Chromosomal mutations assays

Kanaya N, Gill BS, Grover IS, Murin A, Osiecka R, Sandhu SS, Andersson HC (1994) Vicia faba chromosomal aberration assay. Mutat Res 310 231-247 Matsuda H, Ose Y, Nagase H, Sato T, Kito H, Sumida K (1991) Mutagenicity of the components of ozonated humic substance. Sci Total Environ 103 129-140... [Pg.300]

In vitro chromosome aberration test In vitro gene mutation assay Acute oral toxicity Acute inhalation or dermal toxicity... [Pg.13]

In genotoxic assays, commercial hexane, consisting of -hexane and other six-carbon isomers, did not produce chromosomal mutations either in vitro or in vivo Results have generally been negative in bacterial assays and in other mammalian cell assays. Morphologic alterations in sperm were noted in one inhalation study in rats. ... [Pg.381]

In mammalian assays, glycidol has been tested in human lymphocytes and Chinese hamster cells in vitro for induction of chromosomal aberrations and sister chromatid exchanges. It was also tested in vivo in the mouse micronucleus assay. All test results were positive, as were those of gene mutation assays using Chinese hamster V79 cells and mouse lymphoma L5178Y cells. An in-vivo assay to detect chromosomal aberrations in mouse bone-marrow cells gave negative results. [Pg.478]

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... [Pg.337]

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). [Pg.339]

Prenatal and postnatal development none Genetic toxicology0 Ames test, human lymphocyte chromosomal aberration assay, CHO/HGPRT gene mutation assay, mouse micronucleus assay Carcinogenicity none... [Pg.932]

Not genotoxic (Ames, CHO/ HGPRT forward point mutation assay, in vitro chromosomal aberrations in human PBLs)... [Pg.1051]

MILLER B, POTTER-LOCKER E, SEELBACH A, STOPPER H, UTESCH D and MADLE S (1998) Evaluation of the in vitro micronucleus test as an alternative to the in vitro chromosomal aberration assay position of the GUM Working Group on the in vitro micronucleus test. Gesellschaft fur Umwelt-Mutations-Forschung, Mutat Res. 410, 81-116. [Pg.345]

The potential for interaction with genetic material (and therefore risk of carcinogenicity) can be investigated using bacterial and mammalian gene mutation assays and chromosomal aberration assays. The parent CDs do not exhibit mutagenic behavior in any of these assays, and there have been no reports of tumors in oral feeding studies or in the parenteral administration of any of the parent CDs. [Pg.689]

Amdro was negative in Salmonella typhimuriumi Escherichia coli reverse gene mutation assays, Schizosaccharomyces pombe PI forward gene mutation assay, in vitro Chinese hamster ovary chromosome aberration, and Saccharomyces cerevisiae D4 mitotic gene conversion assay. [Pg.88]

No evidence of genotoxicity was observed in vitro with or without metabolic activation in the following assays microbial mutagen tests using mutant strains of Salmonella typhimurium or Escherichia coli, Chinese hamster ovary forward mutation assay, unscheduled DNA synthesis in rat primary hepatocytes, chromosome aberrations in Chinese hamster ovary cells, and spindle inhibition in human lymphocytes. In addition, there was no evidence of genotoxicity in vivo in a mouse micronucleus test there was equivocal evidence of mutagenicity in a mouse domi nant lethal test. [Pg.219]