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Erschienen in: Journal of Nanoparticle Research 3/2013

01.03.2013 | Perspectives

Reference materials and representative test materials: the nanotechnology case

verfasst von: G. Roebben, K. Rasmussen, V. Kestens, T. P. J. Linsinger, H. Rauscher, H. Emons, H. Stamm

Erschienen in: Journal of Nanoparticle Research | Ausgabe 3/2013

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Abstract

An increasing number of chemical, physical and biological tests are performed on manufactured nanomaterials for scientific and regulatory purposes. Existing test guidelines and measurement methods are not always directly applicable to or relevant for nanomaterials. Therefore, it is necessary to verify the use of the existing methods with nanomaterials, thereby identifying where modifications are needed, and where new methods need to be developed and validated. Efforts for verification, development and validation of methods as well as quality assurance of (routine) test results significantly benefit from the availability of suitable test and reference materials. This paper provides an overview of the existing types of reference materials and introduces a new class of test materials for which the term ‘representative test material’ is proposed. The three generic concepts of certified reference material, reference material (non-certified) and representative test material constitute a comprehensive system of benchmarks that can be used by all measurement and testing communities, regardless of their specific discipline. This paper illustrates this system with examples from the field of nanomaterials, including reference materials and representative test materials developed at the European Commission’s Joint Research Centre, in particular at the Institute for Reference Materials and Measurements (IRMM), and at the Institute for Health and Consumer Protection (IHCP).

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1
Several definitions exist for the term nanomaterial (e.g. ISO 2010a). For regulatory purposes, the European Commission published in 2011 a recommendation for a definition for nanomaterials (EC 2011): ‘"Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm’.
 
