Final Risk Evaluation for C.I. Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline- 1,3,8,10(2H,9H)-tetrone) Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure Data CASRN: 81-33-4


AEPA

United States

Environmental Protection Agency

Office of Chemical Safety and
Pollution Prevention

Final Risk Evaluation for

C.I. Pigment Violet 29
(Anthra[2,l,9-def:6,5,10-dfeT]diisoquinoline-
1,3,8,10(2H,9H)-tetr one)

Systematic Review Supplemental File:

Data Quality Evaluation of Environmental
Release and Occupational Exposure Data

CASRN: 81-33-4



H

,N.

O

O

January 2021

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This document is a compilation of tables for the data extraction and evaluation for
PV-29. Each table shows the data point or set or information element that was extracted and
evaluated from a data source in accordance with Appendix D of the Application of Systematic
Review in TSCA Risk Evaluations. If the source contains more than one data set or information
element, the review provides an overall confidence score for each data set or information element
that is found in the source. Therefore, it is possible that a source may have more than one overall
quality/confidence score.

Table of Contents

Page

Releases to the Environment	3

Occupational Exposure	6

Facility	13

Explanatory Notes

These explanatory notes provide context to understand the short comments in the data evaluation tables.

Domain

Metric

Description of Comments Field

Reliability

Methodology

Indicates the sampling/analytical methodology, estimation method, or
type of publication

Representativeness

Geographic Scope

Indicates the country of the study, publication, or underlying data

Applicability

Indicates whether the data are for a condition of use within scope of the
Risk Evaluation

Temporal Representativeness

Provides the year of study, publication, or underlying data

Sample Size

Describes the distribution of the sample or underlying data

Accessibility / Clarity

Metadata Completeness

Describes the completeness of the metadata

Variability and Uncertainty

Metadata Completeness

Indicates if study or publication addresses variability and uncertainty of
the data or information

Page 2 of 18

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Releases to the Environment

Page 3 of 18

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Source Citation:	Sun Chemical. 2020. Environmental Release, occupational exposure and particle size of PV 29- Sun Chemical"s response".

Type of Data Source Releases to the Environment; Environmental Release Data;

Hero ID	6662866

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):

Release Source:

Disposal /Treatment Method:

Environmental Media:

Daily Release Quantity (kg/day):

Annual Release Quantity (kg/yr):

Release Days per Year:

Number of Sites:

Waste Treatment Method:

Manufacturing

Manufacturing

Violet 29 production

WWTP

sludge

0.77 lb PV29/day to river, 21 lb/day to landfill

7200 lbs PV29/yr to landfill from WWTP sludge, 300 lb/yr to river

365.0

1.0

WWTP

EVALUATION











Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability











Metric 1:

Methodology

Medium

X 1

2

Data from Source, but no QA/QC or documentation

Domain 2: Representative











Metric 2:

Geographic Scope

High

X 1

1

US Facility data

Metric 3:

Applicability

High

x 2

2

Data from applicable facility

Metric 4:

Temporal Representativeness

High

x 2

2

2016.0

Metric 5:

Sample Size

N/A



N/A

Not applicable; releases calculated as annual total and normal-

ized by number of operating days; no samples taken

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness	Medium X 1	2 Metadata include most critical metadata: wastewater dis-

charges with estimates of discharge frequency and treatment
effectiveness; no information on specific activities or operations
that generate wastewater

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness	Low	x 1	3 Not discussed

Continued on next page

Page 4 of 18

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— continued from previous page

Source Citation:	Sun Chemical. 2020. Environmental Release, occupational exposure and particle size of PV 29- Sun Chemical"s response".

Type of Data Source Releases to the Environment; Environmental Release Data;

Hero ID	6662866

EVALUATION

Domain

Metric

Rating MWF* Score

Comments



Overall Quality Determination^



High 1.5





* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 5 of 18

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Occupational Exposure

Page 6 of 18

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Source Citation:	Mott, R. C.. 2017. Personal communication between Dr. Robert C. Mott (Sun Chemical Corporation) and Alie Muneer

(EPA) regarding exposure questions.

