Evidence map›Paper›PMID 36804527›Full record

ReviewRegulatory toxicology and pharmacology : RTP2023

Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - A proposal for further actions.

Eric A J Bleeker, Elmer Swart, Hedwig Braakhuis, María Luisa Fernández Cruz, Steffi Friedrichs, Ilse Gosens, Frank Herzberg, Keld Alstrup Jensen, Frank von der Kammer, Jolinde A B Kettelarij and 4 more

Abstract readReview
In one paragraph

Review in Regulatory toxicology and pharmacology : RTP, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
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

23 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Safety Assessment of Graphene-Based Materials.Small (Weinheim an der Bergstrasse, Germany) · 2025
    Article
  12. Review
  13. Review
  14. Review
  15. Nanotoxicology: developments and new insights.Nanomedicine (London, England) · 2025
    Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article
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

14 authors.

Eric A J BleekerNational Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands. Electronic address: eric.bleeker@rivm.nl.
Elmer SwartNational Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands.
Hedwig BraakhuisNational Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands.
María Luisa Fernández CruzInstituto Nacional de Investigación y Tecnología Agraria y Alimentaria (INIA), CSIC, Ctra. De la Coruña Km 7,5, 28040, Madrid, Spain.
Steffi FriedrichsAcumenIST SRL, Rue Fétis 19, 1040, Etterbeek, Belgium.
Ilse GosensNational Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands.
Frank HerzbergGerman Federal Institute for Risk Assessment (BfR), Max-Dohrn-Str. 8-10, 10589, Berlin, Germany.
Keld Alstrup JensenThe National Research Centre for the Working Environment (NRCWE), 105 Lersø Parkallé, DK-2100, Copenhagen, Denmark.
Frank von der KammerUniversity of Vienna, Centre for Microbiology and Environmental Systems Science, Department of Environmental Geosciences, Josef-Holaubek-Platz 2, 1090, Vienna, Austria.
Jolinde A B KettelarijNational Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands.
Jose María NavasInstituto Nacional de Investigación y Tecnología Agraria y Alimentaria (INIA), CSIC, Ctra. De la Coruña Km 7,5, 28040, Madrid, Spain.
Kirsten RasmussenEuropean Commission, Joint Research Centre (JRC), Ispra, Italy.
Kathrin SchwirnGerman Environment Agency (UBA), Woerlitzer Platz 1, 06844, Dessau-Rosslau, Germany.
Maaike VisserNational Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Over the recent years, EU chemicals legislation, guidance and test guidelines have been developed or adapted for nanomaterials to facilitate safe use of nanomaterials. This paper provides an overview of the information requirements across different EU regulatory areas. For each information requirement, a group of 22 experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. Eleven different needs for action were identified, capturing twenty-two information requirements that are specific to nanomaterials and relevant to multiple regulatory areas. These were further reduced to three overarching issues: 1) resolve issues around nanomaterial dispersion stability and dosing in toxicity testing, in particular for human health endpoints, 2) further develop tests or guidance on degradation and transformation of organic nanomaterials or nanomaterials with organic components, and 3) further develop tests and guidance to measure (a)cellular reactivity of nanomaterials. Efforts towards addressing these issues will result in better fit-for-purpose test methods for (EU) regulatory compliance. Moreover, it secures validity of hazard and risk assessments of nanomaterials. The results of the study accentuate the need for a structural process of identification of information needs and knowledge generation, preferably as part of risk governance and closely connected to technological innovation policy.

Indexed as

Chemical SafetyNanostructuresHumansPolicyRisk AssessmentToxicity TestsGuidanceInformation requirementsNanomaterialsNanosafetyTest guidelines

Identifiers

PMID36804527
PMCPMC10060946

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.