Timing, hosts and locations of (grouped) events of NanoImpactNet

NanoSafetyCluster - Compendium 2012
including comparable translocation towards secondary
organs compared to the application by inhalation – the
gold standard of lung toxicology research.
2. In vivo studies to determine toxic effects after acute
(24hrs) exposure for the full panel of ENPs have been
conducted. The data have been analysed and doseresponse
relationships have been established for a
range of endpoints. The intratracheal instillation of
ZnO NM-110 and NM-111 will be repeated for 2 reasons.
1. Due to technical difficulties during blood drawing
after administration of NM-110, no blood analysis was
possible while effects are seen in blood parameters
with ZnO NM-111. 2. Due to advances with ZnO toxicity
testing in other projects, there could be indication for
early changes in lung tissue. In the current protocol
the lung tissue was used for protein and RNA analysis
and not prepared for histopathological analysis.
3. Administration of nanomaterial in ApoE mice has
finished and analysis of all parameters is underway.
The studies in a rapid ageing mouse model have also
started.
4. Oxidative stress and inflammation studies in wildtype
mice by visualizing Matrix MetalloProteinase (MMP)
and Cathepsin have also commenced.
WP6 – Risk Assessment: Models of exposure-dose-response &
structure-activity model development. Risk Analysis: combining
hazard and exposure
The progress of WP6 in the first reporting period is according to
the ENPRA workplan. Specifically, we have achieved the
following:
1. The ENPRA database templates have been produced
for data collection from WP3, 4 and 5.
2. The ground work for Exposure modelling, QSAR, PBPK
and PD modelling is ongoing. When data will be
available, in the first quarter of 2011, results will be
generated.
The most notable results so far for WP6 are:
1. on preparatory work for modelling, including
uncertainty analysis using Monte Carlo simulation. This
is done in collaboration with US partner 19. Period 1
work has concentrated on data generation, with much
of the WP6 work so far being preparatory. In Period 2,
significant and important results from the Risk
Assessment will be available.
In the second reporting period, the data available from other
WP are now increasingly available. The notable progresses in
WP6 are:
1. The collection of data from WP3, 4 and 5 and later also
from the US partners into the ENPRA database for
QSAR analysis.
2. Partner 1 and Partner 14 have met to discuss the
transfer the data for analysis
3. Bio-kinetics data from WP5 have been used for PBPK
modelling
4. In vitro and in vivo endpoints commensurate for
comparison have been identified
5. Model of exposure of ENP are being constructed using
data from Partner 19.
WP7 – Dissemination Strategy to maximise impact
The progress of WP7 in the first reporting period is according to
the ENPRA workplan. Specifically, we have achieved the
following:
1. The main contributors (P14, P5 and P1) of this work
package met face-to-face during the kick-off meeting
(where a general agreement on the initial 6 months
work plan and working procedures was achieved) and
several times virtually by teleconference to agree
organise further steps. Also the annual management
meeting and the expert panel meeting offered
opportunities to meet.
2. The dissemination strategy was implemented as
foreseen by:
• holding the first annual workshop with
participation of the main stakeholders (EU CAs,
Industry, NGOs, COM Services, OECD, other FP6/7
projects) and disseminating its outcome
• organising the three experts' panel meeting and
producing and disseminating the two EONS
reports
• participating in a number of
workshops/conferences both in the EU and the
US
• participating in one OECD experts' meeting
The most notable results for WP7 so far are the regular and
high-impact events to disseminate the idea and results of
ENPRA. Overall, the work package is well on track and the
foreseen milestones and deliverables have been reached
without major problems. This seems to be the case as well for
the next milestones and deliverables.
3.1.1. Expected final results and their potential impact and
use (including the socio-economic impact and the
wider societal implications of the project so far),
ENPRA has reached the Mid-Term Milestones. As demonstrated
above, the major achievement of ENPRA so far are the results
from the in vitro (WP4) and in vivo tests (WP5) together with
the measurement of the ENP physico-chemical characteristics
for Hazard Identification. So far, there is remarkable
concordance between in vitro and vivo results (with the
exception of nano silver). The ENPRA team is currently
analysing and formulating new hypotheses regarding the low
toxicity of the ENP samples in contrast to the published results
in the public domain.
In the second reporting period we continue with the following:
1. The 2 st Annual ENPRA Workshop and Stakeholders
Panel Meeting took place in Somma Lombardo (Italy)
from 10 to 12 May 2011 organised by the JRC-IHCP. This
time the workshop theme was "Challenges of
Regulation and Risk Assessment of Nanomaterials"
20 Compendium of Projects in the European NanoSafety Cluster