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EC number: 216-600-2
CAS number: 1623-05-8
By screening and definitive REACH PBT criteria, PPVE is very persistent,
“vP”. An evaluation of its physical/chemical properties including
Henry’s law constant (HLC), as well as its fate in water or soil
concludes that PPVE is rapidly removed to the atmospheric compartment by
volatilization, and will not partition into water or soil from the
atmosphere. Therefore, this substance is non-persistent in the aquatic
and terrestrial environments. It has a long half-life only in the
atmosphere and is subject to long-range atmospheric transport but is not
subject to deposition in remote or pristine environments. Due to mixing
in the atmosphere and lack of partitioning out of the atmosphere,
concentrations in the biosphere will be negligible. Widespread exposure
to PPVE will not occur.
Based on the expected partitioning behavior of PPVE, additional
laboratory studies on the biodegradation and bioaccumulation in the
water, sediment and soil compartments are not relevant for the
evaluation of the PBT properties of this substance. The “B” criterion in
aquatic organisms is not met based on the screening level criterion log
Kow < 4.5, which is further supported by lack of exposure in the aquatic
compartment. The calculated log Koa value indicates that PPVE cannot
bioaccumulate in air-breathing animals. Collectively, the log Kow, the
HLC, and the calculated Koa indicate that PPVE is not expected to
bioaccumulate in aquatic, sediment or soil organisms. PPVE does not
fulfill the criteria for bioaccumulative (“B”) or very bioaccumulative
Based on available data, PPVE is not classified as carcinogenic,
mutagenic, or toxic to reproduction or specific target organ toxic after
repeated dose. PPVE does not meet the REACH “T” criteria for mammalian
toxicity. This information combined with the lack of acute aquatic
toxicity can be used to conclude that PPVE does not fulfill the
screening criteria for toxic (“T”).
The only Impurity identified at > 0.1% is C3F7-O-CHF-CF3 (TFEE-1) at 1.0
– 1.3%. Information on PBT properties of TFEE-1 was obtained using QSAR
modeling as well as readacross and included a modeled log Kow of 3.44,
(KOWWIN v1.68), a modeled Henry’s Law constant of 9.573E5 Pa-m³/mole
(HENRYWIN v3.20), and a log Koa of 1.127 from Koa = Kow(RT) / HLC, all
determined in accordance with Section 1.4 of Annex XI.
TFEE-1 is not persistent in the aquatic and terrestrial environments.
As an impurity, its release pattern follows that of PPVE: release is
solely to the atmospheric compartment during use. It is not released to
water or soil during use and would partition to the atmosphere if it
were released to the aquatic or terrestrial compartments. TFEE-1 is
not expected to be readily biodegradable, nor does it undergo rapid
hydrolysis or photolysis. The primary fate is degradation in the lower
atmosphere by reaction with hydroxyl radicals although the process is
projected to be slow (atmospheric lifetime, >67 years. It is rapidly
removed from water and soil by volatilization, and it will not partition
into water or soil from the atmosphere due to a high modeled Henry’s Law
constant. Because this low volume impurity has a long environmental
half-life in the atmosphere, will not partition out of the atmosphere,
and will be mixed thoroughly in the atmosphere, concentrations in the
biosphere will be negligible and thus widespread exposure to TFEE-1 will
The modeled log Kow, modeled Henry’s Law constant , and calculated log
Koa , coupled with no known mechanisms of non-lipid bioconcentration,
show that TFEE-1 does not meet does not meet the criteria for
bioaccumulative (“B”) or very bioaccumulative (“vB”). Toxicity was
determined using a read across approach from the analogous substance
HFE-7200 (C4F9OC2H5). HFE-7200 and TFEE-1 are of similar size (MW
TFEE-1 = 286, MW HFE-7200 = 264) and functionality (both highly
fluorinated ethers), with similar hydrophobicity (Log Kow = 3.44 for
TFEE-1 and 4.34 for HFE-7200) with similar partitioning behavior. By
read across, TFEE-1 is not expected to be toxic to aquatic organisms.
Based on available data, TFEE-1 is not classified as CMR, and does not
show specific target organ toxicity after repeated dosing. TFEE-1 does
not meet the REACH “T” criteria for mammalian toxicity. This information
combined with the acute aquatic toxicity data can be used to conclude
that TFEE-1 does not fulfill the screening criteria for toxic (“T”).
The ultimate degradation products of PPVE are expected to be
hydrofluoric acid (HF), perfluoropropionic acid (PFPA) and carbon
dioxide. HF and CO2 are inorganic substances not needing a PBT
assessment. The stable degradation product PFPA showed no
biodegradation (< 3%) but was not inhibitory in the toxicity control.
PFPA is not expected to undergo rapid hydrolysis or photolysis and is
thus expected to be persistent/very persistent in water, soil and
sediment. The log Kow of PFPA ranged from (–1.31) to (–1.33), as
calculated using ACD/Labs v12.00. In a 2002 internal GLP-compliant
bioconcentration study with Cyprinus carpio, following Japanese methods,
PFPA was found to not bioconcentrate. The BCF at 0.01 mg/L exposure was
calculated to be ≤ 4.8 and the BCF at 1.0 mg/L exposure was calculated
to be 1.2. The study was deemed reliable without restrictions. Based on
three toxicokinetic studies with a PFPA salt, the rat serum half-life
following oral exposure is less than 24 hours, with the serum half-life
following intravenous exposure of slightly longer than 24 hours.
Elimination is faster in females than males. Based on the half-life
data from these studies and its log Kow, PFPA does not fulfill the
criteria for bioaccumulative (“B”) or very bioaccumulative (“vB”).
Eight acute aquatic toxicity studies were completed for PFPA. Two
studies were with freshwater fish, one with Daphnia magna and five with
various species of algae and duckweed. The lowest measured ErC50 was
10.4 mg/L with the green algae Pseudokirchneriella subcapitata. The
lowest NOEC was 3.47 for the same species. This algal species was found
to be the most sensitive over all other algal, plant and aquatic
organism species evaluated. PFPA administered via inhalation for 2 hours
to rats (Klimisch 3) resulted in a 4 hour equivalent LC50 value of
greater than 11 mg/L. Administering PFPA to rats for 28 days via oral
gavage resulted in a No Observed Adverse Effect Level (NOAEL) of 320
mg/kg/day (the highest dose tested). PFPA was negative in an Ames assay
and in a chromosome aberration test in the presence and absence of
metabolic activation. Based on available data, PFPA is not classified as
CMR, and does not show specific target organ toxicity after repeated
dosing. PFPA does not meet the REACH “T” criteria for mammalian
toxicity. This information combined with the acute aquatic toxicity data
can be used to conclude that PFPA does not fulfill the screening
criteria for toxic (“T”).
The data show that the properties of the substance PPVE, its sole
relevant contaminant TFEE-1, and its degradation product PFPA, do NOT
meet the specific criteria in Annex XIII Section 1, or while not
allowing a direct comparison with all the criteria, nevertheless
indicate that each substance would not have these properties. Substance
is NOT PBT or vPvB.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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