Cefic-lri Programme | European Chemical Industry Council

N1-FRAU: Tiered Approach to Testing and Assessment of Nanomaterial Safety to Human Health

Principal Investigator

Dr. Otto Creutzenberg
Tel: +49 511 5350-461
Fax: +49 511 5350-155


Dr. V. Richter, Fraunhofer Institute for Ceramic Technologies and Systems, Germany
Dr. C. Gellermann, Fraunhofer Institute for Silicate Research, Germany
Dr. Bärbel Freytag, Frey-Tox Lab, Herzberg, Germany
Prof. Dr. G. Oberdoerster, University of Rochester, USA


The objectives of this project are:

– to test the suitability of existing OECD testing guidelines for nanoscaled amorphous silicon dioxide (NASD) and ZnO;
– to subject these test materials to OECD guideline testing;
– to supplement these guidelines with optional modifications aiming at addressing particle-specific features of toxicity testing;
– to include promising in vitro correlates in the test programme;
– to perform a proper characterisation of NASD/ZnO as well as of a fine fraction reference material;
– to evaluate – based on the results – the potential need to modify or supplement methods of standard tests for nanomaterials including administration methods;
– to propose a tiered testing strategy for these nanoparticles.

The project will present modified testing protocols meeting the special needs for nanoparticle testing (translocation potential; systemic availability and elimination; effects on remote organs besides the respiratory tract) as compared to fine particles.

Related Publications

FINAL REPORT – Measurement of the DNA-damaging and cytotoxic potential of synthetic amorphous silica (NM-200) in cultured primary rat alveolar macrophages, Fraunhofer ITEM Study No. 17N11540 , July 2012.

Prenatal toxicity of synthetic amorphous silica nanomaterial in rats, by Hofmann T, Schneider S, Wolterbeek A, van de Sandt H, Landsiedel R, van Ravenzwaay B, Reprod Toxicol. 2015 Aug 15;56:141-6. doi: 10.1016/j.reprotox.2015.04.006. Epub 2015 Apr 18.

Oral two-generation reproduction toxicity study with NM-200 synthetic amorphous silica in Wistar rats, by Wolterbeek A, Oosterwijk T, Schneider S, Landsiedel R, de Groot D, van Ee R, Wouters M, van de Sandt H, Reprod Toxicol. 2015 Aug 15;56:147-54. doi: 10.1016/j.reprotox.2015.03.006. Epub 2015 Mar 25.


Tiered Approach to Testing and Assessment of Nanomaterial Safety to Human Health by Otto Creutzenberg

Approach on Nanomaterial Safety of ZnO and SiO2 Final Results and Overall Conclusions by Otto Creutzenberg


Zinc oxide – nanosize does not change the toxicological profile by K. Wiench, S. Schulte, L. Ma-Hock, S. Schneider, O. Creutzenberg, C. Ziemann, N. Monteiro-Riviere, B. van Ravenzwaay and R. Landsiedel, 2012

Tiered Approach to Testing and Assessment of Nanomaterial Safety to Human Health – N1: Zinc Oxide by O. Creutzenberg, B. Bellmann, G. Pohlmann, T. Hansen, H. Ernst, D. Schaudien, I. Mangelsdorf, S. Schuchardt, C. Ziemann and K. Wiench

Timeline: December 2008 > November 2010

LRI funding: €1,500,000

Cefic-Lri Programme Responsible Care

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