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The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

Dataset wrap
Nameto

https://www.sciencedirect.com/science/article/pii/S004060311930752X

Image Removed

This is an example for the required tobacco product characterization, property description, and design parameter information in an FDA marketing application for an Electronic Nicotine Delivery System (ENDS) (Vapes). 

Show the attributes or characteristics of the heating element for the E-cigarette .
Dataset wrap
Nameto
Rowcaps
Rows 1-4:Show the records for a tobacco product given SPTOBID of VAPE-Z27.
Rows 1-3:Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette.
Rows 5-8:Show the package type is a Box that contains 1 E-Cigarette that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-13:Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 14-16:
Battery Capacity
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOSCATTOVALTOVALU
1TOB09TOVAPE-Z27

1

TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERElectronic Nicotine Delivery Systems (ENDS) (
VAPES
Vapes)
2TOB09TOVAPE-Z272TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERClosed E-Cigarette
3TOB09TOVAPE-Z273MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes Vapes USA
4TOB09TOVAPE-Z274TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIEREveryday Rich Tobacco
5TOB09TOVAPE-Z275PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORBOX
6TOB09TOVAPE-Z276PRDQUANProduct QuantityNEW PRODUCTPRODUCT DESCRIPTOR1E-CIGARETTE
7TOB09TOVAPE-Z277LENGTHLengthNEW PRODUCTPRODUCT DESCRIPTOR107.2mm
8TOB09TOVAPE-Z278DIAMETERDiameterNEW PRODUCTPRODUCT DESCRIPTOR9mm
9TOB09TOVAPE-Z279NICTNCNCNicotine ConcentrationNEW PRODUCTPRODUCT DESCRIPTOR2mg/L
10TOB09TOVAPE-Z2710
PG
PRPYLGLYPropylene GlycolNEW PRODUCTPRODUCT DESCRIPTOR50%
11TOB09TOVAPE-Z2711
VG
VEGGLYVegetable GlycerinNEW PRODUCTPRODUCT DESCRIPTOR50%
12TOB09TOVAPE-Z2712
CHTRFLAV
CHARFLAVCharacterizing FlavorNEW PRODUCTPRODUCT DESCRIPTOR
TOBACCO
Tobacco
13TOB09TOVAPE-Z2713
VOLUMEE
ELQDVOL
Volume,

E-

liquid

Liquid Volume

NEW PRODUCTPRODUCT DESCRIPTOR1mL
14TOB09TOVAPE-Z2714
WATT
BATCAPC
Wattage
15TOB09TOVAPE-Z2715BATTCAP
Battery Capacity
PRODUCT DESCRIPTOR5.2Watt
NEW PRODUCTPRODUCT DESCRIPTOR600mAh
16
15TOB09TOVAPE-Z27
16
15
DISPCRTG
DSCRTINDDisposable Cartridge IndicatorNEW PRODUCTPRODUCT DESCRIPTORY

The Product Design Parameters (PD) domain is used to represent design specification parameters of the tobacco product. Each property is identified using controlled terminology and is represented in PDPARMCD/PDPARMmanufacturing parameter specifications of the ENDS product as intended for used are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

Dataset wrap
Namepd
Dataset2
RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1TOB09PDVAPE-Z27

1

DRWRSTDraw Resistance90.080.0120.0mm H2O
2TOB09PDVAPE-Z272PUFCNTPuff Count300290310
3TOB09PDVAPE-Z273CRTVOLCartridge Volume315mL
4TOB09PDVAPE-Z274HTELNUMNumber of Heating Elements11

1


5TOB09PDVAPE-Z275HTELGTHHeating Element Length32.743.3mm
6TOB09PDVAPE-Z276HTEDIAMHeating Element Diameter32.953.2mm
7TOB09PDVAPE-Z277HTELRSTHeating Element Resistance0.750.251.5ohm
8TOB09PDVAPE-Z278HTELRNGHeating Element Range175100250C
9TOB09PDVAPE-Z279HTELCFGHeating Element ConfigurationSPIRALSPIRALSPIRAL
10TOB09PDVAPE-Z2710BTVLTORG

Battery Voltage Operating Range

4.536V
11TOB09PDVAPE-Z2711BTCRTORG

Battery Current Operating Range

10006501600mAh
12TOB09PDVAPE-Z2712BATCAPCBattery Capacity11008003000mAh
13TOB09PDVAPE-Z2713BATNOMV