Literatur
Zurück zum Zitat Aschberger K, Micheletti C, Sokull-Klüttgen B, Christensen FM (2011) Analysis of currently available data for characterising the risk of engineered nanomaterials to the environment and human health—lessons learned from four case studies. Environ Int 37:1143–1156CrossRef Aschberger K, Micheletti C, Sokull-Klüttgen B, Christensen FM (2011) Analysis of currently available data for characterising the risk of engineered nanomaterials to the environment and human health—lessons learned from four case studies. Environ Int 37:1143–1156CrossRef
Zurück zum Zitat Braun A, Franks K, Kestens V, Roebben G, Lamberty A, Linsinger TPJ (2011) Certification of equivalent spherical diameters of silica nanoparticles in water, certified reference material ERM®-FD100, EUR 24620 EN, ISBN 978-92-79-18676-9. Publications Office of the European Union, Luxembourg Braun A, Franks K, Kestens V, Roebben G, Lamberty A, Linsinger TPJ (2011) Certification of equivalent spherical diameters of silica nanoparticles in water, certified reference material ERM®-FD100, EUR 24620 EN, ISBN 978-92-79-18676-9. Publications Office of the European Union, Luxembourg
Zurück zum Zitat EC (European Commission) (1967) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. OJ L 196, 16.8.1967, 1–98 EC (European Commission) (1967) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. OJ L 196, 16.8.1967, 1–98
Zurück zum Zitat EC (European Commission) (2004) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. OJ L 50, 20.2.2004, p. 44–59 EC (European Commission) (2004) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. OJ L 50, 20.2.2004, p. 44–59
Zurück zum Zitat EC (European Commission) (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. OJ L 396, 30.12.2006, 1–849 EC (European Commission) (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. OJ L 396, 30.12.2006, 1–849
Zurück zum Zitat EC (European Commission) (2011) Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU). OJ L 275, 20.10.2011, 38–40 EC (European Commission) (2011) Commission Recommendation of 18 October 2011 on the definition of nanomaterial (2011/696/EU). OJ L 275, 20.10.2011, 38–40
Zurück zum Zitat Emons H (2006) The ‘RM family’—identification of all its members. Accred Qual Assur 10:690–691CrossRef Emons H (2006) The ‘RM family’—identification of all its members. Accred Qual Assur 10:690–691CrossRef
Zurück zum Zitat Emons H, Linsinger TPJ, Gawlik BM (2004) Reference materials: terminology and use. Can’t one see the forest for the trees? Trends Anal Chem 23:442–449CrossRef Emons H, Linsinger TPJ, Gawlik BM (2004) Reference materials: terminology and use. Can’t one see the forest for the trees? Trends Anal Chem 23:442–449CrossRef
Zurück zum Zitat Franks K, Braun A, Charoud-Got J, Couteau O, Kestens V, Lamberty A, Linsinger TPJ, Roebben G (2012) Certification of the equivalent spherical diameters of silica nanoparticles in aqueous solution, certified reference material ERM®-FD304, EUR 25018 EN, ISBN 978-92-79-21867-5. Publications Office of the European Union, Luxembourg Franks K, Braun A, Charoud-Got J, Couteau O, Kestens V, Lamberty A, Linsinger TPJ, Roebben G (2012) Certification of the equivalent spherical diameters of silica nanoparticles in aqueous solution, certified reference material ERM®-FD304, EUR 25018 EN, ISBN 978-92-79-21867-5. Publications Office of the European Union, Luxembourg
Zurück zum Zitat ISO (International Organization for Standardization) (2006) ISO Guide 35, reference materials—General and statistical principles for certification. ISO, Geneva ISO (International Organization for Standardization) (2006) ISO Guide 35, reference materials—General and statistical principles for certification. ISO, Geneva
Zurück zum Zitat ISO (International Organization for Standardization) (2008a) ISO Guide 30:1992/Amd.1:2008, Terms and definitions used in connection with reference materials. ISO, Geneva ISO (International Organization for Standardization) (2008a) ISO Guide 30:1992/Amd.1:2008, Terms and definitions used in connection with reference materials. ISO, Geneva
Zurück zum Zitat ISO (International Organization for Standardization) (2008b) ISO 148-2:2008 Metallic materials, Charpy pendulum impact test, Part 2: Verification of testing machines, ISO, Geneva ISO (International Organization for Standardization) (2008b) ISO 148-2:2008 Metallic materials, Charpy pendulum impact test, Part 2: Verification of testing machines, ISO, Geneva
Zurück zum Zitat ISO (International Organization for Standardization) (2009) ISO Guide 34. General requirements for the competence of reference material producers, ISO, Geneva ISO (International Organization for Standardization) (2009) ISO Guide 34. General requirements for the competence of reference material producers, ISO, Geneva
Zurück zum Zitat ISO (International Organization for Standardization) (2010a) ISO/TS 80004–1:2010 Nanotechnologies—Vocabulary—Part 1: Core terms. ISO, Geneva ISO (International Organization for Standardization) (2010a) ISO/TS 80004–1:2010 Nanotechnologies—Vocabulary—Part 1: Core terms. ISO, Geneva
