Reaction mass of disodium [2,2'-(imino-κN)dibutanedioato-κ2O1,O4(4-)]calcium(2-), sodium chloride and aspartic acid disodium salt

Endpoint summary

Description of key information

Acute toxicity to aquatic organisms was not experimentally determined for CaIDHA, but there are available data from studies on the source substances: chelating agent - IDHA, Ca(2Na)EDTA and on other IDHA’s salts as well. 

Acute toxicity to fish

Acute toxicity to fish was experimentally determined for chelating agent IDHA and its salts: FeNaIDHA, Cu(2Na)IDHA, Mn(2Na)IDHA, Zn(2Na)IDHA. None of the substances showed a high toxicity.

The assessment of the acute toxic effects (mortality)  of IDHA chelating agent on a freshwater fish species (Brachydanio rerio) under static test conditions was conducted according to test method which is in most parts identical with OECD Guideline  203. No mortality or any abnormal swimming behaviour were observed. The LC_O(acute fish toxicity)  of IDHA, sodium salt value for the fish is ≥ 100 mg/l (nominal) and ≥ 82.6 mg/I (calculated) (Bayer, 1997). All metal-IDHA complexes Fe(Na)IDHA, Zn(2Na)IDHA, Cu(2Na)IDHA and Mn(2Na)IDHA were investigated according to OECD 203 with Oncorhynchus mykiss, resulting in a nominal LC₅₀(96h) value of > 100 mg/L (Nierzędska, 2007; Fochtman, 2009; Swierkot, 2011; Konfederak, 2013a). The LC50 (96h) values for CaCl₂ for fish Pimephales promelas is 4630 mg/l, for Lepomis macrochirusis 9500-11300 mg/l and for Gambusia affinisis 13400 mg/l.

Acute toxicity to invertebrates

The EC₁₀₀(48h) value > 100 mg/L is reported for Fe(Na)IDHA (Nierzędska, 2007), EC₅₀(48h) > 100 mg/L is reported for Mn(2Na)IDHA (OECD 20, Konfederak, 2013b ), EC₅₀(48h) > 38 mg/L is determined for Cu(2Na)IDHA (OECD 202, Konfederak, 2011) and EC₅₀(48h) > 3.16 mg/L is determined for Zn(2Na)IDHA (Fochtman, 2009), a low to medium toxicity potential is predicted for aquatic invertebrates for IDHA metal-complexes.

There are seven acute toxicity data available for Cladocera. The lowest 48-hour EC50 was 1062 mg/L for Daphnia magna (Koopman at all, 1986 cited in INCHEM, 2002). The acute toxicity studies with other invertebrates showed LC50 or EC50 values in the range of 780-44400 mg/L.

Acute toxicity to algae

A low aquatic toxicity potential towards green algae was determined for iron, copper and manganese IDHA complexes. Cu(2Na)IDHA showed no toxicity potential towards fresh water algae and EC₅₀(72h) > 250 mg/L. Similar result has been obtained with Mn(2Na)IDHA in Pseudokirchneriella subcapitata (E_rC₅₀(72h) = 598 mg/L and E_yC₅₀(72h) of 108.95 mg/L. For FeNaIDHA in OECD test no. 201 the values E_xC50/72 h and E_yC50/72 h above 72.3 mg/L were established based on measured concentrations. The worst results were for Zn(2Na)IDHA. The nominal value are: E_rC₅₀(72h) = 255.97 mg/L and E_yC₅₀(72h) of 8.01 mg/L, the measures values are: E_rC₅₀(72h) = 4.81 mg/L and E_yC₅₀(72h) of 0.86 mg/L.

There is one study for CaCl₂ with fresh water algae, Selenastrum capricornutum, which was conducted according to OECD guideline 201. The 72-hour EC50 and EC20 obtained on the basis of biomass from the study were 2900 and 1000 mg/L, respectively. The 72-hour EC50 and EC20 obtained on the basis of growth rate were ≥ 4000 mg/l and 2700 mg/l respectively (INCHEM, 2002).

Acute toxicity to microorganism

According to Column 2, section 9.1.4. of Annex VIII od REACH Regulation the study does not need to be conducted as the target substance Ca(2Na)IDHA is found to be readily biodegradable.