Safety research for a responsible use of nanomaterials

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BASF Research Press Conference on May 27, 2014 Safety research for a responsible use of nanomaterials Dr.

questions: Large surface higher reactivity? Small size defeat barriers? Life-cycle-dependent nanostructure? Unique properties?

", Helsinki (2013). ISBN 978-952-261-310-3 www.veronananomedicine.it/wordpress/wp-content/uploads/2013/06/nanosafety_2015-2025.

1 BASF Research Press Conference on May 27, 2014 Safety research for a responsible use of nanomaterials Dr. Robert Landsiedel Head of Short-Term Toxicology, BASF SE, Ludwigshafen Safety concerns with nanomaterials Nanoparticles raise questions: Large surface higher reactivity? Small size defeat barriers? Life-cycle-dependent nanostructure? Unique properties? Savolainen, Kai, et al. "Nanosafety in Europe : towards safe and sustainable nanomaterials and nanotechnology innovations.", Helsinki (2013). ISBN BASF: Nano safety research since 2004 More than 150 studies on nanomaterial toxicity More than 25 co-operations and research projects More than 50 scientific publications 2

Cooperations Partners (inter alia) Projects Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit JRC European Commission Harvard University IUTA Institut für Energie- und Umwelttechnik

Volksgezondheid en Milieu Finnish Institute of Occupational Health Health Canada Santé Canada Danmarks Tekniske Universitet RIKILT Wageningen UR Uniwersytet Gdański Université Paris Diderot IOM

Environmental Protection Agency Swiss Empa Materials Science & Technology.

2 Cooperations Partners (inter alia) Projects Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit JRC European Commission Harvard University IUTA Institut für Energie- und Umwelttechnik Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Bundesinstitut für Risikobewertung Umwelt Bundesamt für Mensch und Umwelt ENEA Italian National Agency for New Technology RIVM Rijksinstituut voor Volksgezondheid en Milieu Finnish Institute of Occupational Health Health Canada Santé Canada Danmarks Tekniske Universitet RIKILT Wageningen UR Uniwersytet Gdański Université Paris Diderot IOM Institute of Occupational Medicine Universität des Saarlandes Westfälische Wilhelms- Universität Münster Bayer MaterialScience ILSI Risk Science Innovation and Application Universität Leipzig US Environmental Protection Agency Swiss Empa Materials Science & Technology... 3 Life-cycle and biological pathway of nanomaterials Nanomaterial Powder or embedded in matrix Material properties Dispersion Uptake in the body Aerosol, suspension Lung, skin, gastrointestinal Application and use Release Modification in the body Agglomeration, surface coating Uptake and distribution Distribution Primary effects Primary effects Inflammation Release of material Catalysing formation of reactive compound Direct interaction with biological structures M + ROS, RS,... Toxicity Apical effect Landsiedel, Robert, et al. Advanced Materials (2010): Oomen, Agnes G., et al. Nanotoxicology 8.3 (2014):

3 Use of nanomaterials in cosmetic emulsions in rubber tires in car coatings in concrete 5 Release of nanomaterials Chemical metamorphosis? Mechanical energy input Hirth, Sabine, et al. J Nanopart Res 15.4 (2013): 1-15 Wohlleben, Wendel, et al. Nanoscale 5.1 (2013):

Uptake of nanomaterials Dermal absorption of nano ZnO b c Monteiro-Riviere, Nancy A., et al. Toxicological Sciences 123.

5; 2.5; 10 10 none - SiO2 coated 0.5; 2.5; 10 10 none - CeO2 0.5; 0.5; 10 < 0.

1 Lung: inflammation No BaSO4 2; 10; 50 none - NOAEC [mg/m3] 2 < 0.5 Landsiedel, Robert, et al.

4 Uptake of nanomaterials Dermal absorption of nano ZnO b c Monteiro-Riviere, Nancy A., et al. Toxicological Sciences (2011): Effects of nanomaterials Inhalation exposure Material Conc. [mg/m3] TiO2 2; 10; 50 ZnO 0.5; 2.5; 12.5 SiO2 0.5; 2.5; none - SiO2 coated 0.5; 2.5; none - CeO2 0.5; 0.5; 10 < 0.5 Lung: histiocytosis, inflammation Yes, incomplete MWCNT 0.1; 2.5; Lung: inflammation No BaSO4 2; 10; 50 none - NOAEC [mg/m3] 2 < 0.5 Landsiedel, Robert, et al. Particle and Fibre Toxicity (2014): 16 Ma-Hock, Lan, et al. Particle and fibre toxicology 10.1 (2013): 23 Klein, Christoph L., et al. Archives of toxicology 86.7 (2012): Effects Reversible? Lung: histiocytosis Yes, incomplete Lung: inflammation, necrosis Nose: necrosis Yes 8

Knowing hazard and exposure enables the safe use of nanomaterials Hazard potential High High hazard, low exposure *requires appropriate technical measures for containment

86 Arch Toxicol (2012) 077 1087 Landsiedel, Robert, et al. Advanced Materials 22.24 (2010): 2601 2627 Ma-Hock, Lan, et al. 112.

guidelines are generally suitable for nanomaterials Safety assessment should consider the lifecycle of the material (use, release) as well as the biological pathway

5 Knowing hazard and exposure enables the safe use of nanomaterials Hazard potential High High hazard, low exposure *requires appropriate technical measures for containment *low risk High hazard, high exposure Not acceptable high risk Low Low hazard, low exposure Suitable for all consumer products (e.g. nano-composite materials) low risk Low hazard, high external exposure *requires testing of uptake and hazard *low risk Low Bräu et al. 86 Arch Toxicol (2012) Landsiedel, Robert, et al. Advanced Materials (2010): Ma-Hock, Lan, et al (2009): High External exposure 9 Summary Well-known mechanisms of toxicity, no nano-specific toxicity observed Existing testing methods of the OECD test guidelines are generally suitable for nanomaterials Safety assessment should consider the lifecycle of the material (use, release) as well as the biological pathway (uptake, biopersistence and biological effect) Nanomaterials can be grouped for safety assessment Long-term effects still under investigation 10

6 BASF Research Press Conference on May 27, 2014 Nanotechnology Small dimensions great opportunities

Safe use of nanomaterials Good examples from Finland

Safe use of nanomaterials Good examples from Finland SweNanoSafe Fokusmöte Nanomaterial i arbetsmiljön, World Trade Center, October 24, 2017; Kai Savolainen, MD, Research Professor, Finnish Institute of