Zurück zum Zitat ISO (International Organization for Standardization) (2010b) ISO 1182:2010 Reaction to fire tests for products. Non-combustibility test, ISO, Geneva ISO (International Organization for Standardization) (2010b) ISO 1182:2010 Reaction to fire tests for products. Non-combustibility test, ISO, Geneva
Zurück zum Zitat ISO (International Organization for Standardization) (2011) ISO/DTR 13014, Nanotechnologies, Guidance on physico-chemical characterization for manufactured nano-objects submitted for toxicological testing, (approved for publication) ISO, Geneva ISO (International Organization for Standardization) (2011) ISO/DTR 13014, Nanotechnologies, Guidance on physico-chemical characterization for manufactured nano-objects submitted for toxicological testing, (approved for publication) ISO, Geneva
Zurück zum Zitat IUPAC (International Union for Pure and Applied Chemistry) (1995) Harmonized guidelines for internal quality control in analytical chemistry laboratories. Pure Appl Chem 67:649–666CrossRef IUPAC (International Union for Pure and Applied Chemistry) (1995) Harmonized guidelines for internal quality control in analytical chemistry laboratories. Pure Appl Chem 67:649–666CrossRef
Zurück zum Zitat Johnston HJ, Hutchison GR, Christensen FM, Peters S, Hankin S, Stone V (2009) Identification of the mechanisms that drive the toxicity of TiO2 particulates; the contribution of physicochemical characteristics. Part Fibre Toxicol 6:33. doi:10.1186/1743-8977-6-33 CrossRef Johnston HJ, Hutchison GR, Christensen FM, Peters S, Hankin S, Stone V (2009) Identification of the mechanisms that drive the toxicity of TiO2 particulates; the contribution of physicochemical characteristics. Part Fibre Toxicol 6:33. doi:10.​1186/​1743-8977-6-33 CrossRef
Zurück zum Zitat Johnston HJ, Hutchison GR, Christensen FM, Peters S, Hankin S, Aschberger K, Stone V (2010a) A critical review of the biological mechanisms underlying the in vivo and in vitro toxicity of carbon nanotubes: the contribution of physico-chemical characteristics. Nanotoxicology 4:207–246CrossRef Johnston HJ, Hutchison GR, Christensen FM, Peters S, Hankin S, Aschberger K, Stone V (2010a) A critical review of the biological mechanisms underlying the in vivo and in vitro toxicity of carbon nanotubes: the contribution of physico-chemical characteristics. Nanotoxicology 4:207–246CrossRef
Zurück zum Zitat Johnston HJ, Hutchison GR, Christensen FM, Peters S, Hankin S, Stone V (2010b) A review of the in vivo and in vitro toxicity of silver and gold particulates: particle attributes and biological mechanisms responsible for the observed toxicity. Crit Rev Toxicol 40:328–346CrossRef Johnston HJ, Hutchison GR, Christensen FM, Peters S, Hankin S, Stone V (2010b) A review of the in vivo and in vitro toxicity of silver and gold particulates: particle attributes and biological mechanisms responsible for the observed toxicity. Crit Rev Toxicol 40:328–346CrossRef
Zurück zum Zitat Klein CL, Comero S, Stahlmecke B, Romazanov J, Kuhlbusch TAJ, Van Doren E, De Temmerman PJ, Mast J, Wick P, Krug H, Locoro G, Hund-Rinke K, Kördel W, Friedrichs S, Maier G, Werner J, Linsinger T and Gawlik BM. (2011). NM-Series of Representative Manufactured Nanomaterials, NM-300 Silver, Characterisation, Stability, Homogeneity. EUR 24693 EN. ISBN 978-92-79-19068-1 Klein CL, Comero S, Stahlmecke B, Romazanov J, Kuhlbusch TAJ, Van Doren E, De Temmerman PJ, Mast J, Wick P, Krug H, Locoro G, Hund-Rinke K, Kördel W, Friedrichs S, Maier G, Werner J, Linsinger T and Gawlik BM. (2011). NM-Series of Representative Manufactured Nanomaterials, NM-300 Silver, Characterisation, Stability, Homogeneity. EUR 24693 EN. ISBN 978-92-79-19068-1
Zurück zum Zitat Linsinger TPJ, Roebben G, Solans C, Ramsch R (2011) Reference materials for measuring the size of nanoparticles. Trends Anal Chem 30:18–27CrossRef Linsinger TPJ, Roebben G, Solans C, Ramsch R (2011) Reference materials for measuring the size of nanoparticles. Trends Anal Chem 30:18–27CrossRef
Zurück zum Zitat OECD (Organisation for Economic Co-operation and Development) (1998) OECD Principles on Good Laboratory Practice, in OECD Series on principles of Good Laboratory Practice and Compliance Monitoring, Number 1 ENV/MC/CHEM(98)17 OECD (Organisation for Economic Co-operation and Development) (1998) OECD Principles on Good Laboratory Practice, in OECD Series on principles of Good Laboratory Practice and Compliance Monitoring, Number 1 ENV/MC/CHEM(98)17
Zurück zum Zitat OECD (Organisation for Economic Co-operation and Development) (2005) Guidance Document on the Validation and International Acceptance of new or Updated Test Methods for Hazard Assessment, ENV/JM/MONO(2005)14, in OECD Series on Testing and Assessment, Number 34 OECD (Organisation for Economic Co-operation and Development) (2005) Guidance Document on the Validation and International Acceptance of new or Updated Test Methods for Hazard Assessment, ENV/JM/MONO(2005)14, in OECD Series on Testing and Assessment, Number 34
