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Guidance for understanding solubility as a limiting factor for selecting the upper test concentration in the OECD in
Marilyn J Aardema1, Sheila Galloway, Errol Zeiger
1Bioreliance Corporation, 14920 Broschart Road, Rockville, MD 20850, USA. Marilyn.aardema@bioreliance.com
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.
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