Risk assessment and life cycle assessment for engineered nanomaterials: highlights from NanoValid

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1 MARINA NanoValid conference 29 September 2015 Risk assessment and life cycle assessment for engineered nanomaterials: highlights from NanoValid Dana Kühnel and all WP4 Partners This project has received funding from the European Union s Seventh Programme for research, technological development and demonstration under grant agreement No

2 Outline 1. Hazard assessment based on literature review 2. Hazard assessment methods: applicability to NM 3. Interlaboratory comparision: the case of nag 4. Structured approach: Decision trees and flow charts 5. International persepective 6. Life-cycle assessment (LCA) and life-cylce impact assessment (LCIA)

3 1 Hazard assessment based on literature data Extensive review for selected NM 3

4 2 Applicability of HA methods developed within NV REACH Chemical legislation development REACH and nanomaterials Environmental Risk Assessment Hazard identification and assessment Exposure assessment Risk characterization Human Risk Assessment Hazard identification Dose -response Exposure assessment Risk characterisation Life Cycle Assessment (LCA) Life cycle inventory analysis Life Cycle Impact Assessment Are NanoValid methods applicable for Environmental Risk Assessment and LCA? All methods are discussed Are NanoValid methods applicable for Human Risk Assessment and LCA All methods are discussed? 4

5 2 Applicability of HA methods developed within NV Method HI in RA LCA Standard Bacterial toxicity Suitable Possible EPA Paramecium caudatum assay No No None Daphnia assay Suitable Suggested in literature Artemia Assay Suitable Possible None OECD 202 Zebrafish Suitable Suggested in literature Porcellio scaber feeding assay Suitable Possible None Short food chains To be adapted To be adapted None cells from rainbow trout- cytotoxicity OECD 236 To be adapted To be adapted None 5

6 3 Interlaboratory comparison: pysical-chemical characterisation and toxicity testing (the case of nag) 6

7 3 Interlaboratory comparison: pysical-chemical characterisation and toxicity testing (the case of nag) Comprehensive dataset Ø Systematic analysis of experimental data on nag hazard obtained by 6 partners Ø Harmonised procedure methodology: storage, preparation of stock Ø 10 toxicity assays on a range of environmentally relevant test sprecies Ø nag characterisation in respective test media Recommendation for harmonised procedures for characterisation Ø Dissolution and Ag speciation in the different media (medium compostion alters Ag-species concentration, Ø Control of aging processes (e.g. influence of light, temperature) 7

8 4 Structured approach: decision trees and flow charts for the specification of test design Aim: Ø Guide in designing NM toxicity tests Ø Increase reliability of results by decreasing variation Ø SOP development / documentation Ø Retrospective data analyses Ø A suite of decision trees and flow charts was developed Example study Ø ncuo was experimentally tested under different conditions Ø Test were designed according to structured approach 8

9 4 Structured approach: decision trees and flow charts for the specification of test design Example: Decision on test scenario and applicaton to liquid media 9

10 4 Structured approach: decision trees and flow charts for the specification of test design Example: ncuo Decision on test scenario and applicaton to liquid media 10

11 Input into standardization Ø Development of decision trees and flow charts to foster the harmonization of toxicological test designs Ø Evaluation of procedure at CEN meeting in Brussels (28 th November, 2014) Ø Invitation to join the DIN working group NA UA: Health and environmental aspects Ø First meeting in Berlin at 23 rd June, 2015 Ø Presentation of procedure à further discussions needed Ø To be continued Paper recently submitted by Potthoff 11 et al.

12 5 Global perspective on risk assessment US-EPA: Maureen Gwinn McGill University (CN): Heather McShane INMETRO (Brazil): Mauro Granjeiro UOA (India): Alok Dhawan 12

13 6 LCA and LCIA (1) General approach (2) Case study (TiO 2 in sunscreen) In Cooperation with: Joris Meesters Prof. Dik van de Meent Kim Ettrup Assist. Prof. Alexis Laurent 13

14 Life Cycle Inventory (LCI) and Life Cycle Impact Assessment (LCIA) LCI LCIA 14

15 General approach Life cycle inventory report and database on nanomaterials manufacturing processes Developed LCIA method Life cycle methods applied to the case studies Collection of Cradle-to-gate manufacturing data collected Development of a characterization method to model the human toxic and ecotoxic impact of nanoparticles on environment Evaluation of the environmental impacts of nano-tio 2 embedded sunscreen through Life Cycle Assessment (LCA) with a focus on human toxicity and freshwater ecotoxicity 15

16 General approach Life cycle inventory report and database on nanomaterials manufacturing processes Developed LCIA method Life cycle methods applied to the case studies Cradle-to-gate manufacturing data collected for CNT, SiO 2, Ag, TiO 2, ZnO Aggregation of the data to datasets for each nanoparticle Cradle-to-gate manufacturing impact assessment Results dominated mainly by raw materials and energy use However there are data gaps (direct emissions to water and air, nanoparticle emissions) 16

17 Example of cradle-to-gate impact assessment results (IMPACT 2002+) nag produced by Flame spray pyrolysis (according to Walser et al. 2011) Impacts dominated by raw material (silver octanoate) Silver octanoate impacts can be traced back to desilverising of lead à burning of coal and lead concentrate Lead concentrate à burning of coal, natural gas and diesel 17 Chemicals à xylene, 2-ethylhexanoic acid

