DEQ-CFW_00074745

National Institute for Public Health
and the Environment
Ministry of Health, Welfare and Sport
Evaluation of substances used in the GenX
technology by Chemours, Dordrecht
RIVM Letter report 2016-0174
M. Beekman et al.
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DEQ-CFW 00074745

RIVM Letter report 2016-0174
Summary
In this report, the GenX related perfluorinated substances (FRD-903,
FRD-902 and E1) are evaluated. These substances are used or are
formed during the production of fluoropolymers by Chemours
(Dordrecht) applying the GenX technology. In this technology, the
controversial PFOA substances are replaced. The following questions are
addressed in the evaluation:
1. What is known about the PBTS-properties of FRD-903, FRD-902
and E1?
2. What is known about the possible CMR6-properties and STOT RE -
properties' (especially the toxicity to kidney and liver) of FRD-
903, FRD-902 and E1?
3. What is known about the emission of FRD-903 and E1 by
Chemours (Dordrecht)?
4. What are the possible health effects (now and in the future) for
people living in the vicinity of the Chemours Dordrecht plant due
to exposure to FRD-903 and E1?
For FRD-903 the evaluation is based on read across from FRD-902, since
all available toxicological studies were performed with the ammonium
salt (FRD-902). Read -across of the toxicological properties of the
ammonium salt to the acid (FRD-903) is considered justified for
systemic effects as after dissolution and dissociation of the acid and the
salt the absorption in the intestinal tract and the lungs and distribution
over the body of the anion (2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)-
propanoate) will be the same.
As to the first question above, it is concluded that RIVM cannot exclude
that the GenX related substances meet the PBT/vPvBa criteria. All
evaluated substances (FRD-903, FRD-902 and E1) are perfluorinated
compounds and can be regarded as certainly very persistent. Since FRD-
903 and FRD-902 are more rapidly eliminated than PFOA, it is expected
that both substances bioaccumulate to a lesser degree than PFOA does.
However, it is not possible to reach a conclusion on the human
bioaccumulation potential in absence of data on the human clearance
time. For the substance E1, insufficient information is available to draw
a conclusion about the bioaccumulation potential. Since E1 contains no
hydrophilic group, the human clearance time of the substance and the
bioaccumulation potential are expected to be higher than for PFOA,
although E1 has the potential to be excreted via exhalation. FRD-903
and FRD-902 are considered less hazardous compared to PFOA.
However, no definitive conclusion can be reached whether they meet the
T criteria. E1 will most likely not meet the T criteria.
For the CMR and STOT RE properties, it is concluded that classification
as carcinogenic category 2 (suspected human carcinogen) is justified for
5 Persistent, Bioaccumulative and Toxic
6 Carcinogenic, mutagenic or toxic for the reproduction
7 Specific Target Organ Toxicity, Repeated Exposure
8 Very Persistent and very Bioaccumulative
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FRD-903 and FRD-902. The available studies show that both substances
are not mutagenic. On reproductive toxicity the limited effects observed
in presence of maternal toxicity do not normally result in classification,
whereas PFOA is classified as toxic for the reproduction (category 1B).
The requirement of STOT RE 2 (like liver and kidney) is difficult to
assess due to dose levels tested in mice clearly below the guidance
values, which may be taken as an indication that STOT RE 2 is needed.
The effects in the rat are borderline and difficult to assess due to the
large steps in the dose levels. Effects on the liver are observed at the
similar dose levels for FRD-902 and PFOA.
The available information on the toxicity of E1 is limited but that
information indicates that E1 has a low to very low toxicity. This is
supported by the repeated dose toxicity information on some structural
analogues. However, all available studies were performed in male
animals only and were of limited duration only. The available in vitro
and in vivo data on mutagenicity combined with the read -across data
show that E1 is unlikely to be mutagenic. In addition, the available data
indicate no requirement for classification for acute toxicity nor probably
for STOT RE via inhalation. The requirement for classification for other
hazard classes including carcinogenicity, reproductive toxicity and STOT
RE via oral exposure, however, is unknown.
A chronic inhalation exposure limit of 73 ng/m3 for FRD-903 and FRD-
902 is derived in the present report in a worst -case approach, taking
into account an extra safety margin due to uncertainty in the
accumulation potential. The year -average air concentrations of FRD-903
were calculated based on the permitted emissions. This led to estimated
concentrations in air of about 20 ng/m3 for the nearest populated areas
(along the dike opposite side of the river) and lower concentrations at
greater distances from the plant. Based on the recorded emissions for
2014 the estimated concentrations for the nearest populated areas are
about 15 ng/m3. Comparing these concentrations with the limit value of
73 ng/m3 leads to the conclusion that based on the available data, no
health risk is expected for people living in the vicinity of the Chemours
Dordrecht plant due to exposure to FRD-903.
