Mutagenicity studies

Simmon VF, Poole DC, Newell GW. 1976. In vitro mutagenic studies of twenty pesticides [Abstract]. Toxicol Appl Pharmacol 37 109. 

Fahrig R. 1973. Comparative mutagenicity studies with pesticides. lARC Scientific Publication 10 161-181. 

Moriya M, Ohta T, Watanabe K, et al. 1983. Eurther mutagenicity studies on pesticides in bacterial reversion assay systems. Mutat Res 116 185-216. 

Usha Rani MV, Reddi OS, Reddy PP. 1980. Mutagenicity studies involving aldrin, endosulfan, dimethoate, phosphamidon, carbaryl and ceresan. Bull Environ Contam Toxicol 25 277-282. 

Dashwood, R.H., The importance of using pure chemicals in (anti) mutagenicity studies Chlorophyllin as a case point, Mutat. Res., 381, 283, 1997. 

Monsanto. 1979. Summaries of mutagenicity studies, neurotoxicity studies, teratology studies, long term feeding studies, and 90-day inhalation studies on aryl phosphate ester products. 

Borelli G, Bertoli D Acute, subacute, chronic toxicity and mutagenicity studies of rifaximin (L/105) in rats. Chemioterapia (Florence)... 

D-Phenothrin (I) Not likely to be carcinogenic to humans. Rat liver tumors occurred only at excessively toxic doses (limit dose) and mouse hepatocellular adenomas, which are common, did not achieve statistical significance (p < 0.01). Additionally, acceptable mutagenicity studies were negative for mutagenic potential [97] No tumorigenicity was observed [11]. 

In vivo mutagenicity studies Further repeat-dose study in the rat Second developmental toxicity study Two-generation fertility study in the rat Chronic fish toxicity study Biodegradation simulation studies... 

Reactivity to container material In vivo mutagenicity studies... 

Acute toxicity should be determined in three species subacute or chronic studies should be by the route to be used clinically. Suitable mutagenicity studies should also be... 

In the absence of precipitation or effects on pH or osmolality, the maximum concentration of the main mutagenicity study is a concentration that reduces survival to approximately 20% of the control value. 

The distribution-free multiple comparison test should be used to compare three or more groups of nonparametric data. These groups are then analyzed two at a time for any significant differences (Hollander and Wolfe, 1973, pp. 124-129). The test can be used for data similar to those compared by the rank-sum test. We often employ this test for reproduction and mutagenicity studies (such as comparing survival rates of offspring of rats fed various amounts of test materials in the diet). 

EPA. 1984a. In vitro and in vivo mutagenicity studies on environmental chemicals Research Triangle Park, NC Health Effects Research Laboratory, U.S. Environmental Protection Agency. EPA- 600/1 -84- 003. PB84-138973. 

Positive results in one or more mutagenicity assays do not necessarily translate into human risks. FDA has issued a guidance document on approaches and considerations when positive mutagenicity studies are encountered.18 Among these considerations are the performances of additional studies. Mechanistic studies may show that such responses would not occur in the human cell population, or the concentrations at which positive responses occurred may far exceed any concentration of drug that may occur in the clinical setting. Many marketed drugs have produced some type of positive response in these studies and yet it has been concluded that no human risk is present or the potential risk is not known. See Chapter 15 for more details. 

There are three transgenic models that are primarily used. The p53 model is used exclusively for compounds that have been shown to be positive in one or more mutagenicity studies and are considered to be genotoxic. The Hras2 model is used for nongenotoxic... 

Van Abbe NJ et al. 1982. Bacterial mutagenicity studies on chloroform in vitro. Food Chem Toxicol 20 557-561. 

Nylander G, Berg K. 1991. Mutagenicity study of urine from smoking and non-smoking road tanker drivers. Int Arch Occup Environ Health 63(4) 229-232. 

Genotoxicity. No human or animal in vivo studies on the genotoxicity of 1,3-DNB or 1,3,5-TNB were located. However, several bacterial mutagenicity studies were located for both chemicals. 

Wei Cl, Cohen MD, Swartz DD, et al. 1984. Mutagenicity studies of some nitroaromatics with regular Salmonella typhimurium strains and their corresponding nitroreductase-deficient strains. Environ Mutagen 6 410. 

A variety of reproductive, carcinogenic, and mutagenic studies have found no significant effects. ... 

Both positive and negative results have been reported in mutagenicity studies, although acidic experimental conditions were indicated in most cases of positive mutagenicity. ... 

Hanley TR, Kirk HD, Johnson KA, et al Propylene dichloride (PDC) A two-generation reproductive toxicity and dominant lethal mutagenicity study in rats. Toxicologist 12(1) 200, 1992... 

Miller AC, Fuciarelli AF, Jackson WE, et al Urinary and serum mutagenicity studies with rats implanted with depleted uranium or tantalum pellets. Mutagenesis 13(6) 643-8, 1998... 

A study of the mutagenicity of ZDC used a battery of in vitro mutagenicity studies. ZDMC and ZDEC were positive in both the Ames Salmonella lyphimurium assay and the human lymphoqnie cell mutation assay but not in the mouse lymphoma cell mutation assay. In contrast, ZDBC was not positive in the assays. 

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