Document zdvy9EQwOMJzGQJg2yGN8GGqz
Annex II - PLC status of PCTFE fluoropolymers scientific data and assessment (solubility testing)
S I- -1 INVESTIGATIVE
SCIENCE INCORPORATED
Scientists and Technical Consultants
An ISO 9001Registered Company
REPORT PHYSICAL/CHEMICAL TESTS BY OECD METHODS FOR
REGULATORY NOTIFICATION
Test Item: Polychlorotrifluoroethylene; CASRN: 9002-83-9
Submitted to: Brandon Morris, Ph.D. Honeywell Performance Materials and Technologies
115 Tabor Road Morris Plains, NJ, USA
07950
ISI Job #: 2023-16 ISI Document #: 2023-16 report-1.docx Study Monitor: lntertek Chemicals & Materials, Allentown Date: May 15, 2023 Page 1 of 25
5205 Harvester Rd., Unit 2, Burlington, Ontario, Canada L7L 6B5
Tel.
www.investigativescience.com
Si
INVESTIGATIVE SCIENCE INCORPORATED
Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
SPONSOR
Honeywell Performance Materials and Technologies 115 Tabor Road
Morris Plains, NJ, 07950 USA
PRINCIPAL INVESTIGATOR
Sira Shahrzad, Ph.D.
5205 Harvester Road, Unit 2 Burlington, Ontario, L7L 6B5
Canada
@investigativescience.com
STUDY DATES
Initiation: March 15, 2023 Completion: May 15, 2023
TEST FACILITY
Investigative Science Incorporated 5205 Harvester Road, Unit 2 Burlington, Ontario, L7L 6B5 Canada
Technical Assistance: Sira Shahrzad
STUDY MONITOR
Jean Baldwin, Ph.D. Intertek Chemicals & Materials, Allentown
7001 Hamilton Blvd., RD1 Dock 5 Trexlertown, PA, USA 18087
STUDY NUMBER(S)
Investigative Science Incorporated: Job No. 2023-16 Intertek Chemicals & Materials, Allentown LIMS 137117
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
TABLE OF CONTENTS 1.0 Statement of Compliance with Regulatory Standards........................................ 5 2.0 Study Dates........................................................................................................ 6 3.0 Test Item ............................................................................................................ 6 4.0 Test Facility and Study Team............................................................................. 8 5.0 Requested Tests ................................................................................................ 9 6.0 OECD Test No. 120: Water Solubility / Extractability...................................... 10 7.0 Record Retention ............................................................................................. 15 8.0 References ....................................................................................................... 16 9.0 Investigative Science Incorporated Disclaimer ................................................ 17 APPENDICES Appendix 1: Image of Test Item Container and Label .............................................. 19 Appendix 2: Test Item Certificate of Analysis .......................................................... 21 Appendix 3: OECD Test No. 120. Water Solubility/Extractability Raw Data........... 23
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
2.0 STUDY DATES
Test Item Received: March 14, 2023
Experimental Start Date: March 15, 2023 Experimental Completion Date: March 30, 2023
Draft Reporting Date: May 15, 2023 Final Reporting Date: May 15, 2023
3.0 TEST ITEM
Polychlorotrifluoroethylene is the Test Item that was submitted for testing.
Information on the Test Item is listed in Table 1, and specifics for the sample received at the Test Facility are in Table 2.
The Sponsor is responsible for any necessary characterization of the Test Item related to chemical composition, purity, strength, stability and other data required by current OECD methods.
Table 1. Test Item Information
Common Name1 Chemical Name1 CAS Number1 Chemical Family1 Chemical Formula1
General Characterization
Polychlorotrifluoroethylene Polychlorotrifluoroethylene 9002-83-9 Fluoropolymer
Physical/Chemical Characteristics
Colour
White
State at Room Temperature
Solid
Molecular Weight
Not specified
Note 1: Information taken from ISI form 124 for Polycholorotrifluoroethylene provided with sample
from Jean Baldwin, March 14, 2023
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
Table 2. Test Item Received at the Test Facility
Parameter
Value
Common Name1
Polychlorotrifluoroethylene
Source
Honeywell Performance Materials and
Purity1
Technologies 100%
Container Label
See Appendix 1
Date Received at Test Facility Expiry Date1 Certificate of Analysis1 Storage Instructions1
March 14, 2023 N/A See Appendix 2 Ambient
Note 1: Information taken from ISI form 124 for Polycholorotrifluoroethylene provided with sample
from Jean Baldwin, March 14, 2023
3.1 Special Handling None
3.2 Reference Item None
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Si
INVESTIGATIVE SCIENCE INCORPORATED
Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
4.0 TEST FACILITY AND STUDY TEAM
Table 3. Study Team and Test Facility
Facility
Investigative Science Incorporated
5205 Harvester Rd., Unit 2, Burlington, Ontario, Canada
L7L 6B5
T:
Study Team
Name, Title, e-mail
Principal Investigator
Sira Shahrzad, Ph.D.
