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APFN Work Group Presentation to EPA January 16, 2003
"COMPANY SANITIZED. DOES NOT CONTAIN TSCA CBI"
Agenda
<rBackground
What is the APFN Work Group? Relationship with FMG What is APFN and what is it used for?
r Analytical Methods Development r Toxicology and Environmental Program
Current Knowledge of APFN Ongoing toxicology/ecotoxicology program
r Summary
Fluoropolymer Manufacturers Group (FMG)
r The mission of the FMG is to promote the continued safe manufacture and use of fluoropolymers made using fluoropolymer polymerization aids (FPA) while establishing and supporting responsible use of fluoropolymer products and minimizing the impact on the environment
What is the APFN Work Group?
r Separate SPI Work Group r Formed to evaluate APFN as compared to APFO f Members are producers and users of APFN
Limited number of participants complicates the sharing of some information
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APFN Work Group Members
r Asahi Glass Co. Ltd. r Atofina Chemicals, Inc. ir Solvay Solexis, Inc. (Ausimont)
What is APFN?
r APFN is one of the FPAs used by the FMG member companies to produce fluoropolymers as reported in the FMG mass balance update in Sept. 2002
r FPA - Fluoropolymer polymerization aide
commercially available perfluoroalkyl carboxylate surfactant
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Commercially Available APFN
r CAS number 72968-3-88
CBI redacted
Use of Commercial APFN
CBI redacted
PVDF Applications
r Handled only in industrial processes
Highly weatherable architectural coatings Ultrapure water systems in semiconductor and
pharmaceutical industries Handling of corrosive chemicals - pipes, filter
media, tanks, etc. Fire resistant electrical insulation Lithium ion batteries
** No direct consumer applications
Fluoropolymer Manufacturing Group Point Source Emissions Include APFN r Voluntary worldwide commitment to contain
Global minimum emissions reduction of 50% Base year '99 or '00 Goal years 2004 - 2006
r Emissions reduction forecast completed
49% Reduction by 2004 67% Reduction by 2006
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Analytical Methods Development
r Method development and validation underway at CRO
Selected laboratory experienced with this family of chemistry
Provide quantitation at ppb - ppt levels
r Three matrices:
-Water (LC/MS/MS) -Serum (LC/MS/MS) -Air (LC/MS)
Analytical Methods Development
r Methods developed r Validation in progress r Timing of validation
Water: completed November 2002 to coincide with toxicology testing
Serum: completed December 2002 Air: January 2003
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APFN Toxicology Data
Acute Animal toxicity data in literature
* LC50 4 hr. inhalation - rat: 820 mg/m3 * ALD oral - rat: 187 mg/kg
Repeated dose oral toxicity - mouse
* Dietary exposure - 14 days * Increased liver weight -
males > 1 ppm; females > 3 ppm * Lethality > 300 ppm females; > 3000 ppm males
Commercial APFN
LD50 oral - mouse: 500 - 2000 mg/kg r15% aa. solnl * Ames Test - Negative
Comparison of FPA Data
Acute oral, rat
Com m ercial and purified APFO
LD50 540 mg/kg
Acute derm al, rat
4 hr inhalation, rat G e n o to x icity Target organs
Peroxisom e proliferator M etabolized in v iv o Biodegradation W ater solubility
LD50 6959 mg/kg
LC50 980 mg/m3 Not m utagenic Liver, pancreas, testes Yes
No No - very low >10%
Com m ercial and purified APFN
PFDA
ALD 187 mg/kg
LD 50:500 - 2000 ( m ou se 15% aa soin)
ALD 96 mg/kg
LC50 820 mg/m3 Not m utagenic Liver (lim ited data)
Yes
Not expected Not expected >10%
Not m utagenic Liver, testes, thym us Yes
No Not expected
APFN Testing Strategy
Determine differences and similarities of commercial APFN and APFO Use screening approach to begin 3 Proposed studies Chemical/physical properties Health effects Environmental effects
APFN Studies Planned
r Physical/chemical properties
* Vapor pressure * Water solubility * Stability in water (hydrolysis as a function of pH)
r Health effects
* Acute oral toxicity in rats * 28 day oral study with reproduction screen (rats)
f Environmental effects
* Acute studies in fish, daphnia, algae
APFN Testing Status
r Water method completed Nov. 2002
r 28 day oral study started at TNO in 4th Quarter 2002 Doses selected are 0.1, 0.5, and 2 mg/kg Anticipate results 2nd quarter 2003 Preliminary range finding results were reported to TSCA 8(e) office Dec 20, 2002
r Environmental effects and phys/chem properties testing initiated
Summary
f APFN not widely used Limited mostly to PVDF manufacturing
r Primarily industrial applications; No direct consumer applications
r Significant reduction in potential
exposure sources planned Emissions at fluoropolymer plants
r Toxicity and environmental effects work
progressing on schedule
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