The information on the toxicity of E1 is limited. The data are insufficient
for deriving an inhalation exposure limit for the general population. The
year -average air concentrations for E1 were calculated based on the
permitted emissions. This led to estimated concentrations in air of about
40 ng /m3 for the nearest populated areas (along the dike at the
opposite side of the river) and lower concentrations at greater distances
from the plant. Based on recorded emissions for 2014 the estimated
concentrations for the nearest populated areas are about 20 ng/m3. Due
to the insufficient health effects information available for E1, these
concentrations cannot be evaluated as to the possible health risk they
might pose for people living in the vicinity of the Chemours plant in
Dordrecht.
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RIVM Letter report 2016-0174
2 General information
2.1 Description GenX technology
FRD-902 is used as processing aid in the Teflon PTFE and Teflon FEP
plants of Chemours. Other uses of FRD-902 are not described in the
registration dossier or in the literature. FRD-902 is manufactured by
mixing FRD-903 with an ammonium hydroxide solution. FRD-903 is
imported.
FRD-902 controls the polymerization to make fluoropolymers.
Fluoroploymer resins and finished goods are used in many applications
like wire cables and Teflon coating. During the resin manufacturing
process, FRD-902 is transformed into the hydrophobic water -insoluble
hydride (E1). During the process, FRD-903 and E1 are emitted to air
from the Teflon PTFE and from the Teflon FEP plants. Furthermore, FRD-
902 and FRD-903 are emitted to wastewater. After removal of these
compounds, the wastewater is sent to the local municipal sewage
treatment plant. Exposure of people living in the vicinity of the
Chemours is expected to be primarily through the emission to air.
2.2 Substance identity and status of FRD-902
Name:
ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)-
propanoate
CAS -number:
62037-80-3
EC -number:
700-242-3
Synonyms:
FRD-902, C3-dimer salt
IUPAC name:
ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)-
propanoate
Structure:
C6H4NF11O3
F
fFF
F O NH4
F
REACH: registered by Chemours Netherlands BV: 10 - 100 TPA,
full registration
CLP13: no harmonised classification, 28 notifiers to the CLP
inventory (19 September 2016) (Acute Tox. 4; H302,
Eye Dam. 1; H318, STOT RE 2; H373 (blood)), see
table 1.
13 Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP
Regulation)
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2.3
Physical chemical properties"
Melting point:
208 °C (99.4% purity)
Freezing point:
-21 °C (86% purity)
Vapour pressure:
0.012 Pa (99.4% purity)
Solubility in water:
>1000 g/L (99.4 % purity)
Form:
liquid (86% purity, marketed form), solid (dried
substance, 99.4% purity)
Color:
colourless liquid
Density:
1118 g/L (99.4% purity)
Dissociation constant:
pKa: 3.82 (86% purity)
Substance identity and status of FRD-903
Name: 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic acid
CAS -number: 13252-13-6
EC -number: 236-236-8
Synonyms: FRD-903, C3-dimer
IUPAC name: 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoic
acid, perfluoro-2-methyl-3-oxahexanoic acid
Structure: C6HF1103
O
�a
F
F 0 F
F
F F
F -- — F
F
REACH: not registered
CLP: no harmonised classification, 99 notifiers to the CLP
inventory (including Acute Tox. 4; H302, Skin Corr. 1B or
1C; H314, Eye Dam. 1; H318, STOT SE 3; H335
(Respiratory) and no classification), see table 2.
14 REACH registration data, 19 September 2016
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2.4 Substance identity and status of El
Name:
heptafluoropropyl 1,2,2,2-tetrafluoroethyl ether
CAS -number:
3330-15-2
EC -number:
671-353-1
Synonyms:
propane, 1,1,1,2,2,3,3-heptafluoro-3-(1,2,2,2-
tetrafluoroethoxy)- E1
IUPAC name:
heptafluoropropyl 1,2,2,2-tetrafluoroethyl ether
Structure:
C51-IF11O
F F
F
F F
F H F
-'' F
F
0
F F
REACH: not registered
CLP: no harmonised classification, 3 notifiers to the CLP inventory
(29 August 2016)
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