Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
other: review
Adequacy of study:
supporting study
Study period:
2 to 5 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Review of available data
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
The studies are mainly non-guideline
GLP compliance:
not specified
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Analytical monitoring:
not specified
Details on sampling:
No details of sampling given in review.
Vehicle:
no
Details on test solutions:
No details of test solutions given in review.
Test organisms (species):
other: Daphnia magna and Daphnia sp.
Details on test organisms:
No further details given in review.
Test type:
static
Water media type:
freshwater
Limit test:
no
Post exposure observation period:
No post exposure observation period.
Hardness:
Values ranged between 173-250 mg CaCO3/L.
Test temperature:
Not stated.
pH:
Not stated
Dissolved oxygen:
Not stated
Salinity:
Not stated
Nominal and measured concentrations:
Nominal.
Details on test conditions:
The duration of the test ranged from 24-48 h.
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
26 - 48 mg/L
Conc. based on:
other: fluoride ion (F-)
Remarks on result:
other: benthic trichoptera larvae
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
97 mg/L
Nominal / measured:
nominal
Conc. based on:
other: fluoride ion (F-)
Remarks on result:
other: Daphnia magna
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
153 mg/L
Nominal / measured:
nominal
Conc. based on:
other: fluuoride ion (F-)
Remarks on result:
other: Daphnia magna
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
352 mg/L
Nominal / measured:
nominal
Conc. based on:
other: fluoride ion (F-)
Remarks on result:
other: Daphnia magna
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
270 mg/L
Nominal / measured:
nominal
Conc. based on:
other: fluoride ion (F-)
Remarks on result:
other: Daphnia sp.
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
10.5 mg/L
Nominal / measured:
nominal
Conc. based on:
other: fluoride ion (F-)
Remarks on result:
other: Mysidopsis bahia (marine)
Duration:
120 h
Dose descriptor:
EC50
Effect conc.:
>= 20 - <= 39 mg/L
Nominal / measured:
estimated
Conc. based on:
other: fluoride ion (F-)
Remarks on result:
other: Perna perna (marine)
Details on results:
The EC50 values for daphnids range from 97 to 352 mg/L and are based on nominal concentrations.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
None reported

The reported EC50 values for daphnids range from 97-352 mg/L and are based on nominal concentrations. Water hardness in these studies ranged from 173 to 250 mg CaCO3/L. The EU RAR for hydrogen fluoride notes the existence of additional EC50 values in the range 109 to 340 mg F-/L, cited in the RIVM Integrated Criteria Document Fluoride (Sloof et al, 1988).

EC50 values of 10.5 -39 mg/L are reported for marine invertebrates.

Validity criteria fulfilled:
not specified
Conclusions:
The EC50 values for daphnids exposed to sodium fluoride range from 97 to 352 mg F-/L.
Executive summary:

The EU RAR reviews and summairses the available data on short-term toxicity to aquatic invertebrates. Reported EC50 values for Daphnia spp. range from 97-352 mg/L and are based on nominal concentrations.

Description of key information

Calcium fluoride is the main constituent of the substance, so its worst case value was chosen for the registered dossier. The 2 others constituents of the substance, calcium sulfate and calcium carbonate, are ubiquitous in the environment and essential to living organims: no hazards have been identified for both constituents.

As no studies are available calcium fluoride, data from HF review (EU RAR, 2001) have been used for calcium fluoride:

- short-term toxicity of fluoride to Daphnia magna (freshwater):

EC50 (48h)= 97 - 153 mg/L (based on nominal concentrations of fluoride ions): the worst case value (97 mg/L) corresponds to an EC50 (48h) of 199.5 mg/L for CaF2 ;

As calcium fluoride is present at 47.5% in the reaction mass of calcium fluoride, calcium sulfate and calcium carbonate, the EC50 (48h) used for the registered substance is equal to 420 mg/L (based on fluoride equivalent for the reaction mass).

- short-term toxicity of fluoride to marine invertebrates:

EC50 (96h)= 10.5 mg/L (based on nominal concentrations of fluoride ions): the worst case value (10.5 mg/L) corresponds to an EC50 (96h) of 21.6 mg/L for CaF2 ;

As calcium fluoride is present at 47.5% in the reaction mass of calcium fluoride, calcium sulfate and calcium carbonate, the EC50 (48h) used for the registered substance is equal to 45.5 mg/L (based on fluoride equivalent for the reaction mass).

