Gene mutation assays

Saccharomyces cerevisiae gene mutation assay OECD... 

Brusick and Matheson (1976) reported that 1,1-dimethylhydrazine failed to increase reversions in Salmonella typhimurium or Saccharomyces cerevisiae gene mutation assays with or without metabolic activation. A concentration-related response was observed in the mouse lymphoma assay (with activation). Dominant lethal tests were negative. 

In vitro chromosome aberration test In vitro gene mutation assay Acute oral toxicity Acute inhalation or dermal toxicity... 

Cole, J., Fox, M., Gamer, R.C., McGregor, D.B. and Thacker, J. (1990). Gene mutation assays in cultured mammalian cells. In UKEMS Subcommittee on Guidelines for Mutagenicity Testing. Report Part I rev. (Kirkland, D.J., Ed.). Cambridge University Press, pp. 87-114. 

Genetic Toxicology Saccharomyces cerevisiae. Gene Mutation Assay (Original Guideline, adopted 23 October 1986)... 

Genetic toxicology Saccharomyces cerevisiae, gene mutation assay 1986... 

The Saccharomyces cerevisiae gene mutation assay OECD TG 480 EU Annex V B.15... 

Positive results from the Saccharomyces cerevisiae gene mutation assay indicate that a substance induces point mutations by base pair substitution or frameshift in the genome. Base pair substimtion and frameshift is explained under the in vivo test. 

The genotoxic potency of ethyl chloride appears to be low. It was negative in in vivo micronucleus tests, but it has produced both positive and negative results in bacterial gene mutation assays. ... 

Annotations from Positive Screening Data 11.8.2.1 Gene Mutation Assays... 

Miura, D., Dobrovolsky, V.N., Kasahara, Y, Katsuura, Y. and Heflich, R.H. (2008) Development of an in vivo gene mutation assay using the endogenous Pig-A gene ... 

Phonethepswath, S., Bryce, S.M., Bemis, J.C. and Dertinger, S.D. (2008) Erythrocyte-based Pig-a gene mutation assay Demonstration of cross-species potential. Mutation Research, 657,122-126. 

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. 

Metabolic activation of 1,3-dichloropropene, as suggested by the use of specific inhibitors of metabolism in the Salmonella typhimurium gene mutation assay, proceeds via an hydrolytic-oxidative pathway the first step of which is hydrolysis to chloroallyl alcohol, which is then oxidized to chloroacrolein (Neudecker Henschler, 1986). 

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... 

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). 

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

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. 

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. 

Dichlorobenzenes can covalently bind to nucleic acids. In a concentration dependent manner, 1,2-dichlorobenzene and p-dichlorobenzene were found to be estrogenic in the yeast estrogen screen with relative potencies in relation to B-estradiol of 2.2 x 10 for 1,4-dichlorobenzene and 1.04x10 for 1,3-di-chlorobenzene. No mutagenic potential was observed in the gene mutation assay using mouse lymphoma cells. 

Moore MM, Honma M, Clements J, et al. (2002) Mouse lymphoma thymidine kinase gene mutation assay followup International Workshop on Genotoxicity Test Procedures, New Orleans, Louisiana, April 2000. Environmental and Molecular Mutagenesis 40(4) 292-299. 

Nickel compounds are generally negative in bacterial gene mutation assays, but positive responses have often been found in in vitro mammalian cell assays. 

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