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EC number: 944-574-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Fish
A key study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method 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 medium was prepared as a Water Accommodated Fraction (WAF).
In accordance with the recommendations of REACH, the test was conducted according to the threshold approach recommended by ECHA. Using this approach, the lowest EL50 from either the acute algal or daphnia study is set as the threshold loading rate and a limit test conducted at this threshold loading rate. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LL50 is greater than the threshold loading rate. As the EL50 in both the algal and Daphnia studies was > 100 mg/L loading rate WAF, the test was conducted at a single loading rate of 100 mg/L loading rate WAF to ensure that toxicity was not observed at this loading rate.
Seven fish were exposed to a WAF of the test item, at a single nominal loading rate of 100 mg/L for a period of 96 hours at a temperature of 14 to 15 °C under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.
Analysis of the 100 mg/L loading rate WAF test preparation at 0 and 72 hours (fresh media) showed measured concentrations of 0.636 and 0.251 mg/L respectively. Analysis at 24 and 96 hours (old media) showed measured concentrations of 0.912 and 0.429 mg/L respectively.
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. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.
Exposure of rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
Daphnia
A key study was performed to assess the acute toxicity of the test item to Daphnia magna. The method 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, 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 a Water Accommodated Fraction (WAF) of the test item at a nominal loading rate of 100 mg/L for 48 hours at a temperature of 21 °C under static test conditions. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours.
Analysis of the 100 mg/L loading rate WAF test preparations at 0 and 48 hours showed measured concentrations of 8.2 and 6.8 mg/L respectively.
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 EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect loading rate was 100 mg/L loading rate WAF.
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 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, a Water Accommodated Fraction (WAF) was prepared.
Following preliminary range-finding tests, Pseudokirchneriella subcapitata was exposed to Water Accommodated Fractions (WAFs) of the test item at a single 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 WAF at 0 hours showed a measured test concentration of less than the limit of quantification (LOQ), which was determined to be 0.11 mg/L for the analytical method employed. An increase in the measured test concentration to 2.2 mg/L was observed at 72 hours and this was considered to be due to the sufactant like nature 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 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.
Micro-organisms
A key study was performed to assess the effect of the 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 test concentration) for a period of 3 hours at a temperature of approximately 20°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 100 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 100 mg/L. The reference item gave a 3 -hour EC50 value of 7.0 mg/L, 95% confidence limits 5.3 - 9.2 mg/L
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