Grouping hypotheses and an integrated approach to testing and assessment of nanomaterials following oral ingestion

Luisana Di Cristo, Agnes G. Oomen, Susan Dekkers, Colin Moore, Walter Rocchia, Fiona Murphy, Helinor J. Johnston, Gemma Janer, Andrea Haase, Vicki Stone, Stefania Sabella

Research output: Contribution to journalArticlepeer-review

18 Citations (Scopus)
22 Downloads (Pure)


The risk assessment of ingested nanomaterials (NMs) is an important issue. Here we present nine integrated approaches to testing and assessment (IATAs) to group ingested NMs following predefined hypotheses. The IATAs are structured as decision trees and tiered testing strategies for each decision node to support a grouping decision. Implications (e.g., regulatory or precautionary) per group are indicated. IATAs integrate information on durability and biopersistence (dissolution kinetics) to specific hazard endpoints, e.g., inflammation and genotoxicity, which are possibly indicative of toxicity. Based on IATAs, groups of similar nanoforms (NFs) of a NM can be formed, such as very slow dissolving, highly biopersistent and systemically toxic NFs. Reference NMs (ZnO, SiO2 and TiO2) along with related NFs are applied as case studies to testing the oral IATAs. Results based on the Tier 1 level suggest a hierarchy of biodurability and biopersistence of TiO2 > SiO2 > ZnO, and are confirmed by in vivo data (Tier 3 level). Interestingly, our analysis suggests that TiO2 and SiO2 NFs are able to induce both local and systemic toxicity along with microbiota dysbiosis and can be grouped according to the tested fate and hazard descriptors. This supports that the decision nodes of the oral IATAs are suitable for classification and assessment of the toxicity of NFs.

Original languageEnglish
Article number2623
Number of pages33
Issue number10
Publication statusPublished - 7 Oct 2021


  • biopersistence
  • dissolution
  • durability
  • grouping
  • ingested nanomaterials
  • integrated approach to testing and assessment


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