Type of Data Source Occupational Exposure; Monitoring Data;

Hero ID	4081896

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):
Physical Form:

Route of Exposure:

Exposure Concentration (Unit):

Number of Samples:

Number of Sites:

Type of Measurement or Method:

Worker Activity:

Number of Workers:

Type of Sampling:

Sampling Location:

Exposure Duration:

Exposure Frequency:

Bulk and Dust Particle Size Distribution:

Engineering Control & percent Exposure Reduction:

PPE:

Analytic Method:

Manufacture
Manufacture
Dust

inhalation

0.5 mg/m3 ("inhalation testing has shown exposure was 0.5mg/m3 over
an 12 hour work shift.")

Not specified
1.0

Not specified

Not specified. Exposure concentration listed "over an 12 hour shift"

not specified

Not specified

Not specified

12 hours

Not specified

Not specified

Not specified

not specified (for inhalation exposure - long sleeves and gloves for der-
mal)

Not specified

EVALUATION

Domain	Metric	Rating MWF* Score	Comments

Domain 1: Reliability

Metric 1: Methodology	Low	x 1	3 No discussion of sampling methodology provided. Only state-

ment that "inhalation testing has shown 0.5 mg/m3 over an 12
hour work shift."

Domain 2: Representative

Continued on next page

Page 7 of 18

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— continued from previous page

Source Citation:	Mott, R. C.. 2017. Personal communication between Dr. Robert C. Mott (Sun Chemical Corporation) and Alie Muneer

(EPA) regarding exposure questions.

Type of Data Source Occupational Exposure; Monitoring Data;

Hero ID	4081896

EVALUATION

Domain



Metric

Rating

MWF*

Score

Comments



Metric 2:
Metric 3:
Metric 4:
Metric 5:

Geographic Scope
Applicability

Temporal Representativeness
Sample Size

High
High
High
Low

X
X
X
X

1

2
2
1

1

2

2

3

Source is the only known U.S. manufacturing facility
Manufacturing is in scope.

2017; less than 10 years old

Individual samples not provided and no characterization of
sample distribution is provided.

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness

Low

X

1

3

Reference only states that measurements were of "inhalation
testing", interpreted as breathing zone measurements. No
other metadata provided.

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Low

X

1

3

No discussion of variability or uncertainty

Overall Quality Determination^

Medium





1.9





* MWF = Metric Weighting Factor

I If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 8 of 18

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Source Citation: Sun Chemicals. 2020. Enclosure 1 - EPA request for additional information in response to SACC peer reveiwer and including

public comments on the draft C.I. Pigment Violet 20 Risk Evaluation".

Type of Data Source Occupational Exposure; Monitoring Data;

Hero ID 6656737

EXTRACTION

Parameter Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):

Physical Form:

Route of Exposure:

Exposure Concentration (Unit):

Number of Samples:

Number of Sites:

Type of Measurement or Method:

Worker Activity:

Number of Workers:

Type of Sampling:

Sampling Location:

Exposure Duration:

Exposure Frequency:

Bulk and Dust Particle Size Distribution:

Engineering Control & percent Exposure Reduction:

PPE:

Analytic Method:

Manufacture
Manufacture
Dust

inhalation

Range: 0.22 mg/m3-1.2 mg/m3
5

1.0

Sample collection and analysis was performed in accordance with the
National Institute for Occupational Safety and Health (NIOSH) Manual
of Analytical Methods (NMAM) and OSHA Analytical Methods. Sam-
ples were submitted to an AIHA accredited laboratory. Personal samples
for total dust were collected utilizing pre-weighed PVC cassettes. The
samples were collected by utilizing a battery powered personal pump
calibrated before and after use with a TSI 4100 primary calibrator.
Charging big bags to the blenders on elevation 70, Packing-out on level
14
4

PBZ

Elevation 70 blender, miscellaneous places in building 82

12 hours

Not specified

Safety Glasses, Nitrile Gloves, Tyvek Coveralls, 3M 8511 Paper Dust
Mask (95 percent efficiency) as specified in the detailed work instruc-
tions. Minimum PPE requirements for site-wide production areas in-
clude long-sleeve shirt, long-pants, steeled-toed safety shoes, safety
glasses, and hard hat.