18 General approach Life cycle inventory report and database on nanomaterials manufacturing processes Developed LCIA method Life cycle methods applied to the case studies Development of a characterization method to model the human toxic and ecotoxic impact of nanoparticles on environment Development of characteriation factors for nano-tio 2 in collaboration with DTU and Radboud University 18

19 CF = FF XF EF Fate factor: Development of fate factors with SimpleBox4Nano (Meester et al. 2014) Exposure factor: Development of exposure factors for human intake covering inhalation, direct water ingestion, exposed/ unexposed produce and fish ingestion Knowledge gap for exposure through dairy products and meat ingestion Effect factor: Development of effect factor for human health and ecotoxicity based on a literature review è Development of CF for TiO 2 for human health and ecosystem quality Meesters JAJ, Koelmans AA, Quik JTK, Hendriks AJ, van de Meent D (2014) Multimedia modeling of engineered nanoparticles with SimpleBox4nano: model definition and evaluation. Environ Sci Technol 2014, 48:

20 General approach Life cycle inventory report and database on nanomaterials manufacturing processes Developed LCIA method Life cycle methods applied to the case studies Evaluation of the environmental impacts of nano-tio 2 embedded sunscreen through Life Cycle Assessment (LCA) with a focus on human toxicity and freshwater ecotoxicity Application of the life cycle inventory dataset for nano-tio 2 manufacturing Application of the characterization factors developed to evaluate the toxic effect of nano-tio 2 20

21 Functional unit To provide a sun protection factor of 20 for an adult with average body surface area (equal to cm 2 ) by applying 1/4 of the recommended amount of 2 mg/cm 2 /40 ml per use once a day for 20 days Reference flow 1 bottle of sunscreen containing 200 ml of sunscreen Sunscreen life cycle stages considered 21

22 Human toxicity, cancer effect Cancer Human Human toxicity, toxicity, cancer cancer effects effects 100%% 80%% 60%% 40%% 20%% 0%%!20%% Human toxicity, cancer effects 100%% 100%% 80%% 80%% 60%% 60%% 40%% 40%% 20%% 20%% 0%% 0%% 57% Human%toxicity,%cancer% Human%toxicity,%cancer% Human%toxicity,%cancer% *emissions!20%% to *emissions water to water!20%% 57% 57% *emissions to water Packaging%end!of!life% Packaging%end!of!life% Sunscreen%end!of!life*% Packaging%end!of!life% Sunscreen%end!of!life*% Direct%%skin%absorpDon% Sunscreen%end!of!life*% Direct%%skin%absorpDon% DistribuDon% Direct%%skin%absorpDon% DistribuDon% DistribuDon% Manufacturing% Manufacturing% Manufacturing% Packaging%producDon% Packaging%producDon% Packaging%producDon% Ingredients*manufacturing* Ingredients*manufacturing* Ingredients Ingredients Ingredients manufacturing manufacturing Ingredient Ingredient manufacturing Interpretation Human toxicity, cancer effects are dominated by ingredients manufacturing, which is in turn dominated by nano-tio 2 manufacturing 100%% 80%% 60%% 40%% 20%% 0%% 100%% 80%% 80%% 60% 60% 60% 60% 60% 60% 60%% 60%% 40%% 40%% 20%% 20%% Nano*TiO2* Nano*TiO2* Transport%to%manufacturing% Transport%to%manufacturing% Chemical%plant%infrastructure% Chemical%plant%infrastructure% Propylene%glycol%and%Polyglyceryl!10%Decaoleate% Propylene%glycol%and%Polyglyceryl!10%Decaoleate% Propylene%glycol%and%Polyglyceryl!10%Decaoleate% Acrylates/C10!20%Alkyl%Acrylate%Crosspolymer% Acrylates/C10!20%Alkyl%Acrylate%Crosspolymer% Acrylates/C10!20%Alkyl%Acrylate%Crosspolymer% %Diisopropyl%Adipate,%Cetyl%Ethylhexanoate%and%Diisopropyl%Dimer%Dilinoleate% %Diisopropyl%Adipate,%Cetyl%Ethylhexanoate%and%Diisopropyl%Dimer%Dilinoleate% %Diisopropyl%Adipate,%Cetyl%Ethylhexanoate%and%Diisopropyl%Dimer%Dilinoleate% %Methyl%Gluceth!20%and%Methyl%glucose%sesquistearate% %Methyl%Gluceth!20%and%Methyl%glucose%sesquistearate% Glycerole% %Methyl%Gluceth!20%and%Methyl%glucose%sesquistearate% Glycerole% Butylene%Glycol% Glycerole% Aminomethyl%Propanol%(95%)% Butylene%Glycol% Butylene%Glycol% Hydroxypropyl%Methylcellulose% Aminomethyl%Propanol%(95%)% Aminomethyl%Propanol%(95%)% EDTA% Hydroxypropyl%Methylcellulose% 0%% Hydroxypropyl%Methylcellulose% Deionized%water% EDTA% Human%toxicity,%cancer% EDTA% 22 0%% Deionized%water% Human%toxicity,%cancer% Deionized%water% Human%toxicity,%cancer%

23 Developing Reference Methods for Nanomaterials 23