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
Germany
Tel: +49 511 5350-461

Fax: +49 511 5350-155

Collaborators

Dr. V. Richter, Fraunhofer Institute for Ceramic Technologies and Systems, Germany, volkmar.richter@ikts.fraunhofer.de
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, günter_Oberdoerster@urmc.rochester.edu

Description

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.

Read the final report (Fraunhofer ITEM Study No. 17N11540 , July 2012).

Related Publications

Publications:

Hofmann T, Schneider S, Wolterbeek A, van de Sandt H, Landsiedel R, van Ravenzwaay B. Prenatal toxicity of synthetic amorphous silica nanomaterial in rats. Reprod Toxicol. 2015 Aug 15;56:141-6.

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

Presentations:

Otto Creutzenberg. Tiered Approach to Testing and Assessment of Nanomaterial Safety to Human Health. CEFIC-LRI 13th Annual Workshop, November 2011, Brussels, Belgium.

Otto Creutzenberg. Approach on Nanomaterial Safety of ZnO and SiO2 Final Results and Overall Conclusions. CEFIC-LRI 14th Annual Workshop, November 2012, Brussels, Belgium.

Posters:

O. Creutzenberg, B. Bellmann, G. Pohlmann, T. Hansen, H. Ernst, D. Schaudien, I. Mangelsdorf, S. Schuchardt, C. Ziemann and K. Wiench. Tiered Approach to Testing and Assessment of Nanomaterial Safety to Human Health – N1: Zinc Oxide. CEFIC-LRI 12th Annual Workshop, November 2010, Brussels, Belgium.

K. Wiench, S. Schulte, L. Ma-Hock, S. Schneider, O. Creutzenberg, C. Ziemann, N. Monteiro-Riviere, B. van Ravenzwaay and R. Landsiedel. Zinc oxide – nanosize does not change the toxicological profile. 51rst SOT Annual Meeting, March 2012, San Francisco, CA, USA.

O. Creutzenberg, C. Ziemann, T. Hansen, H. Ernst, D. Schaudien, S. Schuchardt, B. Bellmann. Final Results and Overall Conclusions on Nanomaterial Safety of ZnO and SiO2. Inhaled Particles XI, September 2013, Nottingham, UK.

C. Ziemann, O. Creutzenberg, J. Knebel. Genotoxicity of a synthetic amorphous silica (SAS) in rats. 53rd SOT Annual Meeting, March 2014, Phoenix, AZ, USA.

O. Creutzenberg, G. Pohlmann, T. Hansen, S. Schuchardt, H. Ernst, T. Tillmann, D. Schaudien. Inhalation toxicity of a synthetic amorphous silica (SAS) in rats. 53rd SOT Annual Meeting, March 2014, Phoenix, AZ, USA.

G. Lewin, J. Buschmann, O. Creutzenberg. Oral toxicity of a synthetic amorphous silica (SAS) in rats. 53rd SOT Annual Meeting, March 2014, Phoenix, AZ, USA.

Timeline: December 2008 > November 2010

LRI funding: € 1 500 000

Cefic-Lri Programme Responsible Care

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