title: 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.
abstract: The OECD guideline for the in vitro mammalian cell micronucleus test (OECD 487) was recently adopted in July 22, 2010. Since its publication, it has become apparent that the guidance for testing chemicals where solubility is a limiting factor can be interpreted in a variety of ways. In this communication, we provide clarification for testing insoluble chemicals. The intent of the OECD 487 guideline is for the high dose to be the lowest precipitating concentration even if toxicity occurs above the solubility limit in tissue culture medium. Examination of precipitation can be done by the unaided eye or microscopically. Precipitation is examined at the onset or end of treatment, with the intent to identify precipitate present during treatment.
authors: Bioreliance Corporation, 14920 Broschart Road, Rockville, MD 20850, USA. Marilyn.aardema@bioreliance.com
authors: Marilyn J
authors: MJ
authors: Aardema
authors: Sheila
authors: S
authors: Galloway
authors: Errol
authors: E
authors: Zeiger
authors: Michael C
authors: MC
authors: Cimino
authors: Makoto
authors: M
authors: Hayashi
mesh_terms: D015162:Micronucleus Tests / Q000592:standards*; D009153:Mutagens / Q000008:administration & dosage; D017410:Practice Guidelines as Topic; D012995:Solubility
chemical_list: D009153:Mutagens