Genotoxicity testing

S1 C(R1) Dose Selection for Carcinogenicity Studies of Pharmaceuticals Limit Dose S2A Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals S2B Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals Toxicokinetics and Pharmacokinetics... 

GL23 Safety genotoxicity Studies to evaluate the safety of residues of veterinary drug in human food genotoxicity testing... 

Lohman PHM, Mendelsohn ML, Moore DH, et al. 1992. A method for comparing and combining shortterm genotoxicity test data The basic system. Mutat Res 266 7-25. 

Kado NY, PA Kuzmicky, G Loarca-Pina, MM Mumtaz (1998) Genotoxicity testing of methyl tertiary-butyl ether (MTBE) in the Salmonella microsuspension assay and mouse bone marrow micronucleus test Mut Res 412 131-138. 

Genotoxicity test of proflavine, aflatoxin B benzo(a)pyrene and N- 172... 

Johnson, B.T. 1993. Genotoxicity testing with fish hepatic S9 for evaluation of complex mixtures in the aquatic environment the use of channel catfish as a model. Aquat. Toxicol. 27 293-314. 

Jongen, W.M.F., J.M. Cardinaals, and RM.J. Bos. 1985. Genotoxicity testing of arsenobetaine, the predominant form of arsenic in marine fishery products. Food Chem. Toxicol. 23 669-673. 

Mortelmans et al. 1986 NTP 1991). Negative results were also obtained in mammalian cells, except for one observation of polyploidy in Chinese hamster CHL cells (Ishidate et al. 1984 NTP 1991 Perocco et al. 1983). Only a single report was located on the genotoxicity of 77-hexane metabolites induction of chromosome loss was observed in yeast with 2,5-hexanedione (Mayer and Goin 1994). It is also unclear if incubation with liver microsomes (S9 fraction) in in vitro genotoxicity tests results in similar metabolites to those observed in humans in vivo. 

A further mammalian cell genotoxicity test, with confirmatory in vivo test(s) if any in vitro tests are positive... 

S2A Genotoxicity Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals Jul 95... 

S2B Guidance on Genotoxicity A Standard Battery for Genotoxicity Testing of Pharmaceuticals Availability Notice Nov 97... 

Genotoxicity Test—ICH Mutation Cell Type Method... 

ICH (1996). Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995. Federal Register 61 18198-18202, April 24, 1996. 

Ones not appropriate for genotoxicity testing (instead, assess integration/ insertion frequency in a mammalian cell). 

Preclinical Genotoxicity Testing — Past, Present, and Future Richard H.C. San 305... 

Genotoxicity a standard battery for genotoxicity testing of pharmaceuticals... 

Humans are susceptible to the acute toxic effects of 1,2-dibromoethane from various routes of exposure. Except for adverse reproductive effects in men after occupational exposure, chronic effects of 1,2-dibromoethane exposure have not been documented in humans. Based on data derived from animal studies, mechanisms of action of 1,2-dibromoethane at a cellular level, toxicokinetics, and genotoxicity tests, there is a potential for certain adverse health effects in humans exposed chronically to low environmental levels of 1,2-dibromoethane that could exist near hazardous waste sites or areas of former agricultural use. 

Api AM, San RHC (1999) Genotoxicity tests with 6-acetyl-l,l,2,4,4,7-hexamethyltetraline and l,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-g-2- benzopyran. Mutat Res Genet Toxicol Environ Mutagenesis 446 67-81... 

Simmon VF, Riccio ES, Peirce MV. 1979. In vitro microbiological genotoxicity tests of chlorobenzene, m-dichlorobenzene, o-dichlorobenzene, and p-dichlorobenzene. Final Report. Report to U.S. Environmental Protection Agency by SRI International, Menlo Park, CA. U.S. EPA contract no. 68-02-2947. 

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