Evidence map›Paper›PMID 36461106›Full record

ArticleParticle and fibre toxicology2022

Grouping of orally ingested silica nanomaterials via use of an integrated approach to testing and assessment to streamline risk assessment.

Luisana Di Cristo, Victor C Ude, Georgia Tsiliki, Giuseppina Tatulli, Alessio Romaldini, Fiona Murphy, Wendel Wohlleben, Agnes G Oomen, Pier P Pompa, Josje Arts and 2 more

Open access · goldAbstract read
In one paragraph

Article in Particle and fibre toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 4 countries.

Luisana Di CristoD3 PharmaChemistry, Nanoregulatory Group, Italian Institute of Technology, Via Morego, 30, 16163, Genoa, Italy. Luisana.DiCristo@iit.it.
Victor C UdeNano Safety Research Group, School of Engineering and Physical Sciences, Heriot Watt University, Edinburgh, EH14 4AS, UK.
Georgia TsilikiInstitute for the Management of Information Systems, Athena Research Center, Marousi, Greece.
Giuseppina TatulliNanobiointeractions & Nanodiagnostics, Istituto Italiano Di Tecnologia (IIT), Via Morego, 30, 16163, Genoa, Italy.
Alessio RomaldiniD3 PharmaChemistry, Nanoregulatory Group, Italian Institute of Technology, Via Morego, 30, 16163, Genoa, Italy.
Fiona MurphyNano Safety Research Group, School of Engineering and Physical Sciences, Heriot Watt University, Edinburgh, EH14 4AS, UK.
Wendel WohllebenDepartment Material Physics and Department of Experimental Toxicology & Ecology, BASF SE, Ludwigshafen, Germany.
Agnes G OomenNational Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Pier P PompaNanobiointeractions & Nanodiagnostics, Istituto Italiano Di Tecnologia (IIT), Via Morego, 30, 16163, Genoa, Italy.
Josje ArtsNouryon, Arnhem, The Netherlands.
Vicki StoneNano Safety Research Group, School of Engineering and Physical Sciences, Heriot Watt University, Edinburgh, EH14 4AS, UK.
Stefania SabellaD3 PharmaChemistry, Nanoregulatory Group, Italian Institute of Technology, Via Morego, 30, 16163, Genoa, Italy. Stefania.Sabella@iit.it.
Italian Institute of Technology · ITHeriot-Watt University · GBBASF (Germany) · DEUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNanomaterials can exist in different nanoforms (NFs). Their grouping may be supported by the formulation of hypotheses which can be interrogated via integrated approaches to testing and assessment (IATA). IATAs are decision trees that guide the user through tiered testing strategies (TTS) to collect the required evidence needed to accept or reject a grouping hypothesis. In the present paper, we investigated the applicability of IATAs for ingested NFs using a case study that includes different silicon dioxide, SiO

resultsThe measurement of the dissolution rate of the silica NFs in the oro-gastrointestinal tract and in the lysosome identified them as gradually dissolving and biopersistent NFs. For the local toxicity to intestinal epithelium (e.g. cytotoxicity, membrane integrity and inflammation), the biological results of the gastrointestinal tract models indicate that all of the silica NFs were similar with respect to the lack of local toxicity and, therefore, belong to the same group; in vivo data (although limited) confirmed the lack of local toxicity of NFs. For systemic toxicity, Tier 1 data did not identify similarity across the NFs, with results across different decision nodes being inconsistent in providing homogeneous group(s). Moreover, the available Tier 3 in vivo data were also insufficient to support decisions based upon the obtained in vitro results and relating to the toxicity of the tested NFs.

conclusionsThe information generated by the tested oral IATAs can be effectively used for similarity assessment to support a grouping decision upon the application of a hypothesis related to toxicity in the gastrointestinal tract. The IATAs facilitated a structured data analysis and, by means of the expert's interpretation, supported read-across with the available in vivo data. The IATAs also supported the users in decision making, for example, reducing the testing when the grouping was well supported by the evidence and/or moving forward to advanced testing (e.g., the use of more suitable cellular models or chronic exposure) to improve the confidence level of the data and obtain more focused information.

Indexed as

NanostructuresSilicon DioxideBayes TheoremHumansInflammationRisk AssessmentSilicon DioxideIngestionLocal toxicityNanoformsOral dissolutionSimilarity assessmentSystemic toxicity

Identifiers

PMID36461106
PMCPMC9719179
OpenAlexW4310781578

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.