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THE NANOSAFER V1.1 RISK ASSESSMENT AND MANAGEMENT TOOL
–OVERALL SENSITIVITY ANALYSIS AND
ASSESSMENT OF THE MODEL PERFORMANCE
Keld Alstrup Jensen ([email protected])
Dansk Center for Nanosikkerhed
Det Nationale Forskningscenter for Arbejdsmiljø
København, Danmark
NanoSafer 1.1beta (www.nanosafer.org)
Currently applicable for MNM powder handling
and processes with constant source MNM emission rates
Key elements and information requirements in the Control Banding models
Method
Number of
Input
parameters
asked for
Number of
input parameters used
Number of
control bands
Nano-
relevance
Hazard
scaling
Expo.
scalingHaz. Exp. Risk
ANSES CB Tool ¤ 9 1 5 3 5 4 5
NanoSafer 1.0 # 25 5 5 13 4 5 5
IVAM Guidance ¤ 28 - 2 1 3 3 3
Swiss Precautionary Matrix 28 7 6 6 n.a. n.a. 2
CB Nanotool 53 - 15 5 4 4 4
Stoffenmanager Nano # 47 - 2 26 5 4 3
Modified from Liguori et al. (2016)
¤ The technically simplest model
# The technically most advanced models
Four Assessments in “One Go”(Near-Field and Far-Field – Acute and Daily)
Hazard Assessment- Example with R-sentences
“nanorelevance”
NM with low
solubility (So < 1 g/L)
Is the NM a HARN
(a < 3 µm c > 5 µm
c/a > 3)
traditional risk
assessment is suggested
Htot = 1.00
Hcoat = 0.45
yes
no
yes
yes
yes
no
Are there any R-phrases
for the analogue bulk material
HOEL = 0.20
no
yes
Is the OEL for the analogue
bulk material < 1 mg/m3?
Is the NM surface modified
with an inorganic
and/or organic compound?
no
no
Calculate Htot
jij
n
i itot HHH 11
HOEL = 0.26
Calculate accumulated
HR from R-values
ij j
n
i icarc RRH 11
Rj [0.1;1] for each Hi
Hi = General tox and CMAR
Examples of MNM Hazard Ranking Compared to OELs of analogue bulk materials
Material SSA
[m2/g] HARN Coated
OEL
[mg/m3] Ri
TiO2 21 - 0.45 10.0 -
TiO2 107 - 0.45 10.0 -
ZnO 12.4 - - 4.98 -
ZnO 15.1 - 0.45 4.98 -
graphite 225 - - 3.50 -
carbon black 23.8 - - 3.50 -
carbon black 295 - - 3.50 -
Kaolin 23.1 - - 2.50 -
nanoclay 8.44 - 0.45 5.00 -
SWCNT-OH 407 - 0.45 3.50 R36/R37
MWCNT 233 1 - 3.50 R36/R37
Fe2O3 27.4 - - 5.00 R36/R37/R8
Fe2O3 27.7 - - 5.00 R36/R37/R8
NiFe2O4 87.7 - - 0.200 R43/R49
Ni0.5Zn0.5Fe2O4 104 - - 0.203 R43/R49
NiO 6 - - 0.064 R49/R43/R53
Co(10% O passivated) 60 - - 0.010 R11/R42/R43/R53
Ag 0.03 - 0.45 0.010 -
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0.01 0.1 1 10
OEL [mg/m3]
Hazard
Sco
re;
Hto
tal
AgNP(PVP)
SWCNT-OH
MWCNT
H1
H2
H3
H4
Fe2O3
Organoclay/
coated ZnO
coated TiO2
NiO NiFe2O4/
NiZnFe4O8
Co
kaolinite
CB/graphiteZnO
Exposure Assessment and Scaling- Example of using Powders
CNF
QNF
Source
Emission rate:
Ei = Eo x Ai x dM/dtEi = release rate
Eo = dustiness index
Ai = activity energy factor
Ao: ”zero” (clean transport)
A1: very low (weighing mg’s)
A2: low (< 5 cm drop)
A3 : moderate (5-30 cm drop)
A4 : high (30-100 cm drop)
A5 : very high (> 100 cm drop)
dM/dt = mass flow rate
Exposure Assessment and Scaling- Example of using Powders
FF
Far-Field
NF
Ei
Near-Field
Far-Field
CFF
CNF
Cout = 0
CFF
1,,
tNF
NF
FFNFNFFF
NF
itNF R
V
MMt
V
EC
1,,
tFF
FF
NFFFFFNFtFF R
V
MMC
1
2
t
NF
NF
NFFFNFNFFF
NFett
VCM
1
2
t
NF
NF
NFNFNFFFNF
NFett
VCM
t
FF
tNF
tNFFFe
t
CR
1
1,
1,
t
FF
tFF
tFFFFe
t
CR
1
1,
1,
Dispersion model:
Where M and R are:
Exposure scaling
NF Acute (15 min): Upper limit is 2 xOELnano
NF Daily (8-hour): Upper limit is OELnano
FF Acute (15 min) : Upper limit is 2 xOELnano
FF Daily (8-hour) : Upper limit is OELnano
NF volume = 12.17m3 (2.33 m3)
Exposure scale: Ci / OELnano
OELnano = OELbulk x (VSSAnano / VSSAbulk)
Aerosol decay functions after Schneider et al. (2004)
Exposure Assessment and Scaling- Example of using Powders
