Reaction products of alkenes, oxidized, esterified with alkanol

Endpoint summary

Description of key information

Fish: Exposure of rainbow trout to an analogue 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 (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 (OECD 201 and EU Method C.3).

Microorganisms: The effect of an analogue test item on the respiration of activated sewage sludge microorganisms gave a 3-hour EC50 value of > 1000 mg/L. The Observed No Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L (OECD 209).

Additional information

Fish

A study was performed to assess the acute toxicity of an analogue 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, 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 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. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LL50 is greater than the loading threshold rate. Therefore, as the EL50 value obtained for both the algal growth inhibition study and the acute toxicity to Daphnia magna study were greater than 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 Water Accommodated Fraction (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 °C 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.

Chemical analysis of the freshly prepared test samples at 0 hours and of the expired media at 24 and 96 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method were obtained which was determined to be 0.51 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. Chemical analysis of the freshly prepared test sample at 72 hours showed a measured test concentration of 1.08 mg/L to be obtained. The duplicate sample was also analysed and showed a measured test concentration of 2.00 mg/L. This slightly higher than expected measured concentration was considered to be due to the presence of a small amount of undissolved test item. This was considered to have had no adverse effect on the outcome of the test given that no effects to exposure were observed. 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 loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.

Daphnia magna

A study was performed to assess the acute toxicity of an analogue 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 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 approximately 22°C under static test conditions. Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.

Chemical analysis of the fresh test preparation at 0 hours showed a measured test concentration of 1.72 mg/L. Chemical analysis of the aged test preparation at 48 hours showed a measured test concentration of 1.11 mg/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 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. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

Algae

A 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 preliminary rang-finding tests, Pseudokirchneriella subcapitata was exposed to a Water Accommodated Fractions (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 WAF at 0 hours showed a measured test concentration of 1.5 mg/L. A decline in measured test concentration was observed at 72 hours to 0.80 mg/L.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.

Inhibition of sewage sludge micro-organisms

A study was performed to assess the effect of an analogue test item on the respiration of activated sewage sludge. The method was designed to be compatible with 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 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 analogue test item on the respiration of activated sewage sludge gave a 3 -hour EC50 value of > 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 7.3 mg/L (95 % confidence limits 5.8 to 9.3 mg/L).