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Titolo:
EVALUATION OF THE IN-VITRO MICRONUCLEUS TEST AS AN ALTERNATIVE TO THEIN-VITRO CHROMOSOMAL ABERRATION ASSAY - POSITION OF THE GUM WORKING GROUP ON THE IN-VITRO MICRONUCLEUS TEST
Autore:
MILLER B; POTTERLOCHER F; SEELBACH A; STOPPER H; UTESCH D; MADLE S;
Indirizzi:
F HOFFMANN LA ROCHE & CO LTD,REGULATORY AFFAIRS DEPT,VITAMINS & FINE CHEM DIV CH-4070 BASEL SWITZERLAND NOVARTIS PHARMA AG,PRECLIN SAFETY,TOXICOL PATHOL CH-4002 BASEL SWITZERLAND FED INST HLTH PROTECT CONSUMERS & VET MED D-14191 BERLIN GERMANY UNIV WURZBURG,DEPT TOXICOL D-97078 WURZBURG GERMANY MERCK KGAA,INST TOXICOL D-64271 DARMSTADT GERMANY F HOFFMANN LA ROCHE & CO LTD,REGULATORY AFFAIRS DEPT,VITAMINS & FINE CHEM DIV CH-4070 BASEL SWITZERLAND
Titolo Testata:
Mutation research-reviews in mutation research
fascicolo: 1, volume: 410, anno: 1998,
pagine: 81 - 116
Fonte:
ISI
Lingua:
ENG
Soggetto:
HAMSTER OVARY CELLS; SISTER-CHROMATID EXCHANGES; BLOCKED HUMAN-LYMPHOCYTES; MOUSE LYMPHOMA-CELLS; TEST IN-VITRO; METABOLIC-ACTIVATION; MITOMYCIN-C; METHYL METHANESULFONATE; ANEUPLOIDY INDUCTION; CHLORAL HYDRATE;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
72
Recensione:
Indirizzi per estratti:
Citazione:
B. Miller et al., "EVALUATION OF THE IN-VITRO MICRONUCLEUS TEST AS AN ALTERNATIVE TO THEIN-VITRO CHROMOSOMAL ABERRATION ASSAY - POSITION OF THE GUM WORKING GROUP ON THE IN-VITRO MICRONUCLEUS TEST", Mutation research-reviews in mutation research, 410(1), 1998, pp. 81-116

Abstract

In order to license a pharmaceutical or chemical, a compound has to be tested for several genotoxicity endpoints, including the induction of chromosomal aberrations in vitro. A working group within the GUM hasevaluated published data on the in vitro micronucleus test with the aim of judging its suitability as a replacement for the in vitro chromosomal aberration test. After strict rejection criteria were applied, adatabase including 96 publications and 34 compounds was obtained. For30 of these compounds, data on both tests were available. For 24 of the 30, concordant results in both test systems were obtained (80% correlation). The discordant results in 6 compounds can be explained by a known or suspected aneugenic potential of these compounds. Consideringthat cell types and test protocols were extremely heterogeneous, thiscorrelation is rather encouraging. Comparison of the different protocols, and experience established within the working group yielded several recommendations for the routine use of the in vitro micronucleus test. Although many cell lines are suitable, those most often used in genotoxicity testing (e.g. CHL, CHO, V79, human lymphocytes, L5178Y mouse lymphoma cells) are recommended. Cytochalasin B may be used in the case of human lymphocytes; however, the possibility of its interaction with aneugenic test compounds should be considered. For continuously dividing cell lines, cytochalasin B is not recommended by the working group. Although, there seems to be flexibility in the choice of treatment and sampling times, the average generation time of the chosen cell line of choice should be taken into account when determining sampling time, and treatment of cells for at least one cell cycle duration is recommended. The use of appropriate cytotoxicity tests is strongly recommended. Although studies on some parameters of the test protocol may be useful, the introduction of the in vitro micronucleus test into genotoxicity testing and guidelines should not be delayed. Even in its present state, the in vitro micronucleus is a reliable genotoxicity test. Compared with the chromosomal aberration test, it detects aneugens more reliably, it is faster and easier to perform, and it has more statistical pou er and the possibility of automation. (C) 1998 Elsevier Science B.V.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/09/20 alle ore 10:00:50