Battery Nominal Voltage

4.24.04.5V
14TOB09PDVAPE-Z2714BTCRTRTBattery Current Rating250020002800mA
15TOB09PDVAPE-Z2715BTCHTPLBattery Charging Temperature Limits200100315C
16TOB09PDVAPE-Z2716BTDCTMPLBattery Discharge Temperature Limits20-2060C
17TOB09PDVAPE-Z2717BTENDCVBattery End of Discharge Voltage3.02.03.5V
18TOB09PDVAPE-Z2718BTMXCHCBattery Maximum Charging Current242030mA
19TOB09PDVAPE-Z2719BTMXDCC

Battery Maximum Discharging Current

270024003000mA
20TOB09PDVAPE-Z2720BTULCHVBattery Upper Limits Charging Voltage4.24.14.3V
21TOB09PDVAPE-Z2721PDUVORPDU Voltage Operating Range3.73.24.2V
22TOB09PDVAPE-Z2722PDUCORPDU Current Operating Range12008501800mA
23TOB09PDVAPE-Z2723PDUWTORPDU Wattage Operating Range757080W24TOB09PDVAPE-Z2724PDUTCTOFPDU Temperature Cut-off705565C
2524TOB09PDVAPE-Z272524AIRFLRTAirflow Rate720700740L/min
2625TOB09PDVAPE-Z272625PDUCRCOFPDU Current Cut-off352050mA
2726TOB09PDVAPE-Z272726INHAERTInhaled Aerosol Temperature373540C
2827TOB09PDVAPE-Z272827VENTLTNVENTLTOTTotal Ventilation504060%
2928TOB09PDVAPE-Z272928ELQDVISCE-Liquid Viscosity500751130mPa/s
3029TOB09PDVAPE-Z273029ELQDVOLE-liquid Volume6010120mL
3130TOB09PDVAPE-Z273130PNUMCNCParticle Number Concentration5001081010/cm3
3231TOB09PDVAPE-Z273231CTMDDIAMCount Median Diameter200150250nm
3332TOB09PDVAPE-Z273332PMPM2.5Particulate Matter PM 2.5251235ug/m3

*PG/VG Ratio = Propylene Glycol to Vegetable Glycerin Ratio

The Tobacco Product Testing (PT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? PD dataset).Finally, the PT domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows. 

Row 28:
Dataset wrap
Namept
Rowcaps
Rows 1-32:Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.
Dataset2
RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU

PTREPNUM

PTTPT

PTTPTNUM
1TOB09PTVAPE-Z27

1


DRWRSTDraw Resistance
DESIGN PARAMETER TESTING
91mm H2O9191mm H2O
1
Week 0
1
2TOB09PTVAPE-Z272
PUFCNTPuff
count (for full tank/cartridge)
Count
DESIGN PARAMETER TESTING
NUMBER COUNT

309
NUMBER COUNT

309
1
309
Week 0

1
3TOB09PTVAPE-Z273
CRTVOLCartridge
volume
Volume
DESIGN PARAMETER TESTING
3.09mL
mL1
3.093.09mL
Week 0
1
4TOB09PTVAPE-Z274
HTELNUMNumber of
heating elements
Heating Elements
DESIGN PARAMETER TESTING
NUMBER COUNT

1
NUMBER COUNT

11
Week 0

1
5TOB09PTVAPE-Z275
HTELGTHHeating
element length
Element Length
DESIGN PARAMETER TESTING
2.97mm
mm1
2.972.97mm
Week 0
1
6TOB09PTVAPE-Z276
HTELRST

HTEDIAMHeating
element resistance
Element Diameter
DESIGN PARAMETER TESTING
3.05
ohm
mm
ohm1
3.053.05mm
Week 0