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
-0.5 0.5 1.5 2.5 3.5
Time [hours]
Resp
irab
le I
mm
issio
n P
ote
nti
al
[mg
/m3]
C(NF) - RDI-SC(NF) - UV-Titan L181C(NF) - NM-110 (ZnO)C(NF) - NM-111 (f-ZnO)C(NF) - GraphiteC(NF) - Flammrüss 101C(NF) - Printex 90C(NF) - ASP-90C(NF) - Nanofil®5C(NF) - Fe2O3*C(NF) - NiFe2O4C(NF) - Ni0.5Zn0.5Fe2O4C(NF) - AgNPC(NF) - CNT-NiO-Co
0
0.2
0.4
0.6
0.8
-0.5 0.5 1.5 2.5 3.5
Time [hours]R
esp
irab
le I
mm
issio
n P
ote
nti
al
[mg
/m3]
C(FF) - RDI-SC(FF) - UV-Titan L181C(FF) - NM-110 (f-ZnO)C(FF) - NM-111 (f-ZnO)C(FF) - GraphiteC(FF) - Flammrüss 101C(FF) - Printex 90C(FF) - ASP-90C(FF) - Nanofil®5C(FF) - Fe2O3*C(FF) - NiFe2O4C(FF) - Ni0.5Zn0.5Fe2O4C(FF) - AgNPC(FF) - CNT-NiO-Co
Scooping/filling 5 x 500 g bags in small scale production:
Total mass: 500 g
Mass per transfer (spoonful): 50 g/scoop.
Hi = 0.3
Duration per filling: 10 minutes
Duration per transfer: 0.5 minute
Pause between each filling: 5 minutes
Work area: 3.5 m x 5 m long x 2.9 m high
ventilation rate of 5 h-1
Variation reflects variation
in dustiness
NM not one category
Next step is coupling with risk
management library such as the
ECEL developed by TNO
Sensitivity Analysis (Exposure Algorithm)- One At Time
-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
-50% -25% -5% Base 5% 25% 50%
% C
han
ge i
n t
he
ou
tpt
con
cen
trat
ion
val
ue
% Input changes
Near field short term (15 min) exposure
cse
tim
bre
rep
totvol
ven
A)
-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
120%
-50% -25% -5% Base 5% 25% 50%
% C
han
ge i
n t
he
ou
tpt
con
cen
trat
ion
val
ue
% Input changes
Near field long term (8 hoour) exposure
cse
tim
bre
rep
totvol
ven
B)
-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
120%
-50% -25% -5% Base 5% 25% 50%
% C
han
ge i
n t
he
ou
tpt
con
cen
trat
ion
val
ue
% Input changes
Far field short term (15 min) exposure
cse
tim
bre
rep
totvol
ven
C)
-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
120%
-50% -25% -5% Base 5% 25% 50%
% C
han
ge i
n t
he
ou
tpt
con
cen
trat
ion
val
ue
% Input changes
Far field long term (8 hour) exposure
cse
tim
bre
rep
totvol
ven
D)
Liguori et al. (in prep.)
Sensitivity Analysis (Exposure Algorithm)- One At Time
Main effects
[NF daily] [FF daily]
CSE 50.9573 49.5076
TIM 42.8422 41.6568
REP 32.5480 31.4588
BRE -27.0343 -26.4670
TOTVOL -32.0269 -31.4291
VEN -50.1953 -49.4954
[NF Acute] [FF Acute]
CSE 89.2789 86.3203
TIM 74.0052 72.8325
REP 65.0045 63.9056
BRE -54.9602 -53.9095
TOTVOL -64.2924 -63.8799
VEN -85.7826 -86.2296
Liguori et al. (in prep.)
CSE Constant Source Emission
TIM Duration of work cycle
BRE Pause between work cycles
REP Frequency - Repetition of the workcycle
TOTVOL Room size
VEN Air Exchange rate
-0.4
-0.2
0.0
0.2
0.4
0.6
0.8
1.0
1.2
30
45
60
75
90
105
120
135
150
165
180
195
210
225
240
255
270
285
300
Room size [m3]
Near field short term (15 min) exposure
-50%
-25%
-5%
5%
25%
50%
Next Step is Performance Assessment and Model Calibration
0
5000
10000
15000
20000
25000
30000
35000
40000
-0.5 0.0 0.5 1.0 1.5 2.0
Time [hours]
FM
PS
pa
rtic
le c
on
cen
trati
on
[n
/cm
3]
NF(FMPS) - BG
C(NF) - Vibration feeder
C(FF) - Laboratory air
FF(FMPS) - BG
5
89
SE3000
Challenge is quality and detail of the case studies for comparison
1. Materials well-characterized
2. Suitable toxicological data on MNM (CMAR)
3. High quality MNM exposure measurement data (personal and
stationary)
THANKS TO MY CO-DEVELOPERS AND TESTERS
Biase Liguori (DTU; NRCWE)
Anne T. Saber (NRCWE)
Ismo K. Koponen (NRCWE)
Steffen F. Hansen (DTU)
Anders Baun (DTU)
Alexander C.Ø. Jensen (DTU; NRCWE)
Håkan Wallin (NRCWE)
Danish Centre for NanoSafety