Zurück zum Zitat OECD (Organisation for Economic Co-operation and Development) (2008) OECD-WPMN, Series on the Safety of Manufactured Nanomaterials, Number 6, List of manufactured nanomaterials and list of endpoints for phase one of the OECD testing programme, ENV/JM/MONO[2008]13 (2008) OECD (Organisation for Economic Co-operation and Development) (2008) OECD-WPMN, Series on the Safety of Manufactured Nanomaterials, Number 6, List of manufactured nanomaterials and list of endpoints for phase one of the OECD testing programme, ENV/JM/MONO[2008]13 (2008)
Zurück zum Zitat OECD (Organisation for Economic Co-operation and Development) (2009) Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials. ENV/JM/MONO(2009)21 OECD (Organisation for Economic Co-operation and Development) (2009) Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials. ENV/JM/MONO(2009)21
Zurück zum Zitat OECD (Organisation for Economic Co-operation and Development) (2010) Guidance Manual for the Testing of Manufactured Nanomaterials: OECD’s Sponsorship Programme; first revision. ENV/JM/MONO(2009)20/REV OECD (Organisation for Economic Co-operation and Development) (2010) Guidance Manual for the Testing of Manufactured Nanomaterials: OECD’s Sponsorship Programme; first revision. ENV/JM/MONO(2009)20/REV
Zurück zum Zitat Poland CA, Duffin R, Kinloch I, Maynard A, Wallace WAH, Seaton A, Stone V, Brown S, Macnee W, Donaldson K (2008) Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study. Nat Nanotechnol 3:423–428CrossRef Poland CA, Duffin R, Kinloch I, Maynard A, Wallace WAH, Seaton A, Stone V, Brown S, Macnee W, Donaldson K (2008) Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study. Nat Nanotechnol 3:423–428CrossRef
Zurück zum Zitat Roebben G, Linsinger TPJ, Lamberty A, Emons H (2010) Metrological traceability of the measured values of properties of engineering materials. Metrologia 47:S23–S31CrossRef Roebben G, Linsinger TPJ, Lamberty A, Emons H (2010) Metrological traceability of the measured values of properties of engineering materials. Metrologia 47:S23–S31CrossRef
Zurück zum Zitat Roebben G, Emons H, Reiners G (2011), Nanoscale Reference Materials, in Nanotechnology Standards, eds. V. Murashov, J. Howard, Springer Science+Business Media, New York/Heidelberg, pp 53–75 Roebben G, Emons H, Reiners G (2011), Nanoscale Reference Materials, in Nanotechnology Standards, eds. V. Murashov, J. Howard, Springer Science+Business Media, New York/Heidelberg, pp 53–75
Zurück zum Zitat Scaravelli E, Brohée M, Marchelli R, van Hengel AJ (2009) The effect of heat treatment on the detection of peanut allergens as determined by ELISA and real-time PCR. Anal Bioanal Chem 395:127–137CrossRef Scaravelli E, Brohée M, Marchelli R, van Hengel AJ (2009) The effect of heat treatment on the detection of peanut allergens as determined by ELISA and real-time PCR. Anal Bioanal Chem 395:127–137CrossRef
Zurück zum Zitat Singh C, Friedrichs S, Levin M, Birkedal R, Jensen KA, Pojana G, Wohlleben W, Schulte S, Wiench K, Turney T, Koulaeva O, Marshall D, Hund-Rinke K, Kördel W, Van Doren E, De Temmerman PJ, Abi Daoud Francisco M, Mast J, Gibson N, Koeber R, Linsinger T, Klein CL. (2011), NM-Series of Representative Manufactured Nanomaterials, Zinc Oxide NM-110, NM-111, NM-112, NM-113, Characterisation and Test Item Preparation. EUR 25066 EN, ISBN 978-92-79-22215-3 Singh C, Friedrichs S, Levin M, Birkedal R, Jensen KA, Pojana G, Wohlleben W, Schulte S, Wiench K, Turney T, Koulaeva O, Marshall D, Hund-Rinke K, Kördel W, Van Doren E, De Temmerman PJ, Abi Daoud Francisco M, Mast J, Gibson N, Koeber R, Linsinger T, Klein CL. (2011), NM-Series of Representative Manufactured Nanomaterials, Zinc Oxide NM-110, NM-111, NM-112, NM-113, Characterisation and Test Item Preparation. EUR 25066 EN, ISBN 978-92-79-22215-3
Zurück zum Zitat UNODC (United Nations Office on Drugs and Crime) (2009) Glossary of terms for quality assurance and good laboratory practices, ST/NAR/26/Rev.1 UNODC (United Nations Office on Drugs and Crime) (2009) Glossary of terms for quality assurance and good laboratory practices, ST/NAR/26/Rev.1
Zurück zum Zitat Warheit DB (2010) Debunking some misconceptions about nanotoxicology. Nano Lett 10:4777–4782CrossRef Warheit DB (2010) Debunking some misconceptions about nanotoxicology. Nano Lett 10:4777–4782CrossRef
Metadaten
Titel
Reference materials and representative test materials: the nanotechnology case
verfasst von
G. Roebben
K. Rasmussen
V. Kestens
T. P. J. Linsinger
H. Rauscher
H. Emons
H. Stamm
Publikationsdatum
01.03.2013
Verlag
Springer Netherlands
Erschienen in
Journal of Nanoparticle Research / Ausgabe 3/2013
Print ISSN: 1388-0764
Elektronische ISSN: 1572-896X
DOI
https://doi.org/10.1007/s11051-013-1455-2

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