Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Aquatic invertebrates: TheEL50 (48h) value was reported as 49 mg/L loading rate WAF (OECD 202 and EU Method C.2).

 

Algae: TheEL50 (72h)value was determined to be14 mg/L loading rate WAF based on growth rate. A NOEC (72h) value of 3.2 mg/L loading rate WAF was reported based on growth rate (OECD 201 and EU Method C.3).

Additional information

Aquatic invertebrates

 

A key study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.

 

Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF). Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 10,18, 32, 56 and 100 mg/L for 48 hours at a temperature of 21 °C to 22 °C under static test conditions. The number of immobilised daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.

 

Total Organic Carbon (TOC) analysis of the fresh test preparations at 0 hours showed measured concentrations to range from 2.8 to 30 mg C/L. Analysis of the aged test preparations at 48 hours showed measured concentrations to range from 2.6 to 30 mg C/L. The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.

 

Exposure of Daphnia magna to the test item gave an EL50 value of 49 mg/L loading rate WAF (confidence limits 42-58 mg/L loading rate WAF). The No Observed Effect Loading Rate was reported as 18 mg/L loading rate WAF and the Lowest Observed Effect Loading Rate (LOELR) was determined to be 32 mg/L.

Algae

 

A key study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) 761/2009.

Due to the low aqueous solubility and complex nature of the test item for the purposes of the test the test item was prepared as a Water Accommodated Fraction (WAF). Following preliminary range-finding tests, Pseudokirchneriella subcapitata was exposed to Water Accommodated Fractions (WAFs) of the test item at nominal loading rates of 1.0, 3.2, 10, 32 and 100 mg/L (three replicate flasks per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C. Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a Coulter Multisizer Particle Counter.

 

Total Organic Carbon (TOC) analysis of the test preparations performed at 0 and 72 hours showed measured concentrations of 3.0 to 18 mg C/L at 0 hours and 1.6 to 29 mg C/L at 72 hours. Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only. 

Exposure of Pseudokirchneriella subcapitata to the test item gave EL50 values of 14 mg/L loading rate WAF (confidence limits 11 to 18 mg/L loading rate WAF) based on growth rate and 4.2 mg/L loading rate WAF (confidence limits 3.6 to 4.9 mg/L loading rate WAF) based on yield. The No Observed Effect Loading Rate was 3.2 mg/L loading rate WAF based on growth rate and 1.0 mg/L loading rate WAF based on yield. The Lowest Observed Effect Loading Rate was 10 mg/L based on growth rate and 3.2 mg/L based on yield.