Effects of lowering the proposed top-concentration limit in an in vitro chromosomal aberration test on assay sensitivity and on the reduction of the number of false positives

Author:

Morita Takeshi,Miyajima Atsuko,Hatano Akiko,Honma Masamitsu

Funder

Health and Labor Sciences Research Grants

Publisher

Elsevier BV

Subject

Health, Toxicology and Mutagenesis,Genetics

Reference51 articles.

1. Organization for Economic Co-operation and Development (OECD), Guideline for the testing of chemicals, No. 473, In vitro mammalian cell chromosome aberration test, adopted July 21, 1997 (updated). Available at http://www.oecd-ilibrary.org/environment/test-no-473-in-vitro-mammalian-chromosome-aberration-test_9789264071261-en (accessed August 26, 2013).

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), S2A guideline, Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use, Step 4 in July 1995.

3. Report from working group on in vitro tests for chromosomal aberrations;Galloway;Mutat. Res.,1994

4. Genotoxicity under extreme culture conditions, a report from ICPEMC task group 9;Scott;Mutat. Res.,1991

5. How to reduce false positive results when undertaking in vitro genotoxicity testing and thus avoid unnecessary follow-up animal tests: report of an ECVAM workshop;Kirkland;Mutat. Res.,2007

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