Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.005 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.102 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.01 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
PNEC air
PNEC value:
0.2 µg/m³

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.012 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC derivations for persistent degradation products:

Hydrogen Fluoride (CAS# 7664-39-3): Using available aquatic toxicity data(1) PNECs were calculated to be 0.4 mg/L for freshwater and 0.04 mg/L for marine water. Acute and chronic results were available for three taxonomic groups. For the calculation of the Freshwater PNEC a 21-day LC05 (equivalent to NOEC) of 4.0 mg/L was obtained from a study with Oncorhynchus mykiss. Therefore, an AF of 10 was applied to the fish NOEC, which is the lowest of the three long-term NOECs. Although there are acute data available for marine species, there are no chronic data and there is acute data available for only one additional taxa (mollusk). Therefore, the PNEC derived from the most sensitive chronic study conducted in freshwater is divided by 10 to derive the marine PNEC. For the STP PNEC, a NOEC of 510 mg/L was available for activated sludge respiration inhibition.  An assessment factor of 10 was applied to the NOEC to derive a PNEC of 51 mg/L for STP. No test results for FW Sediment were available. PNEC was extrapolated using the equilibrium partitioning method (EPM) with the freshwater PNEC. PNECsed = (0.783 + (0.0217 x Koc)) x PNECfreshwater, where the Koc was 0.063 and the freshwater PNEC was 0.4 mg/L. PNEC converted to dry weight: (PNEC mg/kg ww) x 4.6 = PNEC of 1.44 mg/kg dry wt. No test results for Marine Sediment were available. PNEC was extrapolated using the equilibrium partitioning method (EPM) with the marine PNEC. PNECmarinesed = (0.783 + (0.0217 x Koc)) x PNECmarinewater, where the Koc was 0.063 and the marine PNEC was 0.04 mg/L. PNEC converted to dry weight: (PNEC mg/kg ww) x 4.6 = PNEC of 0.144 mg/kg dry wt. A large data set of fumigation studies with vegetation was evaluated. Data from studies with a 7-month exposure period were used to derive the PNECair. The lowest value calculated as protective of vegetation was 0.2 ug/m3. Because of the large data set and the long exposure period, no application factor was applied to this protective value to derive the PNEC of 0.2 ug/m3. A great number of soil studies were available. Data from the most sensitive endpoints from long-term studies from three trophic levels were evaluated. An application factor of 10 was applied to the most sensitive NOEC of 106 mg/kg for soil microbe NO3 mineralization. PNEC converted to dry weight: (PNEC mg/kg ww) x 1.13 = PNEC of 12 mg/kg dry weight. HF is an inorganic acid and thus not considered PBT by the REACh criteria. Because this substance is an inorganic acid, and because the Kow value indicates low bioconcentration potential, secondary poisoning is not relevant. Log Kow = -1.4. (1) European Chemicals Bureau European Union Risk Assessment: Hydrogen Fluoride, 2001.

Perfluoropropionic acid (CAS 422-64-0): Using available aquatic toxicity data, the PNECs were calculated to be:  0.0085 mg/L for Freshwater, 0.00085 mg/L for Marine Water, and 1000 mg/L for STP.  For the Freshwater PNEC, three short-term tests were available for each of three trophic levels.  Pseudokirchneriella subcapitata was the most sensitive of all species.  A conservative assessment factor of 1000 was applied to the geometric mean of the two available results.  No Marine Water test data was available.  The Marine Water PNEC was generated using the most sensitive freshwater results.  An Assessment Factor of 10,000 was applied to the geometric mean of the two available results.  For the STP PNEC, a NOEC was available for activated sludge.  An Assessment Factor of 10 was applied to the NOEC to derive a PNEC for STP.  No test results were available for Sediment, Soil (Grassland and Agricultural Soil), or Marine Sediment.  These PNECs were extrapolated using the equilibrium partitioning method (EPM) with the Koc = 1.1 L/kg and the freshwater PNEC = 0.0085 mg/L for freshwater sediment and marine PNEC = 0.00085 mg/L for marine sediment.  The PNECs for Sediment, Marine Sediment, Grassland and Agricultural Soil were calculated to be 0.0313 mg/kg dw, 0.00313 mg/kg dw, and 0.0018 mg/kg dw respectively. Although PFPA is not readily biodegradable, the bioconcentration factor was found to be ≤4.8 in a laboratory study with fish. This substance is not considered bioaccumulative.  Therefore, the PNEC oral is not applicable and was not derived.

Conclusion on classification

PPVE:

CLP Acute Toxicity:  Not classified – conclusive although insufficient for classification

CLP Chronic Toxicity: Not classified - conclusive although insufficient for classification

Classification based on LC50 >10 mg/L nominal in fish and rapid hydrolysis to form PFPA (Algal NOEC of 3.47 and 3.71 mg/L)

OZONE DEPLETION:  PPVE is not listed in the Montreal Protocol on Substances that Deplete the Ozone Layer.  It does not contain reactive halogens (chlorine or bromine) that could play a role in ozone depletion.  PPVE is not hazardous to the ozone layer. Conclusive although not sufficient for classification.

Hydrogen fluoride degradation product (CAS# 7664 -39 -3):

CLP Acute Toxicity: Not classified - conclusive although not sufficient for classification.

CLP Chronic Toxicity: Not classified - conclusive although not sufficient for classification.

Classification as per REACH registration.  EU risk assessment does not assign environmental classifications.

OZONE DEPLETION: HF is not listed in the Montreal Protocol on Substances that Deplete the Ozone Layer. It does not contain reactive halogens (chlorine or bromine) that could play a role in ozone depletion. HF is not hazardous to the ozone layer. Conclusive although not sufficient for classification.

Perfluoropropionic acid degradation product (CAS 422-64-0):

CLP Acute Toxicity: Not classified - conclusive although not sufficient for classification.

CLP Chronic Toxicity: Not classified - conclusive although not sufficient for classification

Based on the most sensitive species for PFPA being algae with EC50 of 8.5 mg/L (mean of > 6.78 mg/L and 10.6 mg/L), and NOEC of 3.47 mg/L and 3.71 mg/L. PFPA effect concentrations for fish and invertebrates are too high to lead to an acute or chronic classification.

OZONE DEPLETION: PFPA is not listed in the Montreal Protocol on Substances that Deplete the Ozone Layer. It does not contain reactive halogens (chlorine or bromine) that could play a role in ozone depletion.  PFPA is not hazardous to the ozone layer.  Conclusive although not sufficient for classification.