Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.008 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.006 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.006 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Hydrogen Fluoride (CAS#7664-39 -3):

Using available aquatic toxicity data(1), the PNECs were calculated to be 0.9 mg/L for Freshwater and 0.09 mg/L for Marine Water.  For the Freshwater PNEC, three long-term tests were available for each of three trophic levels. Daphnia magna was the most sensitive species.  A conservative assessment factor of 10 was applied to the mean of two daphnia chronic NOEC results.  The Marine Water PNEC was generated using the freshwater chronic data because only two useable marine data points were available.  Acute marine data was not more sensitive than chronic freshwater data therefore a conservative assessment factor of 100 was applied to the most sensitive freshwater long-term test result to derive the Marine PNEC. There is no intermittent release of HF to water.

For the STP PNEC, a NOEC was available for activated sludge respiration inhibition.  An assessment factor of 10 was applied to the NOEC to derive a PNEC for STP.  No test results were available for Sediment or Marine Sediment organisms, therefore the EPM method with the freshwater PNEC and marine water PNEC were used to derive sediment PNECs. Koc was estimated using KOCWIN to be 1.6 and the estimated log Kow was 0.23. The PNECs for Sediment and Marine Sediment were calculated to be 1.02 mg/kg and 0.102 mg/kg, respectively.  For Grassland and Agricultural Soil, long-term terrestrial NOECs from three trophic levels were available.  Therefore the PNECs for Grassland and Agricultural Soil were based on the most sensitive terrestrial NOEC of microbial nitrate mineralization over 63 days and applying an Assessment Factor of 10. The atmospheric compartment needs to be considered because the most important exposure route of HF for plants is uptake from the atmosphere.  The lowest NOEC for 7-months exposure of highly sensitive plant species was used to derive the PNEC for the atmospheric compartment. Because it was derived from a large set of toxicity data for different sensitive and highly sensitive plant species, no application factor is considered necessary. A PNEC atmosphere-plant of 0.0002 mg/m3 was obtained.

Trifluoroacetic acid (CAS#76-05-1):

Using available aquatic toxicity data, the PNECs were calculated to be:  0.0077 mg/L for Freshwater, 0.00077 mg/L for Marine Water, and 1 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 result. 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 result. There is no intermittent release of TFA to water.

For the STP PNEC, a NOEC of 10 mg/L was available for activated sludge.  An Assessment Factor of 10 was applied to the NOEC to derive a PNEC of 1.0 mg/L for STP. For Grassland and Agriculture, a NOEC of 1 mg/kg was available for mung beans. An Assessment Factor of 100 was applied to the NOEC to derive the PNEC of 0.010 mg/kg. No test results were available for Sediment or Marine Sediment.  These PNECs were extrapolated using the equilibrium partitioning method (EPM) with the Koc= 0.023 L/kg and the freshwater PNEC = 0.0077 mg/L for freshwater sediment and marine PNEC = 0.00077 mg/L for marine sediment. The PNECs for Sediment and Marine Sediment were calculated to be 0.0060 mg/kg and 0.00060 mg/kg respectively.

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.

There is no intermittent release of PFPA to water.

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= 0.087 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 0.0067 mg/kg, 0.00067 mg/kg, and 0.0061 mg/kg respectively.

(1) Data obtained from European Union Risk Assessment Report, CAS No.: 7664-39-3, EINECS No.: 231-634-8, hydrogen fluoride, 1st Priority List Volume: 8; European Commission Joint Research Centre; EUR 19729 EN, 2001.

Conclusion on classification

CAS#756-13-8:

GHS Acute 3/Chronic3

R-phrases: R52/53

For the GHS and DSD classifications of CAS# 756-13-8, the toxicity was calculated by taking the lowest EC50 for PFPA and then calculating the equivalent value in terms of CAS# 756-13-8 (51.9% of the molecule converts to PFPA).  This equivalent value was found to be 20 mg/L for CAS# 756-13-8.  The evaluation of the BCF of PFPA was utilized for the evaluation of bioconcentration because a BCF test dosing with CAS# 756-13-8 would result in the fish being exposed to PFPA.  The same argument applies to biodegradation, although PFPA was not found to readily degrade.

Hydrogen Fluoride (CAS#7664-39-3):

GHS Acute 3; Not chronically toxic by GHS

R-phrases: Not classified as dangerous to the aquatic environment

Trifluoroacetic acid (CAS#76-05-1):

GHS Acute 2; Not chronically toxic by GHS

R-phrases: R52/53

Perfluoropropionic acid (CAS#422-64-0):

GHS Acute 2; Chronic 2

R-phrases: N; R51/53