The water solubility of calcium fluoride is lower (15 mg/L) than the EC50 (48) values for both organisms, no toxicity of the registered substance is expected on aquatic invertebrates at short term.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
420 mg/L

Marine water invertebrates

Marine water invertebrates
Effect concentration:
45.5 mg/L

Additional information

The substance is a reaction mass of calcium fluoride and calcium sulfate and calcium carbonate. No studies are available on the substance itself nor on the main constituent, calcium fluoride (47.5%). However a number of non-guideline studies have been performed based on the data available in the review of the EU RAR of hydrogen fluoride (2001). The reported EC50 values for Daphnia sp. range from 97-352 mg/L (equivalent to 199.5- 723.5 mg/L for CaF2) and are based on nominal concentrations of fluorides ions; EC50 values of 10.5 -39 mg/L of fluorides ions (equivalent to 21.6 -80.5 mg/L for CaF2) are reported for marine invertebrates. Regarding the 2 others constituents of the substance, calcium sulfate and calcium carbonate, they are known to be ubiquitous in the environment and essential to living organims. Nevertheless, studies are available for both constituents.

A GLP guideline study was performed which assessed the acute toxicity of calcium sulfate dihydrate (NIER, 2003) to Daphnia magna in a limit test. The 48 h LC50 for calcium sulfate dihydrate was found to be >100 mg/L, which is equivalent to >79 mg/L for calcium sulfate anhydrous. No mortalities or adverse effects were noted at this concentration. A further OECD guideline study (van Eijk, 2009), investigated the toxicity of flue gas desulphurisation gypsum on Daphnia magna.The results showed that toxicity of the gypsum (CaSo4.2H20) was low in all samples and no effects were seen when the saturated solution was tested. The 48 h LC50 was 73% of the saturated solution which is equivalent to 1.533 g/L. The gypsum samples contained other trace metals in addition to Ca and it is therefore possible that the effects on Daphnia magna were caused by the other elements present in the test samples. Another study from literature showed a 48 h LC50 values for calcium sulfate as >1970 mg/L for Daphnia magna and >1910 mg/L for Ceriodaphnia dubia (Mount et al, 1997). Using a weight of evidence approach, the acute toxicity of calcium sulfate to invertebrates is generally greater than the highest concentration tested and is considered to be greater than the maximum solubility of calcium sulfate in water. Calcium sulfate showed no short-term toxicity to aquatic invertebrates and is therefore not acutely toxic to invertebrates at the limit of its water solubility.

Regarding calcium carbonate, the nano form was tested because this form was anticipated to represent the worst case as it is likely to be more soluble than the bulk form due to the smaller particle size and hence greater surface area. However, the results are directly applicable to the bulk form of calcium carbonate : the key study (Priestly, 2010) was performed to OECD Guideline 202 and in accordance with GLP and was therefore assigned a reliability of 1. The study assessed the acute toxicity of calcium carbonate (nano) to Daphnia magna in a limit test. No toxic effects were seen when a 100% v/v saturated solution of calcium carbonate was tested. Hence, the 48 h EC50 was >100% v/v saturated solution and the NOEC was 100% v/v saturated solution. The concentration of calcium carbonate (nano) that might cause acute toxicity is therefore greater than the maximum solubility of calcium carbonate in water. Calcium carbonate (nano) showed no short-term toxicity to aquatic invertebrates and is therefore not acutely toxic to invertebrates at the limit of its water solubility.

 Using a weight of evidence approach for the 3 constituents of the substance, calcium fluoride is the main constituent and showed the highest toxicity compared to the other constituent, with a EC50 (48h) of 399 mg/L for freshwater and EC50(96h) of 43.5 mg/L for marine organisms. The 2 others constituents of the substance, calcium sulfate and calcium carbonate, are ubiquitous in the environment and essential to living organims: no hazards have been identified for both constituents based on data available.

As calcium fluoride is present at 47.5% in the reaction mass of calcium fluoride, calcium sulfate and calcium carbonate, the EC50 (48h) used for the registered substance is equal to 420 mg/L and 45.5 mg/L (based on fluoride equivalent for the reaction mass) for freshwater and marine organisms, respectively. The water solubility of calcium fluoride is lower (15 mg/L) than the EC50 (48) values for both organisms, no toxicity of the registered substance is expected on aquatic invertebrates at short term.