NIOSH 0500 method with working range between 1 to 20 mg/m3 for a
100L air sample

Continued on next page

Page 9 of 18

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— continued from previous page

Source Citation: Sun Chemicals. 2020. Enclosure 1 - EPA request for additional information in response to SACC peer reveiwer and including

public comments on the draft C.I. Pigment Violet 20 Risk Evaluation".

Type of Data Source Occupational Exposure; Monitoring Data;

Hero ID 6656737

EVALUATION

Domain

Metric

Rating

MWF*

Score

Comments

EVALUATION

Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability

Metric 1:

Methodology

Low

X 1

NIOSH method 500 was used but lacks the study detail.

Domain 2: Representative
Metric 2:
Metric 3:
Metric 4:
Metric 5:

Geographic Scope
Applicability

Temporal Representativeness
Sample Size

High
High
High
High

X 1

x 2
x 2
x 1

2
2
1

Source is the only known U.S. manufacturing facility
Manufacturing is in scope.

IH survey conducted in 2014; less than 10 years old
Individual sample results provided; distribution can be fully
characterized

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness

High

x 1

Metadata include: samples are PBZ, 12-hr durations, and
worker descriptions provided.

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Medium

x 1

Uncertainty specified by NIOSH method; variability not ad-
dressed

Overall Quality Determination^

High

1.3

* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 10 of 18

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Source Citation:	The EI Group Inc.. 2020. Industrial Hygiene Survey - Sun Chemical Corporation.

Type of Data Source Occupational Exposure; Monitoring Data;

Hero ID	6656714

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):
Physical Form:

Route of Exposure:

Exposure Concentration (Unit):

Number of Samples:

Number of Sites:

Type of Measurement or Method:

Worker Activity:

Number of Workers:
Type of Sampling:
Sampling Location:

Exposure Duration:

Exposure Frequency:

Bulk and Dust Particle Size Distribution:

Engineering Control & percent Exposure Reduction:

PPE:

Analytic Method:

Manufacture
Manufacture

Fine Dust, Crystalized solid
inhalation

Below detection limit, Concentrations range from <0.65 - <1.15 (mg/
m3)

10 SEG1 worker samples, 2 replicate, 2 blanks [Proposed 10 SEG1 worker

samples]

1.0

Personal breathing samples at 2.0 L/min to calculate full-shift TWA
SEG1: spray dryer pack-out operators;SEG2: PV-29 bag transfer to
IPCs for salt grinding operators; SEG3: tray dryer unloading operators
and 3 employees working adjacent process tasks (loading wet press cake
from super sacks onto drying trays/racks and into dryers);SEG4: G&B
charging operators;SEG5: G&B pack-uot operators and adjacent worker
moving boxed, closed super sacks;

16

PBZ

SEG1: B9-2SEG2: C802 (Elevation 40)SEG3: Buildings Bll-1 and Bll-
2 (open areas)SEG4: Building Bll-1, 3rd floorSEG5: Buildings Bll-1
and Bll-2

Range: 30-124 minutes
Not specified
10 "m to 0.043 "m

SEG1 & SEG3: No engineering controls, general dilution ventilation
from fans and open bay doors;SEG2: Not specified;SEG4 & SEG5: Local
exhaust ventilation system (LEV), baghouse

'All SEG1-SEG5 and adjacent workers used tyvek coveralls, hard hats,
safety glasses, nitrile gloves.SEG1 & SEG 3 also wore half-mask negative
pressure air purifying respirators with N95 filters.

