Test Guidelines

NanoHarmony will develop scientifically reliable and regulatory relevant test methodologies specific for engineered nanomaterials (ENM). These will feed into 5 Test Guidelines (TG)/Guidance Documents GD in the field of human and eco-toxicity (bioaccumulation, toxicokinetics, intestinal fate etc.) and 3 TGs/GDs for physico-chemical characterization (solubility, surface chemistry and dustiness).

Bioaccumulation testing in fish

NanoHarmony will provide scientific evidences and data to support and facilitate the acceptance of a tiered approach to bioaccumulation testing in fish and to devise new guidance on how to waive the TG305 Bioaccumulation in Fish Test for manufactured nanomaterials.

In vivo toxicokinetic studies

NanoHarmony will provide the scientific basis for the minimum requirements of the study design of in vivo toxicokinetic studies for ENMs, in order to support the development of a new TG, as the current TG417 on toxicokinetics is not applicable.

Concentrations in biological samples

NanoHarmony will establish the scientific basis for the development of a Guidance Document for the determination of ENM concentrations in biological samples.

Solubility and dissolution rates in water and biologically-relevant fluids

NanoHarmony will establish the consensus on the scientific and regulatory requirements and complete an interlaboratory comparison study to support the development of a new OECD GD for the determination of solubility and dissolution rates of ENMs in water and biologically relevant media (e.g. simulant lung lining, phagolysomal and gastric fluids) in support of OECD TG105.

Surface chemistry and coatings

NanoHarmony will support development of a new OECD GD for identification and quantification of the surface chemistry and coatings on nano- and microscale materials by establishing and completing an interlaboratory comparison study. 

Dustiness testing

NanoHarmony will expand the scientific basis of the dustiness testing for ENMs, including high aspect ratio nanomaterials (HARN), with the aim of supporting the development of an OECD TG on dustiness testing.  In addition, it will produce a document for the development of a GD on how to use dustiness data in assessing risks of explosion (ATEX).

Intestinal fate from oral ingestion

NanoHarmony will provide the scientific basis for the development of a new GD for the understanding of the intestinal fate of orally ingested ENMs by an integrated in vitro approach. 

Short term toxicity studies

NanoHarmony will provide the scientific basis to develop guidance documents on how to conduct short-term toxicity studies in algae, invertebrates (mainly Daphnia sp.) and fish, following the OECD TGs201, 202, and 203, respectively.