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April 10, 2020

EUON Announces That Female Fertility Data Are Lacking for Nanomaterials

Lynn L. Bergeson Carla N. Hutton

The European Union (EU) Observatory for Nanomaterials (EUON) posted an article on April 6, 2020, announcing the availability of a study that found a lack of data on female fertility.  The study, A critical review of studies on the reproductive and developmental toxicity of nanomaterials, was commissioned by the European Chemicals Agency (ECHA) and carried out by DHI A/S and the Danish National Research Center for the Working Environment.  The scope of this project was to perform a critical review of the current knowledge from studies with testing of manufactured nanomaterials for reproductive and developmental toxicity.  The authors conducted a literature search to identify publications with in vivo data where manufactured nanomaterials have been tested for reproductive and developmental toxicity using an exposure route relevant for human exposure.  To identify the most relevant studies, each publication was scored for nano-characterization, reliability/quality of the study, and the relevance in the context of the project.  Based on the learnings from this project, the study provides the following general proposals and considerations for future research and testing:

  • Apply a thorough/more standardized characterization of the nanomaterial and the nanomaterial exposure to include the most important determinants of toxicity;
  • Study the effects of nanoparticles in parallel with larger particles to gain knowledge of differences in toxicity relating to size (or other relevant physico-chemical parameters, such as particle form);
  • Increase focus on the airway route of exposure;
  • Increase focus on female fertility and reproductive parameters;
  • Select meaningful periods of exposure, taking into account that particle translocation probably varies considerably during gestation;
  • In developmental toxicity, include postnatal functional parameters to a larger degree (offspring fertility, neurofunction- and histology, and cardiovascular and immune function);
  • Always report gestational and litter parameters;
  • Follow up on testing of outcomes where previous results raise concern to clarify potential for induction of adverse reproductive or developmental effects;
  • Adhere to the principles of the Organization for Economic Cooperation and Development (OECD) test guidelines to the highest extent possible, even if it is not possible to apply the full study guideline. If not included already, include parameters where previous study results raise concern;
  • Investigate particle transfer across “barriers” (blood-testes-barrier, placenta), with application of highly sensitive methods of detection of both the bulk material and particles;
  • Identify underlying mechanisms of toxicity for grouping of materials; and
  • Coordinate the testing (g., in testing programs) to achieve a more systematic approach for the testing.