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APFN Work Group Presentation to EPA January 16, 2003
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"COMPANY SANITIZED.
DOES NOT CONTAIN TSCA CBI"
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Background
What is the APFN Work Group? Relationship with FMG What is APFN and what is it used for?
Analytical Methods Development Toxicology and Environmental Program
Current Knowledge of APFN Ongoing toxicology/ecotoxicology program
Summary
Fluoropolymer Manufacturers Group CFMG)
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?
Separate SPI Work Group
Formed to evaluate APFN as compared to APFO
Members are producers and users of APFN
Limited number of participants complicates the sharing of some information
APFN Work Group Members
Asahi Glass Co. Ltd. Atofina Chemicals, Inc. Solvay Solexis, Inc. (Ausimont)
What is APFN?
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
FPA - Fluoropolymer polymerization aide
commercially available perfluoroalkyl carboxylate surfactant
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Commercially Available APFN
CAS number 72968-3-88
Use of Commercial APFN
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PVDF Applications
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
Voluntary worldwide commitment to contain
Global minimum emissions reduction of 50% Base year '99 or '00
Goal years 2004 - 2006
Emissions reduction forecast completed
49% Reduction by 2004 67% Reduction by 2006
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Analytical Methods Development
Method development and validation underway at CRO
Selected laboratory experienced with this family of chemistry Provide quantitation at ppb - ppt levels
Three matrices:
-Water (LC/MS/MS) -Serum (LC/MS/MS) -Air (LC/MS)
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Analytical Methods Development
Methods developed Validation in progress Tinning of validation
Water: completed November 2002 to coincide with toxicology testing Serum: completed December 2002 Air: January 2003
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 (15% aa. spin) * Ames Test - Negative
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Comparison of FPA Data
Acute oral, rat
Commercial and purified APFO
LD50 540 mg/kg
Acute dermal, rat
LD50 6959 mg/kg
4 hr inhalation, rat G e n o to x ic ity Target organs
P ero x iso m e prol iterator M etabolized in vivo Biodegradation W ater solubility
LC50 980 mg/m3 Not mutagenic Liver, pancreas, testes Yes
No No - very low >10%
Com m ercial and purified APFN
PFDA
ALD 187 mg/kg
LD50: 500 - 2000 (m ouse)(15% aa soin)
ALD 96 mg/kg
LC50 820 mg/m3 Not mutagenic Liver (lim ited data)
Yes
Not expected Not expected >10%
Not mutagenic 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
Physical/chemical properties
Vapor pressure Water solubility Stability in water (hydrolysis as a function of pH)
Health effects
Acute oral toxicity in rats 28 day oral study with reproduction screen (rats)
Environmental effects
j Acute studies in fish, daphnia, algae
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APFN Testing Status
Water method completed Nov. 2002 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
Environmental effects and phys/chem properties testing initiated
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Summary
APFN not widely used
Limited mostly to PVDF manufacturing
Primarily industrial applications; No direct consumer applications Significant reduction in potential exposure sources planned
Emissions at fluoropolymer plants
Toxicity and environmental effects work progressing on schedule