Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.37 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.17 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.022 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
21.8 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

In order to determine the classification for hazardous properties related to the aquatic environment, the criteria of the Regulation (EC) No 1272/2008 (CLP) version 2016 in Annex I were accurately followed.

Short-term (acute) aquatic hazard:

For classification, acute toxicity data are available for fish, aquatic invertebrates (Daphnia) and algae. The studies have been conducted with NaF and results were expressed as mg F-/L. Using the molecular weight information, the EC50 or LC50 values were converted to mg CaF2/L. The lowest LC50 or EC50 values observed for the different trophic levels in water are:

Fish: LC50 (96h) = 51 mg F-/L = 104.7 mg CaF2/L

Marine invertebrates: EC50 (96h) = 10.5 mg F-/L = 21.6 mg CaF2/L

Freshwater algae: EC50 (96h, growth rate) = 43 mg F-/L = 88.3 mg CaF2/L

The criteria in Table 4.1.0 (a) of Annex I of the CLP Regulation were applied.

The lowest LC50 or EC50 value was observed for marine invertebrates (Mysidopsis bahia) , which are hence the most sensitive species. According to Table 4.1.0 (a) the substance should not be classified for acute aquatic hazard, as the lowest EC50 value, EC50 (96h) for marine invertebrates = 21.6 mg CaF2/L, is larger than the cut-off for classification of 1 mg/L.

Please note that the test conditions for the short-term study on marine invertebrates, i.e. 96h, deviates from the default 48h for crustacea species. Nevertheless, it can reasonably be assumed that this longer testing period does not affect the conclusion to not classify CaF2 for acute aquatic toxicity.

Long-term (chronic) aquatic hazard:

For chronic classification, chronic data available for all 3 trophic levels: fish, aquatic invertebrates and algae. Since the biodegradability concept does not apply for inorganic substance, the approach as described for metals and metal compounds in ECHA guidance on the application of CLP criteria, has been used. The chronic ERV, or in this case NOEC values, used for classifcation are:

Fish (21d): NOEC >9.9 mg NaF/L = > 9.17 mg CaF2/L (lower values were reported in the Pearcy et al. 2015 study, with the lowest being 11.9 mg/L NaF, however, in a 7d chronic assessment. Therefore this value has not been selected as key value for C&L. Nevertheless, since also > 1 mg/L selecting it as key value would have no impact on the classification conclusion).

Daphnia (21d): NOEC = 3.7 mg F-/L = 7.6 mg CaF2/L

Algae (7d): NOEC = 50 mg F-/L = 102.7 mg CaF2/L

Since the lowest chronic ERVs or NOEC value, 7.6 mg CaF2/L is well above 1 mg/L, CaF2 does not need to be classified for long term aquatic hazard.