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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
other: review
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The ICD contains the summarised results of a number of short-term fish toxicity studies
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
The ICD summarises the results of a number of non-guideline studies
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
no
Test organisms (species):
other: various
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 51 - <= 340 mg/L
Nominal / measured:
not specified
Conc. based on:
other: fluoride ion (F-)
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

The ICD reports short-term fish LC50 values in the range 51 -340 mg F-/L

Validity criteria fulfilled:
not specified
Conclusions:
The ICD reports short-term fish LC50 values in the range 51 -340 mg/L.
Executive summary:

The ICD reviews the available data for sodium fluoride and reports short-term fish LC50 values in the range 51 -340 mg/L.

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 reliable studies are available for calcium fluoride, fish acute toxicity data published by Janssen et al. (1989) and Camargo & Tarazona (1991) have been studies; theses studies are cited in HF review (EU RAR, 2001) have been used for calcium fluoride:

LC50 (96h)=51 -108 mg/L (based on nominal concentrations of fluoride ions): the worst case value (51 mg/L) corresponds to an LC50 (96h) of 105 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 LC50(96h) is equal to 221 mg/L.

The water solubility of calcium fluoride is lower (15 mg/L) than the LC50 value (221 mg/L based on fluoride equivalent for the reaction mass), no toxicity of the reaction mass of calcium fluoride, calcium sulfate and calcium carbonate is expected on aquatic fish at short term.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
221 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. However, one acute toxicity study on fish is available on the main constituent of the substance, calcium fluoride (47.5%). The acute toxicity of calcium fluoride was investigated in Tinca vulgaris. The reported LC100 value of 30000 mg/L exceeds the water solubility of the test material (Simonin & Pierron, 1937). Other studies are available in the EU RAR of hydrogen fluoride (2001): LC50 values of 299 mg/L (48h in Leuciscus idus), 51 mg/L in (96h in Onchorynkus mykiss) and 340 mg/L (96h in Gasterosteus aculeatus) of fluoride ions corresponding to 1229, 210 and 1340 mg/L of calcium fluoride, respectively.

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 reliable GLP guideline study was performed which assessed the acute toxicity of calcium sulfate dihydrate (NIER, 2003) to Oryzias latipes in a limit test. The 96 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.

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 203 and in accordance with GLP and was therefore assigned a reliability of 1. The study assessed the acute toxicity of calcium carbonate (nano) to Oncorhynchus mykiss (rainbow trout) in a limit test. No mortalities or adverse effects were noted at the concentration tested. Hence, the 96 h LC50 for calcium carbonate (nano) was found to be >100% v/v saturated solutionand 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.

Using a weight of evidence approach for the 3 constituents of the substance, calcium fluoride is the main constituent and is used as a worst case, with a LC50 (96h) of 105 mg/L. The 2 others constituents of the substance, calcium sulfate and calcium carbonate, are ubiquitous in the environment and essential to living organims : no or low 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 LC50(96h) used for the registered substance is equal to 221 mg/L.

The water solubility of calcium fluoride is lower (15 mg/L) than the LC50 value (221 mg/L based on fluoride equivalent for the reaction mass) , no toxicity of the reaction mass of calcium fluoride, calcium sulfate and calcium carbonate is expected on aquatic fishes at short term.