journal article·2015-06Open access

Integrated probabilistic risk assessment for nanoparticles: the case of nanosilica in food

Rianne Jacobs, Hilko van der Voet, Cajo J. F. ter Braak

Journal of Nanoparticle Research· Volume 17· Issue 6

Abstract

Insight into risks of nanotechnology and the use of nanoparticles is an essential condition for the social acceptance and safe use of nanotechnology. One of the problems with which the risk assessment of nanoparticles is faced is the lack of data, resulting in uncertainty in the risk assessment. We attempt to quantify some of this uncertainty by expanding a previous deterministic study on nanosilica (5-200 nm) in food into a fully integrated probabilistic risk assessment. We use the integrated probabilistic risk assessment method in which statistical distributions and bootstrap methods are used to quantify uncertainty and variability in the risk assessment. Due to the large amount of uncertainty present, this probabilistic method, which separates variability from uncertainty, contributed to a better understandable risk assessment. We found that quantifying the uncertainties did not increase the perceived risk relative to the outcome of the deterministic study. We pinpointed particular aspects of the hazard characterization that contributed most to the total uncertainty in the risk assessment, suggesting that further research would benefit most from obtaining more reliable data on those aspects.
Source: openalex_inverted_index · Quality: baseline

Research context

OpenAlex topics: Nanoparticles: synthesis and applications · Heavy metals in environment

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

References (46)

