In vitro micronucleus test

Miller BM, Pujadas E, Gocke E. 1995. Evaluation of the micronucleus test in vitro using Chinese hamster cells Results of four chemicals weakly positive in the in vivo micronucleus test. Environ Mol Mutagen 26 240-247. 

Fritzenschaf, H., Kohlpoth, M., Rusche, B. Schiffmann, D. (1993) Testing of known carcinogens and noncarcinogens in the Syrian hamster embryo (SHE) micronucleus test in vitro correlations with in vivo micronucleus formation and cell transformation. Mutat. Res., 319, 47-53... 

Micronucleus test in vitro MNT in vitro Chromosome aberrations Induction of micronuclei... 

The purpose of the micronucleus test in vitro is to evaluate the potential of compounds to induce micronuclei (formation of small membrane-bound DNA fragments) in different cell lines or primary cultures, with and without metabolic activation by S9 liver homogenate. 

AU ehgible chemicals under REACH require the conductance of a bacterial reverse mutation (Ames) test (Annex Vll, 8.4.1) (EC 2006). For compounds >10t/a, an additional mammalian in vitro cytogenetic test is required (Aimex VIII, 8.4.2) (EC 2006). For the latter, both the chromosome aberration test and the micronucleus test in vitro are considered acceptable. In the case of a negative result in the mammalian in vitro cytogenetic test and in the in vitro gene mutation test in bacteria, data from an in vitro gene mutation study in mammahan ceUs are required (Annex... 

Physicochemical properties requked include melting/boiling point, vapor pressure, solubiUty, and flammabiUty/explosion characteristics. The toxicological studies include acute toxicity tests, oral, inhalation, and dermal skin and eye kritation skin sensiti2ation subacute toxicity, oral, inhalation, and dermal and mutagenicity tests. In vitro reverse mutation assay (Ames test) on Salmonella typhimurium and/or E.scherichia coli and mammalian cytogenic test. In vivo mouse micronucleus test. 

Toxicological properties Acute toxicity (by two routes of admission) Skin irritation Eye irritation Skin sensitization 28 days subacute toxicity Ames test In vitro metaphase analysis (or mouse micronucleus test)... 

TETA was mutagenic in bacterial assays and was positive in sister chromatid exchanges and unscheduled DNA synthesis tests in vitro It was not clastogenic in the mouse micronucleus test in vivo after oral or intraperitoneal administration. 

In general, genotoxicity standard assays (e.g., bacterial reverse mutation assay [Ames test], in vitro chromosomal aberration assay, mouse lymphoma gene mutation assay, and rodent micronucleus assay) may not be suitable assays because the test cells do not contain the appropriate receptors to transport the product (i.e.,not a relevant species) or because the biopharmaceutical... 

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... 

Chromosomal aberration tests in vitro (e.g. Cytogenetic test) and in vivo (e.g. Micronucleus test in rodents). 

Mouse lymphoma test in mouse lymphoma cells (in vitro) Micronucleus test in rodent bone marrow (in vivo)... 

Endosulfan was not mutagenic in the Ames test or mammalian mutagenic assays and was negative in clastogenesis and micronucleus assays in vitro and in vivo. 

ETBE was negative in mutagenicity assays in bacteria and Chinese hamster ovary cells, in a bone marrow micronucleus test in mice, and in an in vitro chromosome aberration assay. 

In Vitro Micronucleus Test In Mammalian Cells (MNvIt)... 

In Vitro Micronucleus Test in 3D Human Reconstructed Skin Models (RSMN)... 

The micronucleus test in 3D human reconstructed skin models (RSMN) is one of the promising new test methods which aims at solving the low specificity issues shown by the standard in vitro genotoxicity tests and addressing the challenges presented by the requirements of the new Cosmetics Regulation [7],... 

IV. Concerns over growing numbers of nonrelevant positive findings in mammalian cell tests in vitro will also be counterbalanced by limiting the levels of cytotoxicity to at most 50% for in vitro chromosome aberration and micronucleus tests. This proposal is supported by an extensive review of results obtained with in vitro hazard identification testing and in vivo risk assessment testing in the pharmacentical industry. 

No genotoxic activity of polyoxyethylene hydrogenated castor oil was observed in the micronucleus test in mice, or in the reverse mutation test in bacteria and the chromosome aberration test in vitro, with or without metabolic activation (Hirai et al. 1994). 

As summarized previously by this Committee, in tests for chromosomal aberrations in vitro, there was one positive and one negative study in tests for micronucleus formation in vitro, there were two positive results. Two more recent in vitro tests on chromosomal aberration (Lioi et al., 2004) and micronucleus formation (Ehrlich et al., 2002) were also positive. In vivo, as summarized previously by this Committee, chromosomal aberrations were induced in mice (Annex 1, reference 153). In a more recent study, results in rats were negative (Mally et al., 2005b). 

In vitro metaphase analysis (or mouse micronucleus test)... 

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