Principal, Laboratory Director
Technical Staff
Cheryl Sagara, B.Sc. Senior Chemist
@investigativescience.com
Oksana Korol, M.Sc. Chemist
@investigativescience.com
Sira Shahrzad, Ph.D. Principal, Laboratory Director
@investigativescience.com
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
5.0 REQUESTED TESTS The requested test to be performed on Polychlorotrifluoroethylene was:
OECD 120 Solution/Extraction Behaviour of Polymers in Water The test method is described in an individual section with details, materials, methods and test results. Raw data are included in the Appendices.
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
6.0 OECD TEST NO. 120: WATER SOLUBILITY / EXTRACTABILITY
6.1 Method Source
Organisation for Economic Co-operation and Development, OECD Guideline for the Testing of Chemicals. Test No. 120: Solution/Extraction Behaviour of Polymers in Water. January 21, 2000.
6.2 Experimental
6.2.1 Equipment Information
Table 4. Equipment Information
Item
Thermometer Oven
Rotary Evaporator
Constant temperature, shaking water bath
Analytical balances
Mortar and Pestle Sieve
Round bottom flasks Graduated cylinders
Mixed Cellulose Acetate syringe filters
pH paper
(MCE)
Description
Extech digital thermometer Stabil-Therm Laboratory Oven, Blue M Electric Company, Blue Island, Illinois, USA Brinkman Buchi Rotavapor-R New Brunswick Scientific Co. Ltd., Model G76D Sartorius Secura 125-1S (5 decimal) Sartorius ED2200S (2 decimal) Coors USA US Standard Sieve Series, ASTM E11, Sieve #60, 0.250 mm 250 mL 100 mL 0.45 m syringe filters, lot M0410192907, ChemScience Hydrion pH paper Range 1 - 12
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
6.2.2 Reagent Information
Table 5. Reagent Information
Reagent Water
Specifications HPLC grade
Source
HPLC grade, Caledon Laboratories Ltd., Georgetown, Ontario
6.2.3 Test Item
The purity of the Test Item, as provided by the client, was 100%. No correction for purity was required. The test was conducted at neutral pH, as the Test Item has no practicable ionisable groups that would present at pH 2 or pH 9.
Ideally, the test is conducted on material of a particle size between 0.125 and 0.25 mm (as determined by using the appropriate sieves). At room temperature the Test Item is in the form of solid white pellets. The Test Item was ground to a fine powder using a mortar and pestle, then passed through a US Standard Sieve # 60 to get a particle size less than 0.25 mm for OECD 120.
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
6.2.4 Test Flasks Prepared
The Test Item was weighed into triplicate flasks in the ratio of 1 g Test Item to 1 L water and 10 g Test Item to 1 L water.
Table 6. Preparation Details of Test Flasks
Number of Flasks
prepared 3
3
1
Test Item Concentration
0.3 g
3 g
0
Reagent
300 mL Type 1 water
300 mL Type 1 water
300 mL Type 1 water
Condition
pH 6.5, neutral pH 6.5, neutral pH 6.5, neutral
Test Item to Water
Ratio 1 g/L
10 g/L
0 g/L
6.2.5 Definitive Test Measurements and Analytical Method Details
Table 7. Details of Test Measurements
Item
Sartorius Secura 125-1S, 5 decimal balance
pH of final test flasks Temperature Range of Water Bath during incubation
Used in testing Gravimetric determination Neutral: 6.5 20.1 0.1 C
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
6.2.6 Definitive Test
The Flask Method was used for the solubility determination.
The flasks were agitated on a shaking water bath at a speed of 130 RPM and a nominal temperature of 20 C. After 24 hours an aliquot was removed from each flask for analysis.
