Abstract
There is a pressing requirement to define a hazard identification and risk management strategy for nanomaterials due to the rapid growth in the nanotechnology industry and their promise of life-style revolutions through the development of wide-ranging nano-containing consumer products. Consequently, a battery of well defined and appropriate in vitro assays to assess a number of genotoxicity endpoints is required to minimise extensive and costly in vivo testing. However, the validity of the established protocols in current OECD recognised genotoxicity assays for nanomaterials is currently being questioned. In this report, we therefore consider the in vitro OECD genotoxicity test battery including the Ames, micronucleus and HPRT forward mutation assays, and their potential role in the safety assessment of nanomaterial induced DNA damage in vitro.
Highlights
The dramatic expansion in the nanotechnology industry over the last decade has resulted in the development of a myriad of novel materials in the nano-size range
Kirkland et al [5] conducted a detailed study in which they demonstrated that performing the Ames test and in vitro micronucleus assay was ample for the identification of in vivo genotoxins and carcinogens, detecting 78% of in vivo genotoxins
The in vitro genotoxicity assessment framework for NM still requires some validation based on firm experimental evidence that is currently lacking, the difficulty in our ability to define the regulation required for these new products
Summary
The dramatic expansion in the nanotechnology industry over the last decade has resulted in the development of a myriad of novel materials in the nano-size range (sub-100 nm). Even though many nanomaterials are negative for mutagenicity in the Ames test, they have largely been found to have positive genotoxic responses in other in vitro mammalian cell test systems (Table 1) including the chromosomal aberration [9,19,26,27,28,29], micronucleus [30,31,32,33,34,35,36,37,38,39,40] and comet assays [11,30,34,41,42,43,44,45], in addition to positive in vivo test results [13,32,34,46,47,48,49]. Given that there are potential issues with the use of the current bacterial mutagenicity testing system (Ames) as described, it is prudent to utilise a mammalian cell alternative for assessing mutagenicity This is important, as no single assay is capable of detecting all forms of DNA damage (mutation and chromosome damage in particular). In the absence of such investigations it is prudent to follow OECD guidelines for this assay
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