Show source-provided references
1. Atchison J, Shen SM (1980) Logistic-normal distributions: some properties and uses. Biometrika 67(2):261–27210.1093/biomet/67.2.261 ↗
2. Barlow S, Chesson A, Collins JD, Flynn A, Hardy A, Jany K, Knaap A, Kuiper H, Larsen J, Lovell D (2009) Guidance of the Scientific Committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. EFSA Journal 1150:1–72
3. Batke M, Escher S, Hoffmann-Doerr S, Melber C, Messinger H, Mangelsdorf I (2011) Evaluation of time extrapolation factors based on the database RepDose. Toxicol Lett 205(2):122–12910.1016/j.toxlet.2011.05.1030 ↗
4. Bokkers BGH, Slob W (2005) A comparison of ratio distributions based on the NOAEL and the benchmark approach for subchronic-to-chronic extrapolation. Toxicol Sci 85(2):1033–104010.1093/toxsci/kfi144 ↗
5. Bosgra S, van der Voet H, Boon PE, Slob W (2009) An integrated probabilistic framework for cumulative risk assessment of common mechanism chemicals in food: an example with organophosphorus pesticides. Regul Toxicol Pharmacol 54(2):124–13310.1016/j.yrtph.2009.03.004 ↗
6. Bouwmeester H, Dekkers S, Noordam MY, Hagens WI, Bulder AS, de Heer C, ten Voorde SECG, Wijnhoven SWP, Marvin HJP, Sips AJAM (2009) Review of health safety aspects of nanotechnologies in food production. Regul Toxicol Pharmacol 53:52–6210.1016/j.yrtph.2008.10.008 ↗
7. Cockburn A, Bradford R, Buck N, Constable A, Edwards G, Haber B, Hepburn P, Howlett J, Kampers F, Klein C, Radomski M, Stamm H, Wijnhoven S, Wildemann T (2012) Approaches to the safety assessment of engineered nanomaterials (ENM) in food. Food Chem Toxicol 50:2224–224210.1016/j.fct.2011.12.029 ↗
8. Dekkers S, Krystek P, Peters RJ, Lankveld DP, Bokkers BG, van Hoeven-Arentzen PH, Bouwmeester H, Oomen AG (2011) Presence and risks of nanosilica in food products. Nanotoxicology 5(3):393–40510.3109/17435390.2010.519836 ↗
9. Dekkers S, Bouwmeester H, Bos PMJ, Peters RJB, Rietveld AG, Oomen AG (2013) Knowledge gaps in risk assessment of nanosilica in food: evaluation of the dissolution and toxicity of different forms of silica. Nanotoxicology 7(4):367–37710.3109/17435390.2012.662250 ↗
10. ECETOC (1995) Assessment factors in human health risk assessment. Technical report, ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels
11. ECHA (2012) Guidance on information requirements and chemical safety assessment Chapter R. 19: Uncertainty analysis. Technical Report November, European Chemicals Agency
12. Efron B, Tibshirani RJ (1994) An introduction to the bootstrap. Chapman & Hall, New York10.1201/9780429246593 ↗
13. ELC (2011) ELC’s updated position on the basis of the recent EU regulatory developments on the definition and labelling of nano-ingredients. Technical Report ii, Federation of European Specialty Ingredient Industries, Brussels
14. FAO/WHO (1995) Application of risk analysis to food standards issues. Report of the Joint FAO/WHO expert consultation Geneva, Switzerland 13–17 March 1995. WHO, Geneva
15. Flari V, Chaudhry Q, Neslo R, Cooke R (2011) Expert judgment based multi-criteria decision model to address uncertainties in risk assessment of nanotechnology-enabled food products. J Nanopart Res 13(5):1813–183110.1007/s11051-011-0335-x ↗
16. Grieger KD, Hansen SF, Baun A (2009) The known unknowns of nanomaterials: describing and characterizing uncertainty within environmental, health and safety risks. Nanotoxicology 3(3):222–23310.1080/17435390902944069 ↗
17. Grieger KD, Linkov I, Hansen SF, Baun A (2012) Environmental risk analysis for nanomaterials: review and evaluation of frameworks. Nanotoxicology 6(2):196–21210.3109/17435390.2011.569095 ↗
18. Jager T, Vermeire T, Rikken MGJ, van der Poel P (2001) Opportunities for a probabilistic risk assessment of chemicals in the European Union. Chemosphere 43(2):257–26410.1016/S0045-6535(00)00087-4 ↗
19. Lehman A, Fitzhugh O (1954) 100-Fold margin of safety. Assoc Food Drug Q Bull 18:33–35
20. Linkov I, Satterstrom FK, Monica JC Jr, Hansen SF, Davis TA (2009) Nano risk governance: current developments and future perspectives. Nanotechnol: Law Bus 6:203–220
21. Maynard AD, Kuempel ED (2005) Airborne nanostructured particles and occupational health. J Nanopart Res 7(6):587–61410.1007/s11051-005-6770-9 ↗
22. MCRA (2013) MCRA 8.0 Reference Manual. Report Dec 2013. WUR/Biometris, FERA and RIVM. Available at https://mcra.rivm.nl
23. Moerbeek M, Piersma AH, Slob W (2004) A comparison of three methods for calculating confidence intervals for the benchmark dose. Risk Anal 24(1):31–4010.1111/j.0272-4332.2004.00409.x ↗
24. Morgan K (2005) Development of a preliminary framework for informing the risk analysis and risk management of nanoparticles. Risk Anal 25(6):1621–163510.1111/j.1539-6924.2005.00681.x ↗