NIOSH 0600

Continued on next page

Page 11 of 18

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— continued from previous page

Source Citation:
Type of Data Source
Hero ID

The EI Group Inc.. 2020. Industrial Hygiene Survey
Occupational Exposure; Monitoring Data;

6656714

- Sun Chemical Corporation.

EVALUATION

Domain

Metric

Rating

MWF* Score

Comments

EVALUATION

Domain

Metric

Rating

MWF* Score

Comments

Domain 1: Reliability

Metric 1: Methodology Low x 1 3 Study was conducted with a NIOSH method with approved

modification but short sampling durations and low pump flow
rate resulted in non-detect for most of the samples.

Domain 2: Representative

Metric 2;

Geographic Scope

High

Source is the only known U.S. manufacturing facility

Metric 3;

Applicability

High

Manufacturing is in scope.

Metric 4;

Temporal Representativeness

High

Surveys conducted April-May 2020; less than 10 years old

Metric 5;

Sample Size

High

Individual sample results provided; distribution can be fully

characterized

Domain 3; Accessibility/Clarity

Metric 6; Metadata Completeness

Low

x 1

Samples are PBZ, however, full shift is 10.5 hour but all mea-
surements are 30 to 40 min.

Domain 4; Variability and Uncertainty

Metric 7; Metadata Completeness

High

x 1

Some variability discussion in Monitoring Sampling descrip-
tion; measurement uncertainty specified by analytical method

Overall Quality Determination^

High

1.4

* MWF = Metric Weighting Factor

Page 12 of 18

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Facility

Page 13 of 18

-------
Source Citation:	Sun, Chemical. 2017. Safety Data Sheet: PERRINDO" Violet 29.

Type of Data Source Facility; Reports for Data or Information Other than Exposure or Release Data;

Hero ID	4121202

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):
Possible Physical Form:

Chemical Concentration:

Industrial/commercial/consumer use
Merchant ink
Powder
90-95 percent

EVALUATION













Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability

Metric 1:

Methodology

High

X

1

1

Manufacturer Documentation

Domain 2: Representative
Metric 2:
Metric 3:
Metric 4:
Metric 5:

Geographic Scope
Applicability

Temporal Representativeness
Sample Size

High
High
High

N/A

XXX

1

2
2

1

2
2

N/A

US based manufacturer

Physical characteristics of PV-29 applicable to scope
SDS dated 2017; less than 10 years old
No Comment.

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness

High

X

1

1

All concentration metadata provided

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Medium

X

1

2

Concentration provided as range; range addresses either the
variability or uncertainty of concentration

Overall Quality Determination^

High





1.1





* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 14 of 18

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Source Citation:	TCI America. 2017. Safety Data Sheet: 3,4,9,10-Perylenetetracarboxylic Diimide.

Type of Data Source Facility; Reports for Data or Information Other than Exposure or Release Data;
Hero ID	6571256

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):
Possible Physical Form:

Chemical Concentration:

Industrial/commercial/consumer use
Laboratory Chemicals
Crystal-Powder
>95 percent

EVALUATION











Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability

Metric 1:

Methodology

High

X 1

1

Manufacturer Documentation

Domain 2: Representative
Metric 2:
Metric 3:
Metric 4:
Metric 5:

Geographic Scope
Applicability

Temporal Representativeness
Sample Size

High
High
High

N/A

X 1

x 2
x 2

1

2
2

N/A

US based manufacturer

Physical characteristics of PV-29 applicable to scope
SDS dated 2017; less than 10 years old
No Comment.

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness

High

x 1

1

All concentration metadata provided

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Medium x 1

2	Concentration provided as range; range addresses either the

variability or uncertainty of concentration

Overall Quality Determination^

High

1.1

* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 15 of 18

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Source Citation:

Sun, Chemical. 2017. Safety Data Sheet: Violet 29.

