Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

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:
0.4 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Reliable GLP compliant aquatic acute ecotoxicity test results are available for fish, invertebrates and algae. An OECD 203 study reported a 96-h LC50 forBrachydanio rerioof >10 mg/L (corresponding to >5.35 mg F/L) (Solvay Pharmaceuticals, 2010a) and an OECD 202 study showed that the 48-h EC50 inDaphnia magna is 22.8 mg/L (corresponding to 12.2 mg F/L) (Solvay Pharmaceuticals, 1999). These values will be used for the assessment.

For algae two growth inhibition tests were performed with the algal speciesPseudokirchneriella subcapitata according to OECD Guideline 201(ECT Oekotoxikologie, 2012a and b). The tests have been conducted with two different batches of aluminium potassium fluoride: Nocolok Flux and Hot melt PAF. The 72-h EC50 values for growth rate were 33.5 and 12.7 mg/l (corresponding to 17.4 and 7.0 mg F/L). The 72 hr NOErC values were reported to be 11 and 4.3 mg/l (corresponding to 5.7 and 2.4 mg F/L), respectively. The lowest values (ErC50 of 12.7 mg/l and NOErC of 4.3 mg/l) will be used in the assessment.

Long-term ecotoxicity tests with fish and invertebrates are not available.

One GLP-compliant OECD 209 guideline study is available for the toxicity to microorganisms. The 3-h EC50 and 3-h NOEC were both >75 mg/L (corresponding to >40 mg F/L) in activated sludge (Solvay Pharmaceuticals, 2010c). This value will be used in the assessment.

Studies with sediment organisms for aluminium potassium fluoride are not available. Due to the dissolution of aluminium potassium fluoride in water, it is expected, that risk assessment of water compartment covers the realistic worst case situation also for sediment.

For aluminium potassium fluoride exposure via soil (uptake from soil matrix), no data are available. However, it should be noted, that due to the dissolution behaviour, it can be expected, that when aluminium potassium fluoride is mixed to soil matrix and gets in contact with pore water, it is dissolved to different aluminium and fluoride species and no exposure to dissolved aluminium potassium fluoride itself occurs in soil.

PNEC water

Fluoride may enter the environment from both natural (volcanoes, weathering of minerals and marine aerosols) and anthropogenic sources. The latter include the use of production and use of multiconstituent aluminium potassium fluoride.

The concentration of fluoride in natural waters depends on the geological, physical and chemical characteristics at the location. In surface waters that are influenced by F-containing rock formation the natural F-concentration is considerably higher. Water of small rivers in the highlands of Germany (e.g. Black Forest) contained up to 4.7 mg/L (Geochemischer Atlas, 1985). High fluoride levels (>20 mg/L) are also reported in natural waters from other European communities (WHO, 1984).

The median F-concentration in measured from 2000 to 2008 in several Dutch rivers is 0.2 mg/L (www.waterbase.nl). In seawater, F-concentrations are higher than in freshwater with an average of 1.4 mg/L (Slooff et al., 1988).

The substantial variation in background levels throughout Europe means that a PNEC derived from standard tests is not directly applicable to regions with high natural F-levels. Therefore the background concentration is added to the derived PNEC based on fluoride (PNEC freshwater, added and PNEC marine water, added).

As only extensive data is available from the Netherlands, the median concentration in Dutch rivers is taken as the background level for freshwater. For marine water values from Slooff et al. (1988) are taken into account.

Fluoride may enter the environment from both natural (volcanoes, weathering of minerals and marine aerosols) and anthropogenic sources. The latter include the use of production and use of cryolite.

The concentration of fluoride in natural waters depends on the geological, physical and chemical characteristics at the location. In surface waters that are influenced by F-containing rock formation the natural F-concentration is considerably higher. Water of small rivers in the highlands of Germany (e.g. Black Forest) contained up to 4.7 mg/L (Geochemischer Atlas, 1985). High fluoride levels (>20 mg/L) are also reported in natural waters from other European communities (WHO, 1984).

The median F-concentration in measured from 2000 to 2008 in several Dutch rivers is 0.2 mg/L (www.waterbase.nl). In seawater, F-concentrations are higher than in freshwater with an average of 1.4 mg/L (Slooff et al., 1988).

The substantial variation in background levels throughout Europe means that a PNEC derived from standard tests is not directly applicable to regions with high natural F-levels. Therefore the background concentration is added to the derived PNEC based on fluoride (PNEC freshwater, added and PNEC marine water, added).

As only extensive data is available from the Netherlands, the median concentration in Dutch rivers is taken as the background level for freshwater. For marine water values from Slooff et al. (1988) are taken into account.

Conclusion on classification

Reliable GLP compliant aquatic acute ecotoxicity test results are available for fish, invertebrates and algae. An OECD 203 study reported a 96-h LC50 forBrachydanio rerio of >10 mg/L (corresponding to >5.35 mg F/L) (Solvay Pharmaceuticals, 2010a) and an OECD 202 study showed that the 48-h EC50 in Daphnia magnais 22.8 mg/L (corresponding to 12.2 mg F/L) (Solvay Pharmaceuticals, 1999).

For algae two growth inhibition tests were performed with the algal species Pseudokirchneriella subcapitata according to OECD Guideline 201(ECT Oekotoxikologie, 2012a and b). The tests have been conducted with two different batches of aluminium potassium fluoride: Nocolok Flux and Hot melt PAF. The 72-h EC50 values for growth rate were 33.5 and 12.7 mg/l (corresponding to 17.4 and 7.0 mg F/L). The 72 hr NOErC values were reported to be 11 and 4.3 mg/l (corresponding to 5.7 and 2.4 mg F/L), respectively.

One GLP-compliant OECD 209 guideline study is available for the toxicity to microorganisms. The 3-h EC50 and 3-h NOEC were both >75 mg/L (corresponding to >40 mg F/L) in activated sludge (Solvay Pharmaceuticals, 2010c).

Long-term tests with fish and aquatic invertebrates are not available. As inorganic compound, aluminium potassium fluoride is not biodegraded but abiotic dissociation and subsequent interactions occur instead. Based on the available acute ecotoxicity test results regarding fish and invertebrates and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 aluminium potassium fluoride should be classified as chronic to the environmental category 3; H412 (Harmful to aquatic life with long lasting effects).