Guidance for understanding solubility as a limiting factor for selecting the upper test concentration in the OECD In Vitro Micronucleus Assay Test Guideline No. 487

Mutation Research - Genetic Toxicology and Environmental Mutagenesis

Volumn 722, Issue 1, 2011, Pages 89-90

  Aardema, Marilyn J ^a   Galloway, Sheila ^b   Zeiger, Errol ^c   Cimino, Michael C ^d   Hayashi, Makoto ^e  

^a BioReliance Corporation   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Errol Zeiger Consulting   (United States)

^d U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^e Biosafety Research Center Foods Drugs and Pesticides   (Japan)

Author keywords

In vitro micronucleus assay; Insoluble chemicals; OECD; Precipitation

Indexed keywords

ARTICLE; CONCENTRATION (PARAMETERS); CYTOTOXICITY; IN VITRO STUDY; MICRONUCLEUS TEST; PRACTICE GUIDELINE; PRECIPITATION; PRIORITY JOURNAL; SOLUBILITY; TISSUE CULTURE;

MICRONUCLEUS TESTS; MUTAGENS; PRACTICE GUIDELINES AS TOPIC; SOLUBILITY;

MAMMALIA;

EID: 79956018360     PISSN: 13835718     EISSN: 18793592     Source Type: Journal    
DOI: 10.1016/j.mrgentox.2011.03.007     Document Type: Article

References (2)

1. OECD Guideline for the Testing of Chemicals, No. 487, In vitro Mammalian Cell Micronucleus Test, 2010. http://www.oecd.org/document/40/0,3343,en_2649_34377_37051368_1_1_1_1,00.html.
2. EMEA (European Medicines Agency), EMEA/CHMP/ICH/126642/2008, ICH Topic S2 (R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use, Step 3, March 2008. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002769.pdf.