6.2.7 Definitive Test Observations
After 24 hours of incubation, the test flasks were observed to contain a white material that floated on top of a clear aqueous phase in the middle and a small portion of white precipitate at the bottom of the container. A picture of flasks is included in Appendix 3.
6.2.8 Analytical Measurements
There was no suitable analytical method for Polychlorotrifluoroethylene in water. The solubility of the Test Item was determined gravimetrically, The samples were removed from the water bath at the 24-hour mark. A sample was taken from the clear aqueous phase. It was passed through a 0.45 m MCE syringe filter into a 100 mL graduate cylinder to the 100 mL mark. The aqueous solution was then transferred to a pre-weighed 250 mL round bottom flask. This was repeated for each sample. The water was evaporated off, using a Buchi Rotovapor-R with the water bath set at 55 C. The samples were placed in an oven at 55 C overnight to remove any remaining water. The flasks were placed in a desiccator to cool down, then weighed and the amount soluble was determined.
6.2.9 Extractability Calculation
The water extractability is calculated according to the following formula:
Water Extractability (%) =
(Solubility, mg/L)(Sample Volume, L)(Dilution)(100%) (Sample Weight, g)(1000 mg/g)
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
6.3 Results
The results of the test at 10 g/L are summarized in Table 8. The detailed calculations and calibration may be found in Appendix 3.
The testing at 1 g/L will not be reported. Results were all less than the method detection limit and the less than value for extractability will only be reported on the larger sample size.
Table 8. Solubility / Extractability of Polychlorotrifluoroethylene In water - 10 g/L Test Item Loading
Sample ID
Blank sample Replicate #1 Replicate #2 Replicate #3 Mean of replicates
Standard Deviation Relative Standard Deviation (%)
Solubility (mg/L)
< 5 < 5 < 5 < 5 < 5
N/A
N/A
Water Extractability
(mg/g)
n/a (blank) < 0.5 < 0.5 < 0.5 < 0.5
N/A
Water Extractability
(%)
n/a (blank) < 0.05 < 0.05 < 0.05 < 0.05
N/A
pH of Sample at Experiment
End
n/a 6.5 6.5 6.5
N/A
N/A
The solubility of the TI at 20.0 C with a 10 g/L loading was < 5 mg/L. The extractability was < 0.05% of the original starting material.
6.4 Conclusions
The solubility of Polychlorotrifluoroethylene at a ratio of 10 g/L was < 5 mg/L and the water extractability was < 0.05% of the original starting material at neutral pH.
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
7.0 RECORD RETENTION ISI will dispose of any remaining sample when the Final Report has been accepted. ISI will retain the following records for ten years: Copies of Laboratory Notebook pages Sample Log Books Stock Chemical/Standard Records Calibration Records Copies of Methods The Final Report Study Team Qualifications All original raw data and machine outputs After ten years some of this documentation may be securely shredded and discarded.
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
8.0 REFERENCES Environment Canada. Guidance Document for the New Substance Notification
Regulation (Chemicals and Polymers), Version 1.0, 2022. Organisation for Economic Co-operation and Development, OECD Principles on
Good Laboratory Practice. ENV/MC/CHEM(98)17, Paris, January 26, 1998. Organisation for Economic Co-operation and Development, OECD Guideline for
the Testing of Chemicals. Test No. 120: Solution/Extraction Behaviour of Polymers in Water. January 21, 2000.
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
9.0 INVESTIGATIVE SCIENCE INCORPORATED DISCLAIMER This report has been prepared by Investigative Science Incorporated for Honeywell Performance Materials and Technologies and is intended for use only by Honeywell Performance Materials and Technologies with respect to regulatory notification. Neither this report, nor any information contained in it, is intended for use by any other person, corporation, or entity or for any other purpose. Investigative Science Incorporated will not be liable to anyone for any injury or damages: suffered as a result of any use of, or reliance upon, this report, or any information contained in it: by anyone other than those for whom it has been prepared; or suffered by anyone as a result of any use or reliance upon, this report, or any information contained in it, for any purpose other than that for which it was originally intended.
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
APPENDICES
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
Appendix 1: Image of Test Item Container and Label
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
Appendix 2: Test Item Certificate of Analysis
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
Appendix 3: OECD Test No. 120. Water Solubility/Extractability Raw Data
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
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Test Item: Polychlorotrifluoroethylene; CAS #: 9002-83-9; Sponsor: Honeywell Performance Materials and Technologies Document #: 2023-16 report-1.docx; ISI Job #: 2023-16
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