25. Morgan MG, Henrion M (1990) Uncertainty: a guide to dealing with uncertainty in quantitative risk and policy analysis. Cambridge University Press, Cambridge10.1017/CBO9780511840609 ↗
26. OECD (2004) SIDS Dossier on Synthetic Amorphous Silica and Silicates. UNEP; 1-254. http://www.chem.unep.ch/irptc/sids/oecdsids/Silicates.pdf
27. Pasupuleti S, Alapati S, Ganapathy S, Anumolu G, Pully NR, Prakhya BM (2012) Toxicity of zinc oxide nanoparticles through oral route. Toxicol Ind Health 28(8):675–68610.1177/0748233711420473 ↗
28. Peters S (2011) Feasibility and challenges of human health risk assessment for nanomaterials. Human health risk assessment for nanomaterials. http://www.safenano.org/media/69877/SN%20Feature%20Article_Peters2011-Human%20health%20risk%20assessment%20for%20nano.pdf
29. Peters R, Kramer E, Oomen AG, Herrera Rivera ZE, Oegema G, Tromp PC, Fokkink R, Rietveld A, Marvin HJP, Weigel S, Peijnenburg ACM, Bouwmeester H (2012) Presence of nano-sized silica during in vitro digestion of foods containing silica as a food additive. ACS Nano 6(3):2441–245110.1021/nn204728k ↗
30. Pronk MEJ, Wijnhoven SW, Bleeker E, Heugens EH, Peijnenburg WJGM, Luttik R, Hakkert BC (2009) Nanomaterials under REACH. Nanosilver as a case study. RIVM Report, 601780003
31. Rasmussen K, Mech A, Mast J, de Temmerman PJ, Waegeneers N, van Steen F et al (2013) Synthetic Amorphous Silicon Dioxide (NM-200, NM-201, NM-202, NM-203, NM-204). Characterisation and Physico-Chemical Properties. Publications Office of the European Union, pp 1–203. doi: 10.2788/57989
32. Schneider K, Oltmanns J, Hassauer M (2004) Allometric principles for interspecies extrapolation in toxicological risk assessment—empirical investigations. Regul Toxicol Pharmacol 39(3):334–34710.1016/j.yrtph.2004.03.001 ↗
33. Slob W (2002) Dose-response modeling of continuous endpoints. Toxicol Sci 66(2):298–31210.1093/toxsci/66.2.298 ↗
34. Slob W, Cotton R (2013) proast38.9: benchmark dose modelling. R package version 38.9. http://www.rivm.nl/en/Documents_and_publications/Scientific/Models/PROAST
35. Slob W, Bokkers BGH, van der Heijden GWAM, van der Voet H (2011) Integrated probabilistic risk assessment (IPRA) for carcinogens a first exploration. RIVM Report 320121002/2011. http://www.rivm.nl/dsresource?objectid=rivmp:55729
36. Slob W, Bakker MI, Biesebeek JD, Bokkers BG (2014) Exploring the uncertainties in cancer risk assessment using the integrated probabilistic risk assessment (IPRA) approach. Risk Anal 34(8):1401–142210.1111/risa.12194 ↗
37. Slob W, Pieters M (1998) A probabilistic approach for deriving acceptable human intake limits and human health risks from toxicological studies: general framework. Risk Anal 18(6):787–79810.1111/j.1539-6924.1998.tb01121.x ↗
38. So SJ, Jang IS, Han CS (2008) Effect of micro/nano silica particle feeding for mice. J Nanosci Nanotechnol 8(10):5367–537110.1166/jnn.2008.1347 ↗
39. Tooze JA, Midthune D, Dodd KW, Freedman LS, Krebs-Smith SM, Subar AF, Guenther PM, Carroll RJ, Kipnis V (2006) A new statistical method for estimating the usual intake of episodically consumed foods with application to their distribution. J Am Diet Assoc 106(10):1575–158710.1016/j.jada.2006.07.003 ↗
40. van der Voet H, Slob W (2007) Integration of probabilistic exposure assessment and probabilistic hazard characterization. Risk Anal 27(2):351–37110.1111/j.1539-6924.2007.00887.x ↗
41. van der Voet H, van der Heijden GW, Bos PM, Bosgra S, Boon PE, Muri SD, Brüschweiler BJ (2009) A model for probabilistic health impact assessment of exposure to food chemicals. Food Chem Toxicol 47(12):2926–294010.1016/j.fct.2008.12.027 ↗
42. van der Zande M, van de Briel RJ, Groot MJ, Kramer E, Herrera Rivera ZE, Rasmussen K, Ossenkoppele JS, Tromp P, Gremmer ER, Peters RJB, Hendriksen PJ, Marvin HJP, Hoogenboom RLP, Peijnenburg ACM, Bouwmeester H (2014) Sub-chronic toxicity study in rats orally exposed to nanostructured silica. Part Fibre Toxicol. doi: 10.1186/1743-8977-11-810.1186/1743-8977-11-8 ↗
43. van Rossum CT, Fransen HP, Verkaik-Kloosterman J, Buurma-Rethans EJ, Ocké MC (2011) National Food Consumption Survey 2007-2010. Technical Report, National Institute for Public Health and the Environment
44. van Straalen N (2002). Theory of ecological risk assessment based on species sensitivity distributions. In: Species sensitivity distributions in ecotoxicology, environmental and ecological risk assessment. CRC Press, Boca Raton
45. Vermeire T, Stevenson H, Pieters MN, Rennen M, Slob W, Hakkert BC (1999) Assessment factors for human health risk assessment: a discussion paper. CRC Crit Rev Toxicol 29(5):439–49010.1080/10408449991349249 ↗
46. Voss S, Charrondiere UR, Slimani N, Kroke A, Riboli E, Wahrendorf J, Boeing H (1998) EPIC-SOFT ein europäisches Computerprogramm für 24-Stunden-Erinnerungsprotokolle. Zeitschrift für Ernährungswissenschaft 37(3):227–23310.1007/s003940050021 ↗