Type of Data Source

Facility; Reports for Data or Information Other than Exposure or Release Data;

Hero ID

4121201

EXTRACTION



Parameter

Data

Life Cycle Stage:	Industrial/commercial/consumer use

Life Cycle Description (Subcategory of Use):	Coatings and basecoats, Merchant ink, Professional quality watercolor

and acrylic artist paint
Possible Physical Form:	Solid

Chemical Concentration:	100 percent

EVALUATION













Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability

Metric 1:

Methodology

High

X

1

1

Manufacturer Documentation

Domain 2: Representative
Metric 2:
Metric 3:
Metric 4:
Metric 5:

Geographic Scope
Applicability

Temporal Representativeness
Sample Size

High
High
High

N/A

XXX

1

2
2

1

2
2

N/A

US based manufacturer

Physical characteristics of PV-29 applicable to scope
SDS dated 2017; less than 10 years old
No Comment.

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness

High

X

1

1

All concentration metadata provided

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Low

X

1

3

No discussion of uncertainty or variability

Overall Quality Determination^

High





1.3





* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 16 of 18

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Source Citation:	BASF. 2011. (NMP).

Type of Data Source Facility; Reports for Data or Information Other than Exposure or Release Data;
Hero ID	6656682

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):
Process Description:

Possible Physical Form:

Chemical Concentration:

Manufacture
Manufacture

Bulk PV-29 Particle Size Distribution testing:<100 um=64.6 percent

<10 um=18.5 percent , <4 um=5.1 percent

Solid

3-99 percent

EVALUATION











Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability











Metric 1:

Methodology

High

x 1

1

Certified analytical results

Domain 2: Representative











Metric 2:

Geographic Scope

Medium

X 1

2

Analysis of German-produced PV-29

Metric 3:

Applicability

High

x 2

2

Physical characteristics of PV-29 applicable to scope

Metric 4:

Temporal Representativeness

High

x 2

2

Particle size distribution test conducted in 2011; <10 years old

Metric 5:

Sample Size

N/A



N/A

No Comment.

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness	High	X 1	1 All concentration and particle size distribution metadata pro-

vided

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Medium x 1

2

Concentration provided as range; range addresses either the
variability or uncertainty of concentration. Particle size distri-
bution provided, which addresses variability

Overall Quality Determination^

High

1.3





* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 17 of 18

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Source Citation:	Sun Chemical & U.S. EPA. 2020. PV-29 Particle size and EPA"s follow up questions- Sun ChemicaF's response".

Type of Data Source Facility; Reports for Data or Information Other than Exposure or Release Data;

Hero ID	6662857

EXTRACTION

Parameter	Data

Life Cycle Stage:

Life Cycle Description (Subcategory of Use):
Process Description:

Number of Sites:

Possible Physical Form:

Manufacture
Manufacture

Mean weight Diameter= 53 nmMedian weight Diameter=
Diameter= 20 micronsMedian Diameter= 10.4 microns
1.0
Solid

43 nm'Mean

EVALUATION

Domain

Metric

Rating

MWF*

Score

Comments

Domain 1: Reliability

Metric 1:

Methodology

High

X

1

1

Manufacturer Documentation

Domain 2: Representative
Metric 2:
Metric 3:
Metric 4:

Metric 5:

Geographic Scope
Applicability

Temporal Representativeness
Sample Size

High
High
Medium

Medium

XXX X

1

2
2

1

1

2
4

2

US based manufacturer

Physical characteristics of PV-29 applicable to scope

Unknown date, though associated data shows date stamp sug-
gesting >10 years

Characterized by a range with uncertain statistics

Domain 3: Accessibility/Clarity

Metric 6: Metadata Completeness

Medium

X

1

2

Some metadata included

Domain 4: Variability and Uncertainty

Metric 7: Metadata Completeness

Low

X

1

3

No discussion, though some variability provided by statistics,
but uncertainty not discussed

Overall Quality Determination^

Medium





1.7





* MWF = Metric Weighting Factor

t If any individual metrics are deemed Unacceptable, then the overall rating is also unacceptable. Otherwise, the overall rating is based on the following scale:
High: > 1 to < 1.7; Medium: > 1.7 to < 2.3; Low: > 2.3 to < 3.

Page 18 of 18

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