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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Fish: Exposure of rainbow trout to an analogue test item gave LL50 values > 100 mg/L loadingrate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF (OECD 203 and EU Method C.1).

Aquatic invertebrates: Exposure of Daphnia magna to an analogue test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L (OECD 202 and EU Method C.2).

Algae: Exposure of Pseudokirchneriella subcapitata to an analogue test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF (OECD 201 and EU Method C.3).

 

Microorganisms: The effect of an analogue test item on the respiration of activated sewage sludge gave a 3-hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L (OECD 2909).

Additional information

Fish

A key study was performed to assess the acute toxicity of an analogue test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 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 item was prepared as a Water Accommodated Fraction (WAF). In accordance with the recommendations of REACH, the test was conducted according to the threshold approachrecommended by ECHA. Using this approach,the lowest EL50 value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold loading rate and a "Limit test" is conducted at this threshold loading rate.Ifno mortalities are observed this indicates that fish are not the most sensitive species and that theLL50 is greater than the threshold loading rate. Therefore, as the EL50 value obtained for both theAlgal Growth Inhibition study and the Acute Toxicity to Daphnia magna study were greater than 100 mg/L loading rate WAF, the testwas conducted at a single loading rate of 100 mg/L loading rate W AF to ensure that toxicity wasnot observed at this loading rate.Seven fish were exposed to a Water Accommodated Fraction (W AF) of the test item, at a singlenominal loading rate of 100 mg/L for a period of 96 hours at a temperature of 14 °C to 15 °C under semi-static test conditions. The number of mortalities and any sub-lethaleffects ofexposure in each test and control vessel were determined 3 and 6 hours after the start of exposureand then daily throughout the test until termination after 96 hours.

Chemical analysis of the 100 mg/L loading rate W AF test preparations at 0, 24, 72 and 96 hoursshowed measured test concentrations of less than the limit of quantification (LOQ) of theanalytical method employed were obtained,which was determined to be 0.068 mg/L. This doesnot infer that no test item was in solution, just that any dissolved test item was at a concentrationofless than the LOQ.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 rainbow trout to the test item gave LL50 values of greater than 100 mg/L loadingrate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.

Daphnia magna

A key study was performed to assess the acute toxicity of an analogue test item to Daphnia magna. Themethod followed was designed to be compatible with the OECD Guidelines for Testing ofChemicals (April 2004) No 202,"Daphnia sp., Acute Immobilisation Test" referenced asMethod 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 thetest, the test medium was prepared as a Water Accommodated Fraction (W AF). Following a preliminaryrange-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a WaterAccommodated Fraction (W AF) of the test item at a nominal loading rate of 100 mg/L for 48 hoursat a temperature of 21 to 22 °C under static test conditions. Immobilisation and any adversereactions to exposure were recorded after 24 and 48 hours.

 

Chemical analysis of the fresh test preparation at 0 hours showed the measured test concentrationto be 0.19 mg/L. Chemical analysis of the aged test preparation at 48 hours showed a measuredtest concentration of less than the limit of quantification (LOQ) of the analytical methodemployed was obtained which was determined to be 0.043 mg/L.The dissolved test item may have been one or several components of the test item. Given thatthe toxicity cannot be attributed to a single component or a mixture of components, but to thetest item as a whole, the results were based on nominal loading rates only.

 

Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loadingrate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

Algae

A key study was performed to assess the effect of an analogue 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 a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 100 mg/L (six replicate flasks) 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.

Analysis of the 100 mg/L loading rate W AF test preparations at 0 and 72 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method employed were obtained which was determined to be 0.19 mg/L. This does not infer that no test item was in solution, just that any dissolved test item was at a concentration of less than the LOQ. 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 greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.

Inhibition of sewage sludge micro-organisms

A key study was performed to assess the effect of an analogue test item on the respiration of activated sewage sludge. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2010) No. 209 "Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)".

 

Activated sewage sludge was exposed to an aqueous dispersion of the test item at concentrations of 10, 100 and 1000 mg/L (3 replicates of the 1000 mg/L concentration) for a period of 3 hours at a measured temperature of approximately 19 °C with the addition of a synthetic sewage as a respiratory substrate. The rate of respiration was determined after 3 hours contact time and compared to data for the control and a reference item, 3,5-dichlorophenol.

 

The effect of the test item on the respiration of activated sewage sludge gave a 3-hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L. The reference item gave a 3-Hour EC50 value of 6.4 mg/L, 95% confidence limits 4.7 to 8.7 mg/L.