1

7TOB09PTVAPE-Z277
HTELRNG

HTELRSTHeating
element range
Element Resistance
DESIGN PARAMETER TESTING
C

0.77
C
ohm
1
0.77
Week
0.77ohm1
8TOB09PTVAPE-Z278
HTELCFG

HTELRNGHeating
element configuration
Element Range
DESIGN PARAMETER TESTING
1

174C174174C
Week 0
1
9TOB09PTVAPE-Z279
BTVLTORGBattery voltage operating range

HTELCFGHeating Element Configuration
DESIGN PARAMETER TESTING
V

SPIRAL
V1

SPIRALSPIRAL
Week 0

1
10TOB09PTVAPE-Z2710
BTCRTORG

BTVLTORG

Battery

current operating range

Voltage Operating Range


DESIGN PARAMETER TESTING
mAhmAh1

4.6V4.64.6V
Week 0
1
11TOB09PTVAPE-Z2711
BATCAPA

BTCRTORG

Battery

capacity

Current Operating Range


DESIGN PARAMETER TESTING
997mAh
mAh
997
1
997
Week 0
mAh1
12TOB09PTVAPE-Z2712
BATNOMV

BATCAPCBattery
nominal voltage
Capacity
DESIGN PARAMETER TESTING
V

1112mAh
V
1112
1
1112
Week 0
mAh1
13TOB09PTVAPE-Z2713
BTCRTRT

BATNOMV

Battery

Current Rating

Nominal Voltage


DESIGN PARAMETER TESTING
mA1

4.18V4.184.18V
Week 0
1
14TOB09PTVAPE-Z2714
BTCHTPL

BTCRTRTBattery
Charging Temperature Limits
Current Rating
DESIGN PARAMETER TESTING
2488mA
C
2488
1
2488
Week 0
mA1
15TOB09PTVAPE-Z2715
BTDCTMPL

BTCHTPLBattery
Discharge
Charging Temperature Limits
DESIGN PARAMETER TESTING
198C198
1
198
Week 0
C1
16TOB09PTVAPE-Z2716
BTENDCV

BTDCTMPLBattery
end of discharge voltage
Discharge Temperature Limits
DESIGN PARAMETER TESTING
19C
V
19
1
19
Week 0
C1
17TOB09PTVAPE-Z2717
BTMXCHC

BTENDCVBattery
maximum charging current
End of Discharge Voltage
DESIGN PARAMETER TESTING
mA1

3.03V3.033.03V
Week 0
1
18TOB09PTVAPE-Z2718
BTMXDCC

BTMXCHCBattery
maximum discharging current
Maximum Charging Current
DESIGN PARAMETER TESTING
23.5mA
1
23.523.5mA
Week 0
1
19TOB09PTVAPE-Z2719
BTULCHV

BTMXDCC

Battery

upper limits charging voltage

Maximum Discharging Current


DESIGN PARAMETER TESTING
2696
V
mA2696
1
2696
Week 0
mA1
20TOB09PTVAPE-Z2720
PDUVOR

BTULCHVBattery Upper Limits Charging Voltage
Power Delivery Unit (PDU) voltage operating range

DESIGN PARAMETER TESTING
4.21V
1
4.214.21V
Week 0
1
21TOB09PTVAPE-Z2721
PDUCOR

PDUVORPDU
current operating range
Voltage Operating Range
DESIGN PARAMETER TESTING
mA1

3.65V3.653.65V
Week 0
1
22TOB09PTVAPE-Z2722
PDUWTOR

PDUCORPDU
wattage operating range
Current Operating Range
DESIGN PARAMETER TESTING
1202
W
mA1202
1
1202
Week 0
mA1
23TOB09PTVAPE-Z2723
PDUTCTOFPDU
temperature cut
Temperature Cut-off
(if applicable)

DESIGN PARAMETER TESTING
69.9C
1
69.969.9C
Week 0
1
24TOB09PTVAPE-Z2724
AIRFLRTAirflow
rate
Rate
DESIGN PARAMETER TESTING
727L/min
1
727727L/min
Week 0
1
25TOB09PTVAPE-Z2725
PDUCRCOFPDU
current cut
Current Cut-off
(if applicable)

DESIGN PARAMETER TESTING
34.8mA
1
34.834.8mA
Week 0
1
26TOB09PTVAPE-Z2726
INHAERTInhaled
aerosol temperature
Aerosol Temperature
DESIGN PARAMETER TESTING
36.9C
1
36.936.9C
Week 0
1
27TOB09PTVAPE-Z2727
VENTLTN

VENTLTOTTotal Ventilation
DESIGN PARAMETER TESTING
51%51
1
51
Week 0
%1
28TOB09PTVAPE-Z2728
ELQDVISCE-Liquid
viscosity
ViscosityTest performed at 20 degrees CelsiusDESIGN PARAMETER TESTING
1

496mPa/s496496mPa/s
Week 0
1
29TOB09PTVAPE-Z2729
ELQDVOLE-liquid
volume
Volume
DESIGN PARAMETER TESTING
60.1mL60.160.1
Week 0
mL1
30TOB09PTVAPE-Z2730
PNUMCNCParticle
number concentration
Number Concentration
DESIGN PARAMETER TESTING
#/cm31

511/cm3511511/cm3
Week 0
1
31TOB09PTVAPE-Z2731
CTMDDIAMCount
median diameter
Median Diameter
DESIGN PARAMETER TESTING
202nm
1
202202nm
Week 0
1
32TOB09PTVAPE-Z2732
PMPM

PM2.5Particulate Matter 2.5
DESIGN PARAMETER TESTING
24.4ug/
m3
m324.424.4ug/m3
1Week 0
1