OECD, 1997c, Test Guideline 474, Mammalian Erythrocyte Micronucleus Test. 

The mammalian in vivo erythrocyte micronucleus test OECD TG 474 US-EPA OPPTS 870.5395 EU Annex V B.12... 

Positive results in the mammalian in vivo erythrocyte micronucleus test indicate that a substance produces micronuclei in the immature erythrocytes of the test species, which are the result of chromosomal damage or damage to the mitotic apparatus in the erythroblasts of the test species. 

Twenty-seven out of 44 FDA-approved biopharmaceuticals have been tested in a battery of genotoxicity assays. Eighty-five different assays performed yielded negative results. The most commonly performed assays were the Ames test, the chromosomal aberration assay in human lymphocytes, the mouse lymphoma gene mutation assay, and the mammalian in vivo erythrocyte micronucleus test. Examples of the range of biopharmaceutical products tested include, domase alfa (deoxyribonuclease I-DNAse), trastuzumab (mAb to human epidermal growth factor receptor 2), alteplase (tissue plasminogen activator), infliximab (mAb to the human tumor necrosis factor a). 

Bacterial reverse mutation (formerly "Ames") test (OPPTS 870.5100/OECD 471) Mammalian erythrocyte micronucleus (intraperitoneal route) (OPPTS 870.5395/ OECD 474)... 

Genotoxicity studies (micronucleus tests for chromosome aberrations) in mammalian polychromatic erythrocytes and nonhuman mammalian cell culture were positive. Ames Salmonella tests for mutagenicity have been negative. 

Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes Conducting Acute Toxicity Tests on Aqueous Effluents with Fishes, Macroinvertebrates, and Amphibians... 

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