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Endpoint summary

Description of key information

Fish: 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 (OECD 203 and EU Method C.1).

 

Aquatic invertebrates: 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 (OECD 202 and EU Method C.2).

Algae: 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 (OECD 201 and EU Method C.3).

 

Microorganisms: 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.

Additional information

Fish

A key study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchusmykiss). 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 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 threshold loading 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 ºC under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 1, 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours. The test item was a complex mixture containing 42.2 % mineral oil. At the Sponsors request an additional vessel was prepared containing mineral oil at the same concentration as in the test item preparation; 42.2 mg/L.

 

Chemical analysis of the test preparations at 0, 24, 72 and 96 hours showed measured boron concentrations of less than the limit of quantification (LOQ) of the analytical method employed were obtained which was determined to be 0.025 mg/L (equivalent to 1.3 mg/L as test item). 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. Samples of the control, mineral oil control and the 100 mg/L loading rate WAF were taken at 0 and 72 hours (fresh media) and 24 and 96 hours (old media) for Total Organic Carbon (TOC) analysis. All results were determined to be less than the Limit of Quantification (LOQ) of the analytical method, determined to be 1.0 mg C/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 rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rateWAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was consideredunnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.

 

Daphnia magna

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 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 22 °C under static test conditions. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours.

 

Chemical analysis of the fresh test preparation at 0 hours showed that a measured concentration of 0.24 mg/L as boron was obtained (equivalent to 12 mg/L as test item). Chemical analysis of the aged test preparation at 48 hours showed that a measured concentration of 0.27 mg/L as boron was obtained (equivalent to 14 mg/L as test item). Samples of the control, mineral oil control and 100 mg/L loading rate WAF were taken at 0 (fresh media) and 48 hours (old media) for Total Organic Carbon (TOC)analysis. Given the low level of carbon in the test vessels, it was considered that all the results were around the limit of quantification of the analytical method. The dissolved test item may have been oneor several components of the test item. Given that the toxicity cannot be attributed to a singlecomponent 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. 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 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.

 

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. The test item was a complex mixture containing 42.2 % mineral oil. At the Sponsors request additional vessels were prepared containing mineral oil at the same concentration as in the test item preparation; 42.2 mg/L. 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 at 0 and 72 hours showed that measured concentrations of 0.30 and 0.33 mg/L as boron (equivalent to 16 and 17 mg/L as test item) were obtained respectively.

Total Organic Carbon (TOC) analysis of the test preparations was performed at 0 and 72 hours. Given the background level of carbon in the control vessels and also the low level of carbon in the test vessels, it was considered that the results were all around the Limit of Quantification (LOQ), determined to be 1.0 mg C/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. 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 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)".

An initial test was conducted however; the Sponsor requested that additional vessels to be included with the addition of a synthetic sewage as a respiratory substrate. Therefore, the test was repeated. 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 measured temperatures of between 20 and 21 ºC with the addition of a synthetic sewage as a respiratory substrate. The test item was a complex mixture containing 42% mineral oil. At the Sponsors request additional vessels were prepared containing mineral oil at the same concentrations as in the test item preparations; 4.2, 4.2 and 422 mg/L. 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 effect of the mineral oil on the respiration of activated sewage sludge gave a 3-Hour EC50 value of greater than 422 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 422 mg/L. The reference item gave a 3-Hour EC50 value of 8.8 mg/L, 95% confidence limits 6.9 to 11 mg/L.